Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • Bloomberg BNA “AIA Post-Grant Patent Practice Conference,” Arlington, VA, February 19-20

    Bloomberg BNA's upcoming "AIA Post-Grant Patent Practice Conference" presents a unique opportunity to hear from present and former PTAB judges–as well as keynote speakers Hon. Pauline Newman and Hon. Randall Rader.  This two-day conference is based on the Bloomberg BNA treatise Post-Grant Patent Practice, which was authored by four former Administrative Patent Judges and which will be distributed to each conference attendee as part of the materials.

    The first day of the conference will provide an overview of the statutory and regulatory basis for post-grant practice and will discuss how post-grant practice has evolved over its first year.  The second day will feature mock demonstrations of the various hearings that occur during post-grant trials, including inter partes review, post-grant review, and covered business method patent review.  These demonstrations will feature prominent attorneys who have significant experience before the Patent Trial and Appeal Board.

    Here's the complete agenda:

    Day One:  The Law Governing Post-Grant Practice, Including the Fresenius USA v. Baxter Int'l case, and Real-World Experience Practicing Before the PTAB

    • The Fundamentals of Post-AIA Post-Grant Patent Procedures–a panel discussion that includes McAndrews shareholder Herbert D. Hart III
    • Luncheon Address by the Honorable Pauline Newman, Circuit Judge, Federal Circuit
    • Inter Partes and Post-Grant Reviews (including CBM Patent Reviews)
    • Derivation and Interference Procedures
    • Fresenius USA v. Baxter Int'l and its Impact on Post-Grant Practice

    Day Two:  Mock Hearings/Conferences with APJs and Insights from Lawyers "In the Trenches"

    • Motions Based on Estoppel/Privity and Mock Conference
    • Motions for Joinder and Mock Conference
    • Discovery Motions and Mock Conference
    • Luncheon Address by the Honorable Randall Rader, Chief Judge, Federal Circuit
    • Motions to Amend Claims and Mock Hearing on Amendment
    • Final Briefing and Mock Final Hearing

    An advance registration discount is available until Friday, January 31 with the code EARLYBIRD.  For more information or to register, please visit the conference website.

  • CPhI “Pharma IPR India 2014” Conference, Mumbai, India, February 26-28

    CPhI will be presenting its 3rd annual "Pharma IPR India" conference in Mumbai on February 26-28.  The conference features speakers from more than a dozen different countries across the world.  The complete agenda is as follows:

    Day 1: USA, Canada, and Mexico

    • Analysing the scope and implications of Inter Partes Review (IPR) in the United States after one year
    • Evaluating reverse payment settlement cases and decisions after Actavis
    • Determining patent eligibility for a US patent and ascertaining ways to use attorney fees/cost shifting for the benefit of pharmaceutical companies
    • Formulating the best litigation strategies in the US to optimise costs for pharma and biopharma companies
    • Biosimilars status in the USA
    • Evaluating the current regime ofthe Canadian Patent Act
    • Mapping the current patent regime and patent linkage by tracking recent patent infringement cases in Mexico

    Day 2: Europe, South Africa, Brazil, GCC countries, and Australia/New Zealand

    • Overview of current implementation of the Unitary Patent System in Europe, including its coming into force, structure, competence, language, and particularities
    • Ascertaining data exclusivity in Europe and understanding implications of SPCs on pharma companies
    • Formulating strategies to introduce generic products in the European market if there are unavoidable patents not yet invalidated
    • Understanding application of the Doctrine of Equivalents in European patent cases
    • Understanding recent changes in patent legislature in South Africa and analysing current IP infrastructure
    • Understanding the scope of patent law in Brazil and determining reforms therein impacting pharma and biopharma companies
    • Examining patent regimes in GCC countries and basic laws of the market and guidance on how to develop a product for these markets
    • Defining devised changes affecting patentability in Australia/New Zealand by updating recent trends to standards of applications and litigation in the industry

