Patent Law Weblog

recent posts

about

  • Webinar on Defend Trade Secrets Act

    Wolters KluwerWolters Kluwer and Managing IP will be offering a free webinar on "Trade Secrets: Strategies for Understanding & Litigating a DTSA Cause of Action," on September 29, 2016 at 12:00 pm (ET).  R. Mark Halligan of FisherBroyles, Mark L. Krotoski of Morgan Lewis & Bockius, Linda K. Stevens of Schiff Hardin, and Peter J. Toren of Weisbrod, Matteis & Copley will provide an in-depth discussion and update on the federal Defend Trade Secrets Act of 2016, and review the key provisions of the DTSA and the nexus to the Uniform Trade Secrets Act (UTSA) and the Economic Espionage Act of 1996 (EEA).

    Those interested in registering for the webinar can do so here.

  • Supreme Court IP Review

    Chicago-Kent College of LawThe IIT Chicago-Kent College of Law will be holding a Supreme Court IP Review conference on September 22, 2016 from 8:30 am to 5:00 pm (Central) at IIT Chicago-Kent College of Law in Chicago, IL.  The conference will provide intellectual property practitioners, jurists, legal academics, and law students with a review of IP cases from the U.S. Supreme Court's previous Term, a preview of cases on the docket for the upcoming Term, and a discussion of cert. petitions to watch.  Among the sessions being offered at the conference are:

    • Patent I Panel — Stryker Corp. v. Zimmer, Inc. and Halo Electronics, Inc. v. Pulse Electronics, Inc.

    • Patent II Panel — Cuozzo Speed Technologies, LLC. v. Lee

    • The Supreme Court IP Review Address: "Some Thoughts on the Relationship Between the Supreme Court and the Federal Circuit" – presentation by the Honorable Timothy B. Dyk, Circuit Judge, U.S. Court of Appeals for the Federal Circuit

    • Remembering Justice Scalia in IP Cases

    • Supreme Court Analytics on the Past Term

    • Preview of the Upcoming Term: IP cert. grants and cert. petitions to watch

    A complete agenda for the conference, including a list of sessions and speakers can be found here.

    The registration fee for the program is $35 (general admission) and $15 (outside academics).  There is no fee for Chicago-Kent faculty, current Chicago-Kent students, and current students of other law schools.  Those interested in registering for event can do so here.

  • UCB, Inc. v. Yeda Research and Development Co. (Fed. Cir. 2016)

    By Donald Zuhn —

    UCBToday, in UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB's Cimzia® brand antibody does not infringe Yeda's U.S. Patent No. 6,090,923.  In affirming the District Court's grant of summary judgment of non-infringement, the Federal Circuit concluded that Yeda was estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed in the '923 patent.

    The '923 patent is directed to a monoclonal antibody that binds a defined human cytotoxin.  Claim 1 is representative:

    1.  A monoclonal antibody which specifically binds a human cytotoxin having a molecular weight of about 17,500 as determined by polyacrylamide gel electrophoresis, said cytotoxin being obtainable from stimulated human monocytes, said cytotoxin being further characterized by exhibiting a cytotoxic effect on cycloheximide-sensitized SV-80 cells and by being obtainable in a state of enhanced purity by adsorption of the cytotoxin from an impure preparation onto controlled pore glass beads, and subsequent desorption of the cytotoxin in a state of enhanced purity.

    UCB filed suit against Yeda, seeking a declaration that its Cimzia® brand antibody does not infringe the '923 patent and a declaration that the '923 patent is invalid.  Yeda counterclaimed for infringement.  In support of its claim of infringement, Yeda argued that the claims of the '923 priority application should be construed to cover chimeric antibodies since chimeric monoclonal antibodies were known at the time the '923 priority application was filed.  UCB, however, argued that the prosecution history of the '923 patent prohibited coverage of chimeric antibodies.

    YedaDuring prosecution of the '923 patent, Yeda had argued that the term "monoclonal antibody" should encompass chimeric monoclonal antibodies, stating that "[w]e do not believe that the term necessitates that the monoclonal antibody be produced by the original hybridoma cell; the term should encompass chimeric monoclonal antibodies produced by a genetically engineered cell line," and noting that "Applicants are particularly interested in protecting chimeric forms of their anti-cytotoxin mouse monoclonal antibodies."  In support of its argument, Yeda filed a Declaration from Dr. Hartmut Engelmann, in which Dr. Engelmann cited two references that preceded the effective filing date of the '923 priority application and described mouse-human chimeric antibodies.  Yeda also presented new claims 45-48, which were directed to "rat, hamster and human antibodies and chimeras thereof" and to "chimeras of" mouse monoclonal antibodies.  The Examiner rejected the new claims for adding new matter, and Yeda cancelled all of the claims reciting chimeric antibodies.  Claim 41, which issued as claim 1 in the '923 patent, did not mention chimeric antibodies and had not been amended during prosecution to recite chimeric antibodies.

    At trial, the District Court construed "monoclonal antibody," as used in the claims of the '923 patent, to mean "a homogenous population of a single type of antibody produced via hybridoma and not including chimeric or humanized antibodies."  In view of this construction, the District Court granted summary judgment of non-infringement to UCB, determining that the prosecution history of the '923 patent prohibited construction of claim 1 to cover humanized and mouse-human chimeric antibodies.

