• By Donald Zuhn —

    Pfizer Since President Obama signed the Patient Protection and Affordable Care Act into law in March, thereby establishing an approval pathway for biosimilar biological products, the biotech industry has waited to see which company might be the first to take advantage of the new approval pathway.  Last week, Pfizer Inc. joined a growing list of candidates when it announced that it had entered into a strategic global agreement with India's largest biotech company, Biocon Ltd., for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products:  Recombinant Human Insulin, Glargine, Aspart, and Lispro.

    Biocon Under the terms of the agreement, Pfizer will have exclusive rights to commercialize Biocon's Insulin products globally, with certain exceptions, including co-exclusive rights with Biocon for all of the products in Germany, India and Malaysia, and co-exclusive rights with existing Biocon licensees for some of the products.  Biocon will retain responsibility for the clinical development, manufacture, and supply of the biosimilar Insulin products, and for securing regulatory approval for these products in various countries.  Biocon has secured approval for its Recombinant Human Insulin in 27 countries and has launched its Glargine product in India.  Pursuant to the agreement, Pfizer will pay Biocon $200 million, with Biocon receiving up to $150 million in additional milestone payments as well as additional payments linked to Pfizer's sales of the four Insulin biosimilar products.

    David Simmons, president and general manager of Pfizer's Established Products Business Unit, said the collaboration "supports our stated efforts to become a strong player in follow-on biologics as well as in the Diabetes disease area, by adding to Pfizer's broad biotherapeutics portfolio, ranging from biosuperiors to biosimilars, across multiple therapeutic areas."  The release noted that a number of Insulin analogs are expected to lose patent protection by 2015, "resulting in a significant opportunity for the biosimilars market," and that the agreement will allow the companies "to be well positioned to be first movers in this potentially large market opportunity."

    Pfizer's announcement noted that diabetes affects nearly 230 million people worldwide and causes 3 million deaths annually, with the number of afflicted individuals expected to rise to 400 million by 2030.  According to the release, the diabetes pandemic has impacted both the developing and developed world, as evidenced by the 18 million diabetic patients in the U.S. (a number expected to rise to 30 million by 2030).  In the U.S., an estimated $200 billion is spent annually treating the disease.

    After the details of the Pfizer-Biocon deal were released, Biocon announced that it would be investing $161 million on the research and development and production of high-end biosimilars in Malaysia (see International Business Times report).  In particular, Biocon will be investing with the Malaysian Biotechnology Corp. to construct a facility that is expected to be operational by 2014.

    Additional information regarding the agreement between Pfizer and Biocon can be found in Biocon's press release.

  • By Kevin E. Noonan —

    Becton Dickinson Appellees Becton, Dickinson & Co. and Nova Biomedical Corp. filed their responsive brief in Therasense, Inc. v. Becton, Dickinson & Co. on October 8th.  While addressing the Federal Circuit's questions generally directed to its application of the inequitable conduct doctrine, appellees' brief is particularly focused on its main objective — having the en banc Court affirm the District Court's finding that Abbott committed inequitable conduct in procuring the patent-in-suit (U.S. Patent No. 5,820,551).

    Nova Biomedical The brief contends that the standard for materiality that best conforms judicial review of patentee conduct is the U.S. Patent and Trademark Office's Rule 56.  Using the Rule 56 standard is proper, according to appellees, because it makes more consistent the standards used before the USPTO and at trial, thus minimizing any "unfairness" to patentees.  In addition, the brief argues that using the Rule 56 standard is advantageous when compared with standards that are more or less stringent.  Using the "reasonable examiner" standard would result in overdisclosure to the Office, since an applicant could not predict what a court might later find would be "reasonably" material, whereas a "but for" standard would not promote the public interest by motivating applicants to disclose prior art known to them.  The best benchmark is the agency standard, in view of its expertise as well as the administrative considerations that underlie the rule (requiring consistent argument and submission of information or art that established a prima facie case of unpatentability).  The brief notes that the Government's brief also argues for the Rule 56 standard of materiality for similar administrative efficiency reasons.  And the brief argues that adoption of this standard would reduce the number of inequitable conduct claims asserted, since it would (presumably) prevent accused infringers from using less stringent standards (citing Digital Control Inc. v. Charles Machine Works, 437 F.3d 1309, 1314-16 (Fed. Cir. 2006); American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1362-1363 (Fed. Cir. 1984); Dayco Products, Inc. v. Total Containment, Inc., 329 F.3d 1358, 1363-64 (Fed. Cir. 2003); Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1354 (Fed. Cir. 2008), as examples of cases where less stringent standards were applied).

    Moreover, the brief argues that the Rule 56 standard is consistent with Supreme Court precedent — specifically, Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 250-51 (1944); and Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806, 814 (1945).  Appellees read this precedent for the proposition that the Keystone Driller and Hazel-Atlas cases were based on unclean hands principles, in view of the frankly fraudulent behavior patentees in these cases exhibited both before the USPTO and during litigation.  But the brief contends that the Court created an "inequitable conduct" doctrine that was distinct from fraud in the Precision Instrument case:  in that case, appellees argue that that Court stated that "the patentee must disclose 'all facts concerning fraud or inequitableness underlying the applications in issue' to the PTO," and that this distinction signaled that the doctrine should be broader than common law fraud (as well as providing "further guidance about what information should be considered for inequitable conduct").  The public policy rationale for this argument is that "the public has a strong interest in 'seeing that patent monopolies spring from backgrounds free from fraud or other inequitable conduct,'" again citing language that seems to suggest that the doctrine encompasses behavior in addition to common law fraud.  The brief also argues that the current inequitable conduct doctrine is more equitable to patentees, since the "unclean hands" doctrine in the Keystone Driller and Hazel-Atlas cases was "amorphous" and did not set out clear lines for assessing culpable conduct.  And the requirement of common law fraud for reliance and harm resulting from that reliance "may not be evident in the prosecution record in every case," allowing improperly procured patents to issue and be enforceable against the public interest.  Thus, "reverting" to a common law fraud standard, as argued by Abbott and some amici, would be contrary to settled Supreme Court precedent, and would harm the public interest by permitting patents to be enforced that were obtained through inequitable conduct that fell short in some respect to fraud.  "Swinging the pendulum too far in the other direction," to the unclean hands standard of Keystone Driller and Hazel-Atlas is just as bad, according to the brief, because the unclean hands doctrine is even more devoid of standards and guidelines than the current inequitable conduct doctrine.