    Day 3: India, South Korea, Taiwan, China, and Japan

    • Determining the current position of post-grant oppositions filed by pharmaceutical companies in India
    • Determining grounds for invoking compulsory licenses in India, to determine new growth strategies for generic and multi-national companies
    • Understanding patent law and the IP regime in South Korea as they apply to pharmaceuticals
    • Highlighting amendments related to the dual invention/utility model system in Taiwan, and enforcement of patent rights and damages under the Taiwan Patent Act of 2013
    • Understanding the revised version of "Measures for Compulsory Licensing for Patent Implementation" that came into effect in the Chinese patent law
    • Understanding techno-legal aspects involved in the patent system of Japan to facilitate breaking the barriers for the entry of generic companies

    The early bird discounted registration rate for the conference is still available, but only until January 31st.  For more information or to register, please visit the conference website.

  • PTAB Institutes Inter Partes Review of Oracea (doxycycline) Formulation Patents

    Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, IPR2013-00371, IPR2013-00372 (PTAB)

        by Robert F. Kappers

    The U.S. Patent Trial and Appeal Board issued a trio of related decisions on December 17, 2013, each instituting inter partes review of one of three related patents on once-daily formulations of tetracycline. 

    On June 20, 2013, Amneal Pharmaceuticals filed three petitions for inter partes review, seeking to invalidate a family of patents owned by Supernus Pharmaceuticals.  Each of the challenged patents–U.S. Patent Nos. 8,206,740; 8,394,405; and 8,394,406–relates to once-daily, sub-antimicrobial formulations of doxycycline used to inhibit collagen destruction enzymes without provoking undesired side effects attendant to an antibacterial dose.

    Claim 1 of the '740 patent is illustrative of the claimed subject matter: 

    1. An oral pharmaceutical composition of doxycycline, which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 μg/ml and a maximum of 1.0 μg/ml, the composition consisting of

    (i) an immediate release (IR) portion comprising 30 mg doxycycline;

    (ii) a delayed release (DR) portion comprising 10 mg doxycycline; and optionally,

    (iii) one or more pharmaceutically acceptable excipients.

    Amneal asserted the same four grounds of unpatentability in each petition, but the Board accepted only two.  Amneal first asserted that the challenged claims were unpatentable for obviousness over WO 02/080932 A1 ("Ashley '932") as it incorporates Ser. No. 60/281,854 ("Ashley '854").  Amneal also asserted that the challenged claims were unpatentable for obviousness over Ashley '932 as it incorporates Ashley '854 in combination with U.S. 5,348,748 ("Sheth").  According to the petitions, Ashley '932 discloses administering a tetracycline compound in sub-antibacterial doses to treat acne, and further cites and incorporates Ashley '894 for disclosure of administering by sustained release, while Sheth discloses a once-daily formulation of minocycline with varying proportions of quick-release and delayed release dosage forms.

    In each decision (-00368; -00371; -00372), the Board determined that Amneal had failed to demonstrate a reasonable likelihood of unpatentability for obviousness over Ashley '932 alone.  The Board rejected Amneal's argument that a person of ordinary skill would have envisaged the claimed ratios of immediate-release to delayed-release portions from the disclosure in Ashley '854 that at least half of the doxycycline dose be released in the upper GI tract.

    The Board was more receptive to Amneal's second proffered ground of unpatentability; namely, that the subject matter of the challenged claims is obvious over the combination of Ashley '932 and Sheth.  Specifically, Amneal argued that Ashley '932 discloses all limitations of the illustrative claims except for the particular ratios of immediate-release and delayed-release portions of the formulation.  Rejecting Supernus’s counterarguments, the Board agreed that Sheth disclosed formulations of minocycline having a range of immediate-release to delayed-release ratios from which a person of ordinary skill could have envisaged the claimed ratios.

    In the end, the Board instituted inter partes review of each of the three challenged patents, finding that Amneal had demonstrated a reasonable likelihood that the challenged claims in each patent were unpatentable over the combination of Ashley '932 and Sheth.

    The petitions are related to ongoing litigation between the parties (currently stayed by joint stipulation), in which Galderma and Supernus alleged infringement of the '740 patent (the parent of the '405 and '406 patents) by Amneal's ANDA No. 203-278 and proposed generic version of Oracea.  See Galderma Labs. Inc., et al. v. Amneal Pharms., LLC, et al., C.A. No. 11-1106-LPS (D. Del.).

