GENERICally Speaking Hatch Waxman Bulletin

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.

Vol. 4, No. 1

Spring 2014

The Spring 2014 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

Relevant court decisions highlighted in this issue:

  • Endo Pharms. Inc. v. Actavis, Inc. (Fed Cir)
  • Senju Pharmas. Co., Ltd. v. Apotex Inc. (Fed Cir)
  • Shire Dev. LLC v. Watson Pharms., Inc. (Fed Cir)

Read more about these and other important court decisions, New ANDA Cases, ANDA Litigation Settlements, ANDA Approvals, and Generic Launches.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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.
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.
Motion to dismiss for lack of subject-matter jurisdiction was granted where patent-in-suit was previously disclaimed by plaintiff.
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.
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.
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.
Defendants did not have either an express or implied license to practice the inventions claimed in the patents in suit.
Finding the reissued patent invalid under 35 U.S.C. § 251 and invalid based on obviousness-type double patenting.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
Appeal from D. Del., Andrews, J.) (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.
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.
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.
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 asserted claims of patents covering reformulated OxyContin were infringed but found to be invalid.
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.
ANDA product did not infringe asserted claims because it used abacavir in a salt form, not abacavir in its free base or pure form; invention is not obvious because there was very little about anti-HIV therapy that could be described as predictable at the time of the invention.
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.
The parties failed to meet their respective burdens of proving infringement and invalidity concerning patents that claim maximum impurity levels within pharmaceutical batches.
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.

Vol. 4, No. 2

Summer 2014

Vol. 4, No. 4

Winter 2014