    The brief rejects the "but for" test called for by Abbott and some amici, arguing that such a decision would "turn back the clock of progress" to the standard applied prior to establishment of Rule 56 by the Office in 1977.  The brief argues two practical deficiencies for using the "but for" standard:  first, the standard fails to capture situations where the patent issued due to misconduct, but the prosecution record is unclear about the reason for allowance, inter alia because Examiners do not testify in infringement litigation and thus a court "will not know critical facts that may prove inequitable conduct."  This is essentially an evidentiary argument, wherein "patentees may withhold or misrepresent information that significantly impacts the examiner's decision to issue the patent, without creating any record that such information was necessary for issuance" (emphasis in original).  Second, "dishonest patentees could ignore the PTO's disclosure requirements knowing that the courts will apply a narrower materiality standard, without any effective sanction for violating the PTO's Rule" except practitioner disciplinary proceedings in the Office (that the Office itself admits it lacks the capability to properly enforce).  Conversely, the brief argues, "[a]n honest applicant . . . would be left with less guidance about what to disclose because the 'but/for' test is applied in hindsight.  Because he cannot know in advance what will be the 'but/for' reason for allowance, he will be forced to overdisclose to the PTO out of an abundance of caution," further impeding the efficient operation of the Office.  The brief also disputes Abbott's interpretation of Supreme Court and Federal Circuit precedent upon which Abbott relied in its brief.

    Finally, the materiality portion of the brief closes with a section on the materiality of the "misleading" declaration and argument Abbott submitted to the Office to overcome rejection and have the '551 patent grant; significantly, the brief argues that these "misrepresentations" satisfy the "but for" test (and thus that the District Court's finding of unequitable conduct should be affirmed no matter how the en banc Court decides to modify how it applies the inequitable conduct doctrine).

    Turning to the intent prong, the brief argues that the "single most reasonable inference" standard as enunciated in Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1366 (Fed. Cir. 2008), should be used, so that circumstantial evidence can be considered by a court in finding deceptive intent.   Appellees argue that instances where a patentee "admits" to committing inequitable conduct are "rare," as are instances where there is a "smoking gun" evincing an intent to deceive.  Thus, circumstantial evidence and inferences therefrom are important for determining whether a patentee had deceptive intent by clear and convincing evidence, the brief contends.  This standard is necessary, appellees argue, because otherwise "a dishonest patentee could deceive the PTO and then further perpetuate the wrong by simply refusing to admit intent in court."  Using the "single most reasonable" inference standard is fair to patentees, according to the brief, because "[t]his is the most stringent possible standard for intent short of requiring an outright admission."  This is also the standard used by the District Court in finding intent below.

    The question of circumstantial evidence and how it (and what evidence) is applied does not somehow permit courts to find "lesser" evidence of intent the "greater" the evidence of materiality.  Rather, the brief argues that courts can permissibly look to the degree of materiality as circumstantial evidence of intent (since it is difficult and unlikely to have deceptive intent for not disclosing information that is not material).  Provided that a court does not find intent "solely" from the evidence of materiality, and finds both materiality and intent separately by clear and convincing evidence, appellees argue that using facts relating to materiality as circumstantial evidence of intent is proper (although it is apparent that this approach can easily be misapplied), citing Judge Prost's concurring opinion in Optium Corp. v. Emcore Corp., 603 F.3d 1313, 1325 (Fed. Cir. 2010).  Ignoring the degree of materiality in assessing intent would require a court to ignore a portion of the "totality of circumstances" that it should consider for deciding inequitable conduct, the brief argues.  Relevant evidence also includes patentee's excuses for not submitting material information, says the brief, and the credibility of such excuses also comprise relevant evidence for a court to consider in considering the sufficiency of the evidence for deceptive intent.  "Facts common to materiality and intent include the prominence of a withheld reference in prosecution, concealing prior inconsistent statements, and submitting false declarations," which sounds reasonable; however, the brief goes on to argue that "[p]rominence of a reference, even in related litigation, underscores its materiality and the patentee's awareness of its relevance to show he deceptively withheld it" (emphasis added).  This argument underscores arguments by plaintiff and amici that the Court should establish a deceptive intent standard that would not encourage litigation-related "bootstrapping" of evidence of materiality to establish intent.  Appellees also argue that "[t]he 'single most reasonable inference' based on the totality of the evidence provides a high standard of intent, just short of an outright admission.  That totality includes all the facts, including those that may also bear on materiality.  It also limits the inequitable conduct doctrine by giving the patentee every opportunity to provide exculpatory evidence of good faith for his conduct and maintains 'a high bar' for proving intent," citing Eisai Co. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1360 (Fed. Cir. 2008).  This portion of the brief ends with a detailed discussion and argument supporting the District Court's determination that plaintiffs' acted with an intent to deceive.