  • ACI “Patent Reform” Conference, New York City, January 22-23

    ACI is holding its 3rd annual "Patent Reform" conference in New York City next month, on January 22-23.  This is the "critical industry forum on the Leahy-Smith America Invents Act."

    The conference includes the following presentations:

    • USPTO Keynote Address I: The USPTO's Efforts to Implement AIA Provisions Impacting Patent Prosecution
    • Straddling the First-to-Invent/First-to-File Gap: Changing Company Protocols, Cautiously Approaching Amendments, and Strategies for Promoting Likelihood of Issuance
    • Through the AIA Prior Art Looking Glass–Understanding the Global Wonderland of Prior Art, and Utilizing Preissuance Submissions, Suppleental Examination, Ex parte Reexamination, and Reissue
    • USPTO Keynote Address II: Detailing How the New Post-Grant Opposition Procedures Have Impacted Patenting, and Updating on the Implementation of the Post-Grant Review Proceedings
    • Innovative Practice Resources for Meeting with Success During Inter Partes Review
    • Red Skies on the Horizon–Tracking Developments of Covered Business Method Proceedings and Preparing for the Era of the Post-Grant Review
    • Examining the Impact of Patent Reform on Hatch-Waxman Litigation and the Brand/Generic Wars
    • Interactive Open Floor Discussion on Proposed Legislation on Non-Practicing Entities
    • The Showdown Over Diagnostic Methods–Obtaining Patent Protection from the PTO Under the AIA Despite the Supreme Court's Nebulous View of a "Product of Nature"

    In addition, a pre-conference workshop is offered in the morning on January 22, "Patent Reform 101: A Primer on the Fundamental Provisions of the America Invents Act."  And a post-conference workshop is offered in the morning on January 24, "Interactive Working Group Session: A Hypothetical Invention Being Patented Under the AIA."

    Orange Book Blog readers can receive $200 off the registration fee by using code OBB 200.  For additional information or to register, please visit the conference website.

  • Divided Federal Circuit Panel Strikes Down Galderma’s Patents as Obvious—in Shifting the Burden of Production Regarding Secondary Considerations to the Patentee, Did the Majority in Fact Shift the Burden of Persuasion, Too?

    Galderma Labs., L.P. et al. v. Tolmar, Inc., No. 2013-1034 (Fed. Cir.)

        by Dunstan H. Barnes

    On December 11, 2013, a three-judge Federal Circuit panel struck down the asserted claims of five patents belonging to Galderma Laboratories for being invalid as obvious.  In Judge Sharon Prost's opinion for the court, joined by Judge William Bryson, she sought to draw a narrow distinction between shifting to the patentee the burden of production rather than the burden of persuasion, once an accused infringer has shown that the claimed invention falls within a range disclosed in the prior art.  Judge Pauline Newman vociferously criticized this burden-shifting in her dissent.

    The five patents-in-suit are directed to a topical medication used to treat acne that contains 0.3% adapalene.  Claim 5 of U.S. Patent No. 7,838,558 is representative:

    5. A topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutically acceptable medium therefor, said composition being in the form of a topically applicable, pharmaceutically acceptable aqueous gel comprising at least one carbomer gelling agent and wherein the sole anti-acne ingredient is adapalene.

    In September 2009, Tolmar filed an ANDA seeking approval to market a generic version of the patented product, Differin Gel, 0.3%.  In response, in January 2010, Galderma sued Tolmar for patent infringement in the United States District Court for the District of Delaware.  After a bench trial, the district court ruled in favor of Galderma on several issues, including validity.  On appeal to the Federal Circuit, the sole issue before the court was invalidity for obviousness under 35 U.S.C. § 103.

    The Federal Circuit panel majority held that Tolmar had proven obviousness by clear and convincing evidence, and therefor reversed the district court's decision.  Tolmar's obviousness argument relied primarily on three prior art references:  two prior art patents ("Shroot '720 patent" and "Shroot '440 patent") and Galderma's data sheet for its earlier-marketed 0.1% adapalene gel product ("Data Sheet").  Tolmar further supported its obviousness argument with nine scientific journal articles.

