Orange Book Blog

At the intersection of Patent and FDA Law

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  • Rundown of recent Federal Circuit cases

    Since it has been a while since my last post, I’m going to do something a little different and do a quick run down of ten Federal Circuit cases that have issued in the past few months and highlight some key takeaways. I’ll give a quick bullet point review of the cases, with slightly more detailed explanation below.

    • Metacel Pharms. LLC v. Rubicon Research Private Ltd., No. 2023-2386, 2025 WL 1178384 (Fed. Cir. Apr. 23, 2025) – ANDA label suggesting storage at room temperature but permitting refrigerated storage did not induce infringement of claims to refrigerated storage
    • Azurity Pharms., Inc. v. Alkem Lab’ys Ltd., No. 2023-1977, 2025 WL 1036994 (Fed. Cir. Apr. 8, 2025) – Brand’s disclaimer of propylene glycol by addition of “consisting of” preamble in parent patent precluded finding of infringement
    • Janssen Pharms., Inc. v. Mylan Lab’ys Ltd., No. 23-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) – Label describing reinitiation protocol for schizophrenia drug induced infringement of claims to reinitiation process
    • Actavis Lab’ys FL, Inc. v. United States, 131 F.4th 1345, 1353 (Fed. Cir. 2025) – Generic Hatch-Waxman litigation expenses deductible as ordinary business expenses
    • Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 130 F.4th 1372 (Fed. Cir. 2025) – Claims reciting separate elements VEGF antagonist and buffer not likely to be infringed by product with self-buffering VEGF antagonist because of Becton presumption that separate elements are distinct components and intrinsic record supported, rather than rebutted, that presumption
    • Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 130 F.4th 1363 (Fed. Cir. 2025) – PTE statute applies to reissued patent that retained original claims based on regulatory delays following issue date of original patent
    • In re Xencor, Inc., 130 F.4th 1350 (Fed. Cir. 2025) – Claims to method of treating a patient with an antibody not patentable for lack of written description support for treating a patient portion of preamble
    • In re Strongbridge Dublin Ltd., No. 2023-2302, 2025 WL 751116 (Fed. Cir. Mar. 10, 2025) – Claims to a method of administering a drug without concomitant administration of other drugs did not require actively discouraging concomitant usage, but finding mere silence in prior art clinical report not substantial evidence of lack of concomitant use and remanding for further consideration
    • CQV Co. v. Merck Pat. GmbH, 130 F.4th 1344 (Fed. Cir. 2025) – Remanding where Board did not fully address evidence of prior art’s public availability
    • ImmunoGen, Inc. v. Stewart, 130 F.4th 1328 (Fed. Cir. 2025) – Affirming obviousness finding for claims to dosing regimen based on Adjusted Ideal Body Weight because ocular toxicity was a known problem for similar drugs, AIBW dosing regimens were known for avoiding ocular toxicity, and prior art taught dosing in similar amounts based on Total Body Weight 

    In Metacel Pharms. LLC v. Rubicon Research Private Ltd., No. 2023-2386, 2025 WL 1178384 (Fed. Cir. Apr. 23, 2025) the Federal Circuit affirmed a grant of summary judgment of non-infringement where the claims required storage at “at from about 2 to about 8°C” and the accused ANDA label instructed storage at room temperature and stated only that the product can be refrigerated and “can also be stored at 2°C to 8°C.”

    The Federal Circuit described this type of label as an “if/then” statement, i.e., “if a downstream user decides to refrigerate the product, despite instructions to store the product at room temperature (which is noninfringing), then it should store the product at temperatures from 2°C to 8°C” and held “[t]hat is not inducement.” The panel then held that “where, as here, a label is unambiguous, circumstantial evidence cannot override its plain language.” It nevertheless considered the circumstantial evidence but found it too did not create a genuine dispute of material fact. First, it held “Rubicon’s FDA submissions are not available to downstream users and therefore cannot cause inducement.” It then considered expert testimony that a doctor would turn to the brand label which would lead to infringement, but rejected that argument “because it relies on downstream users turning to Metacel’s own Ozobax label as evidence of Rubicon’s specific intent to induce” which was “not persuasive.” The case reaffirmed that the induced infringement standard for ANDAs focuses first and foremost on the label and that the mere probability that users might infringe is not sufficient, absent evidence of specific intent from the ANDA holder.

        

    In Azurity Pharms., Inc. v. Alkem Lab’ys Ltd., No. 2023-1977, 2025 WL 1036994 (Fed. Cir. Apr. 8, 2025) the court affirmed a finding following a bench trial that Alkem’s generic product could not infringe the patents because Azurity had disclaimed any use of propylene glycol during the prosecution.

    During prosecution of a parent patent, Azurity attempted to distinguish a prior art reference using negative limitations excluding propylene glycol as a carrier and eventually obtained claims using the transitional phrase “consisting of” and distinguishing the claims from that prior art reference arguing “the absence of propylene glycol in the claimed invention, in part, distinguish it from [the prior art]” which the Examiner cited as a basis for allowance. During the later application that became the asserted patent, and following receipt of Alkem’s Paragraph IV letter, the applicants stated “For the record, Applicant did not disclaim propylene glycol when submitting the arguments in U.S. 15/126059, and reserves the right to claim propylene glycol in the instant and future cases in this patent family.” However, the claims still used the “consisting of” preamble and did not list propylene glycol.

    Azurity argued that propylene glycol could be the claimed “flavoring agent” and thus was not excluded from the claims due to the closed “consisting of” language. The panel was not convinced, noting that the claims of the asserted patent were nearly identical to the claims of the parent patent, which Azurity had repeatedly argued excluded propylene glycol, and giving little attention to Azurity’s attempt to walk back the disclaimer. The panel noted that while Azurity had tried to narrowly exclude propylene glycol as a carrier, it had relented and used the closed “consisting of” language. Thus, the panel held that even if in the prior art propylene glycol functioned only as a carrier, “what matters most is the broad language that Azurity used to distinguish Palepu” and “[j]ust as the echo matches the shout, Azurity’s repeated, sweeping statements—endorsed by the examiner—return an equally sweeping disclaimer.”

    Finally, the panel agreed with the district court that a stipulated finding of fact that “Suitable flavoring agents include for use in the Asserted Claims include flavoring agents with or without propylene glycol.” The panel noted that the section began with a statement that Alkem “contends that it does not infringe the Asserted Claims due to the presence of propylene glycol in Alkem’s ANDA Products” and it would be nonsensical for Alkem to have framed the infringement dispute that way, but then stipulated to infringement. Among other factors, the panel agreed that in context, the “district court correctly concluded that the disputed stipulation did not preclude application of disclaimer in this case.”

    The case is a good reminder to prosecutors that broad disclaimers in a parent application can limit later claims and that later attempts to undo a disclaimer are unlikely to be effective. And while Alkem prevailed, the case is also a good reminder to be careful with pretrial statements of undisputed facts.

     

    In Janssen Pharms., Inc. v. Mylan Lab’ys Ltd., No. 23-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025), the court affirmed a DNJ decision finding Janssen had proven induced infringement of claims to treating patients with paliperidone palmitate (PP) who had missed a treatment and that Mylan had not demonstrated invalidity by clear and convincing evidence.

    PP, used to treat schizophrenia, comes in two forms, a form that lasts one month (PP1M) and a form that lasts three (PP3M). Janssen markets Invega Trinza, a PP3M. The asserted patent covers methods of reintroducing PP3M to patients who have missed a dose, by first administering PP1M. The label specifically instructs that if a patient has missed a dose, i.e., had his or her last dose between 4 and 9 months ago, “do NOT administer the next dose…[i]nstead, use the re-initiation regimen” recited in the claims.

    Mylan presented three non-infringement arguments: (1) Mylan cannot induce infringement because its label discourages missing doses in the first place; (2) Janssen failed to show infringement would inevitably occur; and (3) there was a divided infringement problem. The panel did not find any argument persuasive. On the first issue, the panel agreed with the district court that “the fact that Mylan’s proposed ANDA labels ‘discourage missed doses’ does not mean that the labels ‘discourage or make optional the practice of the asserted claims (or any claimed steps) in the inevitable situation that doses are missed.” On the second issue the panel found sufficient evidence that some users would inevitably miss doses and be reinitiation, including the testimony of Mylan’s own expert. On the third issue, the panel agreed with the district court that “Mylan’s divided infringement theory was not disclosed in its contentions, and appeared improperly for the first time in Mylan’s rebuttal expert report” and that in view of the “deferential review standard” the district court did not abuse its discretion in not considering it.

