Orange Book Blog

At the intersection of Patent and FDA Law

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  • District of New Jersey Allows ANDA Filer’s Declaratory Judgment Action to Proceed Despite Covenant Not to Sue

    Purdue Pharm. Products v. TWI Pharms., No. 12-5311 (D.N.J.)

        by Alex Menchaca

    In an opinion last week, the U.S. District Court for the District of New Jersey stymied what appears to be an attempt by Purdue Pharma to prevent TWi Pharmaceuticals from obtaining a final judgment of noninfringement of all four Orange Book-listed patents on Intermezzo® (zolpidem tartrate).  A final judgment could trigger the marketing requirement of the first ANDA filer.  If the first filer does not market its product within 75 days of a final judgment, it will forfeit its 180-day exclusivity.

    Purdue holds the NDA for Intermezzo®, a drug used to treat middle-of-the-night insomnia.  Four patents are listed in the Orange Book in connection with the NDA.  By the time TWi filed its ANDA, four other ANDAs had already been filed and presumably at least one of those is entitled to 180-day exclusivity.  Purdue sued TWi on only two of the patents, and granted TWi a covenant not to sue on the other two.  TWi filed a DJ counterclaim for noninfringement of all four Orange Book-listed patents.

    As simplified by the court, TWi's DJ counterclaim is important because it "could potentially trigger the first ANDA filer's 180-day exclusivity period.  This would have the effect of expediting TWi's ability to market its generic version of Intermezzo®."

    Purdue filed a motion to dismiss TWi's counterclaim, presenting three arguments that no case or controversy exists and therefore the court lacks jurisdiction: (1) the "covenant not to sue rendered moot any such controversy," (2) "the Court cannot redress TWi's alleged injury," and (3) "the dispute is not ripe in light of TWi's inability to obtain tentative approval."

    In response to Purdue's mootness argument, the court stated, "[t]here is ample authority supporting the proposition that a later ANDA filer's declaratory judgment claims involving patents for which the patent holder has given a covenant not to sue are justiciable."  The court therefore held that "the binding principles the Federal Circuit set forth in Dey and Caraco compel this Court to conclude that Plaintiffs' covenant not to sue TWi on the '945 and '628 patents does not moot TWi's counterclaims seeking declaratory judgment that these patents are not infringed."

    With regard to whether TWi's injury is redressable, Purdue argued that "a judgment favorable to TWi on the '945 and '628 patents will not redress any injury arising from delay in TWi's ability to market its generic version of Intermezzo® because such a judgment would not independently trigger the first ANDA filer's exclusivity period as TWi has not received tentative approval from the FDA to market its generic product."  In other words, Purdue argued that because "an applicant in TWi's position cannot trigger the first applicant's exclusivity period through a declaratory judgment action unless it has first received tentative approval," the court cannot redress TWi's purported injury.

    The court noted that the Federal Circuit has not addressed whether a subsequent ANDA filer must first have tentative approval to maintain a declaratory judgment action like TWi's.  Nevertheless, it rejected Purdue's argument based largely on Judge Dow's decision in Seattle Children's Hospital v. Akorn (N.D. Ill. 2011).  The Akorn court recognized that the Hatch-Waxman Act "created a civil action to obtain patent certainty ("CAPC") that could be brought by an ANDA applicant at a time when it likely would not have tentative approval," indicating that other DJ actions similarly do not require that the ANDA filer must have tentative approval.  Following Akorn, the court held that tentative approval is not required for TWi to maintain its DJ counterclaim.

    Finally, the court held that the case is indeed ripe, noting that "delaying judicial consideration of TWi's counterclaims could result in depriving TWi of the ability to trigger the first ANDA filer's 180-day exclusivity period, thus causing TWi to lose profits during the period of time it is excluded from the market.  Accordingly, the court found that "delay in resolving TWi's counterclaims will have an immediate and substantial impact on TWi."

    Although not settled until the Federal Circuit weighs in, based on this case and Akorn it appears that the courts will permit ANDA filers to assert DJ counterclaims even before receiving tentative approval from the FDA and despite having a covenant not to sue from the patent owner.