    The Shroot '720 patent disclosed several compositions containing a broad range of adapalene concentrations:  0.001%, 0.1%, and 1%.  Similarly, claim 4 of the Shroot '440 patent listed a preferred range of 0.01 to 1% for cosmetic compounds including the inventive compounds, such as adapalene, as the active ingredient.  The majority pointed out that both Shroot patents were listed in the FDA's Orange Book for Galderma's prior art 0.1% adapalene gel product and its 0.3% adapalene gel product.  Although the Data Sheet disclosed simply 0.1% adapalene as an acne treatment and not a range, it also disclosed virtually every inactive ingredient listed in the asserted claims.

    In addition to the three primary prior art references, Tolmar supported its obviousness argument with nine scientific journal articles that Tolmar believed showed using 0.3% adapalene for acne treatment would have been obvious to a person of ordinary skill in the art at the time of the invention.  The majority noted that "many skilled artisans believed at the time of the invention that 0.1% was the optimal concentration of adapalene for the treatment of acne," a statement that Judge Newman seized upon in her dissent.

    The most interesting aspect of this case involves a legal standard regarding the burdens of production and persuasion.  The majority stated:

    where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations. 

    To support this burden-shifting standard, the majority cited Novo Nordisk A/S v. Caraco Pharm. Labs. Ltd., 719 F.3d 1346, 1352-54 (Fed. Cir. 2013), a case bearing certain similarities to the present case:  Judge Prost authored the majority opinion and Judge Newman wrote a dissenting opinion.  And even though the issue in Novo Nordisk was not precisely the same—the prior art suggested an allegedly obvious combination of two drugs rather than disclosing a range—the Federal Circuit held that there is a shift to the patentee to bear "the burden of production once the court determined that the challenger has established a prima facie case of obviousness."  Id. at 1354.  The Novo Nordisk majority emphasized that it was not shifting the burden of persuasion, "as long is the [district] court reserved its ultimate conclusion on validity until after it considered the evidence from both sides . . . ."  Id.

    In applying this standard, the panel majority examined three secondary consideration factors in reaching its conclusion that the claims are invalid as obvious:  (1) teaching away; (2) unexpected results; and (3) commercial success.  First, the majority held that the district court "clearly erred" by finding that the prior art taught away from a 0.3% concentration, because although the prior art understanding was that 0.1% was the optimal concentration, "[a] teaching that a composition may be optimal . . . does not criticize, discredit, or otherwise discourage investigation into other compositions," and therefore does not qualify as a "teaching away."  Second, the majority found that there were no unexpected results because although "the expected result was an increase . . . in . . . certain side effects[,] [t]he failure of that . . . increase to materialize, though unexpected, constitutes a only a difference in degree from the prior art results."  Third, the majority discounted the commercial success of Galderma's 0.3% gel product because "[t]he now expired Shroot patents blocked the market entry of 0.3% adapalene products until their expiration in 2010," which meant that "no entity other than Galderma could have successfully brought . . . 0.3% to market prior to 2010."

    In her dissent, Judge Newman accused her colleagues of "distort[ing] the burdens of proof and production, ignor[ing] the applicable standard of proof and rely[ing] on their own factual determinations and creative theories of law . . . ."  In doing so, she stated, the panel majority "places on the patentee the burden of establishing patentability based on 'secondary considerations.'"  She suggests that the majority's standard, quoted above, does not shift only the burden of production, but the burden of persuasion, too, because the majority held that Tolmar had met its evidentiary burden simply by demonstrating that "the invention fell within a broad range disclosed in the prior art . . . ."  In addition, Judge Newman was clearly bothered by the majority's lack of deference to the district court, which "applied the correct law to a vast body of evidence, most of which is not discussed by the panel majority."

