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  • Court Report

            By Sherri Oslick —

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

    Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al.
    1:14-cv-01004; filed July 31, 2014 in the District Court of Delaware

    • Plaintiffs:  Unimed Pharmaceuticals LLC; Besins Healthcare Luxemborg SARL
    • Defendants:  Perrigo Co.; Perrigo Israel Pharmaceuticals Ltd.

    Unimed Pharmaceuticals LLC et al. v. Watson Laboratories Inc.
    1:14-cv-01003; filed July 31, 2014 in the District Court of Delaware

    • Plaintiffs:  Unimed Pharmaceuticals LLC; Besins Healthcare Luxemborg SARL
    • Defendant:  Watson Laboratories Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,729,057 ("Testosterone Gel and Method of Use," issued May 20, 2014), 8,741,881 (same title, issued June 3, 2014), 8,754,070 (same title, issued June 17, 2014), and 8,759,329 (same title, issued June 24, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone).  View the Perrigo complaint here.

    Astrazeneca AB et al. v. Zydus Pharmaceuticals (USA) Inc. et al.
    3:14-cv-04782; filed July 31, 2014 in the District Court of New Jersey

    • Plaintiffs:  Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
    • Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

    Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 7,411,070 (same title, issued August 12, 2008), and 8,466,175 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

    Warner Chilcott Co. LLC et al. v. Apotex Inc. et al.
    1:14-cv-00998; filed July 30, 2014 in the District Court of Delaware

    • Plaintiffs:  Warner Chilcott Co. LLC; Warner Chilcott (US) LLC
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent No. 6,106,864 ("Pharmaceutical Formulations Containing Darifenacin," issued August 22, 2000) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Warner Chilcott's Enablex® (darifenacin, used to treat symptoms of overactive bladder).  View the complaint here.

    Impax Laboratories Inc. et al. v. Lannett Holdings Inc. et al.
    1:14-cv-00999; filed July 30, 2014 in the District Court of Delaware

    • Plaintiffs:  Impax Laboratories Inc.; AstraZeneca AB; AstraZeneca UK Ltd.
    • Defendants:  Lannett Holdings Inc.; Lannett Co. Inc.

    Infringement of U.S. Patent Nos. 6,750,237 ("Pharmaceutical Formulations Containing Aolmitriptan," issued June 15, 2004) and 7,220,767 (same title, issued May 22, 2007), licensed to Impax, following a Paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Impax's Zomig® Nasal Spray (zolmitriptan nasal spray, used for the acute treatment of migraine with or without aura in adults).  View the complaint here.

    Taro Pharmaceuticals U.S.A. Inc. et al. v. Perrigo Israel Pharmaceuticals, Ltd.
    1:14-cv-00809; filed July 30, 2014 in the Western District of Michigan

    • Plaintiffs:  Taro Pharmaceuticals U.S.A. Inc.; Taro Pharmaceuticals North America, Inc.
    • Defendant:  Perrigo Israel Pharmaceuticals, Ltd.

    Infringement of U.S. Patent Nos. 8,277,780 ("Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity" issued October 2, 2012) and 8,715,624 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Taro's Topicort® (desoximetasone topical spray, used for the treatment of plaque psoriasis).  View the complaint here.


    Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Amneal Pharmaceuticals LLC
    1:14-cv-04726; filed July 30, 2014 in the District Court of New Jersey

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

    Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Mylan Pharmaceuticals Inc.
    1:14-cv-04727; filed July 30, 2014 in the District Court of New Jersey

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

    The complaints in these cases are substantially identical.  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 defendants' 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 Amneal complaint here.

  • Conference & CLE Calendar

    CalendarAugust 18-19, 2014 - Advanced Patent Prosecution Workshop 2014: Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 19, 2014 – "Alice Corp. v. CLS Bank International: General Purpose Computers Cannot Save Inventions Directed to Abstract Ideas" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    August 21, 2014 – "Inducement to Infringe in Hatch-Waxman Litigation: Strategies for Patent Drafting, Prosecution and Litigation" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 28, 2014 – "Alice Corp. vs. CLS Bank: What’s Eligible, What’s Not, and What’s Still to be Determined?" (Technology Transfer Tactics) – 1:00 to 2:00 pm (ET)

    September 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 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)

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

  • DuPont & Widener University School of Law IP CLE Seminar

    Widener University School of LawDuPont and the Widener University School of Law will be holding the 2014 Intellectual Property Continuing Legal Education Seminar on September 30, 2014 at The DuPont Country Club in Wilmington, Delaware.  Among the presentations being offered at the seminar will be:

    • IP Due Diligence – Global Aspects / Pitfalls to Avoid
    • Non-Practicing Entities: Promoting the Progress of Science and the Useful Arts?
    • Ethics
    • USPTO Perspective — to be presented by Andrew Byrnes, Chief of Staff, U.S. Patent & Trademark Office
    • Patent Highlights
    • Practical Tips on Patent Drafting In View of Recent Case Law
    • Post-Grant Review Strategies Update

    DuPontAdditional information about the seminar, including a program, list of speakers can be found here.

    The registration fee for the seminar is $600.  Those interested in registering for the seminar can do so here.

