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  • Court Report — Part III

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Forest Laboratories LLC et al. v. Sigmapharm Laboratories LLC
    1:14-cv-01119; filed September 3, 2014 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
    • Defendant:  Sigmapharm Laboratories LLC

    Infringement of U.S. Patent Nos. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998) and 7,741,358 ("Crystal Form of Asenapine Maleate," issued June 22, 2010) following a Paragraph IV certification as part of Sigmapharm's filing of an ANDA to manufacture a generic version of Forest's Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder).  View the complaint here.

    Cephalon, Inc. v. Nang Kuang Pharmaceutical Co., LTD et al.
    1:14-cv-05180; filed September 3, 2014 in the Eastern District of New York

    • Plaintiff:  Cephalon, Inc.
    • Defendants:  Nang Kuang Pharmaceutical Co., LTD; Canada NK-1, LLC

    Cephalon, Inc. v. Nang Kuang Pharmaceutical Co LTD et al.
    1:14-cv-01117; filed September 2, 2014 in the District Court of Delaware

    • Plaintiff:  Cephalon, Inc.
    • Defendants:  Nang Kuang Pharmaceutical Co LTD; Canada NK-1 LLC

    Cephalon, Inc. v. Sagent Pharmaceuticals Inc. et al.
    1:14-cv-01116; filed September 2, 2014 in the District Court of Delaware

    • Plaintiff:  Cephalon, Inc.
    • Defendants:  Sagent Pharmaceuticals Inc.; Sagent Agila LLC

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013), 8,609,863 (same title, issued December 17, 2013), and 8,791,270 (same title, issued July 29, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the Sagent complaint here.

    United Therapeutics Corp. v. Teva Pharmaceuticals USA, Inc.
    3:14-cv-05498; filed September 2, 2014 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,765,117 ("Process for Stereoselective Synthesis of Prostacyclin Derivatives," issued July 20, 2004), 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014), 7,999,007 ("Buffer Solutions Having Selective Bactericidal Activity Against Gram Negative Bacteria," issued August 16, 2011), 8,653,137 (same title, issued February 18, 2014), and 8,658,694 (same title, issued February 25, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of United's Remodulin® (treprostinil sodium injection, used to treat pulmonary arterial hypertension).  View the complaint here.

    United Therapeutics Corp. v. Sandoz, Inc.
    3:14-cv-05499; filed September 2, 2014 in the District Court of New Jersey

    Infringement of U.S. Patent No. 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2014) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of United's Remodulin® (treprostinil sodium injection, used to treat pulmonary arterial hypertension).  View the complaint here.

    Mission Pharmacal Co. v. Acella Pharmaceuticals, L.L.C.
    5:14-cv-00771; filed September 2, 2014 in the Western District of Texas

    Infringement of U.S. Patent No. 6,521,247 ("Dual Iron Containing Nutritional Supplement," issued February 18, 2003) based on Acella's manufacture and sale of its Prenaissance Promise, Prenaissance DHA, and Prenaissance 90 DHA prenatal supplements.  View the complaint here.

    Hospira, Inc. v. Janssen Biotech, Inc. et al.
    1:14-cv-07049; filed August 29, 2014 in the Southern District of New York

    • Plaintiff:  Hospira, Inc.
    • Defendants:  Janssen Biotech, Inc.; New York University; NYU Langone Medical Center; Kennedy Trust for Rheumatology Research

    Declaratory judgment of non-infringement and invalidity U.S. Patent Nos. 6,284,471 ("Anti‐TNFa Antibodies And Assays Employing Anti‐TNFa Antibodies," issued September 4, 2001), 7,223,396 ("Methods of Treatment of Fistulas in Crohn's Disease with Anti‐TNF Antibodies," issued May 29, 2007), 7,846,442 ("Methods of Treating Rheumatoid Arthritis with an Anti-TNF-alpha Antibodies and Methotrexate," issued December 7, 2010), 8,298,537 ("Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-α Antibodies and Methotrexate," issued October 30, 2012), and 8,383,120 ("Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate," issued February 26, 2013) based on Hospira's anticipated manufacture and sale of its Inflectra® product, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis).  View the complaint here.

    Boehringer Ingelheim Pharma Gmbh & Co. KG et al. v. Mylan Pharmaceuticals Inc.
    1:14-cv-00146; filed August 29, 2014 in the Northern District of West Virginia

    • Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals, Inc.
    • Defendant:  Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent No. 6,015,577 ("Pharmaceutical Compositions Containing Dipyridamole or Mopidamol and Acetylsalicylic Acid or the Physiologically Acceptable Salts Thereof, Processes for Preparing Them and Their Use in Treating Clot Formation," issued January 18, 2000) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Aggrenox® (extended-release dipyridamole/acetylsalicylic acid, used to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis).  View the complaint here.

  • U.S. Bancorp v. Solutran, Inc. (PTAB 2014)

    By Michael Borella —

    US BancorpIn the weeks since the Alice Corp. v. CLS Bank Supreme Court decision, we have been watching patents and applications fall left and right due to use of that case's more stringent test regarding patent-eligibility.  This test requires that, for purposes of determining whether claims involve statutory subject matter under 35 U.S.C. § 101, one must apply a two prong analysis.  The first prong is to determine whether the claims are directed to a patent-ineligible law of nature, natural phenomenon, or abstract idea.  If so, the second prong is to determine whether any additional claim elements transform the nature of the claim into a patent-eligible application that amounts to significantly more than the ineligible concept itself.