    Judge Newman also analyzed the secondary consideration factors of "teaching away" and "unexpected results."  First, she relied upon the district court's finding (based on "prior art" and "expert testimony presented by both sides") that the prior art as a whole taught away from increasing the adapalene concentration above 0.1%.  Second, Judge Newman found no clear error in the district court's holdings that:  (a) it was "unexpected that the tolerability profile of 0.3% adapalene was not statistically different from that of 0.1% adapalene"; and (b) that the difference was "in kind, not in degree," because Galderma's products "violated the trend" of exhibiting "increased adverse side effects with increased concentration."

    It will be interesting to see whether Galderma petitions for en banc review of this opinion in light of the potentially controversial burden-shifting standard adopted by the panel majority.

  • Momentum Events “IP Counsel Exchange for Biosimilar Applicants and Sponsors,” New York, January 23-24

    Momentum Event Group will be holding its inaugural "IP Counsel Exchange for Biosimilar Applicants and Sponsors" January 23-24 in New York City.  The effect of the recent Sandoz v. Amgen decision on biosimilar patent litigation strategy is expected to be a main topic of discussion.

    The conference begins with an interactive working group, where participants can choose between:

    • "Dissecting the European Biosimilars Experience: What Potential Sponsors and Applicants Can Learn From the Approval of the First Biosimilar Antibody in Europe" and
    • "Navigating the Patent Application Process: Effective Strategies for Ensuring Your Application Obtains Approval and Can Withstand Challenges in the Emerging Biosimilar Market."

    The conference continues with the following presentations:

    • "Patent Caselaw Year in Review: Examining Recent Caselaw Developments Under Section 112 Addressing Written Description and Enablement and the Impact on Patent Strategies for Companies Within the Biosimilar Space"
    • "Orange Book Withdrawal: How Sponsors and Applicants Can Conduct Effective IP Due Diligence and Patent Inventory Assessment in the Absence of an Established FDA Patent Listing Resource"
    • "So You Think You Can Patent Dance: Effective Strategies for Best Posturing Your Product and Narrowing the Litigation Landscape"
    • "Size Matters: Dissecting the Divergent Litigation Pathways of Small vs. Large Molecule Products and What Steps Your Company Should Take Now to Prepare Your Future Litigation Strategy"
    • "Interactive Roundtable Discussion: Addressing the Top 5 Global IP Challenges Facing Current and Prospective Biosimilar Sponsors and Applicants"
    • "Addressing the Potential Use of Trade Secrets (Or Not) in Connection with the FDA's Review of Biosimilar Applications Citing a Reference Product and BLA that Predates the BPCIA"
    • "Case Study: To Collaborate or Not to Collaborate?  How Alliances Can Be Used to Strategically Bolster Your Patent Portfolio When Bringing a Biosimilar/Biobetter Product to Market"
    • "Global IP Considerations, Challenges, Risks, and Opportunities for Biosimilar Applicants and Sponsors When Filing Patent Applications Abroad"

    The conference concludes with your choice of one of three interative roundtable discussions:

    • "Looking Beyond Year 12: How to Ensure Your Patent Strategies Are Adding Value Beyond the Statutory Period of Exclusivity"
    • "Distinguishing Regulatory Pathways for Biosimilar Products: Biobetters vs. Biosimilars and Considering the Impact Your Regulatory Choice Will Have on Your IP Strategy"
    • "Alternative Monetization Strategies for Your IP Portfolio: How to Drive Your Business When You Choose Not to Apply"

    Orange Book Blog readers are entitled to a 10% discount on registration by using code OBB10.  For more information or to register, please visit the conference website.

  • Cadence Prevails Over Exela in OFIRMEV® (Acetaminophen) ANDA Litigation

    Cadence Pharms., Inc. v. Exela Scis., LLC, No. 11-733-LPS (D. Del.)

        by Dunstan H. Barnes

    On November 22, 2013, the U.S. District Court for the District of Delaware issued a Final Judgment and Permanent Injunction barring Exela from manufacturing a generic version of OFIRMEV®, which is an injectable liquid acetaminophen composition.  Judge Leonard Stark held that all fourteen asserted claims from the two patents in suit were not invalid and would be infringed by Exela's generic product.  Judge Stark's reasoning was revealed in his November 14 Memorandum Opinion which was unsealed on November 22.