    Regarding invalidity, the panel found no clear error in the district court’s findings that “nothing in the prior art motivated a skilled artisan to use PP1M after a patient has been advanced to PP3M” and that even considering the prior art teaching of starting on PPM1M, there would have been no apparent reason to transition within the claimed 23rd-27th day where the art taught to stabilize a patient on PP1M for 17 weeks.

    What’s interesting to note with this decision is that it effectively allows Janssen to block an undisputed non-infringing use (regular treatment with PP3M) based on the reinitiation language of the label. Of course substantial non-infringing uses is relevant to contributory infringement, not induced infringement. It is unclear from the record whether Mylan could have carved out the reinitiation language, but it should be a warning to generics that induced infringement can be found even for instructions that do not go to the primary use.

     

    In Actavis Lab’ys FL, Inc. v. United States, 131 F.4th 1345, 1353 (Fed. Cir. 2025) the Federal Circuit agreed “with the trial court’s conclusion that Actavis may deduct its Hatch-Waxman litigation expenses as ordinary and necessary business expenses.” This was hardly a surprise, given the Third Circuit’s similar holding in Mylan Inc. v. Comm’r of Internal Revenue, 76 F.4th 230, 233-38 (3d Cir. 2023), but it’s an interesting read with a concise background of the Hatch-Waxman process. While the nuances of tax law are probably not our reader’s primary interests, the decision was interesting in that it rejected an argument that ANDA litigation was an expense occurred in obtaining capital, holding “the origin of the claim in Hatch-Waxman litigation is a patent claim brought by the NDA holder, and not the pursuit of effective FDA approval of an ANDA sought by the ANDA filer” because “the issues in the litigation and the issues in the regulatory approval process are different, and they are resolved by different decision-makers.” It similarly noted the “intangible asset sought by the ANDA filer is final, effective approval of the ANDA itself – and acquisition of that asset is not facilitated by Hatch-Waxman litigation.”

     

    In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 130 F.4th 1372 (Fed. Cir. 2025) the court affirmed a WDVA court’s denial of Regeneron’s motion for preliminary injunction, finding the trial court correctly held that the separate listing of “VEGF antagonist” and “buffer” required two separate components and could not read on a self-buffering antagonist.

    I wrote about the district court’s decision back in October and was unsurprised to see an affirmance based on the Becton line of cases holding that “where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.”

    The panel first rejected Regeneron’s argument that Becton did not apply because the district court had previously construed “buffer” to cover proteins like aflibercept (the alleged VEGF antagonist), stating that Regeneron “conflates two independent claim construction inquiries” because “claim construction inquiry relevant here, under Becton, is directed to whether a formulation is claimed in a way that clearly implies it requires distinct components” not simply whether the scope of “buffer” and “VEGF antagonist” can overlap.

    Applying the Becton presumption, the panel agreed with the district court that not only did the intrinsic evidence overcome the implication, but that the claims and specification “only reinforce that the claimed components are distinct.” It agreed that all of the claims treat VEGF antagonist as separate from the buffer component, for example reciting their concentrations in different units, and the “the specification describes a formulation containing a VEGF antagonist plus a distinct buffer component” including a separate buffer in all eight examples. The panel noted that “Regeneron’s avoidance of the specification’s disclosures, or lack thereof, is telling and is an apparent concession” the specification did not help. Instead, Regeneron primarily argued that the plain meaning of buffer was broad enough to cover a aflibercept and Regeneron had not disavowed the full scope. But the panel found this unconvincing in light of Becton and the fact that the patent nowhere suggested a VEGF antagonist buffer was a part of the invention.

    The panel also agreed with the district court that it need not even address the extrinsic evidence, but that it in any case it did not err in considering and discounting that evidence finding that it was reasonable for the district court to conclude that a contemporaneous reference’s teaching of buffer-free formulations “actually supports Amgen’s contention that self-buffering proteins were not well known” and that the contemporaneous art “advanced the art over the ’865 patent precisely by disclosing certain buffer-free formulations in which the therapeutic protein is itself capable of maintaining pH stability.”

    While the panel (and district court) seemed unequivocal that infringement could not be found, it didn’t need to go that far, concluding “there is at least a substantial question of noninfringement” and thus Regeneron was not entitled to a preliminary injunction. I expect Amgen to prevail on motion for summary judgment on remand shortly.

    In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 130 F.4th 1363 (Fed. Cir. 2025) the court affirmed a DNJ district court’s conclusion that a reissued patent was entitled to a five-year patent term extension and had not expired.

    Merck’s 340 patent issued on December 30, 2003, directed to cyclodextrin derivatives. Four months later, Merck applied for approval of sugammadex, the active ingredient in BRIDION®. During the pendency of FDA review, Merck filed for a reissue, retaining the original claims but also adding narrower claims to cover sugammadex specifically. BRIDION® was approved in 2015, and Merck successfully filed for PTE seeking the five year maximum, extending expiration of the patent from 2021 to 2026.

    The generic defendants argued that the plain language of the PTE statute (35 U.S.C. § 156) only allows for an extension of “the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued” and that “the patent is issued” should mean the reissue date of the patent, dramatically cutting the length of the extension.

    The panel first found that the statute was ambiguous as to which issue date the statute refers to. It then turned to the context of the PTE statute which it stated was clear: “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.” It sided with Merck, holding that such a construction “compensates Merck for the period of exclusivity lost due to regulatory delay” while the defendants’ reading “denies Merck compensation for all but a small period of the delay” and “[t]here is no reason why the Hatch-Waxman Act’s purpose would be served by disabling extensions of the unexpired term solely based on a patent holder’s decision to seek reissue.” It will be interesting to see if future cases apply Merck as a per se rule, or confine it to the facts of this case where the reissue patent contained the same original claims. For example, would the same result hold if Merck had cancelled its broader original claims and replaced them with all new narrower claims? Perhaps we’ll find out soon.

    In In re Xencor, Inc., 130 F.4th 1350 (Fed. Cir. 2025), the court affirmed a PTAB Appeals Review Panel decision refusing to grant a claim to a method of “treating a patient by administering an anti-C5 antibody” and a similar Jepson claim as lacking written description support.

    The panel first construed the claims and agreed with the PTAB that the “treating a patient” language in the preamble was limiting, because (1) the second part of the preamble, “administering an anti-C5 antibody” was limiting and it would not “splice” the clause into limiting and non-limiting portions; (2) “the more reasonable reading is that both sections of the preamble… give color and meaning to the other”; and (3) “the language in the preamble provides a raison d’être for the claim” and the claim would otherwise be a mere “academic exercise.”

    Then panel then found substantial evidence supported the PTAB’s determination that the specification lacked written description support for treating a patient because it “does not define the term ‘treating,’ and it does not describe or provide any data associated with treating any patient with any disease or condition with any anti-C5 antibody, including an anti-C5 antibody with the claimed Fc modifications.”

    The panel also agreed that the preamble of a Jepson claim requires written description support, otherwise a patent could evade the written description requirement, using the hypothetical that a “patentee cannot obtain a Jepson claim with a preamble that says that a time machine is well-known in the art without describing a time machine, in sufficient detail to make clear to a person of ordinary skill in the art that the inventor is in possession of such a time machine.” It then found that substantial evidence supported the Board’s conclusion that anti-C5 antibodies were not well known in the art.

    The decision highlights the importance of language in the preamble and the need to not allow patentees to overreach in claiming. Interestingly, the decision focuses heavily on the “treating a patient” language, begging the question of whether the claim would have been allowed if it simply recited “administering anti-C5 antibodies” without any identified purpose of administration, let alone test results. Perhaps it would have led to a utility/enablement problem. See In re ‘318 Pat. Infringement Litig., 583 F.3d 1317, 1327 (Fed. Cir. 2009) (claims to treating Alzheimer’s lacked enablement where no test results of any kind because “at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient”). It’s interesting to me the panel did even mention whether such claims might have been patentable.

     

    In In re Strongbridge Dublin Ltd., No. 2023-2302, 2025 WL 751116 (Fed. Cir. Mar. 10, 2025) the court confirmed that a method of administering a drug without “concomitant” drugs did not require actively discouraging use of the concomitant drugs, but only that a single patient not be given the concomitant drugs, but remanded for the Board to determine whether a POSA would have understood a clinical study not mentioning the concomitant drugs to have meant one or more patients was not taking such drugs.