  • Webinar on Post-AIA Section 102 and Prior Art

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Post-AIA Section 102 and Prior Art: Navigating the Expanded Scope of Prior Art and AIA Exceptions" on September 11, 2014 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, Washington; John J. Cheek, Senior Corporate Counsel, Caterpillar; and John Mulcahy of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel regarding post-AIA Section 102 and prior art and offer best practices for utilizing prior art in patent applications.  The webinar will review the following questions:

    • How did AIA expand the definition of prior art?
    • What are the Section 102 exceptions and what is the impact on Section 103 art?
    • How can counsel claim—or defend against—post-AIA patent applications asserting priority over pre-AIA applications?
    • What practices should patent counsel employ in order to utilize prior art?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • Webinar on Section 103 and Obviousness

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Section 103 and Obviousness: Capitalizing on CCPA and Early Federal Circuit Precedent — Strategies for Withstanding Obviousness Rejections and Attacks on Patent Validity and Patentability" on September 16, 2014 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving; Jill K. MacAlpine, Ph.D.; Mary Henninger, Ph.D.; and Deborah M. Herzfeld of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on leveraging decisions by the Court of Customs and Patent Appeals (CCPA) and the Federal Circuit in the application of the Section 103 obviousness standard and offer strategies for evaluating obviousness, handling evidence, and overcoming assertions of unpatentability.  The webinar will review the following questions:

    • How is evidence of unexpected properties by a claimed invention evaluated?
    • What lessons can patent counsel draw from CCPA decisions when applying the statutory obviousness standard?
    • What steps should patent counsel take going forward to avoid making the mistakes of the past?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by August 22, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • Tyco Healthcare Group LP v. Mutual Pharmaceutical Co.

    By Andrew Williams —

    Federal Circuit SealCan filing a lawsuit under the Hatch-Waxman scheme of 35 U.S.C. § 271(e)(2)(A) ever give rise to antitrust liability?  The Federal Circuit last week indicated in the affirmative.  That statute provides that:

    It shall be an act of infringement to submit—
        (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent . . . .

    The case law is well established that an infringement analysis in this context is prospective in nature.  Therefore, it is necessary to look at the drug product that the ANDA applicant will likely market if it receives FDA approval.  This analysis is not limited to the ANDA itself, though.  Instead, a court needs to look to the ANDA, materials submitted by the ANDA applicant in support of the ANDA, "and any other relevant evidence submitted by the applicant or patent holder."  Bayer AG v. Elan Pharmaceuticals Research Corp., 212 F.3d 1241, 1248-49 (Fed. Cir. 2000).  With regard to antitrust liability, it is also well established that a patent holder is ordinarily exempt for bringing a patent infringement lawsuit.  This principle is known as "Noerr-Pennington" immunity.  There is an exception to this immunity for sham litigation, however, which is defined as a lawsuit that is both (1) objectively baseless, and (2) subjectively brought to interfere with a competitor's business relationships.  The intersection of these two well-established principles was clarified in the Federal Circuit's Tyco Healthcare Group LP v. Mutual Pharmaceutical Co. case.  Specifically, the Court found that it is possible for a patent holder to engage in sham litigation by filing a Hatch-Waxman lawsuit if the factual theory of infringement is objectively baseless.  The Court also held that a citizen petition filed by a patent holder could give rise to antitrust liability if an ANDA filer suffers anticompetitive harm.

    Judge Newman dissented, in part, because she believed that a lawsuit brought in accordance with § 271(e)(2)(A) cannot be a sham because "[t]he filing of . . . an Abbreviated New Drug Application (ANDA) in and of itself constitutes probable cause to initiate suit . . . for the Hatch-Waxman statute authorizes the filing of an infringement suit in response to a Paragraph IV filing."  A review of the statute (reproduced above) would suggest that this is not necessarily correct.  For example, there needs to be a patent that is infringed by the drug or the use of a drug to invoke § 271(e)(2)(A) (not to mention that there is also no reference in the statute to Paragraph IV certifications).  Therefore, for example, as the Supreme Court explained in Caraco Pharm. Labs, Ltd. v. Novo Nordisk A/S, if an ANDA applicant "carves-out" a particular field of use in its application with a section viii statement, it can avoid infringement liability under § 271(e)(2)(A) for patents that claim that carved-out use.  In such a case, the patent holder would likely not have probable cause to initiate suit.  Nevertheless, the policy reasons espoused by Judge Newman are still valid.  Unlike infringement suits brought under 35 U.S.C. § 271(a), in which a patent holder normally has ample time to carefully study the accused infringing activity, in the Hatch-Waxman context, an NDA holder receiving a Paragraph IV notification letter only has 45 days to initiate suit.  Moreover, because the ANDA application is not publically available, the patent holder must rely on statements by the ANDA applicant in the Paragraph IV notice letter, which may or may not contain data sufficient to allow the patent holder to make an independent assessment of infringement.  This is in addition to the fact that an ANDA applicant must represent to the FDA that its ANDA product is "bioequivalent" to the marketed drug.  Of course, there is the possibility of obtaining "confidential access" to the ANDA, but negotiations of the terms of such access can consume most (if not all) of the 45-day window.  Therefore, to impose antitrust liability for lawsuits that are found to have been "objectively baseless" seems like an unjustified shift of power in favor of ANDA applicants, and could encourage vague notice letters and protracted negotiations for ANDA confidential access.  And, as Judge Newman put it, it will be the rare litigation that does not now contain an allegation of antitrust liability.