    Plaintiff Cadence Pharmaceuticals, Inc. ("Cadence") holds approved NDA No. 022450 for OFIRMEV®, which was approved by the U.S. Food and Drug Administration in November 2010.  Plaintiff SCR Pharmatop ("Pharmatop") is a French civil law partnership that owns U.S. Patent Nos. 6,028,222 ("the '222 patent") and 6,992,218 ("the '218 patent"), which are directed to, respectively, a formulation of, and a method for preparing, a liquid acetaminophen (or paracetamol) composition.  Paracetamol is the name used outside of the United States for acetaminophen.  Cadence is a Delaware corporation based in California that has an exclusive license to the '222 and '218 patents.

    In 2011, Cadence and Pharmatop sued Exela Pharma Sciences, LLC, Exela Pharmsci, Inc., and Exela Holdings, Inc. (collectively, "Exela") for patent infringement after Exela notified the plaintiffs that it had filed ANDA No. 203092 seeking regulatory approval for a generic version of OFIRMEV®. 

    Cadence and Pharmatop had also sued Perrigo Company, and its subsidiaries Paddock Laboratories, Inc. and Paddock Laboratories, LLC.  Each of these three parties were dismissed from the suit by a joint stipulation of the parties after the parties settled and entered into a license agreement.  Cadence announced in November 2012 that, under the license agreement, Perrigo has the exclusive right of first refusal to negotiate an agreement with Cadence to market an authorized generic version of OFIRMEV® in the United States if Cadence elects to launch an authorized generic version of the product.

    After construing the claims in August 2012, the Court conducted a seven-day bench trial in May and July of 2013.

    At trial, Cadence and Pharmatop successfully proved by a preponderance of the evidence that Exela's generic version of OFIRMEV® literally infringed all ten asserted claims of the '222 patent.  Despite Exela's arguments to the contrary, the plaintiffs successfully proved that in Exela's generic product, sodium ascorbate acted as a "buffering agent" and mannitol acted as a "free radical scavenger" (i.e., an antioxidant).  This meant that Exela's generic product met each of the asserted claim limitations.

    Although Cadence and Pharmatop failed to prove literal infringement of any of the four asserted claims of the '218 patent, the plaintiffs succeeded under the doctrine of equivalents.  The court found no literal infringement because independent claim 1 required the solution to have a dissolved oxygen content of greater than 2.0 ppm prior to the deoxygenation step.  Because the evidence at trial showed no substantial difference based on the time at which the oxygen content is reduced to below 2.0 ppm, the court held that Exela infringed under the doctrine of equivalents.

    To invalidate the '222 patent, Exela argued that three pieces of prior art—Greek Patent Application No. 870101510, Korean Patent No. 1993-011994, and U.S. Patent No. 5,270,050—rendered the '222 patent anticipated or obvious.  Excela's anticipation argument failed because Exela was unable to convince the court that the prior art disclosed a "stable" liquid formulation, as recited in claim 1, the only independent claim at issue in the '222 patent.  Exela's obviousness argument failed for the same reason and additionally because the court was persuaded that each of the following secondary considerations supported a finding of nonobviousness: (1) unexpected results, (2) satisfaction of an unmet need, (3) failure of others, (4) commercial success, (5) successful licensing, and (6) praise of others.

    Exela was similarly unable to win its argument that the '218 patent was invalid as obvious in view of the '222 patent combined with an article from the 1978 Journal of Pharmaceutical Studies.  Importantly, the 1978 article concerned the oxidative degradation of pyrogallol, which is highly sensitive to oxidation, rather than paracetamol, which is not.  The court was unconvinced by Exela's argument for two reasons.  First, the court found independent claim 1 was valid and nonobvious given the technical differences in degradation of paracetamol compared to the degradation of pyrogallol (hydrolysis instead of oxidation), as well as the technical difficulties of deoxygenation.  Second, Cadence and Pharmatop persuaded the court that all six secondary considerations listed above supported the nonobviousness of the '222 patent.