  • ACI “Paragraph IV Disputes” Conference, New York, April 28-28

    American Conference Institute will be holding their 8th annual "Paragraph IV Disputes" conference on April 28-29 in New York.  Highlights of the conference include a district court judges panel, a magistrate judges panel, and an FTC keynote address.  Here is the complete agenda:

    • On the 30th Anniversary of the Drug Price Competition and Patent Term Restoration Act: Understanding Hatch-Waxman's Transformative Impact on the Pharmaceutical Industry
    • Assessing Pharmaceutical Patent Sustainability and Vulnerability: Strategies and Considerations for Brand Names and Generics in Anticipating, Identifying and Determining Which Patents Will be Ripe for Challenges of Invalidity and Non-Infringement
    • Use of IPR and Other PTO Proceedings in a Paragraph IV Challenge: Strategies for Brand Names and Generics in Navigating PTO Proceedings in ANDA Litigation
    • The Gauntlet Rethrown: The Paragraph IV Certification and Notice Letter
    • Of Prior Art and Double Patenting: Exploring the Dichotomy Between the Federal Circuit and PTO on Obviousness Findings and Potential Impact of the Goodlatte Bill on Obviousness-Type Double Patenting
    • Let the Games Begin: Advanced Strategies for Drafting and Perfecting Pleadings and Effectively Using Dispositive Motions in Paragraph IV Disputes
    • Working With Local Counsel and Within Local Rules: Magistrate and Local Counsel Roundtable
    • A View From the Bench: District Court Judges Panel
    • Claim Construction and Markman Hearings: Standards, Jurisprudential Splits and Strategies for Paragraph IV Litigation
    • FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis
    • Perils of the Safe Harbor: Understanding How the Resetting of the Boundaries of 271(e)(1) in the Aftermath of Classen and Momenta is Impacting Paragraph IV Litigation Strategies
    • In the Limelight: Strategies and Theories of Inducement, Contributory, and Divided Infringement in Paragraph IV Litigation Concerning Method of Treatment Patents
    • Assessing GDUFA Implementation and Additional Regulatory Developments of FDA Which Impact Paragraph IV Litigation
    • Looking Beyond 180 Days: New Exclusivity Challenges for Brand Names and Generics and Related Implications for Paragraph IV Challenges
    • A Pros and Cons Analysis of Launching At Risk and Survey of New Developments in Seeking Injunctive Relief and Damages
    • Ethical Considerations for Paragraph IV Matters Before the PTO and District Courts: Inequitable Conduct and More

    In addition to the main conference, ACI is offering a post-conference workshop on pharmaceutical patent settlements.

    Orange Book Blog readers can receive discounted registration with code OBB200.  For more information or to register, please visit the conference website.

  • Second Biosimilar Company Files Declaratory Judgment Action Before Filing FDA Application

    Celltrion Healthcare v. Janssen Biotech, No. 14-11613 (D. Mass.)

        by Sandra A. Frantzen

    On March 31, Celltrion filed a Complaint for Declaratory Judgment in the District of Massachusetts against Janssen Biotech, seeking a declaration of invalidity and unenforceability of three Janssen patents.  In its Complaint, Celltrion alleges that it has developed Remsima®, a biosimilar version of Janssen’s infliximab product, which it claims "will become the first biosimilar of an antibody drug ever approved in the United States."  Celltrion's Complaint states that it intends to apply for marketing approval of Remsima® during the first half of 2014 and expects FDA approval by early 2015.  Celltrion alleges that because "it expects to face infringement allegations from Janssen, Celtrion wants to start the adjudicative process regarding the invalidity and unenforceability of Janssen's patents."     

    Celltrion is the second company developing a biosimilar product to file a declaratory judgment action before filing an application for licensure with the FDA.  Last June, Sandoz filed a declaratory judgment action against Amgen and Hoffman-La Roche in the Northern District of California alleging patent invalidity and noninfringement in a case relating to a biosimilar version of Amgen's Enbrel product.   Like Celltrion, Sandoz filed its case before filing a marketing application with the FDA.  As we discussed in a previous post, the district court dismissed the case, holding that Sandoz's declaratory judgment action was premature as there was not yet a "real and immediate injury" to be addressed.  The court further stated that a lawsuit may not be filed "unless and until" a reference product sponsor and biosimilar applicant engage in the "series of statutorily-mandated exchanges of information" under the Biologics Price Competition and Innovation Act ("BPCIA").