    The panel first construed the term “avoiding concomitant administration” and held that it did not require actively encouraging patients to avoid such drugs, because the “plain and ordinary meaning of ‘avoid’ is [] consistent with claim coverage in situations in which patients are simply not taking famotidine or methotrexate while they are taking dichlorphenamide” noting that by “way of example, a person who drives one route home from work avoids or keeps away from a traffic jam that takes place on an alternative route home even if that person does not take the active step of deciding to avoid that traffic jam.” The panel further noted that the applicants had originally sought claims with more active language and thus was not attempting “to rewrite the claims to confine them to the very claims it cancelled.”

    Interestingly, the panel then turned to the Board’s finding of anticipation by a reference (Sansone) that disclosed the treatment method claimed, but did not mention the concomitant drugs, but held that there was not substantial evidence that the reference taught the method without the use of those drugs. It held that the “correct anticipation inquiry in this case is whether the examiner established on a preponderance of evidence that only one patient in Sansone was not taking” the concomitant drugs.

    It then held that the Board’s findings that (1) Sansone does not mention the concomitant drugs and (2) the patient classes in Sansone are unrelated to the patient classes who take the concomitant drugs “are relevant but not substantial evidence in and of themselves” because “[t]here must be something more to suggest that the silence is significant, or other reasons that establish by a preponderance of the evidence that it is likely that one or more of the patients in Sansone were not taking famotidine or methotrexate at some time during the nine week and/or fifty-two-week length of the study.” “This could include, for example, proof from the structure of the study, the results of the study, or statistical analysis as to the likelihood that at least one patient was not taking famotidine or methotrexate.” I’m a bit surprised by this holding, as it seems to require the Examiner/Board to obtain expert testimony analyzing the Sansone reference or performing statistical analysis. It seems clear to me at least, that there is sufficient evidence for one to infer that a study would have mentioned concomitant administration of other drugs and their absence is at least prima facie evidence, sufficient to shift the burden to patentee. Otherwise, this seems to make it extremely difficult for examiners to ever reject claims with such negative limitations. Perhaps the Examiner/Board could have evaded such a problem by issuing an obviousness rejection in the alternative. It will be interesting to see how it handles the case on remand.

     

    In CQV Co. v. Merck Pat. GmbH, 130 F.4th 1344 (Fed. Cir. 2025) the court remanded a final written decision finding claims not unpatentable because the Board failed to address all of the evidence showing a sample batch was prior art.

    The court first addressed Merck’s argument that CQV lacked standing to appeal, but held that “[g]iven at least one customer’s purchase and use of Adamas® products in the United States, Merck’s communications with that customer [asserting infringement], and CQV’s indemnity agreement with that customer, CQV has established that it has standing to pursue this appeal.”

    The court then addressed CQV’s arguments on the merits and found them persuasive. The Board considered three pieces of evidence that demonstrated that “Sample C” was publicly available: (1) “general statements about the availability of the Xirallic® product line that were not linked to Sample C”; (2) fact testimony that “CVQ purchased Sample C in about October 2011”; and (3) evidence that “Merck manufactured Sample C in 2007 and is incentivized to sell a batch as soon as possible so as not to waste shelf-life.” However, the Board did not address other evidence, such as testimony that after being released from quality control, a customer can purchase product. The panel stated that “CQV raised highly material and unrebutted evidence that Sample C would have been made available to the public within a few weeks of being placed into quality control, which the Board discarded without explanation.”

    While noting that “failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it,” (quoting Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017)) the panel held that the Board’s decision “goes beyond a failure to discuss a ‘cursory argument’” and the panel “cannot reasonably discern whether the Board followed a proper path.” Thus, it remanded the case for further fact finding. Interestingly, the panel did not address whether substantial evidence would have supported the Board’s determination.

    I expect this decision to be cited often in appeals from IPR decisions whenever a party perceives that the Board did not fully address all arguments. It will be interesting to see how future panels strike a balance between the holding here and the holding in Novartis.

     

    In ImmunoGen, Inc. v. Stewart, 130 F.4th 1328 (Fed. Cir. 2025), the court affirmed the district court’s agreement with the PTAB/examiner’s rejection of claims to dosing regimens of a drug for treating ovarian and peritoneal cancer.

    The panel first addressed ImmunoGen’s arguments that because the claimed drug was not known to cause ocular toxicity, such concerns could not have motivated a POSA to modify the prior art, but rejecting it noting that while “[w]here a problem was not known in the art, the solution to that problem may not be obvious,” (quoting Forest Lab’ys, LLC v. Sigmapharm Lab’ys, LLC, 918 F.3d 928, 935 (Fed. Cir. 2019),  “it does not follow that a claimed solution to an unknown problem is necessarily non-obvious.” The panel then found no clear error in the district court’s “findings that a person of ordinary skill in the art, despite not knowing of IMGN853’s ocular toxicity, would have nonetheless been motivated to monitor for those side effects when administering the drug to humans” because ocular toxicity was a “well-known adverse event in the administration” of related compounds.

    It then addressed ImmunoGen’s arguments that a POSA would not have been motivated to try a “AIBW” dosing regimen, but again found no clear error in the court’s findings that such a regimen “would have been within the range of knowledge of a person of ordinary skill in the art when confronted with dosing-induced toxicities, and particularly when confronted with dosing-induced ocular toxicity” because “AIBW dosing was a well-known methodology that had been implemented on drugs both smaller and larger than IMGN853 and had been used to specifically reduce ocular toxicity.”

    Then panel then addressed whether a POSA would have been motivated to select the claimed dose of 6 mg/kg AIBW (AIBW “refers to a size descriptor that accounts for sex, total body weight, and height” and is a modification of total body weight or TBW). The panel then noted that two prior art references taught dosing of the drug at 6 mg/kg of TBW and 5 mg/kg TBW, and agreed with the district court that a POSA “would start with doses of around 5 mg/kg or 6 mg/kg AIBW and then determine the precise dose based on routine optimization.” Indeed, the panel noted that evidence showed that “for patients who weigh exactly their ideal body weight, a dose of 6 mg/kg AIBW is identical to a dose of 6 mg/kg TBW,” and thus for some patients the prior art explicitly taught the claimed dosing amount.

    Finally, the panel rejected ImmunoGen’s argument that the district court failed to find a reasonable expectation of success “that a 6 mg /kg AIBW dose would solve ocular toxicity” because the “claims are silent as to any ocular toxicity problem.”

    The case is a good reminder of the flexibility of the obviousness inquiry and the difficulty on appeal of attacking motivation to combine factual findings.

  • Federal Circuit confirms no collateral estoppel from PTAB findings in District Court

    I wrote previously about oral argument in the Kroy v. Groupon case, where the Federal Circuit grappled with how to apply collateral estoppel from PTAB decisions in IPRs and PGRs where related unchallenged claims from the same patent are at issue in district court. As I wrote then, the appellant presented an interesting argument that the clear and convincing evidence standard should not apply since the patent office has revisited the patentability determination of related claims.

    The Federal Circuit finally issued its opinion, and confirmed its view that collateral estoppel simply does not apply due to the different evidentiary standards. Unfortunately, the Federal Circuit dodged the appellant's strongest argument. This argument may not have been fully developed in the briefing (which took place before the Federal Circuit's previous opinion reaching a similar conclusion in Parkervision), but I am a bit surprised that the panel did not address it, especially given the length of time it took for the opinion to issue. 

    But the takeaways are clear—an accused infringer must challenge all patents in the patent office to take advantage of any collateral estoppel effects of a final written decision. Thus, defendants in district court litigation should be prepared to challenge every claim of any asserted patent within the one year time bar.

    Not only will the defendant not be able to argue for collateral estoppel, the defendant likely will not be able to raise the IPR to a jury at all. See, e.g., Prolitec Inc. v. ScentAir Techs., LLC, No. CV 20-984-WCB, 2024 WL 341342, at *1 (D. Del. Jan. 30, 2024) (Bryson, J., sitting by designation) ("The invalidity of the unasserted claims is irrelevant to the issues in this case. And any effort to mitigate the risk of prejudice to Prolitec from disclosing that those claims have been held invalid would require excessive digression into the nature of inter partes review proceedings and the different standard of proof applied to invalidity inquires in inter partes review proceedings, as compared to district court proceedings. Accordingly, the jury will not be told that those claims have been held invalid."); Medtronic, Inc. v. Axonics Modulation Techs., Inc., No. 8:19-CV-02115-DOC-JDE, 2024 WL 3550482, at *5 (C.D. Cal. July 18, 2024) ("any probative value of discussion of the PTAB's invalidation of other claims of the patents-in-suit would be substantially outweighed by the dangers of unfair prejudice, jury confusion, and waste of time").