    While not explicitly targeting software and business methods, in reality the Court has made these types of patents more difficult to obtain.  The U.S. district courts, the Federal Circuit, and the U.S. Patent and Trademark Office have been applying the CLS Bank test aggressively.  In the vast majority of cases, the claims under consideration are found to be patent-ineligible.

    Consequently, one of the difficulties we have when trying to draft or amend claims so that they withstand scrutiny is that there are very few examples of claims that are patent-eligible under CLS Bank.  All Federal Circuit case law interpreting § 101 prior to June 19 of this year (the date of the CLS Bank decision), is suspect.  Thus, when a post-CLS Bank case that applies the CLS Bank test finds claims patent-eligible, that case is worthy of attention.

    U.S. Bancorp v. Solutran, Inc. was a covered business method review before the Office's Patent Trial and Appeal Board.  While this case does not carry the weight of precedent, it does provide a glimpse at what some of the Office's administrative patent judges may be thinking regarding § 101.

    U.S. Bancorp petitioned for the review in order to challenge the patentability of claims 1-6 of U.S. Patent No. 8,311,945, owned by Solutran.  As an example, claim 1 of the '945 patent recites:

    1.  A method for processing paper checks, comprising:
        a) electronically receiving a data file containing data captured at a merchant's point of purchase, said data including an amount of a transaction associated with MICR information for each paper check, and said data file not including images of said checks;
        b) after step a), crediting an account for the merchant;
        c) after step b), receiving said paper checks and scanning said checks with a digital image scanner thereby creating digital images of said checks and, for each said check, associating said digital image with said check's MICR information; and
        d) comparing by a computer said digital images, with said data in the data file to find matches.

    The Board first verified that this patent is ripe for covered business method review, in that the petitioner had been sued for infringement of the patent, the claims for which review had been requested were directed to a financial product or service, and that the challenged patent was not technical in nature.  The last part of this test as applied by the Board is notable.  The Board sought to determine "whether the claimed subject matter as a whole recites a technological feature that is novel and unobvious over the prior art; and solves a technical problem using a technical solution."  In answering this question in the negative, the Board wrote that the claimed features of "checks, digital image scanners, and computers were known technologies in the prior art before the effective filing date of the '945 patent in 2006," and that "no limitation of claim 1 . . . represents a technological feature that is novel or unobvious over the prior art."  With that threshold test out of the way, the Board initiated the review.

    Among other points, U.S. Bancorp contended that "[o]ther than the claimed idea of a non-merchant entity performing check scanning, claim 1 includes nothing but mental process steps, insignificant extra-solution activity, and conventional computer hardware components for performing basic computer  functions."  The Board responded by indicating that "[i]n determining whether a method or process claim recites an abstract idea, we must examine the claim as a whole."  Thus, the Board found U.S. Bancorp's arguments unpersuasive because "they are directed to each method step individually without accounting sufficiently for the claims as a whole."

    Instead, when conducting the first prong of the CLS Bank test, the Board found that the claim 1 was directed to "a method of processing paper checks, which is more akin to a physical process than an abstract idea."  Thus, despite claim 1 reciting "some fundamental economic practices . . . such as crediting an account for a merchant," the additional features of "receiving said paper checks and scanning said checks with a digital scanner and comparing by a computer said digital images . . . are not fundamental economic practices, mathematical algorithms, or basic tools of scientific and technological work."

    Noting that "application of the Supreme Court's test cannot disembody such recitations from the claim viewed as a whole," the Board held that claim 1 was directed to processing paper checks rather than an abstract idea.  Thus, the Board concluded that U.S. Bancorp "has not demonstrated that it is more likely than not that challenged claims 1-6 are unpatentable under 35 U.S.C. § 101."  (Ultimately, the Board ordered a covered business method review of the claims because it also concluded that the claims were more likely than not obvious over applicant admitted prior art and a secondary reference.)

    The procedural stance of this case is unusual.  It was before the Patent Trial and Appeal Board rather than a federal court.  Also, this opinion only considered whether it is more likely than not that the claims would eventually be found to be unpatentable.  Nonetheless, the Board's application of the first prong from CLS Bank is informative, and provides patent holders with a tool than can be used to rebut contentions of patent-ineligibility — namely, an example of a business method patent that is not directed to an abstract idea.

    Since the Board decided that the claims were not directed to an abstract idea, it never reached the issue of whether the claims recite "significantly more."  A case that illustrates how to apply the second prong would be welcome.

    U.S. Bancorp v. Solutran, Inc., Case No. CBM2014-00076, 2014 WL 3943913 (PTAB Aug. 7, 2014)

  • Federal Trade Commission “Meets the Press”

    By Kevin E. Noonan —

    Federal Trade Commission (FTC) SealFederal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's crusade against the pharmaceutical industry (branded and generic).  Seemingly emboldened by its partial victory at the Supreme Court in FTC v. Actavis, in this action the Commission has expanded its allegations of anticompetitive behavior beyond cash payments from branded to generic drug companies (provocatively termed "pay-for-delay" agreements) to other forms of agreements (and not for the first time).

