Client Alert

Top Developments in Hatch-Waxman Litigation for February 2018

13 Mar 2018

This month, we highlight several significant decisions including The Medicines Company v. Hospira, Inc. and Index Pharmaceuticals, LLC v. Gilead Sciences, Inc. and the Trump administration’s legislative proposal to increase the availability of generic drugs.


The Medicines Company v. Hospira, Inc. (Fed. Cir. 2/6/18)
The Federal Circuit held that the district court erred in concluding that a distribution agreement entered into by The Medicines Company was not a commercial offer for sale, where the terms of the agreement specified the commercial price and transfer of title to a third party. The court reversed and remanded for the district court to determine whether the offer to sell covered the patented invention. The court also affirmed the finding that Hospira’s process for making the accused product does not infringe the asserted patents.

Medical Diagnostic Laboratories, L.L.C., v. Protagonist Therapeutics, Inc. (N.D. Cal. No. 17-cv-05572-EMC, 2/7/18)
The district court granted defendant’s motion to dismiss because the allegedly infringing development activity regarding IL-23 receptor inhibitors, including entering into a collaboration with Janssen and selling clinical trial materials to Janssen, fell within the 35 U.S.C. § 271(e)(1) safe harbor. As to future commercialization plans or payments, the court found them not sufficiently concrete or immediate to create a case-or-controversy.

Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D. Mass. Civil Action No. 11-11681-NMG, 2/7/18)
The district court found that Momenta should have disclosed its patent to US Pharmacopeia when that standard setting organization was considering methods to test compounds with 1,6-anhydro rings to incorporate into the enoxaparin monograph. Accordingly, the court granted defendant’s motion for judgment that the equitable defenses of waiver and estoppel apply, and that plaintiff was estopped from enforcing its patent as to certain assays.

Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2/9/18)
The Federal Circuit affirmed the district court’s finding that Merck failed to prove infringement by a preponderance of the evidence. The appellate court rejected Merck’s argument that the district court had abused its discretion by not compelling Amneal to produce additional samples of its ANDA product for testing before trial, despite Amneal’s violation of a standing discovery order to immediately make available to Merck samples of commercial batches sent to the FDA. The appellate court also concluded that the district court had not erred in finding that Merck failed to prove that the samples provided to it—forming the basis for the district court’s non-infringement finding—were not representative of Amneal’s final commercial product. Finally, the court rejected the argument that the district court had clearly erred in finding that three Raman spectroscopy peaks were required to confirm the polymorphic form in the accused product.

Idenix Pharmaceuticals, LLC v. Gilead Sciences, Inc. (D. Del. C.A. No. 14-846-LPS, 2/16/18)
The district court granted Gilead’s motion for JMOL that the asserted genus claims of the patent in suit were invalid for lack of enablement. The district court found that the structural limitations of the claims covered such a large number of compounds that undue experimentation was necessary to refine that broad set of compounds to the far narrower group that also satisfy the claims’ functional limitations requiring that the compounds exhibit effective anti-HCV activity. The district court also denied Gilead’s motions for JMOL that the asserted claims were invalid for lack of written description and to reduce the jury’s damages award from $2.54 billion.

Amgen Inc., v. Aurobindo Pharma Ltd. (D. Del. Civ. No. 16-853-GMS, 2/27/18)
The district court considered the effect of the terms “comprising” in the claim preamble, and “consisting of” in certain Markush groups drawn to binders and disintegrants used in the claimed formulations. The court held that Amgen had not “overcome the very strong presumption that the Markush groups for the binder and disintegrant elements are closed to unrecited binders and disintegrants.” The closed nature of the Markush groups, however, did not foreclose Amgen from relying on the doctrine of equivalents to prove infringement of the binder or disintegrant elements of the claims.


Mylan Pharmaceuticals Inc. v. Saint Regis Mohawk Tribe (Nos. IPR2016-01127; IPR2016-01128; IPR2016-01129; IPR2016-01130; IPR2016-01131; IPR2016-01132) (2/23/18)
The Patent Trial and Appeal Board denied the Tribe’s motion to terminate the IPR proceedings based on its tribal sovereign immunity. The PTAB held in a per curiam opinion that the Tribe had not established entitlement to assert its tribal immunity in the IPR proceedings. The PTAB also found that, even if the Tribe were entitled to sovereign immunity, the proceedings could continue because the license from the Tribe to Allergan transferred “all substantial rights” in the challenged patents back to Allergan. Finally, the Board held that the Tribe was not an indispensable party to the IPR proceedings.


The Trump administration’s proposed 2019 budget includes a legislative proposal to attempt to increase the availability of generic drugs by making the tentative approval of a subsequent generic drug applicant blocked solely by a first applicant’s 180-day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180-day exclusivity. In such circumstances, the period of exclusivity would immediately begin for the first filer upon tentative approval of the subsequent ANDA.

U.S. Senator Susan Collins (R-Maine) is reportedly working on legislation that would restrict the practice of “evergreening.”


Maryellen Noreika and Colm F. Connolly, both nominated by President Trump to fill vacancies in the United States District Court for the District of Delaware, appeared before the Senate Judiciary Committee on February 14th as part of the confirmation process. Their nominations will now be voted on by the Committee and then the full Senate.




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