  • Almost Heaven for Regeneron: Federal Circuit Upholds Injunction Against Foreign Companies Sued in West Virginia for Proposed EYLEA® Biosimilar

    By: Rocco Screnci

    In today’s blog, we are straying from our Orange Book roots to discuss the Federal Circuit's recent decision in Regeneron Pharmaceuticals v. Mylan Pharmaceuticals, a case arising under the BPCIA. Regeneron owns several patents covering its EYLEA® product. EYLEA® contains the protein aflibercept, a VEGF antagonist, and is used to treat various conditions that affect the eyes. Several companies filed abbreviated Biologics License Applications (aBLAs) seeking approval for EYLEA® biosimilars. Regeneron then sued four of these aBLA filers in West Virginia and secured a preliminary injunction against them.

    On appeal, one of the defendants—Samsung Bioepis—argued that the preliminary injunction should be reversed on the merits and because the district court in West Virginia could not exercise personal jurisdiction over Samsung because Samsung was “at home” in Korea and lacked adequate suit-related conduct in West Virginia to establish the requisite “minimum contacts” there. The court, however, disagreed with Samsung and affirmed. And while the decision includes some interesting obviousness-type double-patenting analysis, perhaps the most interesting part of the Federal Circuit’s opinion is the part that addresses personal jurisdiction. To this end, the court held that, under its decision in Acorda Therapeutics v. Mylan Pharmaceuticals, 817 F.3d 755 (Fed. Cir. 2016), personal jurisdiction in West Virginia was appropriate because Samsung’s proposed bioequivalent product will be sold throughout the U.S., including West Virginia, albeit through a distributor. Regeneron, slip op. at 13.

    By way of background, Acorda addressed whether an ANDA filer could be sued under the Hatch-Waxman Act in Delaware even though it was “at home” for personal jurisdiction purpose in another state, prepared the ANDA in that other state, and filed the ANDA at the FDA’s Maryland office. The court said, “Yes.” While the Due Process Clause requires a defendant to have adequate “minimum contacts” with a forum before it can be sued there, the Acorda court held that those contacts could be established through reliable, non-speculative evidence about conduct that will take place should the defendant’s ANDA be approved. Acorda, 817 F.3d at 762. Or as the court put it: “[I]t suffices for Delaware to meet the minimum-contacts requirement in the present cases that Mylan’s [ANDA] filings and its distribution channels establish that Mylan plans to market its proposed drugs in Delaware and the lawsuit is about patent constraints on such in-State marketing.” Id. at 762-63. Through that lens, Regeneron seems like a natural application of Acorda in the BPCIA context. But that lens glosses over some key factual differences between the two cases.

    For starters, the Acorda defendant and Samsung have very different relationships with their respective forum states. In Acorda, the defendant was “registered to do business and appointed an agent to accept service in Delaware,” and registered with the Delaware Board of Pharmacy as a licensed “Pharmacy-Wholesale” and a “Distributor/Manufacturer CSR.” Acorda, 817 F.3d at 758, 763.  Indeed, it even sent the Paragraph IV notice letter to the plaintiff’s U.S. subsidiary’s headquarters in Delaware. Samsung, by contrast, has no facilities in West Virginia, no employees there, has not registered to do business with the West Virginia Secretary of state, does not have a registered agent for accepting service in West Virginia, and has no current or planned business with companies in West Virginia.

    Second, and perhaps more importantly, evidence showed that the Acorda defendant had, unlike Samsung with West Virginia, taken concrete, affirmative steps to exploit the Delaware market. More specifically, the Acorda defendant had established “a network of independent wholesalers and distributors with which it contracts to market the drugs in Delaware.” Acorda, 817 F.3d at 763. But Samsung has no such network. Indeed, the sole basis for finding personal jurisdiction in West Virginia over Samsung was that Samsung had contracted with Biogen for nationwide distribution rights for the biosimilar and that Samsung “has not sought to limit the States where SB15 will be marketed, distributed, or sold.” Regeneron, slip op. at 14 (emphasis added). And while it was unclear exactly how much control Samsung would have over Biogen’s distribution and sales of the prospective biosimilar product, see generally id. at 13-14, the court outright rejected the argument that it made a difference whether Samsung used a third-party distributor or did its own distribution based on the language in Acorda about the defendant’s Delaware distribution network. See slip op. at 15.

    But the factual differences between Acorda and Regeneron are quite significant ones for personal jurisdiction. The typical rule is that the defendant must purposefully direct conduct to the forum state for that conduct to count in the “minimum contacts” analysis.  Acorda, as I understood the decision until recently, adhered to that rule by focusing on concrete steps that the defendant had taken to exploit the Delaware market with its proposed ANDA product. Regeneron, on the other hand, focuses not on any purposeful conduct directed at West Virginia, but on the absence of any disclaimer of future conduct directed there. This seemingly turns decades of jurisprudence on its head. In effect, Regeneron holds that prospective biosimilar (or generic) manufacturers have purposefully availed themselves to states that they may never actually do business in for a drug that may never launch simply because they have chosen not to narrow their distribution plans a priori. The upshot is that, absent a carve out, a nationwide distribution agreement may subject the companies to personal jurisdiction in every judicial district in every state.

    In sum, Regeneron seems to drastically expand the scope of personal jurisdiction, particularly for foreign-based prospective defendants who have few ties to the United States. This may have huge consequences for generic and biosimilar manufacturers who hope to avoid litigating in certain forums, so it will be interesting to see how Regeneron influences companies’ pre-approval, pre-commercialization conduct.

  • Federal Circuit affirms that inhaler patents cannot be listed in Orange Book

    The Federal Circuit today affirmed the D.N.J. decision that Teva's inhaler patents cannot be listed in the Orange Book, because they do not claim the drug for which the application was listed. 

    As I wrote in my last post below, I thought Teva would have a hard time prevailing given that the patents at issue did not even claim an active ingredient, let alone any specific active ingredient. The Federal Circuit panel agreed, focusing on this absence.

    For example, in its discussion of the patents, it noted "None of the claims in the five asserted patents explicitly require the presence of an active drug, let alone any specific active drug." Interestingly, the panel ruled entirely based on the first clause, requiring that the patent to "claims the drug" and not the more specific requirement that the patent “is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent.” 21 U.S.C. § 355(b)(1)(A)(viii). Specifically, the panel held that "claims a drug" means "when it particularly points out and distinctly claims the drug—not simply when the claim could somehow be interpreted to read on the drug." It then rejected Teva's argument that the definition of drug controlled, focusing instead on the entirety of the FDA regulatory scheme. The panel noted that while Teva's product may be a drug, the inhaler alone (without an active ingredient) would be a device, not a drug, and it is only the active ingredient that makes the product a drug. Thus, "to claim that drug, the patent must claim at least the active ingredient."

    The Court then addressed a question I raised in my previous post—how specific must one claim the active ingredient to "claim a drug." Teva argued that the claims, though not explicitly reciting an active ingredient, should be construed to require one. The panel found this argument "dubious" but held even a "claim requiring the presence of 'an active drug' is far too broad to particularly point out and distinctly claim the drug approved in Teva’s NDA." The panel left open the question of what would be sufficient (e.g. claiming albuterol generally? A class that includes albuterol?).

    The clear message to patent drafters is that to be listable, a claim must be as specific as possible in claiming the active ingredient approved.

  • Federal Circuit grapples with scope of Orange Book listings

    As readers of this blog surely known, parties seeking to launch a generic drug must address the patents listed in the Orange Book for the reference listed drug. Listing of a patent in the Orange Book is a powerful tool for pharmaceutical patent owners, as it gives the right to an automatic 30 month stay against generic competition without meeting the stringent requirements for a preliminary injunction (an "extraordinary remedy"). Moreover, unlike a typical preliminary injunction which requires the patentee to post a bond allowing the enjoined party to seek compensation for its losses during the enjoined period if the patent is determined to be invalid or not infringed, there is no effective recourse for lost sales of a generic during during the automatic 30-month stay (at least that I am aware of).