    On appeal, Yeda argued that claim 1 had never been rejected on the ground of new matter, and that only the specific species claims (i.e., claims 45-48) had been rejected by the Examiner for containing new matter.  Yeda also argued that claim 1 does not recite any particular monoclonal antibody or species of chimera, and that the claim should not be limited to the examples in the specification.  While acknowledging that "Yeda is correct in that generic terms in claims are construed in light of that which is already known," the Federal Circuit noted that "the content of the specification and actions and arguments during prosecution must also be considered, in defining the scope of a generic term in a claim," and cited Advance Transformer Co. v. Levinson, 837 F.2d 1081, 1083 (Fed. Cir. 1988), for the proposition that "[p]ositions taken in order to obtain allowance of an applicant's claims are pertinent to an understanding and interpretation of the claims that are granted by the PTO . . . and may work an estoppel as against a subsequent different or broader interpretation."  The Court explained that (citations omitted):

    During prosecution, Yeda submitted new claims specific to "rat, hamster and human antibodies and chimeras thereof" as well as claims specifically encompassing "chimeras of" mouse monoclonal antibodies and "nonmurine" monoclonal antibodies.  Yeda argued that its invention is not limited to murine antibodies to human cytotoxin, and "should encompass chimeric monoclonal antibodies produced by a genetically engineered cell line."  The Examiner rejected the proposed claims on the ground of new matter not supported in the specification.  Yeda then withdrew the proposed specific claims, and the application was passed to issuance.  The district court held that Yeda cannot now obtain a claim construction that recovers claim scope that was yielded in order to obtain issuance of the patent, and construed the claims as excluding chimeric and humanized antibodies.

    In response to Yeda's argument that there could be no prosecution estoppel with respect to the scope of claim 1 absent a narrowing amendment to the claim 1, the Court noted that this "is not a correct general principle," stating that "[a]lthough each claim in a patent warrants independent consideration in light of its particular facts and history, the general rule is that a patent applicant cannot later obtain scope that was requested during prosecution, rejected by the Examiner, and then withdrawn by the applicant."  The Federal Circuit determined that "[s]uch estoppel was reasonably applied to claim 1 by the district court, although claim 1 had not been amended," and therefore affirmed the District Court's holding that Yeda was estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed in the '923 patent.

    UCB, Inc. v. Yeda Research and Development Co. (Fed. Cir. 2016)
    Panel: Circuit Judges Newman, Lourie, and Chen
    Opinion by Circuit Judge Newman

  • Hartig Drug Co. v. Senju Pharmaceutical Co. (3d Cir. 2016)

    By Kevin E. Noonan —

    3rd CircuitPerhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure.  Particularly when the professor is bold enough to engage students on the intricacies of the topic, those intricacies can make for a challenging final exam.  These experiences should come to mind for many antitrust lawyers when considering the Third Circuit's decision in Hartig Drug Co. v. Senju Pharmaceutical Co., where the Court applied subject matter jurisdiction principles to reverse a District Court's dismissal of Hartig's antitrust allegations on the pleadings.

    The facts while relevant were not dispositive.  At issue were the actions of Senju and its co-defendants, Kyorin Pharmaceutical Co and Allergan Inc. related to ANDA litigation over its medicated eyedrop products, Zymar (a 0.3% gatifloxacin solution) and Zymaxid (a 0.5% gatifloxacin solution).  Allergan, pursuant to a license to U.S. Patent No. 6,333,045, filed NDAs for these products in 2003 and 2010, respectively; Hartig was a secondary purchaser of these drugs from Amerisource Drug Corp., who assigned its rights to Hartig.

    In its complaint, Hartig alleged several bases for antitrust injury:

    [T]he Defendants engaged in a number of illegal practices to prevent or delay the introduction into the market of generic alternatives to Zymar and Zymaxid.  First, the Defendants filed a baseless lawsuit against another pharmaceutical company, Apotex, claiming patent infringement and delaying FDA approval of that company's generic version of Zymar.  Next, the Defendants engaged in so-called "product hopping" (A35) — discouraging doctors from prescribing generic alternatives to the original 0.3% Zymar eyedrops by phasing out that product in favor of "new" 0.5% Zymaxid eyedrops.  To buy time for that shift in marketing strategy, the Defendants prolonged the Apotex litigation by filing a frivolous motion for a new trial.  They also asked the United States Patent and Trademark Office to reexamine claims of the '045 Patent, but failed to disclose material information both from the trial record in the Apotex case and from their own expert that undermined their reexamination claims.  After the FDA approved Apotex's 0.3% gatifloxacin eyedrops, the Defendants sued Apotex a second time.  Although the courts ultimately held that the Defendants' suit was barred by claim preclusion, Apotex was deterred from launching a generic competitor to Zymar.  Since then, the Defendants have filed numerous lawsuits against competing drug manufacturers to bar the market entry of generic equivalents to both Zymar and Zymaxid.

    Put more succinctly, Hartig argued that, but for Defendants' actions in violation of the Sherman Antitrust Act, generic versions of these eyedrops would have entered the marketplace after the patent on the drug itself expired in 2010 (specifically, "at least from June 15, 2010 until October 3, 2013"), based in part on Apotex's Paragraph III certification on that base patent and the asserted invalidity of the '045 patent.