    The drug at issue in this case was temazepam, which is used to treat insomnia.  Tyco markets under the brand name Restoril, which it obtained from Sandoz Limited in 2001, along with several related patents. The patents all claimed formulations with specific surface areas between 0.65 and 1.1 square meters per gram (m2/g).  In general, the smaller the particle size of the drug material in a formulation, the greater the specific surface area will be.  Specific surface area is often measured using a gas-adsorption technique referred to as B.E.T. testing (for Bruanauer, Emmet, and Teller).  This procedure measures the amount of an adsorbate gas bound to the surface of the particles.  However, the sample must be prepared by removing all gas or vapor from the surface in a process referred to as outgassing.  The temperature at which the outgassing is performed is important, because if the temperature is too high, it can physically alter the test material (by softening or melting it).  Conversely, if the temperature is too low, it is possible that the test material will not be "cleaned" of all of the gas or vapor, resulting in less surface area available for the adsorbate gas.

    Mutual filed an ANDA with the FDA to market a generic version of temazepam, in which Mutual represented that the ANDA product would have a specific surface area of not less than 2.2 m2/g, thereby taking it outside the scope of the claims.  However, Mutual was using an outgassing temperature of 40°C, rather than the 105°C that Tyco used in all of its tests.  Neither party disputed that the specific surface area of Mutual's ANDA product would fall within the infringing range using an outgassing temperature of 105°C.  Instead, Mutual alleged that its material was physically altered by such temperatures, resulting in larger particles and decreased specific surface area.  The District Court granted a judgment of non-infringement to Mutual on August 4, 2009.  The next day, Tyco filed a citizen petition with the FDA, urging that the criteria for evaluating bioequivalence of generic temazepam products be heightened in view of Mutual's representation to the Court that its drug particles are different than those which had already been approved as safe and effective by agency.  The FDA approved the ANDA, and subsequently denied the petition.  On May 10, 2010, the District Court granted summary judgment that the claims at issue were invalid as obvious, which the Federal Circuit affirmed.  Ultimately, the District Court turned to the antitrust counterclaims filed by Mutual, but granted summary judgment to Tyco.  The present case is the appeal of this decision.

    Infringement

    Mutual's first antitrust allegation was that Tyco's infringement suit was "objectively baseless" because the Federal Circuit had already held, in the Bayer case cited above, that if the  specific surface area of an ANDA product fell outside the scope of the patented range, it could not infringe under § 271(e)(2)(A).  However, in Bayer, neither party submitted evidence that the specific surface area of the commercial ANDA product would differ from that reported in the ANDA.  As such, the statements contained in the ANDA were controlling.  Instead, the Court in the present case reaffirmed that it is not unreasonable to allege infringement if the patent owner has independent evidence apart from the ANDA filing that the as-marketed product will infringe.

    That did not end the "objectively baseless" inquiry for the majority, however.  Mutual had presented expert evidence that its use of a lower outgassing temperature should have underestimated the specific surface temperature, not overestimated it.  This was because the lower temperature, at worst, would result in an incomplete "cleaning" of the test particles, leaving less available surface for the test gas to adsorb to.  The argument goes, therefore, that the 2.2 m2/g should be the low end of the specific surface area of the ANDA product, resulting in a finding of non-infringement at any temperature used.  If this was the case, then the Court believed that Tyco's factual theory of infringement could have been objectively baseless.  The Court remanded for this determination, as well as whether the subjective element had also been satisfied.

    Validity

    Mutual's second antitrust allegation was that Tyco lacked any reasonable prospect of successfully defending the validity of the patents.  The Court did uphold the lower court's ruling that, in this case, such allegations were without merit.  Nevertheless, the Court stopped short of stating that "the presumption of validity of a duly granted patent negates ruling that the routine defense of a patent's validity constitutes 'sham' litigation," as Judge Newman would have held.  She had a problem with the majority's suggestion that antitrust liability could in situations where a patent holder has the "burden of production," such as with secondary considerations of non-obviousness.  Her concern was that such a requirement could import a "chilling effect" of antitrust liability into routine patent debates.  Judge Newman predicted that this decision will cause accused infringers to assert Sherman Act violations in almost all patent suits going forward.

    The Citizen Petition

    Mutual's next antitrust allegation was that Tyco's citizen petition to the FDA was a sham, and therefore Tyco did not have Noerr-Pennington immunity.  The lower court held that the sham exception was limited to litigation, and therefore was not applicable to administrative petitions.  The majority disagreed as a matter of law, and remanded for a determination whether the citizen petition was objectively baseless, and whether the filing of the petition caused antitrust injury to Mutual.  Judge Newman pointed out in dissent that Tyco's petition communicated public information that Mutual's ANDA product was not the same as the FDA-approved product, a conclusion based on the fact that an outgassing temperature of 105°C impacted the two allegedly equivalent drug products differently.  "An accurate communication," Judge Newman explained, "cannot be an antitrust violation, even if it relates to competitors, as firmly established by Noerr-Pennington."