    The brief then addresses the appropriateness of the "materiality-intent-balancing" test that the Federal Circuit uses to determine whether there is sufficient evidence to support the exercise of the court's equitable powers to render a patent unenforceable.  Appellees argue that this is the appropriate standard in cases ("the vast majority") where "the [withheld] information at issue bears on patentability of claims," but concede that there may be other cases where a court should not use its powers to negate patent rights.  Such cases include those where the conduct in question has no bearing on patentability (e.g., disclosures regarding Inventorship [PerSeptive Biosystems, Inc. v. Pharmacia Biotech, Inc., 225 F.3d 1315 (Fed. Cir. 2000)], Petitions to Make Special [General Electro Music Corp. v. Samick Music Corp., 19 F.3d 1405], or Small Entity Status [Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223 (Fed. Cir. 2007)].  While being careful to note that "[t]he issue of non-patentability cases is not before the Court on the facts here," the brief suggests that "[c]ourts should have the discretion to refer such cases to the PTO for disciplinary action or, in rare circumstances, find the patent unenforceable under the unclean hands doctrine."  The balancing test permits courts "to balance the equities before finding inequitable conduct," comprising "an important safeguard where the overall context of the case shows that the conduct was too insignificant to justify the severe penalty of unenforceability."  However, the brief concedes that for most cases, "[o]nce materiality and intent are independently established, the balance will typically favor finding inequitable conduct," citing Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995), and Refac Int'l Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1582-1583 (Fed. Cir. 1996).  Nonetheless, even under these circumstances, the balancing test permits a court to exercise its discretion in imposing sanctions short of complete unenforceability.

    The brief's arguments that the District Court's finding of inequitable conduct should be affirmed are straightforward.  The declaration was an affirmative misrepresentation about the meaning of the language that a membrane was "optional" as disclosed in the relevant prior art, and statements in the declaration and argument that a membrane was "required" were completely contradictory to arguments submitted to the European Patent Office and not disclosed to the U.S. examiner.  The declarant and attorney knew about the information and its materiality and did not disclose it to the USPTO.  These circumstances are particularly prone to inequitable conduct because a declaration comprises extrinsic evidence that an examiner cannot independently verify; this is in contradistinction with submitted art and attorney argument, both of which an examiner is capable of assessing on her own.  The "excuses" proffered by the declarant and attorney to explain their conduct were "incredible," and the District Court found their testimony to be unbelievable.  Under these circumstances, the District Court's determination that the '551 patent was obtained through inequitable conduct and thus should be unenforceable was not an abuse of discretion and would be the conclusion no matter what changes the en banc Court may make in how the inequitable conduct doctrine should be applied.  Thus, appellees argue that the District Court's inequitable conduct determination should be affirmed.

    For additional information regarding this topic, please see:

    • "Bayer Submits Brief in Therasense v. Becton Dickinson," October 20, 2010
    • "PhRMA Files Amicus Brief in Therasense Case," August 22, 2010
    • "PTO Files Amicus Brief in Therasense Case," August 19, 2010
    • "American Bar Association Files Amicus Brief in Therasense Case," August 17, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. — Briefing Schedule Update," August 8, 2010
    • "BIO Files Amicus Brief in Therasense Case," August 8, 2010
    • "Pharma and Software Companies File Joint Amicus Brief in Therasense Case," August 3, 2010
    • "IPO Files Amicus Brief in Therasense Case," August 2, 2010
    • "Abbott Files Brief in Therasense Case," July 28, 2010
    • "CAFC Sets Date for Oral Argument En Banc in Inequitable Conduct Appeal," June 9, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. — Briefing Schedule Update," May 16, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. Briefing," May 13, 2010
    • "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson," April 28, 2010

  • By Donald Zuhn —

    USPTO Seal In a joint press release issued on Monday, the U.S. Patent and Trademark Office and European Patent Office announced that the two offices would be working together to develop a joint patent classification system.  One of the goals of the joint effort will be to align the EPO classification and U.S. classification systems with the International Patent Classification (IPC) system, which is administered by the World Intellectual Property Organization (WIPO).  However, the USPTO and EPO noted that the jointly developed system will be more detailed than the IPC system in order to improve patent searching.  The joint classification system is expected to help the USPTO and EPO eliminate unnecessary duplication of work, thereby promoting more efficient examination and enhancing examination quality.

    EPO Regarding the joint effort, USPTO Director David Kappos and EPO President Benoît Battistelli stated that the USPTO and EPO had agreed "to work toward the formation of a partnership to explore the development of a joint classification system based on the European Classification system (ECLA) that will incorporate the best classification practices of the two offices," noting that the new system would be aligned with the World Intellectual Property Organization (WIPO) classification standards and the International Patent Classification (IPC) structure.  The joint release called the effort "a milestone achievement" for the Five IP Offices (IP5) — consisting of the EPO, USPTO, Japan Patent Office (JPO), Korean Intellectual Property Office (KIPO), and State Intellectual Property Office of the People's Republic of China (SIPO) — which would bring the IP5 closer to a Common Hybrid Classification, one of the IP5's ten Foundation Projects.

  • By Sherri Oslick —

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

    Sandoz Inc. v. Boehringer Ingelheim
    1:10-cv-01767; filed October 19, 2010 in the District Court of the District of Columbia

    Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 7,429,602 ("Treating Conjunctivitis by Topically Administering An Epinastine Solution to the Conjunctiva," issued September 30, 2008), licensed to Allergan, based on Sandoz's filing of an ANDA to manufacture a generic version of Allergan's Elestat® (epinastine hydrochloride ophthalmic solution, used to prevent itching associated with allergic conjunctivitis), and based on the continued listing of the '602 patent in the Orange Book, despite Boehringer's disclaimer of all claims and all term of the '602 patent and request that it be delisted from the Orange Book.  View the complaint here.