    Allergan filed a motion to dismiss based on Federal Rule of Civil Procedure 12(b)(1), that the Court did not have subject matter jurisdiction.  Co-defendants Kyorin and Senju filed motions to dismiss under Rule 12(b)(6) that Hartig had failed to state a claim (Allergan later joined in this motion).  Allergan's motion was based on its Distribution Services Agreement (DSA) with Amerisource that precluded that primary distributor from assigning its rights without Allergan's express written agreement.  The Third Circuit's opinion notes that the DSA was not part of Hartig's complaint but was appended to Allergan's motion to dismiss (a factual point relevant to the Court's decision).

    The District Court granted Allergan's motion.  On appeal, none of the parties challenged the Court's basis for rendering its decision, but several amici did (including Walgreen Co., The Kroger Co., Safeway Inc., Albertson's LLC, HEB Grocery Company LP, CVS Health Corporation, and Rite Aid Corporation).  The basis for this challenge is that while the anti-assignment clause in the agreement between Allergan and Amerisource might impact whether Hartig had antitrust standing, it did not affect the question of whether the Court could render a decision under Article III of the Constitution.  The Third Circuit first addressed the propriety of considering this issue, on the grounds that under normal circumstances an amicus "cannot expand the scope of an appeal with issues not presented by the parties on appeal," citing Nuveen Mun. Tr. ex rel. Nuveen High Yield Mun. Bond Fund v. WithumSmith Brown, P.C., 692 F.3d 283, 300 n.10 (3d Cir. 2012).  However, the Court also noted that the question of subject matter jurisdiction raised by the amici was one that a court has "an independent obligation" to raise in situations where its jurisdiction (and hence institutional competence) are called into question, citing Arbaugh v. Y&H Corp., 546 U.S. 500, 514 (2006).  The Court continued that "federal courts [also] have a strict duty to exercise the jurisdiction that is conferred upon them by Congress," citing Quackenbush v. Allstate Ins. Co., 517 U.S. 706, 716 (1996), and "have no more right to decline the exercise of jurisdiction which is given, than to usurp that which is not," quoting Cohens v. Virginia, 19 U.S. (6 Wheat.) 264, 404 (1821).  Accordingly, the panel concluded that it had a duty to question the District Court's decision that it did not have jurisdiction regardless of whether this was an issue for the parties.  (The opinion also cites a recent, similar case, Group Against Smog and Pollution, Inc. v. Shenango Inc., 810 F.3d 116 (3d Cir. 2016), where the question was whether the proper grounds for a motion to dismiss was Rule 12(b)(1) or 12(b)(6).)

    In considering this issue, the opinion sets out the distinctions between the two Rules, noting that "the 12(b)(6) standard affords significantly more protections to a nonmovant."  In a Rule 12(b)(6) motion, the court properly considers "only the complaint, exhibits attached to the complaint, matters of public record, as well as undisputedly authentic documents if the complainant's claims are based upon these documents," citing Mayer v. Belichick, 605 F.3d 223, 230 (3d Cir. 2010), and also must consider all allegations in the complaint as true as well as all reasonable inferences that can be drawn from them when taken in a light most favorable to the nonmovant.  Rule 12(b)(1), on the other hand, provides the defendant the ability to present competing facts (i.e., the defense is not limited to the facts alleged in the complaint).  The Plaintiff bears the burden of proof that jurisdiction is proper, and a court can consider all evidence without the presumptions that attach under Rule 12(b)(6); importantly here, a court can also consider evidence "outside the pleadings."  Consequently, "a 12(b)(1) factual challenge strips the plaintiff of the protections and factual deference provided under 12(b)(6) review" according to the opinion.

    Here, according to the Court, "the District Court should have treated antitrust standing not as an Article III jurisdictional issue, but rather as a merits issue, and thus should have resolved the motion to dismiss under Rule 12(b)(6) rather than Rule 12(b)(1)."  But the opinion goes on to explicate its reasoning for this decision in a way informative on the difference between the two grounds for standing (while acknowledging that its discussion is complicated by the varying uses of the term "standing").  First the opinion reviewed the requirements for Article III standing, according to Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992):

    First, [a plaintiff] must establish that it has suffered an "injury in fact," meaning a concrete and particularized invasion of a legally protected interest.  Id.  Second, it must establish a "causal connection between the injury and the conduct complained of — the injury has to be fairly traceable to the challenged action of the defendant, and not the result of the independent action of some third party not before the court."  Id.  . . .  Third, it must show a likelihood "that the injury will be redressed by a favorable decision."  Id. at 561.

    Even if the Article III requirements for standing are satisfied, however, another prerequisite for standing is antitrust standing, which requires that the injury a plaintiff suffered was one "that the antitrust statute was intended to forestall," citing Barton & Pittinos, Inc. v. SmithKline Beecham Corp., 118 F.3d 178, 181 (3d Cir. 1997), quoting Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 538, 540 (1983).  The opinion further explained that even if a plaintiff suffered injury as a result of an antitrust violation, if the standing requirement is not satisfied the antitrust laws do nor permit a plaintiff to be a "private attorney general" under the statute.  And the opinion set out the distinction plainly:  Article III jurisdiction "implicat[es] a court's subject matter jurisdiction" while antitrust standing affects "only the plaintiff's ability to succeed on the merits."  Whether or not a plaintiff has antitrust standing does not implicate the subject matter jurisdiction under Article III according to the opinion, citing Ethypharm S.A. France v. Abbott Laboratories, 707 F.3d 223, 232 (3d Cir. 2013).  And this distinction, according to the Court, is at the heart of the Supreme Court's explanation of the "direct purchaser rule" in Illinois Brick Co. v. Illinois, 431 U.S. 720 (1977), wherein the Court stated that "although indirect purchasers 'may have been actually injured by antitrust violations' through passed-on overcharges, the 'legislative purpose[s]' underlying the antitrust statutes would still be better served by limiting recovery to the direct purchasers paying those overcharges in the first instance."  431 U.S. at 746.