    The drug at issue is Androgel, "a topical pharmaceutical gel product approved for testosterone replacement therapy in men with low testosterone", which has been the subject of other FTC actions, (including FTC v. Actavis); the Commission stated that the branded drugmakers, AbbVie and Besin Helathcare, had annual sales of over one billion dollars for this drug.  The e-mail announcing the press conference (as well as statements made during the conference) was awash with the scarlet rhetoric (and self-congratulatory hagiography) that has characterized the Commission's anti-reverse settlement campaign.  This is "the latest action to ensure competition in the nation's healthcare markets" according to the Commission, its aim to stop "several major pharmaceutical companies [from] illegally blocking American consumers' access to lower-cost versions of the blockbuster drug AndroGel."  The Commission describes the goal of its efforts as "stop[ping] anticompetitive conduct by AbbVie, Besins Healthcare and Teva which has forced consumers to overpay hundreds of millions for the drug AndroGel," and by filing the lawsuit to "reinforce[] the Commission's longstanding commitment to protect American consumers from collusive arrangements between branded and generic pharmaceutical companies that inflate the prices of prescription drugs and harm competition."  The Commission also wants to force the parties to "disgorge their ill-gotten gains" (a remark the brings to mind Humphrey Bogart's comment in The Maltese Falcon that "the cheaper the gunsel, the gaudier the patter") in addition to having a court issue a permanent injunction against the parties regarding this settlement.

    The Commission describes its complaint as alleging that "AbbVie Inc. and its partner Besins Healthcare Inc. filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of the testosterone replacement drug AndroGel," a charge also asserted by Ms. Feinstein during the press conference.  The specific ground for the complaint is a settlement between the parties that the Commission characterizes as "an anticompetitive pay-for-delay settlement agreement."  But as further explained by Chairwoman Ramirez and Director Feinstein, the complained-of agreement was in fact not a "pay-for-delay" agreement.  On the contrary, what the Commission wants to ban in this case is an agreement wherein AbbVie agreed to permit Teva to market an authorized generic for a cholesterol drug called TriCor.  The Commission makes much of the fact that annual U.S. sales of this drug were more than $1 billion in 2011, and thus "highly profitable for Teva" (of course, this can also be characterized as "consideration"; as noted in In re Lamictal Direct Purchaser Antitrust Litig., 2014 U.S. Dist. LEXIS 9257, at *24, "[a] law student learns in the first semester that consideration is an essential element of any enforceable contract.  In this sense, there is 'payment' in every settlement.")  Also, the Commission contends that this arrangement "made no independent business sense for AbbVie."  Thus the agreement constituted anticompetitive behavior.  Such contentions are a far cry from the Supreme Court's holding in the Actavis case.

    The Commission's complaint also asserts as one ground that the branded drug makers' lawsuit was a sham (an allegation also made by Teva in the underlying ANDA litigation in support of an antitrust counterclaim but one that comes close to finding anticompetitive behavior by way of statutory compliance).  The litigation is asserted to be a sham because the Orange Book listed patent, U.S. Patent No. 6,503,894, claimed a testosterone formulation containing a specific (skin) penetration enhancer, isopropyl myristate (IPM), and the generic formulations comprised other penetration enhancers (specifically, isostearic acid or isopropyl palmitate).  The complaint alleges that the Besin's plaintiff and patentee Unimed (a predecessor-in-interest to AbbVie) had narrowed broad claims as filed to any penetration enhancer to encompass only formulations comprising IPM, and had distinguished over formulations comprising other enhancers.  Thus, the Commission contended in its complaint that the generic formulations did not literally infringe the '894 claims and could not infringe under the doctrine of equivalents because prosecution history estoppel barred the claims from having this scope.  (Ironically, the Commission should be in exactly the position foretold by Chief Justice Roberts in his Actavis dissent, of having to prove the patenting issues as a predicate to considering the antitrust issues.)  Moreover, the Commission alleged in its complaint that plaintiffs had successfully used a Citizens' Petition to convince the FDA to require generic defendants to file NDA's on their formulations, based on differences between IPM and the other penetration enhancers.  The Commission also alleged that the incentive for filing ANDA litigation was to trigger improperly the 30-month stay in FDA approval mandated by the statute.

    It is possible that this attempt to expand the factual grounds for putting ANDA settlement agreements under the Commission's antitrust microscope may be going too far for some of the Commissioners; as Chairwoman Ramirez and Director Feinstein admitted, for the first time the vote to bring the complaint was not unanimous, and indeed was 3-2, with Commissioners Maureen K. Ohlhausen and Joshua D. Wright dissenting (there is no public record of either the deliberations or the dissents).  The complaint was also filed in light of rejection of the FTC's theory that actions other than cash payments can trigger application of the Supreme Court's Actavis precedent, in a decision in the District Court of Rhode Island regarding the drug Loestrin.  In that case, District Court Judge William E. Smith (on September 4, 2014, four days before the FTC filed its complaint in this case) granted defendants' motion to dismiss an antitrust claim based on an agreement over an authorized generic rather than a cash payment (while recognizing that how district courts are deciding the question of whether non-cash arrangements fall within the scope of the Actavis decision has been inconsistent, an outcome also anticipated by Chief Justice Roberts in his Actavis dissent).