    Eli Lilly & Co. v. Accord Healthcare, Inc.

    1:10-cv-00781; filed October 19, 2010 in the Middle District of North Carolina

    Infringement of U.S. Patent No. 5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued November 7, 1995) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Lilly's Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  View the complaint here.


    Mylan Pharmaceuticals Inc. v. Galderma Laboratories Inc. et al
    .
    1:10-cv-00892; filed October 18, 2010 in the District Court of Delaware

    • Plaintiff:  Mylan Pharmaceuticals Inc.
    • Defendants:  Galderma Laboratories Inc.; Galderma Laboratories LP; Supernus Pharmaceuticals Inc.

    Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), licensed to Galderma based on Mylan's filing of an ANDA to manufacture a generic version of Galderma's Oracea® (doxycyline delayed release capsules, used to treat inflammatory lesions of rosacea).  View the complaint here.


    Genzyme Corp. v. Medicis Pharmaceutical Corp. et al
    .
    1:10-cv-11763; filed October 15, 2010 in the District Court of Massachusetts

    • Plaintiff:  Genzyme Corp.
    • Defendants:  Medicis Pharmaceutical Corp.; Medicis Aesthetics, Inc.

    Infringement of U.S. Patent No. 5,399,351 ("Biocompatible Viscoelastic Gel Slurries, Their Preparation and Use," issued March 21, 1995) based on Medicis' manufacture, use, sale, and offer for sale of its Restylane®, Perlane®, Restylane-L and Perlane-L products (hyaluronic acid, used to correct moderate to severe facial wrinkles and folds).  View the complaint here.

  • By Sherri Oslick —

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

    Galderma Laboratories LP et al. v. Actavis Mid Atlantic LLC
    1:10-cv-00887; filed October 15, 2010 in the District Court of Delaware

    • Plaintiffs:  Galderma Laboratories LP; Galderma SA; Galderma Research and Development SNC
    • Defendant:  Actavis Mid Atlantic LLC

    Infringement of U.S. Patent No. 7,579,377 ("Administration of 6-[3-(1-adamantyl)-4methoxyphenyl]- 2-naphthoic Acid for the Treatment of Dermatological Disorders," issued August 25, 2009) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Galderma's Differin® gel (adapalene, used in the topical treatment of acne vulgaris).  View the complaint here.


    Warner Chilcott Co., LLC v. Mylan Inc. et al.

    1:10-cv-07840; filed October 13, 2010 in the Southern District of New York

    • Plaintiff:  Warner Chilcott Co., LLC
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Famy Care Ltd.

    Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive," issued December 23, 2003) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Femcon Fe® (formerly Ovcon® 35 Fe, norethindrone and ethinyl estradiol tablets, and ferrous fumarate tablets, used for oral contraception).  View the complaint here.


    Purdue Pharmaceutical Products L.P. et al. v. Hospira, Inc.

    1:10-cv-06471; filed October 8, 2010 in the Northern District of Illinois

    • Plaintiffs:  Purdue Pharmaceutical Products L.P.; Purdue Pharma L.P.; Purdue Pharma Technologies Inc.
    • Defendant:  Hospira, Inc.

    Infringement of U.S. Patent No. 6,589,960 ("Hydromorphone And Hydrocodone Compositions And Methods For Their Synthesis," issued July 8, 2003) following a Paragraph IV certification as part of Hospira's filing of an ANDA to manufacture a generic version of Purdue Pharma's Dilaudid® (hydromorphone hydrochloride for injection, used to treat moderate to severe pain).  View the complaint here.


    Celgene Corp. v. Natco Pharma Ltd.

    2:10-cv-05197; filed October 8, 2010 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 5,635,517 ("Method of Reducing TNFα Levels with Amino Substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines," issued June 3, 1997), 6,045,501 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued April 4, 2000), 6,281,230 ("Isoindolines, Method of Use, and Pharmaceutical Compositions," issued August 28, 2001), 6,315,720 ("Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an Adverse Side Effect Known or Suspected of Being Caused by the Drug," issued November 13, 2001), 6,555,554 ("Isoindolines, Method of Use, and Pharmaceutical Compositions," issued April 29, 2003), 6,561,976 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued May 13, 2003), 6,561,977 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued May 13, 2003), 6,755,784 (same title, issued June 29, 2004), 7,119,106 ("Pharmaceutical Compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline," issued October 10, 2006), and 7,465,800 ("Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione," issued December 16, 2008) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Celgene's Revlimid® (lenalidomide, used in the treatment of multiple myeloma patients who have received at least one prior therapy, and in the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality).  View the complaint here.