    The Walker-Process Allegation

    Mutual's final allegation was that Tyco was aware that Sandoz fraudulently obtained the patents at issue, and therefore it was stripped of its immunity from antitrust liability based on the Supreme Court's Walker Process case.  The Federal Circuit rejected this argument and affirmed the lower court because, even if Sandoz had committed fraud in obtaining the patent, there was insufficient evidence on the record to support the inference that Tyco was aware of it.  First, a reasonable fact-finder could not conclude that Tyco had knowledge of the alleged fraud just because it had reviewed the prosecution record.  In addition, just because Tyco might have been aware that there could be a strong validity challenge to the patents, this does not support an inference of knowledge of fraud.  Finally, Mutual's Paragraph IV notice letter was insufficient to put Tyco on notice (pun in the original) of the alleged fraud, because Mutual had not sufficiently articulated these allegations at that time.

    One important consideration of this case is that the Federal Circuit did not comment on the subjective component of the "sham litigation" exception to antitrust liability, other than to instruct the lower court to consider it on remand.  Before declaring antitrust allegation to be the new plague on the patent system, as least as far as ANDA litigation is concerned, it will be necessary to see how lower court's apply this second prong.  Hopefully Judge Newman's premonition of antitrust counterclaims in almost every case will not come to pass.

    Tyco Healthcare Group LP v. Mutual Pharmaceutical Co. (Fed. Cir. 2014)
    Panel: Circuit Judges Newman, Bryson, and Moore
    Opinion by Circuit Judge Bryson; dissenting opinion by Circuit Judge Newman

  • FDA Releases Another Prospective Guidance

    By Kevin E. Noonan —

    FDAOn August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act."  Before setting forth the first word of the Guidance, the Administration set forth the following caveat:

    This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's or the Agency's) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.

    The term of market exclusivity under the BPCIA (12 years; Sec. 351(k)(7), codified at 42 U.S.C. 55 262(k)) requires that the agency identify the date from which to calculate the term.  This Guidance, prefaced by the quote set forth above, provides some grounds for making that determination.  However, as with many of the FDA's Guidances on provisions of the law, the tentativeness of the principles set forth are more akin to hints than rules and provide little other than further evidence that the Administration will act with utmost caution (a stance understandable when taken with regard to substantive grounds for biosimilar approval but somewhat less so in the context of this Guidance).

    The critical date with which the Guidance is concerned is the "date of first licensure" of the reference product under PHSA Sec. 351(k)(7)(C).  This date determines not only the length of the market exclusivity of the reference product but also the time (4 years) that a biosimilar applicant must wait before filing an application for biosimilar approval.  The Guidance notes that "[n]ot every licensure of a biological product under 351(a) is considered a 'first licensure' that gives rise to its own exclusivity period," where some changes in "previously licensed" reference products, from either the same or "related" reference product sponsors are expressly excluded from being considered as a date of first licensure.  Because the agency recognizes that it is the reference drug sponsor who will have "superior information" about such changes or such relationships between companies, the Guidance sets forth "the types of information that reference product sponsors should provide to facilitate FDA's determination of the date of first licensure for their products."

    The Guidance then sets forth these types of "superior information."  Typically, the date of first licensure is "the initial date the particular product at issue was licensed in the United States."  But there are exceptions codified into the statute; these include

    • a supplement for the biological product that is the reference product; or

    • a subsequent application filed by the same sponsor or manufacturer of the biological product (or a licensor, predecessor in interest, or other related entity) for:

    — a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or

    — a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.

    (These can be seen as "anti-evergreening" provisions.)  The Guidance notes that the Agency has "experience in construing other provisions that require examination of the relationships between business entities to determine eligibility of a new drug application for exclusivity" (citing "Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions" (patent and exclusivity final rule), published in the Federal Register of October 3, 1994 (59 FR 50338 at 50359 and 50362)).  In view of this experience, the Guidance asserts that the Agency will construe certain terms of the statute consistently to its previous determinations.  Thus:

    • the term "predecessor in interest" will be "any entity that the sponsor has taken over, merged with, or purchased, or that has granted the sponsor exclusive rights to market the biological product under the 351(a) application, or had exclusive rights to the data underlying that application";

    • a "licensor" will be "any entity that has granted the sponsor a license to market the biological product, regardless of whether such license is exclusive" and shall "include, for instance, entities that continue to retain rights to develop, manufacture, or market the biological product, and/or rights to intellectual property that covers the biological product"; and

    • one corporate entity will be considered an "other related entity" "if (1) either entity owns, controls, or has the power to own or control the other entity (either directly or through one or more other entities) or (2) the entities are under common ownership or control" or "if the entities are or were engaged in certain commercial collaborations relating to the development of the biological product(s) at issue."  In this regard, the FDA "expects to consider not only ownership and control of the investigational new drug application (IND) and the BLA, but also the level of collaboration between the entities during the development program as a whole."