    The complaint, alleging violations of the FTC Act for monopolization and restraint of trade, was filed under seal in the U.S. District Court for the Eastern District of Pennsylvania on September 8, 2014 and only a redacted version has been made public.

  • Court Report — Part II

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Roxane Laboratories, Inc. v. Zydus Pharmaceuticals USA, Inc.
    2:14-cv-05423; filed August 28, 2014 in the District Court of New Jersey

    Roxane Laboratories, Inc. v. Amneal Pharmaceuticals, LLC
    2:14-cv-05420; filed August 28, 2014 in the District Court of New Jersey

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease).  View the Zydus complaint here.


    Novartis Pharmaceuticals Corp. et al. v. Zydus Noveltech Inc. et al.
    2:14-cv-05405; filed August 28, 2014 in the District Court of New Jersey

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
    • Defendants:  Zydus Noveltech Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

    Novartis Pharmaceuticals Corp. et al. v. Zydus Noveltech Inc. et al.
    1:14-cv-01104; filed August 27, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
    • Defendants:  Zydus Noveltech Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the Delaware complaint here.

    Senju Pharmaceutical Co. Ltd. et al. v. Micro Labs Ltd. et al.
    1:14-cv-01105; filed August 27, 2014 in the District Court of Delaware

    • Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
    • Defendants:  Micro Labs Ltd.; Micro Labs USA Inc.

    Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001) following a Paragraph IV certification as part of Micro Labs' filing of an ANDA to manufacture a generic version of Allergan's Zymaxid® (0.5 w/v % gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis).  View the complaint here.

    Bristol-Myers Squibb Co. v. Amneal Pharmaceuticals LLC
    1:14-cv-01086; filed August 22, 2014 in the District Court of Delaware

    Infringement of U.S. Patent No. 5,206,244 ("Hydroxymethyl (Methylenecyclopentyl) Purines and Pyrimidines," issued April 27, 1993) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of BMS's Baraclude® (entecavir, used to treat chronic hepatitis B virus infectrion).  View the complaint here.

    Janssen Pharmaceuticals Inc. v. VIVUS Inc.
    1:14-cv-01088; filed August 22, 2014 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,071,537 ("Anticonvulsant Derivatives Useful in Treating Obesity," issued June 6, 2000) based on Vivus' manufacture and sale of its Qsymia product (phentermine and topiramate, used to for chronic weight management in adults with a high initial body mass index (BMI)).  View the complaint here.  [NB: The case was voluntarily dismissed two days after filing.]

    Acorda Therapeutics, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
    1:14-cv-00139; filed August 22, 2014 in the Northern District of West Virginia

    • Plaintiffs:  Acorda Therapeutics, Inc.; Alkermes Pharma Ireland Ltd.
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

    Infringement of U.S. Patent Nos. 5,540,938 ("Formulations and Their Use in the Treatment of Neurological Diseases," issued July 30, 1996), 8,007,826 ("Sustained Release Aminopyridine Composition," issued August 30, 2011), 8,354,437 ("Method of Using Sustained Release Aminopyridine Compositions," issued January 15, 2013), 8,440,703 (same title, issued May 14, 2013), and 8,663,685 ("Sustained Release Aminopyridine Composition," issued March 4, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Acorda's Ampyra® (dalfampridine extended release, used to improve walking in patients with multiple sclerosis).  View the complaint here.

  • UCI Conference on Meaning of Myriad

    UCI School of LawThe University of California-Irvine School of Law will be holding a conference entitled "The Meaning of Myriad" from 9:00 am to 5:00 pm on September 12, 2014 at the University of California, Irvine.  The conference schedule is as follows:

    • Panel 1: The New, New Subject Matter
        - Mark Janis, IU Bloomington — Expressive Eligibility
        - Amelia Rinehart, University of Utah — Myriad Lessons Learned

    • Panel 2: Implications for Scientific Research and Medicine
        - Peter Lee, UC Davis — Law, Forbearance, and Definitional Fluidity: The Impact of Myriad Genetics on Scientific Research
        - Anna Laakmann, Lewis & Clark — The New Genomic Semicommons

    • Keynote Address: Hon. Andrew Guilford, USDC — "Judging Myriad"

    • Panel 3: International and Comparative Assessments
        - Brad Sherman, Griffith University — What Does it Mean to Invent Nature?
        - Jessica Lai, University of Lucerne — Myriad Genetics in the European Context: A Contrast to the U.S. Approach

    • Panel 4: Scouting the Way Ahead
        - Lisa L. Oullette, Stanford University — Non-Patent Innovation Incentives and Patentable Subject Matter
        - Mark Lemley, Stanford University — Can Mayo and Myriad be Reconciled?

    Additional information about the conference can be found here.  There is no registration fee for the conference.  Those interested in registering for the seminar can do so here.