  • CalendarOctober 25, 2010 – Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) – San Francisco, CA

    November 8, 2010 – Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) – New York, NY (Groupcasts to be held in Atlanta, Philadelphia, Pittsburgh, and Mechanicsburg, PA)

    November 8-9, 2010 – Patent Litigation 2010 (Practising Law Institute) – Atlanta, GA

    November 15-16, 2010 – European Pharmaceutical Regulatory Law Boot Camp*** (American Conference Institute) – New York, NY

    November 15-16, 2010 – Patent Litigation 2010 (Practising Law Institute) – New York, NY (Groupcasts to be held in Philadelphia, Pittsburgh, and Mechanicsburg, PA)

    November 30 to December 1, 2010 – 12th Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA

    December 7-8, 2010 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, England

    December 8-9, 2010 – Paragraph IV Disputes*** (American Conference Institute) – San Francisco, CA

    January 26-27, 2011 – The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) – New York, NY

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

  • San Francisco #1 American Conference Institute (ACI) will be holding a West Coast edition of its Paragraph IV Disputes conference on December 8-9, 2010 in San Francisco, CA.  The conference will allow attendees to:

    • Identify patents for small molecules and small proteins that may be ripe for a Paragraph IV challenge;
    • Recognize an ANDA applicant's initial obligations and reevaluate Orange Book tactics;
    • Incorporate post-KSR obviousness considerations into Paragraph IV litigation strategies;
    • Comprehend the procedural and substantive requirements for the contents and delivery of the Notice Letter;
    • Develop a plan to use the 45 day post-Notice Letter receipt period more effectively and know when it makes sense to file suit;
    • Master techniques for drafting the initial Paragraph IV pleadings and factor in considerations relative to venue, jurisdiction, local rules, and cost;
    • Understand the criteria for 180-day exclusivity and the circumstances under which it may be forfeited;
    • Appreciate the significance of generic versus generic actions for brand names and generics;
    • Navigate the intricacies of litigation with multiple ANDA filers;
    • Spearhead discovery dilemmas, optimize the use of experts, and perfect Markman timing;
    • Analyze the CAFC's latest findings on declaratory judgments, inequitable conduct, preliminary injunctions, and Rule 11 sanctions vis-a-vis Paragraph IV cases; and
    • Weigh the options over an at risk launch.

    Brochure In particular, ACI's faculty will offer presentations on the following topics:

    • Pre-suit due diligence strategies in anticipation of the Paragraph IV challenge;
    • Assessing the ANDA applicant's initial obligations;
    • New takes on obviousness:  Pre-suit considerations for brand-names and generics;
    • Throwing down the gauntlet:  The Paragraph IV notice letter — delivery and receipt;
    • Let the games begin:  The start of the Paragraph IV law suit — Pleadings and considerations;
    • Exploring exclusivity and forfeiture dilemmas relative to Paragraph IV litigation;
    • A closer look at generic versus generic law suits;
    • Litigating with multiple ANDA filers:  Brand name and generic perspectives;
    • FTC keynote:  Pay for delay settlements;
    • Recent decisions impacting Paragraph IV challenges and motion practice;
    • Discovery strategies and pre-trial maneuvering tactics for brand names and generics; and
    • Assessing danger and mitigating liabilities associated with injunctions and "at risk launches."

    Two additional workshops will be offered before and after the conference.  A pre-conference workshop, entitled "Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals," will be offered from 10:00 am to 5:00 pm on December 7, 2010.  During this workshop, ACI's faculty will offer presentations on the following topics:

    • A guide to the essentials of the FDA approval process for drugs and biologics for life sciences patent lawyers;
    • Patent and IP overview for drugs and biologics:  Hatch-Waxman, trade dress, and more;
    • Patent and non-patent exclusivity;
    • Bioequivalence and the "same active ingredient" vis-à-vis patentability; and
    • Exploring pharmaceutical patent extensions:  Patent Term Adjustment and Patent Term Restoration.

    In addition, a post-conference workshop, entitled "The Master Class on Settling Paragraph IV Disputes:  Brand-Name and Generic Perspectives," will be offered from 9:00 am to 12:30 pm on December 10, 2010.  In this workshop, ACI faculty will explore the best practices for reaching and finalizing settlements that the parties and the FTC can live with.

    The agenda for the Paragraph IV Disputes conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference Institute The registration fee for the conference is $2,295 (conference alone), $3,195 (conference and pre-conference workshop), $2,895 (conference and post-conference workshop), $3,595 (conference and both workshops), or $1,395 (pre-conference workshop alone).  Those registering by November 12, 2010 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of the Paragraph IV Disputes conference.

  • By James DeGiulio —

    Novo Fails to Dismiss Suit over Validity of Prandin Patent

    Novo Nordisk The five year dispute over the validity of the patent covering the diabetes drug Prandin continues, as Novo Nordisk's attempt to dismiss the case with Sun Pharmaceutical Industries and Caraco Pharmaceutical Laboratories was recently denied.

    Caraco Pharmaceutical Laboratories Novo originally filed suit against Caraco in 2005 in the U.S. District Court for the Eastern District of Michigan, alleging infringement of U.S. Patent No. 6,677,358 based on their ANDA covering a generic version of Prandin.  Sun was later added to the lawsuit.  Sun and Caraco counterclaimed that Novo's patent was invalid and would not be infringed by the sale of their generic version of the drug.  In 2007, the FDA notified Caraco that it could not grant final approval of the ANDA because of the Novo lawsuit.  Caraco then amended its ANDA with a Section VIII statement, but Caraco's claim was rendered moot when the FDA allowed Novo to modify the use code of the '358 patent to include the method.  Novo's request for a change of its use code was contested and appealed to the Federal Circuit, which ultimately ruled in April that the change was allowed (see "Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)").  In July, the Federal Circuit denied an en banc rehearing of the case.  As a result, Novo moved for dismissal, arguing that there was no longer a controversy in the case because Caraco had dropped its Paragraph IV certification in favor of the Section VIII statement.

    Sun Pharma On October 6, Judge Avern Cohn denied Novo's motion to dismiss.  Judge Cohn disagreed with Novo's argument, noting that Caraco had continued to pursue Paragraph IV certification in conjunction with the Section VIII statement.  Judge Cohn also noted that Caraco's Paragraph IV certification is still pending before the FDA.  Judge Cohn's Order can be viewed here.