    The BPCIA created an abbreviated regulatory pathway ("the subsection (k) pathway") for the approval of "biosimilar" drugs.  Under the BPCIA, a company developing a biosimilar version of a licensed biologic product (or "reference product") may file a subsection (k) application with the FDA for licensure.  Once the FDA notifies the company that its application has been accepted for review, the applicant must then provide certain information about its product and manufacturing process to the reference product sponsor.  Under the Act, the parties then engage in a patent information exchange process which may culminate in a patent lawsuit.  To date, while two lawsuits involving potential biosimilar products have been filed, no company has publicly announced filing a subsection (k) biosimilar application with the FDA.

    The Sandoz v. Amgen case is now on appeal at the Federal Circuit.  Sandoz recently filed its principal brief.  The Defendants' responsive brief is currently due on May 27.

    UPDATE:  Celltrion filed a second Complaint for Declaratory Judgment relating to its Remsima® product–this one in the Southern District of New York against Kennedy Trust for Rheumatology Research and seeking a declaration of invalidity of three Kennedy patents.  Like its allegations against Janssen, Celltrion alleges that it "expects to face patent infringement allegations from Kennedy" over Remsima® and thus "wants to start the adjudicative process . . . and immediately avail itself of the processes available in the federal judiciary to discover information relating to Kennedy’s patents."

  • Federal Circuit Affirms Validity of Pfizer’s Lyrica (Pregabalin) Patent

    Pfizer Inc. et al. v. Teva Pharms. USA et al., No. 2012-1576 (Fed. Cir.)

    Teva and several other generic pharmaceutical companies each submitted an ANDA seeking approval to market a generic version of Lyrica, for treating seizures and pain. In a unanimous decision last Thursday, the Federal Circuit affirmed the judgment of the U.S. District Court for the District of Delaware by finding claim 2 of U.S. Patent Nos. 6,197,819, covering the active ingredient of Lyrica, pregabalin, infringed and not invalid for lack of enablement, written description, or obviousness.

    Pfizer and Northwestern University initally asserted four Orange Book-listed patents against the ANDA filers, but the case ultimately hinged on claim 2 of the '819 patent, which reads quite simply:

    2. 4-amino-3-(2-methylpropyl) butanoic acid, or a pharmaceutically acceptable salt thereof.

    The compound of claim 2 contains a single chiral center, and may exist, for example, in enantiomerically pure (R)- or (S)- forms or a racemic form, the latter containing equal quantities of both enantiomers. Lyrica and the proposed generic products each contain pregabalin, which is only the S-enantiomer of 4-amino-3-(2-methylpropyl) butanoic acid. Before the district court, the defendants asserted that claim 2 of the '819 patent should be interpreted to cover only the racemic form of 4-amino-3-(2-methylpropyl) butanoic acid (also "3-isobutyl-gamma-aminobutyric acid" or "3-isobutylGABA"). If so construed, the proposed products would not literally infringe the claim. Further, the defendants alleged that claim 2 is invalid for failing the enablement and written description requirements of 35 U.S.C. 112(a) and for obviousness under 35 U.S.C. 103 in view of three asserted prior art references.

    The district court's Markman order construed claim 2 of the '819 patent to encompass all stereochemical forms of 3-isobutylGABA. The parties stipulated to infringment by the defendants' proposed products if claim 2 was found valid and enforceable, as interpreted by the district court. This appeal followed the district court's finding that claim 2 of the '819 patent was enforceable and not invalid for the reasons offered by the defendants. On appeal, the defendants asserted that the district court erred in claim construction and its findings with respect to enablement, written description, and obviousness. The Federal Circuit affirmed the district court on all issues.