    Based on its findings, the court enjoined Exela from producing its generic version of OFIRMEV® until the '222 and '218 patents expire:  August 5, 2017 for the '222 patent and June 6, 2021 for the '218 patent.

  • PTAB Finds § 315(b) Barred Petition for Inter Partes Review Challenging Claims Amended in Reexamination

    BioDelivery Sciences Int'l, Inc. v. MonoSol RX, LLC, IPR2013-00315 (PTAB)

        by Robert F. Kappers

    On November 13, 2013, the Patent Trial and Appeal Board issued a decision denying the petition for inter partes review filed by BioDelivery Sciences targeting MonoSol Rx's U.S. Patent 7,425,292.  The '292 patent relates to thin films with non-self-aggregating uniform heterogeneity for use in drug delivery systems.

    BioDelivery filed its petition for inter partes review on June 12, 2013, more than one year after MonoSol served BioDelivery with a complaint asserting infringement of the '292 patent, but less than one year after an ex parte reexamination proceeding terminated upon issuance of a reexamination certificate that confirmed or amended each of the original claims.

    The Board denied BioDelivery's petition because it was untimely filed under 35 U.S.C. § 315(b).  Specifically, the Board found that § 315(b) barred BioDelivery's petition even though the petition challenged claims that were amended by a reexamination certificate issued after service of the complaint.  In adopting a broad interpretation of § 315(b), the Board emphasized that reexamination does not result in a new patent:

    A reexamination certificate merely "incorporates in the patent any proposed amended or new claim determined to be patentable."  35 U.S.C. § 307(a).  The reexamination certificate itself states: "The patent is hereby amended as indicated below."  The identical reference in § 315(b), to the "date on which the petitioner . . . is served with a complaint alleging infringement of the patent" indicates that the timeliness analysis is to be made with reference to "the patent."

    This decision comes as further development of the PTAB's broad interpretation of § 315(b).  See, e.g., Accord Healthcare v. Eli Lilly and Co., IPR2013-00356 (a second complaint in the second of two prior lawsuits did not reset the time for filing a petition); St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., IPR2013-00258 (counterclaim is a "complaint alleging infringement of the patent" within the meaning of § 315(b).)

  • Motion to Amend Pleadings to Assert Inequitable Conduct Denied in Rapamycin Case

    Pfizer Inc. v. Sandoz Inc., No. 12-654-GMS-MPT (D. Del.)

        by Malaika D. Tyson

    Undue delay that resulted in prejudice to Pfizer coupled with failure to demonstrate good cause are some of the reasons why on November 4, 2013, Magistrate Judge Mary Pat Thynge issued a report and recommendation denying Sandoz’s motion to amend its answers, defenses and counterclaims to add an inequitable conduct defense.

    On May 24, 2012, Pfizer filed suit against Sandoz for infringement of U.S. Patent No. 8,026,276 directed to parenteral formulations of rapamycin.  In Sandoz's expert reports, which were served August 20, 2013, Sandoz first raised the theory of inequitable conduct.  On September 20, 2013, Sandoz moved to amend its pleadings to add claims of inequitable conduct.  The deadline to amend the pleadings was March 22, 2013.

    When deciding whether to grant leave to amend pleadings under Rule 15(a), the court considers four elements: 1) undue delay by the movant; 2) unfair prejudice to the nonmovant; 3) improper purpose; and 4) futility.  As for the good cause requirement of Rule 16(b), the movant must demonstrate "that the amendment could not have been reasonably sought in a timely manner despite diligence."

    While undue delay alone is "not sufficient to justify a denial of leave to amend," it weighs in favor of denial.  Here, the court focused on the actions of Sandoz, concluding that because Sandoz had the required documents in its possession within a few weeks of the deadline to amend the pleadings, its delay was undue.  The court was not convinced by Sandoz’s explanation for the delay–the volume of the record and concurrent litigation–concluding that Sandoz did not establish good cause under Rule 16(b) because it could not "satisfactorily explain its substantial delay."