    Cobalt Pharmaceuticals and Sepracor Settle Lunesta Patent Litigation

    Cobalt Pharmaceuticals Cobalt Pharmaceuticals has reached a settlement with Sepracor, thus ending its involvement in the multi-defendant infringement suit brought by Sepracor over the sleep drug Lunesta.

    Sepracor In March 2009, Sepracor brought suit in the U.S. District Court for the District of New Jersey against nine generic companies who intended to make generic versions of the sleep drug Lunesta (see "Court Report," March 29, 2009).  Sepracor alleged that the generic maker's ANDAs infringed four patents covering the drug:  U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724.  Wockhardt and Glenmark were dismissed from the litigation in August, and Teva settled in September of this year (see "Biotech/Pharma Docket," August 12, 2010; "Biotech/Pharma Docket," September 2, 2010).

    On October 12, Judge Dennis M. Cavanaugh signed off on a stipulation of dismissal without prejudice between the parties.  Cobalt and Sepracor had previously informed Judge Cavanaugh that the matter had reached a resolution.  Under the terms of the stipulation, the parties agreed that their claims and counterclaims were moot, following the resolution.  Each party agreed to pay its own fees and costs.  Judge Cavanugh's Order can be viewed here.


    Warner Chilcott Settles Loestrin, Femcon Patent Suit with Lupin

    Warner Chilcott Warner Chilcott and Lupin have settled a patent dispute regarding Lupin's development of generic forms of the birth control drugs Loestrin 24 Fe and Femcon Fe.

    Lupin Warner Chilcott brought suit against Lupin in September 2009 in the U.S. District Court for the District of Maryland, accusing Lupin of infringing U.S. Patent Nos. 5,552,394 and 6,667,050, covering the birth control drugs Loestrin 24 Fe and Femcon Fe, respectively (see "Court Report," September 27, 2009).  The case was transferred to the U.S. District Court for the District of Delaware in November 2009.

    Under the settlement agreement, Lupin cannot launch generic Loestrin before July 22, 2014, or begin selling generic Femcon before Jan. 1, 2013.  Warner Chilcott has also granted Lupin a nonexclusive license for Femcon, allowing Lupin to sell an authorized generic supplied by Warner Chilcott.  Both parties' motions to dismiss have yet to receive court approval.

    James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law.  Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.

  • By Kevin E. Noonan —

    Bayer Co-defendant Bayer Healthcare LLC has submitted its brief in the Federal Circuit's en banc reconsideration of inequitable conduct in Therasense Inc. v. Becton Dickinson & Co.  The brief's basic argument is that the Court's application of the inequitable conduct doctrine needs to be revised in keeping with traditional standards and that the Court should apply an "unclean hands" approach.  "The Court does not need the hatchet offered by Abbott and need only take a scalpel to a few targeted areas of the inequitable conduct doctrine," according to Bayer's brief.  The inequitable conduct doctrine is broader than common law fraud, and should be applied with flexibility to protect the public's interest.

    While conceding that that the Court's application of the doctrine needs to be modified, the brief takes the position that "this Court's materiality-intent framework properly tailors the general requirements of the doctrine to the specific context of duty of candor inequitable conduct cases."  The modification Bayer suggests is that inequitable conduct should be returned to its roots in the equitable doctrine of unclean hands, which requires "an (a) intentional, (b) 'wrongful' act (c) connected to the patent that is the subject of the litigation."  While broad, this standard falls well below common law fraud or the "but for" tests proposed by Abbott and several amici, and Bayer argues that this is consistent with Supreme Court precedent.  According to Bayer's brief, the Supreme Court "trilogy" of inequitable conduct cases — Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 250-51 (1944); and Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 814 (1945) — supports the argument that merely casting doubt on the validity of a patent can be sufficient, thereby negating the reliance requirement of fraud.  The brief accuses Abbott and amici with "mischaracterizing" the Supreme Court's precedent, saying that the unclean hands doctrine is adequate and is "sound policy" because the patent grant is a "special privilege" that the Supreme Court has held requires an "uncompromising duty" of candor.  The brief also contends that the special status of patents as "exception[s] to the general rule against monopolies" provokes a public interest that supports using the broader unclean hands doctrine rather than the common law standard advanced by Abbott and amici.  Bayer further argues that a higher standard of candor is demanded due to the ex parte nature of patent prosecution.  Paradoxically, however, (in view of the deleterious consequences for the Patent Office occasioned by the current inequitable conduct standard) the brief cites the "ever increasing" patent application burden as a reason applicants must be compelled to comply with a higher standard of disclosure.

    Conveniently, Bayer rejects the rather well-defined requirements of common law fraud with the more "flexible" unclean hands doctrine, that is "not bound by formula or restrained by any limitation that tends to trammel the free and just exercise of discretion," citing Keystone.  Moreover, the brief argues that a significant distinction between common law fraud and inequitable conduct is that inequitable conduct does not require reliance, citing Morton Salt (a patent misuse case) in support of this argument.  In contrast, Bayer argues that the materiality-intent test "appropriately applies" the unclean hands doctrine in the context of inequitable conduct, saying that the test tracks the requirements for unclean hands:  intent (intent), a wrongful act (failure to disclose), and a connection (nexus) between the wrongful act and the cause of action (i.e., a lawsuit based on improperly-procured patent).