  • Court Report

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    UCB Inc. et al. v. Watson Laboratories Inc. (NV) et al.
    1:14-cv-01083; filed August 21, 2014 in the District Court of Delaware

    • Plaintiffs:  UCB Inc.; UCB Manufacturing Ireland Ltd.; UCB Pharma GmbH; LTS Lohmann Therapie-Systeme AG
    • Defendants:  Watson Laboratories Inc. (NV); Watson Laboratories Inc. (DE)

    Infringement of U.S. Patent Nos. 6,699,498 ("Transdermal Therapeutic Systems Having Improved Stabilty and Their Production," issued March 2, 2004), 6,884,434 ("Transdermal Therapeutic System Which Contains a D2 Agonist and Which is Provided for Treating Parkinsonism, and a Method for the Production Thereof," issued April 26, 2005), 7,413,747 ("Transdermal Therapeutic System for Treating Parkinsonism," issued August 19, 2008), 8,246,979 ("Transdermal Delivery System for the Administration of Rotigotine," issued August 21, 2012), 8,246,980 ("Transdermal Delivery System," issued August 21, 2012), and 8,617,591 ("Transdermal Delivery System for the Administration of Rotigotine," issued December 31, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of UCB's Neupro® (rotigotine transdermal systm, used to treat the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe Restless Legs Syndrome).  View the complaint here.

    Mallinckrodt LLC et al. v. Hi-Tech Pharmacal Co. Inc. et al.
    1:14-cv-01084; filed August 21, 2014 in the District Court of Delaware

    • Plaintiffs:  Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
    • Defendants:  Hi-Tech Pharmacal Co. Inc.; Akorn Pharmaceuticals Inc.; Akorn Ophthalmics Inc.; Akorn Inc.

    Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,546,450 (same title, issued October 1, 2013), 8,618,164 (same title, issued December 31, 2013), and 8,741,956 (same title, issued June 3, 2014) following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
    2:14-cv-05260; filed August 21, 2014 in the District Court of New Jersey

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

    Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
    1:14-cv-01076; filed August 20, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) and RE43,932 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued January 15, 2013) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the Delaware complaint here.

    Janssen Products LP et al. v. Cipla Ltd. et al.
    1:14-cv-01056; filed August 15, 2014 in the District Court of Delaware

    • Plaintiffs:  Janssen Products LP; Janssen R&D Ireland
    • Defendants:  Cipla Ltd.; Cipla USA Inc.

    Infringement of U.S. Patent Nos. 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010), 7,126,015 ("Method for the Preparation of Hexahydro-furo-[2,3-b]furan-3-ol," issued October 24, 2006), 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009), and 8,518,987 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued August 27, 2013) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

    Salix Pharmaceuticals Ltd. et al. v. Mylan Pharmaceuticals Inc.
    1:14-cv-01055; filed August 15, 2014 in the District Court of Delaware

    • Plaintiffs:  Salix Pharmaceuticals Ltd.; Salix Pharmaceuticals Inc.; Glycyx Pharmaceuticals Ltd.
    • Defendant:  Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 6,197,341 ("Formulations of Balsalazide and Its Derivatives," issued March 6, 2001) and 8,497,256 ("Formulations and Uses of 2-Hydroxy-5-Phenylazobenzoic Acid Derivatives for the Treatment of Males," issued July 30, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Salix's Giazo® (balsalazide disodium, used for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older).  View the complaint here.

    Forest Laboratories, LLC et al. v. Lupin Ltd. et al.
    1:14-cv-01058; filed August 15, 2014 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories, LLC; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.; Par Pharmaceutical Inc.; Anchen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Inc.; Amerigen Pharmaceuticals Ltd.

    Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

    Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
    2:14-cv-05139; filed August 15, 2014 in the District Court of New Jersey

    Infringement of U.S. Patent No. 8,731,963 ("Sensitive Drug Distribution System and Method," issued May 20, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

    Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
    1:14-cv-05144; filed August 15, 2014 in the District Court of New Jersey

    • Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
    • Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 8,754,131 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued June 17, 2014) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

    United States Department of Health and Human Services et al. v. Cipla Ltd. et al.
    2:14-cv-05135; filed August 15, 2014 in the District Court of New Jersey

    • Plaintiffs:  United States Department of Health and Human Services; Board of Trustees of the University of Illinois
    • Defendants:  Cipla Ltd.; Cipla USA, Inc.

    Infringement of U.S. Patent Nos. 7,470,506 ("Fitness Assay and Associated Methods," issued December 30, 2008) and 8,597,876 ("Method of Treating HIV Infection," issued December 3, 2013), both licensed to Janssen, following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

  • Conference & CLE Calendar

    CalendarSeptember 7-9, 2014 – 42nd Annual Meeting (Intellectual Property Owners Association) – Vancouver, Canada

    September 11, 2014 – "Post-AIA Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and AIA Exceptions" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 11-12, 2014 - Advanced Patent Prosecution Workshop 2014: Claim Drafting & Amendment Writing (Practising Law Institute) – Chicago, IL

    September 16, 2014 – "Section 103 and Obviousness: Capitalizing on CCPA and Early Federal Circuit Precedent — Strategies for Withstanding Obviousness Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 18-19, 2014 – FDA Boot Camp (American Conference Institute) – Boston, MA

    September 25, 2014 – "Charting New Territory: Prosecution and Diligence Strategies in the Wake of the AIA" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) – 1:00 to 2:30 pm (ET)

    September 26, 2014 – IP & Diagnostics Symposium (Biotechnology Industry Organization) – Alexandria, VA

    September 30, 2014 – 2014 Intellectual Property Continuing Legal Education Seminar (DuPont and Widener University School of Law) – Wilmington, DE

    September 30 – October 1, 2014 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago, IL

    October 2, 2014 – "USPTO Guidance for Determining Subject Matter Eligibility In View of U.S. Supreme Court's Mayo and Myriad Decisions" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    October 2, 2014 – "Conflicts in Patent Prosecution: Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 20-22, 2014 – Business of Biosimilars (Institute for International Research) – Boston, MA

    October 29-30, 2014 - Congress on PIV Litigation (Momentum) – Philadelphia, PA

    ***Patent Docs is a media partner of this conference or CLE

  • News from Abroad: Myriad Patent Upheld by Full Federal Court of Australia

    By Claire Gregg* and Martin O'Brien** —

    Australia Coat of ArmsThe Full Federal Court of Australia has handed down its long awaited decision in D'Arcy v Myriad Genetics Inc today, affirming that isolated DNA and RNA are patentable subject matter under Australian law.