    The significance of this distinction in this case stems in part from the Court's appreciation that "Allergan's motion to dismiss under Rule 12(b)(1) was always premised, at bottom, on Hartig's purported lack of antitrust standing," despite Allergan premising its motion on Rule 12(b)(1).  This is not the correct question, according to the Court; for a motion to dismiss on an Article III basis the "case or controversy" standards are those enunciated by the Supreme Court in Lujan and the panel held that Hartig had satisfied these requirements.

    The opinion closes with a discussion of whether Allergan and its co-defendants properly moved to dismiss Hartig's claims under Rule 12(b)(6) and found that they did not.  This judgment turns on the differences in scope of the factual challenges permitted under each of these rules, and the Third Circuit panel recognized that the District Court relied on evidence regarding the DSA that would not be permitted in deciding a motion predicted on Rule 12(b)(6) (where all allegations in the complaint are taken as being true and all inferences drawn in the nonmovant's favor).  And finally, while the panel acknowledged that the question of whether the District Court could have (or will in future) properly consider the DSA was not before it, the opinion suggests that this agreement is not sufficient under Pennsylvania law to strip Hartig of its capacity to bring suit under the antitrust laws.

    The Court vacated the judgment below and remanded to the District Court, providing perhaps another opportunity for the parties to craft appropriate motions under the rules of civil procedure to effect their aims.

    Hartig Drug Co. v. Senju Pharmaceutical Co. (3d Cir. 2016)
    Panel: Circuit Judges Ambro, Jordan, and Greenberg
    Opinion by Circuit Judge Jordan

  • PTAB Life Sciences Report

    By John Cravero and Richard Martin —

    USPTO SealAbout the PTAB Life Sciences Report:  Each week we will report on recent developments at the PTAB involving life sciences patents.

    Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH

    PTAB Petition:  IPR2016-01665; filed August 22, 2016

    Patent at Issue:  U.S. Patent No. 6,858,650 ("Stable salts of novel derivatives of 3,3-diphenylpropylamines," issued February 22, 2005) claims derivatives of 3,3-diphenylpropylamines and salt forms.

    Amerigen Pharmaceuticals, Ltd. is challenging the '650 patent on three grounds as being obviousness under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '650 patent is involved in litigation in the District of Delaware, Pfizer, Inc. and UCB Pharma GmbH v. Mylan Pharmaceuticals, Inc., No. 1:15-cv-00079-GMS; the Northern District of West Virginia, captioned Pfizer Inc. and UCB Pharma GmbH v. Mylan Pharmaceuticals Inc., No. 1:15-cv-00013-IMK; and in the District of Delaware, captioned Pfizer, Inc. and UCB Pharma GmbH v. Sandoz, Inc., et al., No. 1:13-cv-01110-GMS.  Petitioner Amerigen Pharmaceuticals, Ltd. seeks joinder with IPR2016-00510 through a Motion for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  IPR2016-00510 (Mylan Pharmaceuticals Inc. v. UCB Pharma GmbH); Petitioners Mylan Pharmaceuticals Inc. and Mylan Laboratories Ltd.; filed 2/2/2016; instituted 7/20/2016.


    Alembic Pharmaceuticals Limited v. UCB Pharma GmbH

    PTAB Petition:  IPR2016-01596; filed August 22, 2016

    Patent at Issue:  U.S. Patent No. 6,858,650 ("Stable salts of novel derivatives of 3,3-diphenylpropylamines," issued February 22, 2005) claims derivatives of 3,3-diphenylpropylamines and salt forms.

    Amerigen Pharmaceuticals, Ltd. is challenging the '650 patent on three grounds as being obviousness under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '650 patent is involved in litigation in the District of Delaware, Pfizer, Inc. and UCB Pharma GmbH v. Mylan Pharmaceuticals, Inc., No. 1:15-cv-00079-GMS; the Northern District of West Virginia, captioned Pfizer Inc. and UCB Pharma GmbH v. Mylan Pharmaceuticals Inc., No. 1:15-cv-00013-IMK; and in the District of Delaware, captioned Pfizer, Inc. and UCB Pharma GmbH v. Sandoz, Inc., et al., No. 1:13-cv-01110-GMS.  Petitioner Amerigen Pharmaceuticals, Ltd. seeks joinder with IPR2016-00510 through a Motion for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  IPR2016-00510 (Mylan Pharmaceuticals Inc. v. UCB Pharma GmbH); Petitioners Mylan Pharmaceuticals Inc. and Mylan Laboratories Ltd.; filed 2/2/2016; instituted 7/20/2016.