    Materiality is what determines whether there is a wrongful act — it provides the link, since withholding immaterial information does not create a harm to the public.  The brief cites Norton v. Curtiss, 433 F.2d 779 (CCPA 1970), and Molins PLC v. Textron, Inc. for the proposition that such withholding "constitutes the 'wrongful act' necessary to invoke unclean hands."  The brief also cites language relating to "fraud or other inequitable conduct" from the Supreme Court's Precision decision to suggest the wrong that occasions inequitable conduct must be broader than fraud.  Such an interpretation is consistent with the public interest, Bayer argues, since fraud is a wrong between private parties while inequitable conduct implicates a harm to the public (interestingly, citing a labor law case for this proposition).  The brief also notes (not for the first time) that including requirements from common law fraud (specifically, the "but for" reliance prong) is contrary not only to Bayer's reading of Precision Instrument, but also to prior Federal Circuit precedent (which is what the Court is reconsidering by rehearing this case en banc, after all).

    Bayer's brief does acknowledge that "the materiality-intent test may not be appropriate for every inequitable conduct allegation," specifically the "arguably less egregious conduct" cases.  However, since intentional contravention of any PTO rule related to patentability should result in inequitable conduct, the brief suggests that such instances be subject to a different (and less draconian) remedy than complete unenforceability (although it does not suggest either where the line should be drawn nor any alternative remedies).

    The brief does find a use for the common law fraud standard — in Walker Process cases involving antitrust liability.  The brief supports this argument with its reading of the Precision Instruments decision, but again uses Federal Circuit precedent (which is what the en banc Court has put at issue) to support the use of the fraud standard in determining the existence of Walker Process fraud (specifically Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1070 (Fed. Cir. 1998)).  The brief also asserts that nothing in the 1952 Patent Act (as specifically codified at 35 U.S.C. § 292) mandates using a common law fraud standard for inequitable conduct (while recognizing that the statute does not provide any guidance on what standard should be used for finding inequitable conduct).

    Bayer argues that the Court should adopt the PTO's Rule 56 as the proper standard for materiality.  This standard is fair to patentees, Bayer's brief argues, since it would not impose in litigation a higher standard than is applied for prosecution.  The brief specifically rejects the proposition by Abbott and some of the amici that materiality be required to rise to a "but for" standard, but agrees with "the near consensus of amici" regarding the uncertainties caused by the absence of a consistent standard for materiality and the inefficiencies that situation has created in the PTO.  Using Rule 56 as a standard would benefit from the "considered, expert judgment of the PTO" on the matter, Bayer argues; included in this "considered . . . judgment" was the PTO's rejection of a proposed "objective 'but for' test" during adoption of the current version of Rule 56.  Rule 56 provides an objective definition, according to Bayer, and is integrated into other PTO rules, like its disciplinary rules.  Moreover, the brief argues, Rule 56 "fosters disclosure of information the PTO needs to examine patent applications."  Bayer argues that Rule 56 properly puts the burden of disclosure (and deciding what gets disclosed) on the applicant; however, the brief attempts to support this position using arguments set forth by the Office in rejecting the objective "but for" test, "that the rule was unnecessary and would require prosecutors to scour the earth for any potentially inconsistent statement made by an applicant" (which arguably is exactly what now occurs).

    Importantly for its arguments in this case, Bayer's brief rejects excluding attorney argument from the definition of material information, arguing that it should be treated like any other instance of argument "inconsistent with a position taken by an applicant."  This standard would also be consistent with an unclean hands standard, Bayer argues, analogizing to how courts handle these determinations in other contexts.  Again, Bayer argues that the Federal Circuit has "recognized that the materiality standard should reflect the PTO's standard," which begs the question of whether that precedent has been correctly decided.  The brief is clear that Dígital Control Inc. v. Charles Machine Works, 437 F.3d 1309 (Fed. Cir. 2006), should be overruled, if only because it revived the logic of American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350 (Fed. Cir. 1984), that was repudiated by the en banc Court in Kingsdown Med. Consultants, Ltd. v. Hollister, Inc.  The brief also makes an administrative law argument on the grounds that Rule 56 "reflects the considered, formal, and expert judgment of the PTO and is therefore entitled to 'great respect' under United States v. Mead Corp., 533 U.S. 218 (2001)."  And any other standard "would not promote efficient and effective patent prosecution"; the "reasonable examiner" test would undermine efficient patent examination (because it is too vague and is responsible for disruptive applicant behavior)," and the "but for" test because it is inconsistent with Federal Circuit precedent (again, seemingly missing the point of en banc review) and "was rejected by the PTO" (which decision is not binding on the Court).  The brief also argues that the PTO needs a way to police applicant behavior that is broader than invalidity and that encompasses within its scope individuals outside the scope of PTO disciplinary proceedings.

    With regard to intent, the brief asserts that "inequitable conduct requires proof of specific intent"  that cannot be inferred solely from the materiality of withheld information, and citing Kingsdown Medical, negligence or recklessness is not enough.  The brief argues that the en banc Court should repudiate those cases that adopted a "knew or should have known" standard, because intent requires "at least actual knowledge of ail three of the following:  (a) the reference or information at issue; (b) the omission or misstatement regarding the reference or information; and (c) the materiality of the reference or information," citing Molins.  However, intent can be inferred from the "totality of the circumstances," the brief argues, because there is no requirement for direct evidence of an intent to deceive (a "smoking gun," citing Paragon Podiatry Lab., Inc. v. KLM Labs. Inc., 984 F.2d 1182,1189 (Fed. Cir. 1993), because "[d]irect proof of wrongful intent is rarely available," citing LaBounty Mfg., Inc. v. U.S. ITC, 958 F.2d 1066, 1076 (Fed. Cir. 1992), so that "[i]ntent is generally inferred from the facts and circumstances surrounding the appiicant's overall conduct," citing M. Eagles Tool Warehouse, Inc. v. Fìsher Tooling Co., 439 F.3d 1335, 1340 (Fed. Cir. 2006).  Such determinations are within the expertise of district courts to perform, and courts should have "wide latitude" to consider evidence from the totality of the circumstances in making these determinations.  The brief also argues that the materiality of a reference can be one of the circumstances in the totality, somewhat diminishing any bright line between the two determinations.  The brief states that:

    If an applicant fails to disclose a reference that it knows is highly material, the limited range of possible innocent explanations provides greater justification to infer intent.  The other facts and circumstances necessary to cross the threshold of clear and convincing evidence of specific intent to deceive are therefore less than if the information only barely crosses the materiality threshold.