    The first instance decision of Nicholas J was appealed to the Full Federal Court on the grounds that the earlier Federal Court decision erred in its conclusion that isolating a gene is sufficient to render it a manner of manufacture.  We refer you to our article of 15 February 2013 for a more detailed discussion of the first instance Federal Court decision.

    Under Australian law, s 18(1)(a) of the Patents Act 1990 requires that, in order to constitute patentable subject matter, the claimed invention must be 'a manner of manufacture within the meaning of section 6 of the Statute of Monopolies'.  The meaning of 'manner of manufacture'was broadly construed by the High Court of Australia in National Research Development Corporation v Commissioner of Patents (NRDC), which held that a claim directed to a product found in nature may constitute a manner of manufacture provided that the claimed product involves an artificially created state of affairs and has utility in a field of economic significance.

    In view of the principles laid down in NRDC, the Full Federal Court unanimously upheld the decision of Nicholas J, emphasizing that '[t]his case is not about the wisdom of the patent system.  It is about the application of Australian patent law, as set out in the Act and as developed by the courts since the Statute of Monopolies'.

    The Court went on to note that it is not the role of the courts to decide 'whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability', re-iterating that the Australian Parliament has previously considered such questions and chosen not to exclude gene sequences from patentability.

    The Court concluded that an isolated gene sequence is different to the gene as it exists in nature, with specific reference to the functional differences that arise as a result of isolation.  The Court further rejected the view of the U.S. Supreme Court that Myriad's claims are concerned 'primarily with the information contained in the genetic sequence'.  Rather, the Full Court emphasized that the claim in question 'is to a compound; a nucleic acid.  It is not a claim to information'.

    The Full Court's decision that the isolated nucleic acid in question has 'resulted in an artificially created state of affairs for economic benefit' and is therefore capable of defining patentable subject matter, has maintained the status quo in Australia in relation to the patentability of isolated gene sequences.  However, the possibility of an application for Special Leave to Appeal to the High Court still exists, and thus it may be some time before this matter is finally put to rest in Australia.

    The decision of the Full Federal Court of Australia can be found here.

    * Dr. Gregg is a Patent Scientist with the Chemical / Life Sciences Team of Spruson & Ferguson in Sydney, Australia.

    ** Dr. O'Brien is a Principal / Patent Attorney with the Chemical / Life Sciences Team of Spruson & Ferguson in Sydney, Australia.

  • AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)

    By Donald Zuhn —

    Kennedy TrustLast month, in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed a determination by the District Court for the Southern District of New York that U.S. Patent No. 7,846,442, which is owned by the Mathilda & Terence Kennedy Institute of Rheumatology Trust ("Kennedy Trust"), was invalid under the doctrine of obviousness-type double patenting in view of the Kennedy Trust's U.S. Patent No. 6,270,766.

    The '766 and '442 patents are directed towards methods of treating rheumatoid arthritis by co-administering a disease-modifying antirheumatic drug (such as methotrexate) and an anti-TNFα antibody.  Representative claim 8 of the '766 patent recites (with emphasis added):

    8.  A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an [anti-TNFα] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.

    and representative claim 1 of the '442 patent recites (with emphasis added):

    1.  A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate comprising adjunctively administering with methotrexate therapy a different composition comprising an anti-human [TNFα] antibody or a human [TNFα] binding fragment thereof to the individual, wherein the anti-human [TNFα] or fragment thereof (a) binds to an epitope on human [TNFα], (b) inhibits binding of human [TNFα] to human [TNFα] cell surface receptors and (c) is administered at a dosage of 0.01-100 mg/kg, and wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.

    The relevant differences between the two representative claims are as follows: (1) while the '766 method is directed towards any "individual in need," the '442 method is directed towards individuals with "active disease"; (2) while the '766 method recites "co-administering" methotrexate and an anti-TNFα antibody, the '442 method recites "adjunctively administering" an anti-TNFα antibody with methotrexate.

    The '766 patent application, which was filed on August 1, 1996, claimed the benefit of an application that was filed on October 8, 1992.  After the '766 patent issued in 2001, the Kennedy Trust filed the '442 patent application.  Although the specification of the '442 patent is identical to that of the '766 patent, the '442 patent only claims the benefit of the '766 patent's August 1, 1996 filing date.  As a result, while the '766 patent expired on October 8, 2012, the '442 patent does not expire until August 21, 2018.