    Celltrion, Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2016-01667; filed Month August 24, 2016

    Patent at Issue:  U.S. Patent No. 7,976,838 ("Therapy of autoimmune disease in a patient with an inadequate response to a TNF-alpha inhibitor," issued July 12, 2011) claims the use of antagonists that bind to B cell surface markers to treat autoimmune disease in a mammal that experiences an inadequate response to a TNF-alpha inhibitor.

    Celltrion, Inc. is challenging the '838 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.

    Related Matters:  According to the petition, the '838 patent was involved in IPR2015- 00417 (Boehringer Ingelheim Pharmaceuticals, Inc v. Genentech, Inc.); Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim International GmbH; filed on 12/15/2014; instituted on 07/14/2015; terminated on 10/01/2015 through Petitioner Request for Adverse Judgment for Abandonment of the Contest under 37 C.F.R. § 42.73(b)(4).  The '838 patent was also involved in IPR2015-01733 (Celltrion, Inc. v. Genentech, Inc.); Petitioner Celltrion, Inc.; filed 08/14/2015; motion for joinder to IPR2015-00417; dismissed without prejudice 10/6/2015.


    Dexcom, Inc. v. AgaMatrix, Inc.

    PTAB Petition:  IPR2016-01679; filed August 25, 2016

    Patent at Issue:  U.S. Patent No. 7,146,202 ("Compound material analyte sensor," issued December 5, 2006) claims a method of measuring the concentration of an analyte within an animal body, specifically the detection of glucose levels in blood.

    Dexcom, Inc. is challenging the '202 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 2 and 4) or obviousness under 35 U.S.C. § 103(a) (grounds 1 and 3).  View the petition here.

    Related Matters:  According to the petition, the '202 patent is involved in litigation in the District of Oregon, captioned AgaMatrix, Inc. v. Dexcom, Inc., 3:16-cv-536-JE.


    Dexcom, Inc. v. AgaMatrix, Inc.

    PTAB Petition:  IPR2016-01680; filed August 25, 2016

    Patent at Issue:  U.S. Patent No. 8,187,433 ("Compound material analyte sensor," issued May 29, 2012) claims a method of measuring the concentration of an analyte within an animal body, specifically the detection of glucose levels in blood.

    Dexcom, Inc. is challenging the '433 patent on seven grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.

    Related Matters:  According to the petition, the '433 patent is involved in litigation in the District of Oregon, captioned AgaMatrix, Inc. v. Dexcom, Inc., 3:16-cv-536-JE.


    Mylan Pharmaceuticals Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2016-01693; filed August 30, 2016

    Patent at Issue:  U.S. Patent No. 6,407,213 ("Method for making humanized antibodies," issued June 18, 2002) claims humanized antibodies and methods for making and using such humanized antibodies.

    Mylan Pharmaceuticals, Inc., Mylan Inc., Mylan GmbH, and Biocon Ltd. Mylan N.V. are challenging the '213 patent on eight grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or obviousness under 35 U.S.C. § 103(a) (grounds 3-8).  View the petition here.

    Related Matters:  According to the petition, the '213 patent is related to U.S. Patent Nos. 6,639,055; 6,800,788; 6,719,971; and 8,075,890.


    Mylan Pharmaceuticals, Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2016-01694; filed August 30, 2016

    Patent at Issue:  U.S. Patent No. 6,407,213 ("Method for making humanized antibodies," issued June 18, 2002) claims humanized antibodies and methods for making and using such humanized antibodies.

    Mylan Pharmaceuticals, Inc., Mylan Inc., Mylan GmbH, and Biocon Ltd. Mylan N.V. are challenging the '213 patent on seven grounds as being obviousness under 35 U.S.C. § 103(a) (grounds 1–7).  View the petition here.

    Related Matters:  According to the petition, the '213 patent is related to U.S. Patent Nos. 6,639,055; 6,800,788; 6,719,971; and 8,075,890.


    Arthrex, Inc. v. KFx Medical, LLC

    PTAB Petition:  IPR2016-01697; filed August 31, 2016

    Patent at Issue:  U.S. Patent No. 9,044,226 ("System and method for attaching soft tissue to bone," issued June 2, 2015) claims a bone anchor comprising a base and a top so that the suture material may be compressed between the surfaces on the base and top to secure the suture to the anchor and an associated inserter.

    Arthrex, Inc. is challenging the '226 patent on seven grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.

    Related Matters:  According to the petition, the '226 patent is involved in litigation in the District of New Jersey, captioned Arthrex, Inc. v. Joseph Tauro et al., 3:15-cv-06580-PSG-LHG.


    Arthrex, Inc. v. KFx Medical, LLC

    PTAB Petition:  IPR2016-01698; filed August 31, 2016

    Patent at Issue:  U.S. Patent No. 8,926,663 ("System and method for attaching soft tissue to bone," issued January 6, 2015) claims a bone anchor comprising a base and a top so that the suture material may be compressed between the surfaces on the base and top to secure the suture to the anchor and an associated inserter.

    Arthrex, Inc. is challenging the '663 patent on seven grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.

    Related Matters:  According to the petition, the '663 patent is involved in litigation in the District of New Jersey, captioned Arthrex, Inc. v. Joseph Tauro et al., 3:15-cv-06580-PSG-LHG.