    Understandably then, much attention has been given to what patents may be listed in the Orange Book. The senate passed the Orange Book Transparency Act of 2020 (unanimously!), which in part sought to clarify the scope of patents that could be listed in the Orange Book, limiting them to “claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent” or "claims a method of using such drug for which approval is sought or has been granted in the application." 21 U.S.C. § 355(b)(1)(A)(viii)(I). The OBTA replaced language that allowed listing of "any patent which claims the drug for which the applicant submitted the application" which was introduced in response to a concern that companies may be “submitting patents potentially for the purpose of blocking generic competition.” H.R. Rep. No. 116-47 at 4 (2019).

    In Teva et al. v. Amneal et al., Teva sued Amneal for filing an ANDA to a generic version of ProAir HFA, which Teva describes as being regulated “single-entity combination products,” meaning a drug and a device “combined or mixed and produced as a single entity, asserting claims reciting the inhaler portion (but as best I can tell, not claiming even a genus of the active ingredient). Amneal counterclaimed for an injunction requiring Teva to delist the patents. The district court granted Amneal's motion for judgment on the pleadings and ordered delisting. Teva appealed, and the Federal Circuit recently heard oral argument. See https://oralarguments.cafc.uscourts.gov/default.aspx?fl=24-1936_11082024.mp3. 

    On appeal, Teva focused on the definition of "drug" in the FDCA, which it argued broadly covers "not just the active ingredient, but the entirety—specifically including any 'component'—of any article' used for the 'treatment' or prevention of disease' or to 'affect … any function of the body,' for example." Citing 21 U.S.C. § 321(g)(1). Thus, Teva argued a patent need not "recite the active ingredient by name in order to claim the drug" because "a patent claiming a genus of compounds reads on a drug whose active ingredient is one species within the genus." Teva thus argued that "the scope of what a patent 'claims' must be determined through an infringement-type analysis," i.e., that if the claims would cover the drug product, they claim the drug product. 

    Amneal defended the district court's judgment, arguing that to qualify for listing, a "drug product" patent "must satisfy three criteria": (1) a claim of infringement can be reasonably asserted (citing 21 U.S.C. § 355(b)(1)(A)(viii)); (2) the patent is a “drug product” patent, i.e., claims a drug product (citing 21 U.S.C. § 355(b)(1)(A)(viii)(I)) and (3) “claims the drug for which the applicant submitted the application.” (again citing 21 U.S.C. § 355(b)(1)(A)(viii)(I)). Amneal argued that the "second and third requirements work in tandem to require a drug product patent to claim not just any 'drug product,' but the specific NDA 'drug product,' as that term is defined by the FDA" which requires the drug product to "contain a drug substance" or "active ingredient." Citing 21 C.F.R. § 314.3. Amneal argued that Teva's argument would render the "claims the drug" requirement superfluous, and that the statute cannot be read to treat a device as if it is a drug.

    The briefing of both parties is heavy on statutory and regulatory citations which I have not exhaustively reviewed, but the Federal Circuit panel seemed to struggle with a more simple issue – what does it mean to claim a "drug product." The panel used the hypothetical of a steering wheel and a car. Does a claim to a steering wheel cover a car? the panel asked. According to Teva, the answer was yes, a claim to a steering wheel claims a Ford Bronco. Judge Taranto seemed skeptical, saying "nobody, nobody, would think that if I have a patent, which I claim as my invention the steering wheel, that I'm claiming the car that it is in." But Teva responded that if the claim recited a "car comprising a steering wheel" it would claim a car. Judges Taranto and Prost seemed skeptical. Teva argued that Amneal's construction would require a claim to cover every component of a drug product to claim the drug product and would threaten listings for inactive ingredient and genus claims.

    The panel seemed more interested in this concern, and asked Amneal to address it. Amneal argued that Teva can still assert the inhaler patents, they simply don't get the "superpower" effect of Orange Book listing given under the statute. Amneal argued that if the statute allowed Orange Book listing for any patent that "claims a drug" then Teva would win, but the statute does not. 

    Like the panel, I am skeptical of Teva's position broadly that any claim to any component of a drug product is sufficient, regardless of whether it claims the specific drug substance. Surely a claim to an excipient used in the NDA product does not "claim" the drug product, even though it would read on the product. But Teva's argument about genus claims is a bit more interesting. For example, the active ingredient in the drug product is albuterol sulfate, a class of bronchodilators. It seems clear a claim to an "inhaler comprising albuterol sulfate" would claim the "drug product" (even though it doesn't claim every single component or excipient). Presumably too, a claim to an "inhaler comprising albuterol" would suffice. But would a claim to "an inhaler comprising a bronchodilator"? How broad can the genus be and still claim the "drug product"? Would "an inhaler comprising a drug substance" be sufficient? 

    While Teva argued that Amneal's construction would exclude claims to genuses, it didn't appear to make any argument that any of its claims included a limitation to a genus (and the claim it identified on the front cover of its brief does not claim any genus of active ingredients). I am thus skeptical the Court will need to grapple with this line drawing or that Teva will prevail on a genus argument. 

    An interesting issue is what tools to generics have to combat improper Orange Book listings? While Amneal was apparently able to get a relatively rapid ruling from the district court, Teva still obtained roughly a quarter of the 30 month automatic stay. It will be interesting to see if Congress attempts to make any sort of recourse available for generics who are found to be improperly stayed. Or will courts consider this a ground for awarding attorneys fees? Time will tell.

  • Astellas v. Sandoz – Post-Remand Procedural Issues Following At-Risk Launch

        By: Rocco Screnci

    Ben recently covered Astellas Pharma, Inc. v. Sandoz Inc., in which the Federal Circuit vacated a district court decision for violating the principle of party presentation. 117 F.4th 1371 (Fed. Cir. 2024). Today’s post focuses on some interesting procedural issues that have since developed on remand.

    By way of background, the district court in Astellas found the patent-in-suit invalid under § 101 even though the defendants’ invalidity contentions nowhere raised a § 101 defense and the parties had stipulated to trying only infringement and § 112 invalidity. The Federal Circuit thus vacated and ordered a limited remand to address those issues. But while the appeal was pending, the FDA approved the ANDAs, meaning that the generic manufacturers could launch their competing sustained-release mirabegron tablets. As a result, on remand, Astellas sought to amend its complaint to demand a jury trial and to supplement with infringement claims under 35 §§ 271(a)-(c) based on the generic manufacturers’ post-FDA-approval conduct. The district court, however, denied Astellas’s motion.

    As to the infringement claims for the post-approval activities, the district court found that allowing amendment would be “counterproductive to a just, speedy, and inexpensive” disposition. This is because pivoting to a traditional infringement theory would require the parties to conduct additional discovery, address infringement based on the actual products (rather than the ANDA submissions), and assess damages. The district court also reasoned that letting Astellas raise a new infringement theory would contradict the Federal Circuit’s decision, which contemplated a limited remand to decide only the issues “properly raised and adequately supported by the record.” See 117 F.4th at 1379.

    As for the jury demand, the court declined to exercise its discretion to empanel a jury to try the ANDA issues for two main reasons. First, the district court explained that Astellas had no Seventh Amendment right to a jury for the ANDA issues because Astellas’s original complaint only sought declaratory and injunctive relief. Second, the district court found that Astellas had waived any jury-trial right on the ANDA issues when it proceeded to a bench trial without objection. According to the court, Astellas made a strategic decision by proceeding with the Hatch-Waxman route—which gave Astellas the chance at an injunction blocking generic entry—rather than letting a claim for damages ripen and thereby suffering real-world economic harm. To this, the court added that the Seventh Amendment does not give litigants “a second bite at the apple” simply because they regret choosing the bench-trial route after an adverse ruling. Slip. op. at 10. That all said, the district court explained that Astellas could still pursue post-launch infringement claims against the generic manufacturers in a separate action. And as the district court emphasized, nothing in its decision would prevent the parties from demanding a jury should Astellas bring those post-launch claims.

    Likely unsatisfied with this outcome, Astellas has since urged the court to amend the scheduling order to postpone the trial date and let it present the post-launch evidence to a jury. But unlike the previously denied proposed amended and supplemental complaint, which added infringement claims under §§ 271(a)-(c) that were not ripe at the onset of the case, Astellas’s request to amend the scheduling order premises its request on its prayer for relief in the original complaint under § 271(e)(4)(C). That provision lets a court award “damages or other monetary relief” for infringement under § 271(e)(2) “only if there has been commercial manufacture, use, offer to sell, or sale . . . of an approved drug.” See 35 U.S.C. § 271(e)(4)(C). This framing is seemingly intended to undermine the district court’s stated justification for denying the motion to supplement—that Astellas chose the ANDA route as “a matter of strategy” rather than wait for the more conventional infringement claims to ripen. At the same time, however, the rest of Astellas’s motion echoes the arguments the court rejecting in denying leave to supplement the original complaint and to add a jury demand.