    Regarding the statutory proscriptions against considering for the date of first licensure situations wherein there is "a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength" unless there are "modifications in the structure of the biological product" that results in a change in "safety, purity or potency," the Agency will need to determine what qualifies as "modifications in the structure of the biological product" that satisfy the statute.  To do so, "a sponsor seeking to assist FDA in determining the date of first licensure for a reference product licensed under 351(a), should describe the structural similarities and differences between its proposed product and any previously licensed biological product that was the subject of a 351(a) application filed by the same sponsor or manufacturer (or its licensor, predecessor in interest, or other related entity)."  Specifically, for a protein product the reference drug sponsor should describe "any differences in amino acid sequence, glycosylation patterns, tertiary structures, post-translational events (including any chemical modifications of the molecular structure such as pegylation), and infidelity of translation or transcription, among others."  In addition, the Agency will perform a structural comparison of the reference drug product and the modified product, including "whether the modified product affects the same molecular target as the previously licensed product."  For changes in cell lines to make the reference product, the Agency asserts that "modification of the structure will not simply be presumed" but rather require the product sponsor to submit relevant evidence that establishes the change.

    In addition, according to the statute, the reference product sponsor will be required by the Agency to show the structural modification "results in a change in safety, purity or potency" (or alternatively and interchangeably, "safety and effectiveness").  The Agency will do this on a "case-by-case basis" based on scientific data (as provided by the sponsor).  The Agency is willing to presume such a change if the sponsor establishes that the modified "product demonstrates that it affects a different molecular target than the original product" (where the Guidance defines "a difference molecular target" to mean any molecule in the body whose activity is modified by the product, resulting in a desirable therapeutic effect," including "receptors, enzymes, ion channels, structural or membrane transport proteins, nucleic acids, and pathogens, among others").

    The final section of the Guidance sets forth expressly the information the Agency "suggests" the reference product sponsor should submit to support its date of first licensure.  This information includes:

    1. A list of all licensed biological products that are structurally related to the biological product that is the subject of the 351(a) application being considered. This list should include products that share some of the same principal molecular structural features of the product being considered, but generally can be limited to products that affect the target should be included. Where specific molecular targets have not been defined, this list should include products that share the narrowest target that can be characterized. This may be a pathway, cell type, tissue, or organ system. If this assessment results in the conclusion that no product that has the same molecular target or shares some of the same principal molecular structural features has been licensed, a sponsor should provide an adequate justification to support the assertion that there are no previously licensed products that are relevant for purposes of determining the date of first licensure.

    2. Of those licensed biological products identified in item 1 above, a list of those for which the sponsor or one of its affiliates, including any licensors, predecessors in interest, or related entities, are the current or previous license holder.

    3. Description of the structural differences between the proposed product and any products identified in item 2 above. For protein products, this should include, but is not limited to, changes in amino acid sequence, differences due to post-translational events, infidelity of translation or transcription, differences in glycosylation patterns or tertiary structure, and differences in biological activities.

    4. Evidence of the change in safety, purity, and/or potency between the proposed product and any products identified in item 2 above. This should include, but is not limited to, a description of how the structural differences identified in item 3 above relate to changes in safety, purity, and/or potency.

    And, of course, "any other information and data that would assist the FDA in making its determination."

    Finally, the Guidance notes that it "is reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure" and will provide the information to the public on its website when the Agency decision has been made.

  • News from Abroad: The Regretful Patentee — The Re-Emergence of File Wrapper Estoppel & Equivalence in the UK

    By Ralph Cox* and Simon Spink** —

    Overview

    ActavisFor the best part of 10 years, since the judgment of Lord Hoffmann in Kirin-Amgen v Hoescht Marion Roussel[1], it has been widely assumed that there is no file wrapper estoppel in the UK and no doctrine of equivalents either.  Both these assumptions are thrown into doubt by the Patent Court's decision in Actavis v Eli Lilly[2].  The judge, Mr Justice Arnold, held that the court should not shut its eyes to the prosecution file but should ensure a patentee did not abuse the system by accepting narrow claims during prosecution and then argue for a broader construction in a subsequent infringement action.  The judge also applied the more or less defunct Improver or Protocol Questions[3] in a manner that potentially opens the door to a doctrine of equivalence in all but name.

    Use of the File Wrapper

    In Kirin-Amgen, Lord Hoffmann said that there were good reasons why the German and English courts discouraged, if not actually prohibited, the use of patent office files in aid of the construction of claims.  The reasons included that the meaning of a patent does not change depending on whether a party has access to the office file or not and anyway the file may reflect no more than a patentee's desire to get the patent granted quickly without further argument with the examiner.  In short, it was a difficult and likely unproductive exercise to use the file wrapper to try to work out what the patentee meant by a claim's terms.

    Taking the hint, parties and the courts made little use of file wrappers in subsequent cases with Sir Robin Jacob observing in Eli Lilly v Human Genome Sciences[4] that he was not confident it was legitimate to do so even though the UK courts had yet to decide the matter conclusively.  Going further, Mr Justice Floyd in Qualcomm v Nokia[5] warned that it was positively counterproductive to be referred to prosecution documents as it alerted the tribunal to the fact that there might be something to be said for the alternative construction.

    Doctrine of Equivalents

    While Lord Hoffmann considered that Article 69 of the European Patent Convention firmly shut the door on any doctrine which extended protection outside the claims, he acknowledged that equivalence could be an important part of the background that would affect the skilled person's understanding of a claim.  This was consistent with Article 2 of the Protocol on the Interpretation of Article 69, which states that, in balancing the literal and purposive construction of a patent's claims, due account should be taken of "any element which is equivalent to an element specified in the claims".  However, he doubted the usefulness of the Improver Questions in reaching a purposive construction saying that there was only one compulsory question:  what would a person skilled in the art have understood the patentee to have used the language of the claim to mean?