  • Oxford Immunotec Ltd. v. Qiagen, Inc. (D. Mass. 2016)

    Magistrate Recommends That Defendants' Motion to Dismiss Be Allowed for Kit Claims and Denied for Method Claims

    By Donald Zuhn —

    D. MassLast month, in Oxford Immunotec Ltd. v. Qiagen, Inc., Magistrate Judge Donald L. Cabell of the U.S. District Court for the District of Massachusetts issued a report and recommendation that the joint motion to dismiss under Fed. R. Civ. P. 12(b)(6) filed by Defendants Qiagen, N.V.; Qiagen, Inc.; Quest Diagnostics, Inc.; and Laboratory Corporation of America Holdings ("Qiagen") be allowed in part and denied in part.  Qiagen filed the motion to dismiss in response to a claim of infringement by Plaintiff Oxford Immunotec, Ltd. ("Oxford").

    Oxford, which develops tests to diagnose and monitor patients with auto-immune diseases, had asserted six patents against Qiagen, asserting that Qiagen's development, use, and sale of a tuberculosis ("TB") test infringed the patents.  The six patents — U.S. Patent Nos. No. 7,632,646; 7,901,898; 8,216,795; 8,507,211; 8,617,821; and 9,005,902 — relate to an in vitro method of diagnosing TB.  Oxford's claimed method uses eight peptides from ESAT-6, a unique protein produced by Mycobacterium tuberculosis, the bacterium that causes TB.  In Oxford's test, the eight ESAT-6 peptides are mixed with a test subject's blood and if T cells in the patient's blood produce IFN-γ, indicating that the patient has been exposed to M. tuberculosis, the patient is diagnosed with TB.

    Prior to the development of Oxford's test, there were two standard methods for diagnosing TB:  the Mantoux tuberculosis skin test (TST), which involves injecting a small amount of TB protein derivative into a patient's forearm and then observing the injection site 48 to 72 hours after the injection, and the sputum culture test, which involves collecting and culturing phlegm from a patient's upper respiratory tract to determine whether an infected patient actually has TB.  Oxford's test is superior to the standard tests because it is faster, more convenient, less dependent on the administering physician's subjective judgment, and has a lower rate of false positives.

    The patents asserted by Oxford contain both kit claims and method claims.  Claim 7 of the '646 patent is representative of the kit claims at issue:

    7.  A kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses ESAT-6, comprising a panel of eight peptides represented by SEQ ID NOS: 1 to 8.

    The other asserted kit claims are claim 7 of the '898 patent and claim 17 of the '795 patent.

    Claim 1 of the '211 is representative of the method claims at issue:

    1.  An assay for identifying Mycobacterium tuberculosis-specific immediate effector T cells in a subject, comprising: (a) providing a sample from said subject containing T cells; (b) exposing said T cells to an immunogenic amount of a peptide subfragment of ESAT-6 that contains a CD8+ epitope; and (c) prior to the generation of new immediate effector T cells in the sample, determining whether said T cells are activated by said peptide subfragment by measuring secretion of a cytokine from said T cells; wherein activation of said T cells identifies the presence of Mycobacterium tuberculosis-specific immediate effector T cells that were present in the original sample, in said subject.

    The other asserted method claims are claim 1 of the '902 patent and claims 1 and 6 of the '821 patent.

    Qiagen's motion to dismiss was based on the argument that Oxford's patents are directed to a law of nature, and therefore are directed to patent ineligible subject matter.  With respect to the kit claims, Qiagen argued that the peptides used in the Oxford's claimed TB kit are naturally occurring (i.e., as part of ESAT-6) and therefore are products of nature.  With respect to the method claims, Qiagen argued that Oxford's claimed methods do not involve an inventive concept because the steps recited in the claimed methods are inherent to practicing the natural law, and the methods are routine and conventional methods that were well known before the patents were issued.

    Oxford countered that the peptide panel recited in the kit claims is not a product of nature because the peptides are synthetic and function differently from naturally occurring ESAT-6.  Oxford also contended that its in vitro testing method was not a product of nature because in vitro testing is performed in the artificial conditions of a laboratory, and that its method is a substantial improvement over the prevailing skin test because it is faster and yields fewer false positive results.

    Applying the two-step inquiry of Alice Corp. Pty. Ltd. v. CLS Bank Int'l, the Court first determined that the claims at issue are directed to a law of nature.  In particular, the Court found that "the claims are drawn to ESAT-6, a naturally occurring protein, and the human immune system's naturally occurring response to ESAT-6."  With respect to the kit claims, the Court noted that while it "appreciates that isolated peptides perform differently than peptides contained in an intact ESAT-6 strand, the Court does not find this fact significant to its analysis," adding that:

    The inquiry at step one of the Mayo analysis is whether the peptides are drawn to patent ineligible subject matter.  Applied here, the question is whether the peptides exist in nature or whether, instead, they have been changed from their natural state.  It is undisputed that the peptides have not been changed beyond the act of isolation.  The Court thus finds that the isolated peptides are products of nature.

    With respect to the method claims, the Court determined that although the isolated peptides act differently than ESAT-6 in certain respects when the peptide panel kit is used to test for TB, "the end result of both reactions [whether in the body or in the in vitro test] is the same, the body's production of IFN- γ."  The Court therefore concluded that Oxford's method claims are drawn to a law of nature, namely that T-cells that have previously been exposed to M. tuberculosis will excrete IFN-γ.