    Even so, it seems like Astellas’s recent motion paid off. In response to that motion, the court issued a brief order instructing the parties to submit briefs on how they believe the case should progress, with particular attention to their positions on supplementing the record, bifurcating trial, and conducting a jury trial on damages under § 271(e)(4)(C). It thus appears that the court is somewhat inclined to side with Astellas on supplementation, as the court likely would have denied the motion for the same reasons it denied Astellas leave to amend and supplement its complaint.

    But perhaps the most fascinating issue implicated by the court’s order is whether Astellas is entitled to a jury trial because it now seeks monetary relief for infringement. This issue is particularly interesting because caselaw interpreting § 271(e)(4)(C) is scant. And while courts so far have assumed that damages under § 271(e)(4)(C) are no different from those awarded under § 284 for more conventional forms of infringement and thus require a jury trial, others have made compelling arguments that the statutory text mandates that the two damages provisions be treated differently. Robert A. Matthews, 2 Annotated Patent Digest § 10:172.100; Brian D. Coggio & Sandra A. Bresnick, The Right to A Jury Trial in Actions Under the Hatch-Waxman Act, 79 J. Pat. & Trademark Office Soc’y 765, 771-72 (1997). Relevant to Astellas’s recent motion, some have argued that the relief available under § 271(e)(4)(C), though monetary, is equitable because the statute commits the decision to award damages to the court’s discretion. See Coggio & Bresnick, supra, at 777-780.  By contrast, § 284 requires damages be awarded for infringement under §§ 271(a)-(c), and contemplates that a jury—not the court—will usually be responsible for calculating those damages.

    I, for one, am uncertain about the right answer to whether as a matter of first principles relief for at-risk launches ought to go to a jury or the bench. It seems logical and consistent with Hatch-Waxman that Congress intended judges, not juries, to decide all issues relating to an infringement claim brought under § 271(e)(2) and craft the relief accordingly. Indeed, the Supreme Court has emphasized how an action under § 271(e)(2) and the accompanying remedies under § 271(e)(4) are “artificial” and intended to “enable the judicial adjudication” of ANDAs. Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990) (emphasis added).  I also tend to agree that the differences between § 271(e)(4) and § 284—not only in language, but in structure—should make some difference in how the two apply. After all, remedies under the former provision appear aimed at preserving the status quo. And because relief preserving the status quo is traditionally associated with equitable relief, not “legal” relief within the scope of the Seventh Amendment, the defendants could fairly argue that a jury trial is not required there. But I also think that the statutory-interpretation argument can cut the other way. Given that damages are the “quintessential legal remedy,” it seems that specifying that “damages” are available under § 271(e)(4)(C) could be dispositive in the Seventh Amendment analysis.

    In any event, it will be interesting to see whether the district court will confront these questions in ruling on Astellas’s motion. A ruling that no jury trial is required under § 271(e)(4)(C) will likely favor defendants generally in future cases, as the consensus is that plaintiffs fare better in patent cases when trying them to a jury. I am also interested in the potential preclusive effects of a judgement in the ANDA case on any post-launch infringement claims that Astellas may bring in a separate action. But I plan to explore those in a separate post depending on how the court rules on the pending motions and the merits of the remaining infringement and § 112 issues.

  • Collateral Estoppel from IPRs in District Court

    Continuing on the subject of defendants challenging multiple related patents, I listened to oral argument recently in a case involving an allegation of collateral estoppel from IPR proceedings on district court litigation of related claims that raised some interesting arguments. (Kroy IP Holdings, LLC v. Groupon, Inc., Case No. 23-1359). 

    In that case, the district court granted summary judgment finding claims invalid for not being patentably distinct from related claims invalidated in an IPR. The appellant challenged whether estoppel could apply in district court, given that the evidentiary burden in district court was higher. The panel interrupted the appellant, asking whether they had reviewed the Court's recent decision in ParkerVision, Inc. v. Qualcomm Inc., No. 2022-1755, 2024 WL 4094640 (Fed. Cir. Sept. 6, 2024), which the panel succinctly summarized as saying "you win" and suggesting the appellant take a seat. In ParkerVision, the court held that "Although we have not previously addressed the question of whether a finding underlying an unpatentability decision in an IPR proceeding collaterally estops a patentee from making validity arguments regarding separate, related claims in district court litigation, we now hold that it does not."

    The appellee, prepared to address Parkervision, attempted to distinguish it on its facts, noting that there the challenger had unsuccessfully challenged the allegedly patentably indistinct method claims and failed to prove them unpatentable, and that the holding in Parkervision should be limited to scenarios in which the PTAB finds the allegedly estopped claims not proven unpatentable. 

    I am skeptical the appellee will prevail on this argument, given that Parkervision's holding was not based at all on the fact that the allegedly estopped claims had been found not unpatentable in an IPR (which was mentioned only in background). In fact, Parkervision did not address an application of collateral estoppel to determine related claims unpatentable, but rather granted a Daubert motion holding the IPR "collaterally estopped ParkerVision from relitigating characteristics of the prior art reference on which Qualcomm's invalidity contentions rested." Thus, the fact that the PTAB had found the method claims not proven unpatentable (which as a matter of logic would necessitate a finding that the method claims were patentably distinct from the invalidated apparatus claims) was not the reason collateral estoppel should not apply, but rather the different burdens of proof on underlying factual findings. The panel rightly seemed skeptical of this effort to distinguish Parkervision. 

    However, the appellee further argued (persuasively in my opinion) that the underlying basis for the presumption of validity and subsequent clear and convincing evidence standard is that the patent office has passed upon the validity of the claims, but that this presumption should not apply where the patent office has actually determined that the subject matter claimed is not patentable. The appellee also touched on the Federal Circuit's earlier decision in XY, LLC v. Trans Ova Genetics, 890 F.3d 1282 (Fed. Cir. 2018) (claims cancelled in an IPR have preclusive effect in district court litigation) and briefly touched on the difference between issue preclusion and claim preclusion. In my opinion, this is the key to distinguishing Parkervision. 

    The panel appears to have conflated issue preclusion (collateral estoppel applying to factual findings) with claim preclusion (res judicata, precluding relitigation of the same or materially similar claims). The use of these terms interchangeably is commonly done, even by the esteemed judges of the Federal Circuit. See, e.g., Soverain Software LLC v. Victoria's Secret Direct Brand Mgmt., LLC, 778 F.3d 1311, 1319 (Fed. Cir. 2015) ("Soverain argues that issue preclusion should not apply because claim 39 was not previously found obvious and does not present identical issues. Complete identity of claims is not required to satisfy the identity-of-issues requirement for claim preclusion.").

    But these are slightly different concepts. See Phillips/May Corp. v. United States, 524 F.3d 1264, 1267 (Fed. Cir. 2008) ("The doctrine of res judicata involves the related concepts of claim preclusion and issue preclusion.”). Parkervision addressed issue preclusion ("a finding underlying an unpatentability decision"), not claim preclusion (whether the claims are materially distinct). The Kroy case in contrast, addresses whether claim preclusion applies to the bar relitigation of patentably indistinct claims . Thus, a conclusion in Kroy that claim preclusion may still apply would not be in conflict with Parkervision, and would seem to be in harmony with XY. After all, if the PTAB's unpatentability determination effectively cancels the claim, why shouldn't it apply to patentably indistinct claims? Of course, the challenger still must prove the claims to be patentably indistinct.

    Further, the panel did seem concerned about the practical effects of requiring defendants to challenge every single asserted claim in an IPR—a concern that would be obviated by drawing a distinction between issue and claim preclusion in this context. Such a ruling would allow a defendant to knock out all patentably indistinct claims in one IPR, but also preserve a patentee's right to assert patentably distinct claims without any estoppel effects for underlying factual findings made on a lower evidentiary standard in IPR. 

    I'll be interested to see how the panel handles the case, and if it does not draw this distinction, whether it entertains further briefing in rehearing allowing the appellee to more fully address Parkervision (which issued after briefing had occurred). 

  • PTO considering OTDP and Terminal Disclaimer Rule Change – Is There a Compromise?

    Following up on Rocco's discussion of obviousness-type double patenting (OTDP), I have some thoughts on the PTO's proposed rule changes to OTDP and terminal disclaimer practice.

