The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

• Endo Pharms. Inc. v. Actavis, Inc. (Fed Cir)
  Defendants did not have either an express or implied license to practice the inventions claimed in the patents in suit.
• Senju Pharmas. Co., Ltd. v. Apotex Inc. (Fed Cir)
  Amended and/or new claims of a reexamined patent does not create new causes of action for patentee, separate from the causes of action created by the original patent. Therefore, motion to dismiss second action on the basis of claim preclusion was affirmed.
• Shire Dev. LLC v. Watson Pharms., Inc. (Fed Cir)
  In light of district court’s erroneous claim construction, finding of infringement was reversed and case remanded.
• Alcon Research Ltd. v. Barr Labs., Inc. (Fed Cir)
  Because ANDA product is significantly different from the compositions tested in patentee’s study, non-infringing holding is affirmed; section 112 holdings of non-enablement and lack of written description are reversed when patents adequately describe operable embodiments of the invention.
• GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed Cir)
  District court’s finding that the written description requirement is met is affirmed because “solvates” of dutasteride are not distinguished by a particular performance property. 
• Takeda Pharma. Co. Ltd. v. Zydus Pharmas. USA, Inc. (Fed Cir)
  Finding of infringement reversed in light of erroneous claim construction which imported an improper 10% deviation of measurement; finding of no invalidity affirmed when defendant failed to prove Section 112 arguments.
• Pfizer Inc. et. al v. Teva Pharmaceuticals USA, Inc. et al. (Fed Cir)
  Affirming construction of the term “4-amino-3-(2-methylpropyl) butanoic acid,” judgment of non-infringement based on that construction and validity of the patents.
• The Medicines Co. v. Hospira, Inc.
  The parties failed to meet their respective burdens of proving infringement and invalidity concerning patents that claim maximum impurity levels within pharmaceutical batches.
• Eli Lilly and Company  v. Teva Parenteral Medicines, Inc.
  Patent in suit was not obvious because a prior-art mouse study did not necessarily translate into the invention’s being carried out in a human, and also because certain prior-art references taught away from the claimed invention.
• Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.
  The patents-in-suit were obvious because the prior art not only disclosed that the use of risedronate to effectively treat osteoporosis, but they also disclosed dosing regimens that would lead a POSA to expect a linear relationship for the dosage schedule to extend to the claimed monthly regimen.
• G.D. Searle LLC  v. Lupin Pharms, Inc.
  Finding the reissued patent invalid under 35 U.S.C. § 251 and invalid based on obviousness-type double patenting.
• Par Pharms., Inc. v. TWi Pharms., Inc.
  Because combining nanotechnology with megestrol acetate would have been obvious to someone skilled in the art—due to the viscosity and inter-patient variability associated with the micronized formulation— patent-in-suit was invalid.
• Classen Immunotherapies, Inc. v. Shionogi, Inc.
  Because there is no pre/post FDA approval dichotomy under the safe-harbor provision, plaintiffs motion to dismiss under Rule 12(b)(6) was granted.
• Endo Pharmas. Inc. v. Mylan Pharmas. Inc.
  After claim construction resulted in stipulation of infringement, asserted claims were not invalid as anticipated, obvious or failing to meet the written-description and enablement requirements.
• In re Lamictal Direct Purchaser Antitrust Litigation
  Where a settlement agreement that resolves a Hatch-Waxman patent litigation does not include a reverse payment, the Supreme Court’s FTC v. Actavis analysis is inapplicable.
• Warner Chilcott Co. LLC v. Lupin Ltd.
  Because the amount of APIs and their method of administration was not available to a POSA in the prior art, the patent-in-suit was not invalid as obvious.
• Purdue Pharma L.P. v. Teva Pharms. USA, Inc.
  The asserted claims of patents covering reformulated OxyContin were infringed but found to be invalid.
• Allergan, Inc. v. Sandoz Inc.
  An ANDA product having a pH range of 6.8-7.2 infringes, literally and under the doctrine of equivalents (amendments related only tangentially to pH), a claim term related to pH of “about 7.3;” and given the unpredictability of ophthalmic formulation, among other things, the patents in suit are not invalid.
• Apotex, Inc. v. Daiichi Sankyo Co.
  Motion to dismiss for lack of subject-matter jurisdiction was granted where patent-in-suit was previously disclaimed by plaintiff.

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