    The court then concluded that Pfizer would be subject to unfair prejudice if the leave to amend was granted.  Even though the inequitable conduct allegations were based on documents within Pfizer's control, the court concluded that Pfizer had "a significantly compressed time frame" for a response compared to the "fourteen months" Sandoz had to develop its inequitable conduct defense.

    The court also concluded that Sandoz's amendment would be futile (improper purpose was not challenged by Pfizer and therefore not addressed by the court).  Inequitable conduct is based in fraud and under Rule 9(b) the elements of fraudulent claims must be plead with particularity.  Sandoz argued that Pfizer’s Rule 131 and Rule 132 declaration were "unmistakably false and the falsehood is both material and evidence of specific intent."  But the court concluded that Sandoz failed to "create a reasonable inference of specific intent to deceive the PTO" because "other than alleging that the inventor filed two false affidavits, [Sandoz] does no more than argue that information and belief is sufficient to reasonably infer intent. Thus, there is an insufficient factual basis to draw an inference of specific intent to deceive."

    Finally the court held that "[e]ven if the proposed amendment is not futile, the failure to demonstrate good cause and inadequately explained delay for filing the motion resulting in prejudice warrant denying the motion."

    On November 12, 2013, the parties jointly submitted a letter to the court stating that they had agreed to settle the case.

  • First-Ever Judicial Interpretation of Biosimilar Patent Litigation Statute Results in Dismissal of DJ Action

    Sandoz v. Amgen and Hoffman-La Roche, No. 13-204 (N.D. Cal.)

        by Aaron F. Barkoff

    In what appears to be the first court decision interpreting the patent litigation provisions of the BPCIA (the "Biosimilar Act"), the U.S. District Court for the Northern District of California granted Amgen's motion to dismiss Sandoz's declaratory judgment complaint concerning patents protecting Enbrel (etanercept).  In its order dismissing the case, the court stated that "neither a reference product sponsor, such as Amgen, nor [a biosimilar] applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information."

    Sandoz filed its complaint in June, alleging that it is conducting clinical trials on a "biologic drug containing etanercept" and that it "intends to file an FDA application for licensure of its etanercept product as biosimilar to Enbrel" upon completion of the clinical trials.  Sandoz sought a declaration that its biosimilar product does not infringe either U.S. Patent No. 8,063,182 or 8,163,522 and that the two patents are invalid and unenforceable.

    Amgen responded by filing a motion to dismiss for lack of subject matter jurisdiction, arguing that the complaint was premature for two reasons: (1) a district court lacks statutory authority to consider a patent dispute involving a biosimilar product until after such time as an application for FDA approval of the biosimilar product has been filed, and (2) as a factual matter, a cognizable case or controversy does not presently exist.

    Sandoz argued in its opposition brief that the Biosimilar Act "provides [declaratory judgment] actions can be filed by either party upon the biosimilar manufacturer's notice of commercial marketing, which Sandoz has given here."  But the court disagreed:

    First, as set forth in the section on which Sandoz relies, a "notice of commercial marketing" is required to be given by the applicant to the reference product sponsor "not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)."  Here, Sandoz cannot, as a matter of law, have provided a "notice of commercial marketing" because, as discussed above, its etanercept product is not "licensed under subsection (k)."  Second, even after an applicant provides a "notice of commercial marketing," it cannot bring an action for declaratory relief until, at a minimum, it has complied with its obligations under § 262(l)(2)(A).

    In addition, the court determined that Sandoz failed to establish a "case or controversy" as required by Article III of the Constitution.  Here, the court found that Amgen never threatened to sue Sandoz and that Sandoz did not submit "evidence demonstrating [Amgen], by some means other than an express threat to sue, subjected Sandoz to an 'immediate' threat of injury."  Further, citing two Federal Circuit cases in support, the court found that "Sandoz's allegation that it intends in the future to file an application with the FDA is insufficient to create a case or controversy."

    Ever since the Biosimilar Act was passed in 2010, litigators have studied the patent litigation provisions of the Act and debated which strategies to pursue.  The court's interpretation of the Act in this case is significant–particularly since it is the first.  If other district courts interpret the Act in the same way, certain litigation strategies will be off the table.