    Following this decision, the Improver Questions have seldom been used in UK patent actions.  In Smith & Nephew v Convatec Technologies[6] it was even questioned whether a 1992 decision on infringement of a numerical limitation would have been decided the same way following Kirin-Amgen as it had been using the Improver Questions.

    The Actavis v Eli Lilly Decision

    LillyThe Actavis case concerned Eli Lilly's European patent protecting its cancer treatment, Alimta.  The patent claims the active ingredient, pemetrexed disodium, in combination with vitamin B12 and, optionally, a folic protein binding agent.  Actavis sought declarations that its proposed generic version of Alimta, which would contain one of pemetrexed diacid, pemetrexed dipotasium or pemetrexed dimethamine, did not infringe.  As Actavis was not challenging validity, it was allowed to seek declarations of non-infringement under the French, Italian and Spanish designations of the patent as well as the UK designation.

    In his judgment, Mr Justice Arnold carefully reviewed the case law on both use of file wrappers and the doctrine of equivalence.  On the latter, he identified three main classes of case in which patentees resort to arguments on equivalence, namely where:

    (i)       the patent has been poorly drafted (as in the Improver case);

    (ii)      technology has moved on significantly since the patent was filed (as in Kirin-Amgen); and

    (iii)     the patent regrets a decision taken during the course of prosecution.

    The Actavis case was a clear example of the third category.  Eli Lilly had attempted to broaden its claims in prosecution to cover "pemetrexed", failed and accepted the narrower claims to pemetrexed disodium.  It had reserved the right to file a divisional application, but did not do so.  It clearly now wished it had broader claims in order to catch Actavis on infringement.  But there was "no reason why the law should be sympathetic to the patentee", which not only had the benefit of skilled professional advice but also had the opportunity to appeal against adverse decisions by patent examiners.  Further, allowing examiners' decisions effectively to be overturned by the courts on claim construction would undermine their important role.  Against this background, Mr Justice Arnold made use of the prosecution history as one of several reasons why Eli Lilly's broad construction, that pemetrexed disodium encompassed other salts because the important pemetrexed anion was present irrespective of the cation used, should be rejected.

    He also used the Improver Questions, partly because there was no dispute that the alleged infringement was not within the primary, literal meaning of the claim and partly because the parties used them for consistency in their submissions on the non-UK designations.

    Conclusion

    Mr Justice Arnold observed that the US has a doctrine of equivalence and a doctrine of file wrapper estoppel to counterbalance it.  While following prior case law, the UK had neither, file wrapper estoppel is back albeit only in the case of the regretful patentee.  Even then, as Arnold J warned, the courts should be cautious using the prosecution history only when it is short, simple and shows clearly why the claims are in their granted form and not broader.

    As regards equivalence, using the Improver Questions having held that there is plainly no literal infringement comes very close to Lord Hoffmann's description of the US approach in Kirin-Amgen as being "to adhere to literalism in construing the claims and evolve a doctrine which supplements the claims by extending protection to equivalents".  Even if not explicitly recognised as a doctrine of equivalence, the decision may therefore lead to a resurrection of the Improver Questions by patentees effectively arguing just that.

    * Ralph Cox is a Partner with Fasken Martineau LLP (London, UK)
    ** Simon Patrick Spink is a Senior Associate with with Fasken Martineau LLP (London, UK)

    [1] [2005] RPC 9

    [2] [2014] EWHC 1511 (Pat)

    [3] From Improver v Remington Consumer Products [1990] FSR 181 – in brief, as guidance on arriving at a purposive construction of a claim, the Questions ask whether a variant has a material effect on the way an invention works, whether this was obvious at the patent's publication date and whether strict compliance with the primary meaning of the claim is nonetheless essential.

    [4] [2013] RPC 22

    [5] [2008] EWHC 329 (Pat)

    [6] [2013] EWHC 3955 (Pat)

  • Examination of Myriad-Mayo Guidance Comments — International Bioindustry Associations

    By Donald Zuhn —

    USPTO SealOn March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance"), to implement a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).  At a biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting in April, the Office announced that it would be hosting a public forum on the Guidance in May to receive public feedback on the Guidance, and at that forum encouraged shareholders to submit written comments on the Guidance.  The original "end of June" deadline for submitting comments on the Guidance was subsequently extended to July 31.  With that extended deadline now passed, Patent Docs has begun to focus on selected comments in a series of posts.

    The Office has posted the comments that were submitted on the USPTO website.  The comments are divided into five groups (with the number of submissions in each group also provided):  Intellectual property organizations and other associations (18), academic and research institutions (7), law firms (6), companies (9), and individuals (42).  Today, we examine the comments submitted by the International Bioindustry Associations, a coalition of twelve associations and organizations representing "thousands of biotech businesses, academic and nonprofit research centers, technology transfer organizations and other entities dedicated to biotechnological innovation throughout the world."  The twelve signatories to the comments include:  ASEBIO — The Spanish Bioindustry Association; AusBiotech, Australia's Biotechnology Organisation; Belgian Biotechnology Industry Organisation; BIA, The UK BioIndustry Association; BIO Deutschland; BIOTECanada; Biotechnology Industry Organization; CropLife International; EuropaBio; HollandBIO; Japan Bioindustry Association; and P-BIO, Portugal's Biotechnology Industry Organization.