    The Court therefore moved onto step two of the Alice inquiry.  As explained by the Court:

    Here, the plaintiff has discovered a law of nature — namely which specific peptides in ESAT-6 are most likely to induce a recognition response by the T-cells of patients who have TB without creating false positive responses by the T-cells of those who have merely been vaccinated.  The question therefore is whether plaintiff's process of combining its panel of selected peptides with a patient's blood in a test tube and then measuring cytokine production is an inventive process that adds enough to the natural law to bring the patent claims into the realm of patentable material.

    Finding that "the patented invention improves on existing methods for diagnosing TB by making diagnosis more convenient, less dependent on a physician's subjective interpretation of results, and more accurate," the Court determined that "[t]here is thus a plausible reading of the patents by which one could find that the plaintiff's in vitro tuberculosis test involves an inventive concept."  The Court therefore recommended that Qiagen's motion to dismiss be allowed insofar as it seeks dismissal of the Oxford's claims for infringement of the kit claims, and denied in all other respects.

    Report and Recommendation on Defendants' Joint Motion to Dismiss by Magistrate Judge Cabell

  • Court Report

            By Sherri Oslick —

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

    Horizon Therapeutics, Inc. v. Lupin Ltd. et al.
    1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey

    • Plaintiff:  Horizon Therapeutics, Inc.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 9,254,278 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued February 9, 2016) and 9,326,966 (same title, issued May 3, 2016) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone).  View the complaint here.


    Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
    2:16-cv-00820; filed July 21, 2016 in the Eastern District of Texas

    • Plaintiff:  Allergan, Inc.
    • Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

    Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
    1:16-cv-00620; filed July 20, 2016 in the District Court of Delaware

    • Plaintiff:  Allergan, Inc.
    • Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), 8,685,930 (same title, issued April 1, 2014), and 9,248,191 (same title, issued February 2, 2016) following a Paragraph IV certification as part of TWi's filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye).  View the Delaware complaint here.


    AstraZeneca AB et al. v. Aurobindo Pharma Ltd. et al.
    3:16-cv-04414; filed July 20, 2016 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.


    Valeant Pharmaceuticals Luxembourg S.A.R.L. et al. v. Actavis Laboratories UT. Inc. et al.
    2:16-cv-04344; filed July 15, 2016 in the District Court of New Jersey

    • Plaintiffs:  Valeant Pharmaceuticals Luxembourg S.A.R.L.; Valeant Pharmaceuticals North America LLC
    • Defendants:  Actavis Laboratories UT. Inc.; Actavis, Inc.; Allergan PLC

    Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp).  View the complaint here.


    Shionogi Inc. et al. v. Actavis Laboratories UT, Inc.
    1:16-cv-00606; filed July 14, 2016 in the District Court of Delaware

    • Plaintiffs:  Shionogi Inc.; Concordia Pharmaceuticals Inc.
    • Defendant:  Actavis Laboratories UT, Inc.

    Infringement of U.S. Patent Nos. 6,793,931 ("Ectoparasite Asphyxiator Compositions and Methods for their Applications," issued September 21, 2004) and 7,294,342 (same title, issued November 13, 2007) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Shionogi's Ulesfia® (benzyl alcohol lotion, 5%, for the topical treatment of head lice infestation in patients 6 months of age and older).  View the complaint here.


    Actavis Elizabeth LLC v. Novartis Corp. et al.
    1:16-cv-00604; filed July 13, 2016 in the District Court of Delaware

    • Plaintiff:  Actavis Elizabeth LLC
    • Defendants:  Novartis Corp.; Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG

    Declaratory judgment of noninfringement of U.S. Patent No. 9,283,209 ("Oral Formulations of Deferasirox," issued March 15, 2016) based on Activis' Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novartis' Jadenu® (deferasirox, used for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions).  View the complaint here.


    Helsinn Healthcare S.A. v. Zydus Pharmaceuticals (USA) Inc. et al.
    3:16-cv-04239; filed July 13, 2016 in the District Court of New Jersey

    • Plaintiff:  Helsinn Healthcare S.A.
    • Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

    Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.


    DSM IP Assets, B.V. et al. v. Lallemand Specialties, Inc. et al.
    3:16-cv-00497; filed July 13, 2016 in the Western District of Wisconsin

    • Plaintiffs:  DSM IP Assets, B.V.; DSM Bio-Based Products & Services B.V.
    • Defendants:  Lallemand Specialties, Inc.; Mascoma LLC

    Infringement of U.S. Patent No. 8,795,998 ("Fermentative Glycerol-Free Ethanol Production," issued August 5, 2014) based on defendants' manufacture and sale of certain  transgenic yeast cells, including their TransFerm Yield+ product.  View the complaint here.