    With respect to claim construction and infringement, the Federal Circuit declined to read limitations into claim 2 that were not present in the claim text. After noting that the defendants' expert admitted that claim 2 covers "3-isobutylGABA in any isomeric form," the court stated that the '819 patent made clear that the patent applicants were capable of indicating when individual enantiomers and when racemic forms of compounds were intended, by using the appropriate (R,S)- or (R)- or (S)- prefixes. Nor could the court find any clear disavowal in the '819 patent that would indicate that a lack of stereochemical indication was intended to limit the disclosure to only the racemic form. In view of the lack of any stereochemical limitation within claim 2, the court upheld the district court's interpretation and finding of infringement of claim 2 of the '819 patent.

    On enablement, the ANDA filers asserted that if claim 2 were interpreted to cover all compositions of 3-isobutylGABA, regardless of enantiomeric form, then the specification failed to "teach a skilled artisan how to prepare every conceivable mixture of 3-isobutylGABA’s enantiomer." However, the defendants failed to convince the court that such mixtures were anything other than routine to one of ordinary skill in the art. The court noted that the '819 patent disclosed the method for synthesizing the compound and states that the compound's "enantiomers may be prepared or isolated by methods already well known in the art." Citing In re Hogan, 559 F.2d 595, 606 (CCPA 1977), the court declined to require an applicant to disclose "a detailed recipe for preparing every conceivable permutation of the compound they invented to be entitled to a claim covering that compound."

    For written description, Appellant Sun Pharmaceuticals (only) focused on a lack of disclosure by the '819 patent regarding isolation of the individual enantiomers. Sun proposed that since later application filings by the patentee indicated that enantiomer separation for 3-isobutylGABA may have been less than routine, and that the inventors admitted that at the time of filing of their original applications, they had not yet actually separated the 3-isobutylGABA enantiomers, then the applicants were not in possession of the broader claim scope. However, the court found Sun's focus on the enantiomers to be unpersuasive. Rather, the court focused on whether "relevant identifying characteristics" were provided such that "persons of ordinary skill in the art [] recognize that the inventor invented what is claimed." Here, the court noted that disclosure of the claimed structure (in the absence of stereochemical definition), in vitro and in vivo data for the compound, and a method of synthesizing the compound satisfied the statutory requirements.

    Finally, the ANDA applicants argued that the district court erred in finding claim 2 of the '819 patent not obvious in view of three proffered prior art references. The references were alleged to disclose that 3-isopropylGABA and other homologous compounds may have anticonvulsant activity, that 3-isobutylGABA would have been expected to have similar activity because of its close structural simlarity to the former, and that the anti-convulsant gabapentin, another 3-substituted gamma-amino butyric acid (GABA) derivative, provided motivation to try other substitutions as the 3-position of GABA.

    The court applied the two-part test for obviousness of a chemical compound outlined in Eisai and Takeda by reviewing for (1) whether the asserted prior art compound would have been selected as a lead compound for further modification and (2) whether the prior art would have taught a skilled artisan to make the "specific molecular modifications" necessary to the selected lead compound to yield the claimed compound with a reasonable expectation of success.

    As to the first prong, the court reiterated that more than "mere structural similarity" is necessary for a prior art compound to serve as a lead compound. Rather, other properties, such as chemical activity or potency, inform the lead compound selection. Here, the court was unmoved by the offer of either 3-isopropylGABA or gabapentin as a lead compound. The court found insufficient details in the cited art regarding properties of either compound that would have lead to their selection for further research. With respect to gabapentin, the prior art was vague as to whether the compound was in the prior art at all, and if so, whether any of its relevant properties, such as anticonvulsant activities in the context of other anticonvulsants known at the time would have highlighted the compound for further modification. For 3-isopropylGABA, the court noted that the prior art failed to teach its "mechanisms of action, including whether it has anticonvulsive properties."

    Moving to the second prong, the court noted that even if either compound were selected as a lead compound, the proffered art failed to teach the precise modifications necessary to yield 3-isobutylGABA. Rather, the court noted that the cited art merely suggest "trillions" of compounds "without calling out alkyl groups in particular or singling out isobutyl specifically." The court concluded by agreeing with the district court's finding that the appellees had convincingly established the complicated and unpredictable nature of anticonvulsant field at the time of filing, thereby precluding any reasonable expectation of success in achieving anticonvulsant in 3-isobutylGABA "even if Appellants were able to establish that the prior art taught the substitution of isobutyl at GABA’s 3-position."

  • 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.