    The coalition begins its comments letter by expressing "concern over the recent judicial and administrative expansion of nonstatutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States, as manifested in the PTO's March 4 Guidance."  The group also "note[s] with concern the significant departure from internationally accepted norms of patentability that would be established by the Guidance, particularly with regard to industrial, agricultural, and pharmaceutical preparations of naturally-derived substances, compositions, and processes."  Among the many examples of inventive preparations based on naturally-occurring substances, the letter points to a number of vaccine antigens, crop protection products, plant biotechnology and breeding, industrial enzymes, immunosuppressive drugs, anticancer compounds, and antibiotic drugs (in several footnotes, the coalition lists an array of specific naturally-occurring substances, many of which have been patented).

    With respect to drug discovery, the letter states that "preparations of novel and unobvious naturally occurring molecules continue to be an important source for drug discovery," citing Swinney & How, 2011, Nat. Rev. Drug Discov. 10: 507-19, for the proposition that "naturally-occurring molecules and their close derivatives have contributed an estimated 36% of all first-in-class small molecules approved by the FDA between 1999 and 2008."  Pointing to the costs associated with drug discovery (the letter indicates that the average drug requires an investment of $1.2 billion with clinical testing taking eight years), the coalition explains that:

    For every successful biopharmaceutical product, thousands of candidates are designed, screened, and rejected after large investments have been made.  Only a small minority of drugs even advance to human clinical trials and most of those fail to obtain regulatory approval.  Investment therefore is predicated on the availability of patent protection that enables biotechnology businesses to attract capital and commercial partners in order to advance basic inventions — including those based on naturally-occurring substances and processes — from the laboratory to the marketplace and ultimately to generate an expected return on investment in the form of patent-protected products or services.

    While suggesting that "[t]he use of naturally-occurring substances and the practical application of newly discovered biomarkers is playing out with equal importance in the area of diagnostics and personalized therapy," the group contends that:

    The proposed Guidance, by its unfavorable treatment of these inventions, has the potential to seriously impair the scientific advances of U.S. universities over universities in e.g. Europe and Japan, which provide broader patent protection to inventors.  In the end, this could lead to the United States falling behind in this extremely important area of research, one that has significant implications on drug discovery and development.

    Arguing that "it is extremely important that investment in biotechnological innovation is not discouraged by systematically erecting special hurdles to patent protection for all inventions that relate to naturally-derived substances and processes," the coalition expresses concern for the "investment-hostile extrapolation and expansion of nonstatutory U.S. patent law that was not required by the U.S. Supreme Court's decisions" as manifested in the Guidance.  The group explains that "[t]he Court's multiple cautionary statements about the narrowness of its holding and of all the questions it was explicitly not deciding, signal a narrow, incremental decision that should not compel broad changes in examination practice."  The group specifically takes issue with the way the Guidance handles combinations of naturally-occurring products, methods of treatment, and purified naturally-occurring substances, asserting that:

    [T]he Supreme Court's decisions do not require the application of a heightened patent-eligibility test to inventions such as combination products (especially in instances where the claimed combination occurs neither in a natural state nor in the prior art); methods of drug administration or the use of medicinal molecules for the treatment of disease; or purified naturally-occurring substances (such as antibiotics or vaccine antigens) which, in the claimed purified state, are for the first time provided for real-world practical uses and having industrial applicability not possessed in their natural, impure state.

    The group concludes its comments letter by noting the absence of "a policy justification for why the USPTO adopted such a far-reaching interpretation of judicial decisions and departed so profoundly from its own past policies and from internationally accepted practices."  The letter argues that "what is . . . needed is a public dialogue not just over what the law 'is,' but over what the right policies ought to be," adding that "there is a real risk of 'getting it wrong' when trying to extract generalizations and uniformly applicable principles from an unstable jurisprudence and from judicial decisions that stand in tension with each other," particularly "in light of consistent reminders by the U.S. Supreme Court that the statute is inclusive and the exceptions to it are narrow — not the other way round."

    Patent Docs will examine other Guidance comments in subsequent posts.

    For additional information regarding this topic, please see:

    • "Examination of Myriad-Mayo Guidance Comments — ACLU," August 5, 2014
    • "Guest Post: Overview of First Published Comments on Myriad-Mayo Patent Eligibility Guidance," July 13, 2014
    • "Guest Post: USPTO Public Forum on Patent Guidance: My Thoughts as a Speaker and Attendee," June 11, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part IV," May 22, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part III," May 15, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part II," May 14, 2014
    • "Guest Post: How to Patent Grapefruit Juice — The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour," May 13, 2014
    • "USPTO Holds Forum on Subject Matter Eligibility — Part I," May 12, 2014
    • "USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance," April 16, 2014
    • "USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products," March 4, 2014

  • Court Report

            By Sherri Oslick —

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

    Glycobiosciences Inc. v. Dara Biosciences, Inc. et al.
    1:14-cv-01281; filed July 28, 2014 in the District Court of the District of Columbia

    • Plaintiff:  Glycobiosciences Inc.
    • Defendants:  Dara Biosciences, Inc.; Helsinn Healthcare SA

    Infringement of U.S. Patent No. 6,335,035 ("Sustained Release Delivery System," issued January 1, 2002) based on defendants' manufacture and sale of its Gelclair product, a bioadherent oral rinse gel for management of mucositis.  View the complaint here.