    In May, the patent office proposed a rule in which "to overcome double patenting the patentee would need to agree that the patent with the terminal disclaimer will be enforceable only if the patent is not tied and has never been tied through one or more terminal disclaimers to a patent in which any claim has been finally held unpatentable or invalid over prior art." By now the proposed rule changed to obviousness-type double patenting and the filing of terminal disclaimers has been heavily discussed, and heavily criticized. 

    As many have discussed, it seems highly unlikely this rule would pass, and questionable whether the patent office even has the authority to pass such a rule in light of a Congressional statute that unequivocally stated "Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims." 35 U.S.C. § 282. Nor does it seem particularly fair to patentees to make such a rigid rule in which a single overly broad claim could invalidate an entire patent family. 

    But the concern of the patent office is quite valid, as practitioners in the ANDA field are quite aware, litigation costs can balloon when patentees seek numerous continuations and create what some call a "patent thicket," or serially bring continuation patents in new litigations. And it does seem materially unfair to Defendants to repeatedly face litigation on claims the patent office deemed materially indistinct from invalidated claims, each time obtaining a fresh presumption of validity, requiring clear and convincing evidence to overcome.

    While I admittedly have not exhaustively reviewed the writing on this topic, there seems to me a simple and obvious compromise that I have not seen discussed, that would preserve a patentee's right to continue to assert related claims while protecting Defendants from serially having to prove invalidity by clear and convincing evidence: for any patent which contains a terminal disclaimer over an invalidated patent, shift the burden to the patent owner to prove by a preponderance of the evidence that the claims are patentably distinct and thus valid.

    This would seem to be a fair compromise, in that a patentee who essentially acquiesces to a finding that the claims are not patentably distinct in the patent office must bear the burden of proving otherwise in court, while avoiding a rigid rule in which a single invalidated claim knocks out an entire family. 

    I tend to agree that this change cannot come from the patent office. But given that OTDP is a judge-made doctrine, it seems like the change could come from the judiciary in addition to Congress. Indeed, a panel of the Federal Circuit appeared to come pretty close to this compromise in SimpleAir, Inc. v. Google LLC, 884 F.3d 1160 (Fed. Cir. 2018), but determined it was bound by earlier precedent.

    In an opinion authored by Judge Lourie, the panel stated "Although a terminal disclaimer does not conclusively show that a child patent involves the same cause of action as its parent, the terminal disclaimer is still very relevant to that inquiry" and "a terminal disclaimer is a strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent." "But as our precedent indicates, that strong clue does not give rise to a presumption that a patent subject to a terminal disclaimer is patentably indistinct from its parent patents." Specifically Judge Lourie wrote, "our cases foreclose the inference that filing a terminal disclaimer functions as an admission regarding the patentability of the resulting claims" and, perhaps suggesting to the defendant that it seek en banc hearing, stated "As a panel, we lack the authority to deviate from this precedent."

    Interestingly, Google did file a petition for rehearing en banc, but did not argue for any rebuttable presumption. Rather, it appeared to argue for an absolute rule akin to that proposed by the Patent Office. The Federal Circuit did take the somewhat unusual step of inviting a response, but ultimately denied the petition for en banc hearing without comment or dissent. 

    I do wonder if at least Judge Lourie might have been interested in taking the case en banc to address a compromise position, such as a rebuttable presumption. Perhaps someone will try this and we'll see what the Federal Circuit's appetite is. That seems more likely to me than Congress intervening, though perhaps the PTO's actions will force Congress to act. But this does seem to be an issue gaining attention, and I expect we'll see some changes sooner rather than later.

    I welcome any thoughts or comments anyone has!

     

     

     

  • Obviousness-Type Double Patenting for Patent-Term-Adjusted Patents post-Allergan and In re Cellect (2/2)

      by: Rocco J. Screnci

    This is the second post in a two-part series on obviousness-type double patenting (“ODP”). Part one summarized the two recent precedential Federal Circuit decisions in this area.

    To sum up where last post left off: The Federal Circuit’s decision in Cellect initially seemed to drastically expand the application of ODP, and the Allergan decision limited the broadest readings of Cellect by explaining that later-filed, later-issued patents cannot be used as ODP references against the “first” patent in the family even if patent-term adjustment (“PTA”) awarded for Patent Office delays during prosecution means that the “first” patent expires later. At the same time, Allergan seemingly reaffirmed its earlier ODP cases, including Cellect, in which expiration date controlled the outcome. This leaves a few important takeaways.

    First, Allergan did not disturb past cases applying ODP to invalidate later-filed and later-expiring patents. Indeed, Allergan contrasted its facts with those in past cases, like Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366 (Fed. Cir. 2014), in which the patentee secured a second, later-expiring patent by filing a continuation that received 750 days more PTA than the first patent in the family, and Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), in which the patentee secured a second, later-expiring patent by beginning a new application chain with a later priority date. With that in mind, it is important for defendants to always keep an eye on a plaintiff’s earlier-filed, earlier-expiring patents as potential grounds for invalidity against later-filed, later-expiring patents. And plaintiffs will need to keep its earlier-filed, earlier-patents in mind when developing their prosecution and Orange Book-listing strategies.

    Second, Allergan left intact Cellect’s central holding: that the PTA-added expiration date is the expiration date that matters for ODP purposes. It will thus be important for ANDA filers to keep track of not just when Orange Book-listed patents expire, but also when the NDA holder’s other patents expire. What’s more, given that PTE and PTA are treated differently for ODP purposes, ANDA filers will want to account for both PTE- and PTA-added expiration dates when planning their filing strategies. On the flipside, NDA holders will want to consider revisiting their Orange Book-listed patents to see if any terminal disclaimers are necessary for later-filed patents with PTA.

    Third, Allergan clarified that issuance date matters in the ODP analysis. This limits the available references that can be asserted to support an ODP defense. Defendants now know that they cannot simply invoke PTA-added expiration dates when arguing invalidity on ODP grounds. That said, the precise contours of Allergan’s holding on that point are a bit unclear.

    On one hand, Allergan seems to shut the door on the idea that a later-filed, later-issued “child” patent without PTA can invalidate a “first” or “parent” patent. But that only invites the question of what it means to be a “first” or “parent” patent. Recall that the ODP reference patents in Allergan were not the immediate descendants of the challenged “first” patent in the family. The ODP reference 011 and 709 patents in Allergan were the metaphoric grandchild and great-grandchild, respectively, of the 356 patent. The 011 patent issued on a divisional of an application that itself was a continuation of the 356 patent’s application, and the 709 patent was a continuation of the 011 patent’s application. Indeed, the 356 patent issued before the applications leading to the 011 and 709 patent were filed. And the Federal Circuit emphasized those facts when explaining why the facts in Allergan exemplified why ODP did not apply. As a result, some may construe Allergan as narrowly applying to the precise fact pattern there: The patent issuing from the first nonprovisional application in the family cannot be invalidated by later-issued patents that were applied for only after the first patent issued. This could mean that patents issuing from continuations are still susceptible to attack, or that a different rule applies if the reference patent’s application was copending.

    On the other hand, some may read Allergan as foreclosing ODP whenever the later-expiring patent was earlier filed and earlier issued than the would-be reference patents, even if the patents were copending and have different priority chains. This broad reading stems from Allergan’s favorably citing past cases in which the Federal Circuit declined to extend ODP to similar situations. See 111 F.4th at 1370. But those cases were limited to distinct scenarios or expressed their narrow views on ODP only in dicta. See Cellect, 81 F.4th at 1230 (“We do, however, note that the non-asserted claims in the challenged patents are entitled to their full term, including the duly granted PTA, unless they are found to be later-filed obvious variations of earlier-filed, commonly owned claims.”); Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1374 (Fed. Cir. 2018) (“[T]he traditional concern with obviousness-type double patenting” is not raised where “it is the earlier-filed, earlier issued … patent, not the later-filed, later-issued … patent, that has the later expiration date”); Novartis Pharms. Corp. v. Breckenridge Pharm. Inc., 909 F.3d 1355, 1366 (Fed. Cir. 2018), (declining to invalidate patent on ODP grounds “[i]n th[e] particular situation where we have an earlier-filed, earlier-issued. . . patent that expires after the later-filed, later-issued . . . patent due to a change in statutory patent term law”).

    Of course, the real impact of Allergan is yet to be seen and likely lies somewhere between the narrowest and broadest possible readings. One can imagine a middle-ground approach that forecloses ODP as a form of patent patricide. In other words, the rule from Allergan would bar defendants from pitting later-filed, later-issued patents against the earlier-filed, earlier-issued patents in the same priority chain. This rule would potentially balance the Federal Circuit’s policy concerns about depriving patentees of their original patent terms while leaving room for the courts to curb any gamesmanship that may arise when patentees try to stagger priority chains to secure longer patent terms.