    AbbvieAs the opinion notes, AbbVie, Inc. and AbbVie Biotechnology Ltd. ("AbbVie"), which license the '766 patent but not the '442 patent, paid the Kennedy Trust more than $100 million in royalties in order to sell its anti-TNFα antibody, Humira, in combination with methotrexate for the treatment of rheumatoid arthritis.  However, when the '442 patent issued in 2010 and the Kennedy Trust sought an additional license from AbbVie, AbbVie instead filed a declaratory judgment action seeking a determination that the '442 patent was invalid for obviousness-type double patenting.

    At trial, the Kennedy Trust contended that the '442 patent was patentable over the '766 patent because the latter claims a broad genus of methods for treating rheumatoid arthritis, and the former claims a narrower species of those treatment methods having unexpected results.  The District Court, however, determined that the claims of the '442 patent that were at issue in the declaratory judgment action were invalid over certain claims of the '766 patent.  In reaching that decision, the District Court determined that the adjunctive administration of the '442 method was one of three forms of co-administration covered by the '766 patent, and that the term "active disease" as recited in the '442 method covered all patients suffering from rheumatoid arthritis and requiring treatment.  Thus, the District Court determined that the '442 patent covered the same invention as the '766 patent, and as a result that the asserted claims of the '442 patent were invalid over the asserted claims of the '766 patent for obviousness-type double patenting.

    In an opinion by Judge Dyk, joined by Judges Wallach and Chen, the Federal Circuit affirmed the District Courter's determination, finding the '442 patent invalid for obviousness-type double patenting in light of the '766 patent.  As the opinion inicates, the Kennedy Trust argued that:

    [T]he statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist and the doctrine should be discarded.  More specifically, [the] Kennedy [Trust] contends that the Uruguay Round Agreement Act (URAA), Pub. L. 103-465, 108 Stat. 4809, effective June 8, 1995, and its implementation of a 20-year period of patent protection that runs from a patent's earliest claimed priority date, eliminated the need for the obviousness-type double patenting doctrine.  . . .  Now that the patent term is measured from the earliest claimed priority date, as opposed to the date of issuance, [the] Kennedy [Trust] contends that the submarine patent problem no longer exists and that the URAA amendment vitiated the policy basis for the doctrine of obviousness-type double patenting.

    The Court, however, countered that:

    [T]his argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing a second, later expiring patent for the same invention.  . . .  That problem still exists.  Patents claiming overlapping subject matter that were filed at the same time still can have different patent terms due to examination delays at the PTO.

    As a result, the Court determined that "the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates."  With respect to the dispute between AbbVie and the Kennedy Trust, the Court stated that the Kennedy Trust was "not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct."

    Before reaching a decision on whether the differences between the '766 and '442 patents rendered their claims patentably distinct, the Court addressed the disputed terms of "co-administering" and "active disease."  With respect to the first term, the Kennedy Trust argued that the District Court's construction excluded a fourth form of co-administration, namely, administration of the anti-TNFα antibody antibody alone after discontinuing the administration of methotrexate.  The Court, however, noted that "[t]he '766 patent's specification confirms the correctness of the district court's claim construction," in that "[t]he specification never uses the term 'co-administering' to refer to patients who only received the antibody after discontinuing treatment with methotrexate."

    With respect to the second term, the Kennedy Trust argued that the prosecution history revealed that a more specific definition of "active disease" (i.e., particularly sick patients) was critical to the Examiner's allowance of the '442 patent claims.  "[A]ssum[ing], without deciding, that [the Kennedy Trust's] proposed construction of 'active disease' was correct," the Court noted that "[t]he consequence is the genus claimed in the '766 patent (treating all patients in need thereof) is broader than the species claimed in the '442 patent (treating patients with 'active disease,' i.e., particularly sick patients)."  As a result, the Court stated that it "must decide whether a patent that claims to treat a subset of patients with more severe rheumatoid arthritis (the '442 patent) is an obvious variant of a patent that claims treatment of rheumatoid arthritis patients generally (the '766 patent)."

    While noting that "[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus," the opinion points out that "species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class."  In the instant case, the opinion stated that "it is clear that a reader of the '766 patent could have easily envisioned a species limited to sicker patients," and determined that the District Court was correct in concluding that the species of the '442 patent was not patentably distinct from the genus of the '766 patent.

    As for the Kennedy Trust's argument that the species of the '442 patent showed unexpected results, the Court found that argument to be unsupported.  Looking to the specification to assess what results were expected at the time the '766 patent application was filed (which the Court stated was permissible), the Court determined that "the '442 patent merely claims the known utility of the '766 patent and does not claim a species with unexpected results."  The Court therefore concluded that the '442 patent was invalid for obviousness-type double patenting in light of the '766 patent.

    AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust (Fed. Cir. 2014)
    Panel: Circuit Judges Dyk, Wallach, and Chen
    Opinion by Circuit Judge Dyk

  • IPR Update – Prosecution Bars

    By Andrew Williams —

    USPTO SealAre proceedings before the Patent Trial and Appeals Board ("PTAB") more like prosecution or more like litigation?  This might appear to be a purely academic question, except for one significant issue — litigation prosecution bars.  Prosecution bars are often included in Protective Orders or Discovery Confidentiality Orders to prevent litigation counsel from using the confidential information produced in a lawsuit during subsequent prosecution before the Patent Office.  Of course, with the advent of the PTAB's post-issuance proceedings, the issue of whether practice before the Board should be subject to such bars needed to be resolved.