    Warner Chilcott Co. LLC et al. v. Aurobindo Pharma Ltd. et al.
    1:14-cv-00990; filed July 28, 2014 in the District Court of Delaware

    • Plaintiffs:  Warner Chilcott Co. LLC; Hoffmann-La Roche Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement of U.S. Patent Nos. 6,165,513 ("Film-Coated Tablet For Improved Upper Gastrointestinal Tract Safety," issued December 26, 2000), 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007), and 7,718,634 (same title, issued May 18, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis).  View the complaint here.

    Taro Pharmaceuticals USA Inc. et al. v. Perrigo Israel Pharmaceuticals Ltd.
    1:14-cv-00989; filed July 28, 2014 in the District Court of Delaware

    • Plaintiffs:  Taro Pharmaceuticals USA Inc.; Taro Pharmaceuticals North America Inc.
    • Defendant:  Perrigo Israel Pharmaceuticals Ltd.

    Infringement of U.S. Patent Nos. 8,277,780 ("Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity" issued October 2, 2012) and 8,715,624 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Taro's Topicort® (desoximetasone topical spray, used for the treatment of plaque psoriasis).  View the complaint here.

    Enteris Biopharma, Inc. v. Clinical Pharmacology of Miami, Inc.
    1:14-cv-22770; filed July 28, 2014 in the Southern District of Florida

    Infringement of U.S. Patent Nos. 6,086,918 ("Oral Peptide Pharmaceutical Products," issued July 11, 2000) and 8,377,863 ("Peptide Pharmaceutical for Oral Delivery," issued February 19, 2013) based on defendant having conducted a Phase I clinical trial relating to the development of Steath Peptide's BendaviaTM, after  termination of plaintiff's clinical manufacturing service agreement with Steath, in which plaintiff's oral formulations of BendaviaTM were used.  Also, various claims sounding in state law.  View the complaint here.

    IPXpharma, LLC v. Millennium Pharamaceuticals, Inc.
    3:14-cv-01545; filed July 28, 2014 in the Middle District of Tennessee

    Infringement of U.S. Patent No. 6,171,786 ("Methods for Preventing Multidrug Resistance in Cancer Cells," issued January 9, 2001) based on Millennium's manufacture and sale of its Velcade® product (bortezomib, used to treat multiple myeloma).  View the complaint here.


    Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical, Inc.
    9:14-cv-80990; filed July 28, 2014 in the Southern District of Florida

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendant:  Breckenridge Pharmaceutical, Inc.

    Novartis Pharmaceuticals Corp, et al. v. Breckenridge Pharmaceutical, Inc.
    1:14-cv-05729; filed July 25, 2014 in the Southern District of New York

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendant:  Breckenridge Pharmaceutical, 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 Breckenridge'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 SDNY complaint here.

    Alkermes Pharma Ireland Ltd. v. Sun Pharma Global FZE et al.
    1:14-cv-00986; filed July 25, 2014 in the District Court of Delaware

    • Plaintiff:  Alkermes Pharma Ireland Ltd.
    • Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Inc.

    Infringement of U.S. Patent No. 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

    Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al.
    1:14-cv-00985; filed July 25, 2014 in the District Court of Delaware

    • Plaintiffs:  Unimed Pharmaceuticals LLC; Besins Healthcare Inc.; Besins Healthcare Luxenbourg SARL
    • Defendants:  Perrigo Co.; Perrigo Israel Pharmaceuticals Ltd.; Perrigo UK FINCO Ltd. Partnership

    Infringement of U.S. Patent Nos. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003), 8,466,136 ("Testosterone Gel and Method of Use," issued June 18, 2013), 8,466,137 (same title, issued June 18, 2013), 8,466,138 (same title, issued June 18, 2013), and 8,486,925 (same title, issued July 16, 2013) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone).  View the complaint here.


    Impax Laboratories Inc. et al. v. Lannett Holdings Inc. et al.
    1:14-cv-00984; filed July 25, 2014 in the District Court of Delaware

    • Plaintiffs:  Impax Laboratories Inc.; AstraZeneca AB
    • Defendants:  Lannett Holdings Inc.; Lannett Co. Inc.

    Infringement of U.S. Patent Nos. 6,750,237 ("Pharmaceutical Formulations Containing Aolmitriptan," issued June 15, 2004) and 7,220,767 (same title, issued May 22, 2007), licensed to Impax, following a Paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Impax's Zomig® Nasal Spray (zolmitriptan nasal spray, used for the acute treatment of migraine with or without aura in adults).  View the complaint here.

    Otsuka Pharmaceutical Co., Ltd. v. Torrent Pharmaceuticals Ltd. et al.
    1:14-cv-04671; filed July 25, 2014 in the District Court of New Jersey

    • Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
    • Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

    Infringement of U.S. Patent No. 8,642,760 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued February 4, 2014) following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.