    In any event, perhaps the most important takeaway from Allergan is that the Federal Circuit continues to develop its view on ODP case-by-case. In its latest cases addressing ODP, the Federal Circuit has carefully parsed its ODP jurisprudence to determine how ODP ought to apply to the issues on appeal. Allergan continues this trend by limiting earlier ODP cases to their particular facts and by narrowing Cellect to the issue framed by the appellant about how PTA interacts with ODP. This trend is important for two key reasons. First, it shows how critical it is for defendants to continue to identify and raise potential ODP defenses as the law in this area continues to develop, and for plaintiffs to anticipate these arguments when preparing for litigation. Second, it reminds all litigants to consider how they frame arguments. Given some of the Federal Circuit’s concerns in Allergan, perhaps the fact pattern in Cellect could have played out differently had the appellant taken a more moderate approach in urging to reverse the ODP determinations by the Patent Trial and Appeals Board.

  • Obviousness-Type Double Patenting for Patent-Term-Adjusted Patents post-Allergan and In re Cellect (1/2)

        by: Rocco J. Screnci

    This post is the first in a two-part series about recent developments in the law of double patenting. This post provides relevant background and summarizes the Federal Circuit’s recent decisions in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023) and Allergan USA, Inc. v. MSN Laboratories Priv. Ltd., 111 F.4th 1358 (Fed. Cir. 2024). For those already familiar with the decisions, please feel free to move on to the next post in this series, which discusses the potential implications of these cases for Orange Book patents.

    The doctrine of obviousness-type double patenting (“ODP”) is judge made and bars a patentee from securing multiple patents with different expirations for patentably indistinct (i.e., obvious) variants of the same invention. The doctrine developed to address gamesmanship that arose under earlier versions of the patent act when patent applications were not published and when expiration dates were determined by the issuance dates. ODP was thus needed to combat “submarine” patents, a practice by which patentees maintained a chain of secret applications before drafting patentably indistinct claims on a competing product long after the original patent had expired. But submarine patents are now a relic of the past. This is because applications are published and because filing date—not issuance date—determines patent term. Even so, ODP still persists as an invalidity defense when two patents claiming patentably indistinct subject matter expire at different times.

    In fact, the law on ODP is dynamic as ever. Last year, in In re Cellect, the Federal Circuit explained for the first time how ODP interacts with patents that have received a patent-term adjustment (“PTA”) for delays during prosecution. The patentee in Cellect had secured a web of patents with a shared priority date, but having different PTAs and thus different expiration dates as depicted in the following timeline. Several patents were challenged on ODP grounds in petitions for ex parte reexamination. Because each of the challenged patents were patentably indistinct from the reference patents (as shown in the table below), the sole issue was what expiration date mattered when analyzing ODP.

    Challenged Patent ODP Reference Patent
    742 369
    369 036
    626 369
    621 626

    The patentee relied on earlier decisions that had held that ODP challenges to patents with patent-term extensions (“PTE”)—additional patent term awarded to certain drug or medical device patents due to time spent awaiting FDA approval—must use the expiration date before accounting for any PTE. In other words, if there are no ODP concerns for a patent’s original patent term, it can enjoy its full original patent term plus PTE. The patentee in Cellect argued that the same rule should apply for PTA, but the Federal Circuit disagreed. As a result, each patents was held invalid on ODP grounds.

    Many saw Cellect as a drastic expansion of ODP. While some took issue with the disparate treatment of PTE and PTA when evaluating ODP, the bigger concern was the Cellect seemingly stood for the premise that PTA-added expiration date—and that expiration date alone—is all that matters for ODP purposes. This would mean that later-filed, later-issued patents could invalidate earlier-filed, earlier-issued patents simply because the earlier patent received PTA and the later patents did not. That rule would be surprising because it would create an invalidity defense that escapes prosecution. Usually, the Patent Office catches ODP concerns during examination of later-filed patent that claim obvious variants of previously issued patents. To overcome an ODP rejection, the applicant must file a terminal disclaimer, which ties expiration date of the later-filed claims to those of the earlier-filed claims. But a broad reading of Cellect would flip that scenario on its head, meaning that issued patents could have their patent terms truncated if later continuations received less PTA. And because earlier Federal Circuit decisions prevent patentees from terminally disclaiming to already-expired patents, that broad reading would mean that it was too late to save some otherwise valid patents. This reading would be even more impactful given that Cellect arose from ex parte reexaminations.

    Ex parte reexamination is a post-grant proceeding in which the Patent Office reopens patent prosecution if a petition for reexamination identifies a "substantial new question of patentability." While the petitioner in an ex parte reexamination has less involvement in proceedings than its counterpart in inter partes review ("IPR"), ex parte reexamination has some noteworthy advantages over IPR. For one, IPR has tighter filing deadlines and limits challenges to novelty and obviousness based on printed prior art (i.e., patents and publications). A petition for ex parte reexamination, by contrast may be filed any time before the patent expires and also may raise ODP as an invalidity ground. The generous filing deadline makes ex parte reexamination a particularly powerful tool in the ODP context because it means that a party can wait until after the reference patents expire to challenge a patent on ODP grounds, leaving the patentee no time to file a terminal disclaimer to overcome ODP. With that in mind, a broad interpretation of Cellect would empower defendants to invalidate an entire patent simply by waiting until it is too late to cure ODP with a terminal disclaimer.

    At least one district court endorsed that broad reading of Cellect. In Allergan v. MSN Laboratories, the district court applied ODP to invalidate Allergan’s Orange Book-listed 356 patent covering eluxadoline, a drug used to treat IBS-D sold under the brand name Viberzi®. The district court found that the 356 patent was patentably indistinct from Allergan’s two earlier-expiring patents in the same patent family that also claimed eluxadoline. Relying on Cellect, the district court said it was irrelevant that the 011 and 709 patents were later-filed, later-issued descendants of the 356 patent. The district court read Cellect for the broad proposition that “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates…[N]o exception[s].” Allergan USA, Inc. v. MSN Laboratories Priv. Ltd., 694 F. Supp. 3d 511, 540 (D. Del. 2023).

    But in late-August, the Federal Circuit explained that Cellect is not so broad. In a precedential decision, the Federal Circuit reversed the district court in Allergan v. MSN Laboratories, 111 F.4th 1358 (Fed. Cir. 2024). The court explained that Cellect addressed only the narrow issue about how ODP interacts with PTA. “Cellect does not address,” the court continued, the threshold issue about when a patent “can properly serve as an ODP reference.” Allergan, 111 F.4th at 1368. The court then concluded that the 011 and 709 patents could not be asserted as ODP references against the 356 patent because the 356 patent was the “first” patent to cover eluxadoline. There was thus no concern that Allergan tried to prolong its monopoly on eluxadoline beyond the original patent term because the first-issued, first-filed 356 patent—not the later-filed, later-issued 011 and 709 patents—dictated that patent term. Put another way, the Federal Circuit declined to let a “second” patent truncate the effective patent term of the “first” patent.

    The Federal Circuit also took time to address pre-Cellect cases that seemingly stood for the proposition that patent filing dates are irrelevant when analyzing ODP. The court distinguished those cases by explaining that they confronted different scenarios. Those cases, the court explained, each involved later-expiring patents that, at a minimum, were filed after the ODP reference patents. According to the court, those cases presented the opportunities for gamesmanship that ODP seeks to prevent. By contrast, the facts in Allergan presented, as the court put it, “‘a prime example’ of when ODP does not apply.” 111 F.4th at 1371. Because the 011 and 709 patents did not exist when the 356 patent issued, the 356 patent in no way “result[ed] in an extension of patent term of the invention[s] claimed in the [011 and 709] patent[s].” Id. In other words, the court recognized that letting the later-filed, later-issued patents invalidate the "first" patent would defy the rationale underlying ODP, which is to prevent a patentee from using serial continuations to prolong a patent monopoly. If later-filed, later-issued patents could serve as ODP reference patents, patentees would effectively be forced to forgo PTA or cease filing continuations altogether.

    While Allergan seems to have reined in Cellect’s impact, the Federal Circuit still left intact most pre-Cellect caselaw. Part two of this post explores what this means for Orange Book patents. It also identifies a few ambiguities in Allergan and their potential implications.