    The PTAB – IPRs are Litigation

    Earlier this year, the PTAB addressed the issue, concluding that its proceedings were more like litigation.  In Google Inc. v. Jongerious Panoramic Techs., LLC (Case IPR2013-00191), the Board concluded that "[a]n inter partes review is neither a patent examination nor a patent reexamination."  See id. Paper No. 50, at 4 (P.T.A.B. Feb. 13, 2014).  The issue being decided was whether petitioner's litigation counsel could be admitted pro hac vice.  The requirement for the Board to recognize counsel pro hac vice is good cause, provided lead counsel is a registered practitioner.  See 37 C.F.R. § 42.10(c).  In this case, Mr. James R. Batchelder submitted a declaration in which he indicated that he had extensive experience litigating patent cases, and that he had familiarity with the relevant subject matter because of his representation of Apple in district court litigation involving the same patents (Apple was co-petitioner with Google).  Not surprisingly, the Patent Owner argued that the prosecution bar in the underlying litigation should prevent Mr. Batchelder from participating in the IPR.  That protective order precluded attorneys receiving access to confidential information from engaging in "prosecution activities," and therefore the Patent Owner believed that it would be a violation if Mr. Batchelder were admitted in the case.  See Google Inc., Paper No. 50, at 4.

    In that case, the PTAB was unpersuaded by the Patent Owner's arguments.  The Board observed that an IPR is "a trial, adjudicatory in nature and constitutes litigation."  Id.  The Board also noted that, even though it prohibited "prosecution activities, the protective order was silent regarding trials before the PTAB.  Also, all of the substantive briefings had been filed in the case already.  Most importantly, however, the PTAB appeared to shift the focus back to the district court.  Mr. Batchelder was still subject to sanctions if he violated the order.  The Patent Owner did not suggest that Mr. Batchelder was in violation of the protective order, even though he had already been assisting the Petitioner's counsel.  If the Patent Owner believed that Mr. Batchelder was violating the protective order, it could seek relief at the district court.  Of course, this left open the question of how a district court would handle such prosecution bars.

    District Court – Counsel May Participate in IPR Proceeding Regardless of Prosecution Bar

    The United States District Court for the Southern District of New York recently answered that question in a similar manner, but took it an additional step.  The litigation entailed 11 separate lawsuits against several different ANDA filers that were attempting to market generic versions of OPANA® ER, an opiod painkiller.  The relevant case for these purposes was Endo Pharmaceuticals Inc. v. Amneal Pharmaceuticals, LLC, 12 Civ. 8115 (TPG).  Endo was represented in the litigation by the law firm of Dechert LLP.  Amneal filed an IPR before the PTAB related to the validity of three of the patents involved in the lawsuit — U.S. Patents 8,309,122, 8,329,216, and 7,851,482.  Endo retained the law firm of Mayer Brown LLP to serve as its primary counsel in that proceeding, but desired to have the two firms collaborate about claims and defenses at issue in both proceedings.  The problem was that a protective order had been filed in the litigation preventing the Dechert attorneys from engaging in patent prosecution or claim amendment before the PTO.

    In its decision of August 13, 2014, the District Court noted that the protective order did not specifically bar participation in IPR proceedings, citing the Board's Google decision approvingly.  The Court also noted that both Dechert and Endo had assured the court that the attorneys involved will not participate in claim amendment proceedings.  These, in and of themselves, would have been sufficient to allow Dechert's participation in the IPR.  Nevertheless, the Court went on to conclude that even if the protective order did bar the attorneys from IPR participation, it would have made an exception on the facts of this case.

    The Court cited the Federal Circuit's In re Deutsche Bank Trust Co. Americas case, which provided factors to evaluate a party's request for an exemption from a prosecution bar.  First, it must be shown that "representation of the client in matters before the PTO does not and is not likely to implicate competitive decisionmaking related to the subject matter of the litigation so as to give rise to a risk of inadvertent use of confidential information learned in litigation . . . ."  Deutsche Bank, 605 F.3d 1373, 1381 (Fed. Cir. 2010).  The District Court noted that the questions at issue in this case, obviousness and the relevant prior art, would not implicate competitive decisionmaking or claim amendments.  The second factor entails a weighing of the potential injuries: whether "the potential injury to the moving party . . . outweighs the potential injury to the opposing party . . . ."  In this case, the District Court noted that there was minimal risk of inadvertent disclosure, because Dechert's attorneys are explicitly prohibited from participating in claim amendment discussions.  In contrast, the injury to Endo would be significant because the prior art references are the same in both proceedings.  Mayer Brown simply did not have Dechert's considerable expertise and extensive knowledge regarding those references.  Finally, the Court noted the policy concerns of allowing a petitioner/alleged infringer to prevent trial counsel from participating in PTAB proceedings.  The result would be that a patent holder would be required to defend a patent in two separate venues with two sets of attorneys, resulting in a waste of time and resources.  Moreover, the decision at the PTAB would have direct consequences on the district court proceedings, and therefore patent holders have a legitimate interest in formulating consistent strategies.

    Even though this was a positive result for patent holders embroiled in both litigation and IPR proceedings, it is only one case.  Therefore, it will be interesting to see how other jurisdictions handle similar questions regarding prosecution bars.  We will continue to monitor and report on any significant updates.