    In maiking this argument, the brief appears to come close to advocating a "balancing" test that it otherwise rejects.  It also cites Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1366 (Fed. Cir. 2008), for the proposition that, in inferring intent, that inference must be "the single most reasonable inference."  But Bayer argues that any such determination should be entitled to deference by the Federal Circuit, because the district court is entitled to such deference when the Court applies an "abuse of discretion" standard of review.

    According to Bayer's brief, there should be no "balancing" between materiality and intent.  Any balancing by the trial court is properly performed to determine whether the court should exercise its discretion to render the patent unenforceable, but only after threshold determinations of materiality and intent are established by clear and convincing evidence.  Unenforceability is not an automatic consequence but should be imposed in the court's discretion after consideration of "all of the relevant circumstances."

    Regarding the Federal Circuit's final question to the parties, Bayer argues that it does not think standards developed in other agencies or contexts are appropriate, "because of statutory, regulatory, and precedential differences" particularly with regard to copyrights and trademarks.

    Turning to this case, Bayer argues that the district court's finding of inequitable conduct should be affirmed.  Here, the same people (Abbott's lawyer and scientist) were involved in arguing to the PTO something that was contradictory to what was argued to the EPO.  The existence of an inconsistent argument provides materiality, according to the brief, and the absence of an "innocent explanation" provides intent.  The brief also emphasizes that the statements at issue are not limited to attorney argument, but include the scientific declaration and under circumstances where the Examiner could not properly assess the evidence since the arguments made before the EPO were not in front of the Examiner.  In addition, the court's determination that the reference that was the "subject of inequitable conduct" was sufficient to invalidate Abbott's claims provided "but for" causation, so that the District Court's inequitable conduct decision should be upheld even should the en banc Court adopt a common law fraud standard for inequitable conduct.

    For additional information regarding this topic, please see:

    • "PhRMA Files Amicus Brief in Therasense Case," August 22, 2010
    • "PTO Files Amicus Brief in Therasense Case," August 19, 2010
    • "American Bar Association Files Amicus Brief in Therasense Case," August 17, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. — Briefing Schedule Update," August 8, 2010
    • "BIO Files Amicus Brief in Therasense Case," August 8, 2010
    • "Pharma and Software Companies File Joint Amicus Brief in Therasense Case," August 3, 2010
    • "IPO Files Amicus Brief in Therasense Case," August 2, 2010
    • "Abbott Files Brief in Therasense Case," July 28, 2010
    • "CAFC Sets Date for Oral Argument En Banc in Inequitable Conduct Appeal," June 9, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. — Briefing Schedule Update," May 16, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. Briefing," May 13, 2010
    • "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson," April 28, 2010

  • By James DeGiulio —

    GlaxoSmithKline Earlier this year, we reported on the therapeutic potential of gene therapy experiencing a revival of sorts after falling out of favor for over 10 years (see "Gene Therapy Experiencing a Revival").  That revival continues, as evidenced by a press release issued by GlaxoSmithKline on Monday, in which the pharmaceutical company reports that it has licensed a gene therapy treatment for a rare disease that afflicts just 350 children worldwide.  Following its recent formation of a rare disease unit, GSK has allied with two Italian groups, Fondazione Telethon and Fondazione San Raffaele, and has obtained an exclusive license to develop an experimental gene therapy for a disease called ADA severe combined immune deficiency (ADA-SCID).

    New England Journal of Medicine The ADA-SCID gene therapy news may remind some of the infamous 1999 attempt to cure the related disease severe combined immune deficiency using gene therapy.  Unfortunately, due to carcinogenic viral integration, the therapy caused leukemia in some of the patients.  While ADA-SCID is similar to severe combined immune deficiency, the techniques used in this gene therapy treatment are different, and the Italian group has provided very promising results.  In this ex vivo stem cell therapy, the patient's hematopoietic stem cells are harvested from the body, functional copies of the gene are inserted into the stem cells using a modified viral vector, and the cells are re-introduced to the patient.  Because the technique uses the patient's own cells, there is much less risk of immune rejection compared to a bone marrow transplant, which is currently the best treatment option available.  Most importantly, the ex vivo technique appears to be extremely safe.  On July 22, 2010, the San Raffaele Telethon Institute group published an article in the New England Journal of Medicine showing successful treatment in 8 of 10 children without substantial side effects, including no leukemia cases observed after four years.

    GSK also plans to work with the Italian researchers to develop ex vivo stem cell therapy for six other rare diseases, with the potential to treat a range of rare disorders.  The first two disorders will be metachromatic leukodystrophy and Wiskott-Aldrich Syndrome — clinical trials for both of these disorders were initiated last spring.  Others include beta-thalassemia, mucopolysaccharoidosis type I (MPS), globoid leukodystrophy (GLD), and chronic granulomatous disorder (CGD).  All of these disorders have molecular mechanisms that are well understood and all are caused by faults in a single gene.  GSK's rare disease unit will look at roughly 200 of the 6,000 rare diseases.  The unit will not be conducting its own research, but will instead further develop approaches discovered in academia or within other GSK units.

    James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law.  Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.