  • Conference & CLE Calendar

    CalendarSeptember 6, 2016 - Policy Roundtable on Written Description Requirement (U.S. Patent and Trademark Office) – 1:00 to 4:30 pm (EDT)

    September 7, 2016 – "USPTO's Subject Matter Eligibility: A 2016 Update" (The Knowledge Group) – 12:00 to 2:00 pm (EST)

    September 7, 2016 – "What is Patent Eligible: The Ever-evolving Section 101 Standard" (Dilworth IP) – 1:00 to 2:00 pm (EDT)

    September 8, 2016 – "After-Final Practice: Navigating Expanding PTO Options to Compact Patent Prosecution — Utilizing Post-Prosecution Pilot Program (P3), After-Final Consideration Pilot 2.0, Pre-Appeal Conference and More" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 8, 2016 – "Europe's Unified Patent Court and Patents with Unitary Effect: Status, Perspectives and Impact of Brexit" (Practising Law Institute) – 1:00 to 2:00 pm (Eastern)

    September 11-13, 2016 - 44th Annual Meeting (Intellectual Property Owners Association) – New York, NY

    September 13, 2016 – Patent Quality Chat webinar on "Future Information Disclosure Practice in a Global Dossier Environment" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET) on 

    September 14-15, 2016 - Advanced Patent Prosecution Workshop 2016: Claim Drafting & Amendment Writing (Practising Law Institute) – Chicago, IL

    September 15, 2016 – "On Sale and Public Use Bars to Patentability: Leveraging Recent Developments — Minimizing Risk of Patent Ineligibility or Invalidation" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 20, 2016 – "The Shifting Landscape of Bio/Pharma Litigation: The Influence of PTAB Proceedings" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    September 20, 2016 – "Defending Patents in IPR Proceedings: Best Practices to Mitigate Risks of Claim Cancellation — Leveraging Preliminary Responses, Using Experts, Filing Motions to Amend and Substitute Claims, Evaluating Secondary Considerations" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 21, 2016 – "Structuring Freedom-to-Operate Opinions: Reducing Risk of Patent Infringement — Combating Troubling FTO Results, Overcoming Potential Roadblocks, Addressing Impact of Post-Grant Process on FTO Opinions" (Strafford) – 1:00 to 2:30 pm (EDT)

    September 22-23, 2016 - Seminar on European Patent Law (Grünecker) – Munich, Germany

    September 23, 2016 - Current State of the Law under 35 U.S.C. 101? & Use of Fact and Expert Witnesses at the PTAB: Costs, Strategies, and Pitfalls (Patent Litigation Committee and Patent Trial and Appeal Board/Trademark Trial and Appeal Board Committees of the Federal Circuit Bar Association (FCBA) & Virginia Bar Association) – 12:00 to 2:30 pm (ET)

    September 29, 2016 - IP & Diagnostics Symposium (Biotechnology Innovation Organization) – Alexandria, VA

    September 29-30, 2016 – Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

    October 3-4, 2016 – Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

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

  • USPTO Policy Roundtable on Written Description Requirement

    USPTO SealThe U.S. Patent and Trademark Office will be hosting a roundtable discussion on the written description requirement and broad patent claims on September 6, 2016 from 1:00 to 4:30 pm (EDT) at the Elijah J. McCoy Midwest Regional U.S. Patent & Trademark Office in Detroit, MI. Presentations will be made by Duane Marks of Eli Lilly and Company and Damian Porcari of Ford Motor Company.  A moderated panel discussion and Question & Answer session will follow presentations by our speakers.  Robert W. Bahr, Deputy Commissioner for Patent Examination Policy, and Dr. Daniel Kolker, a Supervisor in Technology Center 1600, will represent the USPTO on the panel.

    Additional information regarding the roundtable can be found here.

  • FCBA Program on § 101 and the PTAB

    Federal Circuit Bar AssociationThe Patent Litigation Committee and Patent Trial and Appeal Board/Trademark Trial and Appeal Board Committees of the Federal Circuit Bar Association (FCBA), in connection with the Virginia Bar Association, will be offering a program consisting of two separate panels on September 23, 2016 from 12:00 to 2:30 pm (ET):

    Part I – Current State of the Law under 35 U.S.C. 101? – Patrick Keane of Buchanan Ingersoll & Rooney PC and Joerg-Uwe Szipl of Griffin and Ezipl, P.C. will moderate a panel consisting of Tom Krause, Deputy Solicitor, U.S. Patent and Trademark Office; Bob Bahr, Deputy Commissioner for Patent Examination Policy, U.S. Patent and Trademark Office; David Kappos of Cravath, Swain & Moore LLP and former Director of the U.S. Patent and Trademark Office.  The panel will discuss how the USPTO is applying the Supreme Court decisions in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. and Alice Corp v. CLS Bank Int'l, and how the law in this area will further develop?

    Part II – Use of Fact and Expert Witnesses at the PTAB: Costs, Strategies, and Pitfalls – Rick Neifeld of Neifeld IP Law, PC will moderate a panel consisting of Christopher Suarez of William & Connolly LLP; Kenie Ho of Finnegan Henderson Farabow Garrett & Dunner LLP; and Megan F. Raymond of Ropes & Gray LLP.  The panel will delve into the costs and benefits of various approaches to PTAB proceedings from the perspective of an in-house practitioner trying to make recommendations to its senior management and a seasoned PTAB practitioner trying to select the most effective approaches based on the newest practice trends and rules.  Topics covered will include the strategic implications of recent amendments to the PTAB trial guide — such as allowing patent owners to submit expert testimony to the PTAB before an IPR institutes, different approaches for establishing priority date or printed publication status, and experts in litigation versus PTAB proceedings.

    The registration fee for the program is $125 (private practitioner non-member rate) or $50 (government/academic/retired non-member rate).  There is no cost for FCBA members.  Additional information regarding the program can be found here.