The Federal Circuit recently affirmed a decision by the District of New Jersey finding two patents owned by Hoffmann-La Roche invalid for obviousness. The patents-at-issue in Hoffmann-La Roche v. Apotex Inc., No. 2013-1128, are directed to methods of treating osteoporosis through a once-monthly administration of ibandronate, commercially available as Boniva. The Court applied surrogate testing […]
On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic drug company who is not a first-filer has standing to assert a counterclaim for non-infringement despite the issuance […]
A district court judge in New Jersey recently granted an API supplier’s motion to dismiss claims filed against the supplier in an ANDA suit, raising questions about whether an API supplier belongs as a defendant in these litigations. United Therapeutics Corp. v. Sandoz, Inc., No. 12-CV-1617 (March 10, 2014). The Court concluded that a declaratory […]
It is a common practice in Hatch-Waxman and other civil litigation for parties to try to hide the ball in producing documents by interposing vague objections to document requests and then producing select documents subject to their vague objections. Some courts are beginning to deem that such conditional responses to requests for production are not […]
The recent appeal of Alcon Research Ltd. v. Barr Labs., Inc., No. 2012-1340 (Fed. Cir. Mar. 18, 2014) touched on several of the patent-law issues you will encounter in ANDA cases: infringement, written description, and enablement. Barr sought to market a generic version of Alcon’s glaucoma and ocular hypertension drug Travatan Z®. Alcon filed suit […]
The Federal Circuit recently affirmed the District of Delaware’s rejection of a lack of written description defense in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 2013-1593 (Fed. Cir. 2014). GlaxoSmithKline sued several generic companies for infringement of U.S. Patent No. 5,565,467, which is listed in the Orange Book for Avodart (dutasteride), a treatment for enlarged […]
The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its longstanding policy concerning 5-year new chemical entity (“NCE”) exclusivity for fixed-combination drug products. For many years, FDA’s interpretation of the word “drug” in certain provisions […]
On Friday, a divided Federal Circuit confirmed that it will continue to apply a de novo standard of review to claim construction and rejected calls to give more deference to district court decisions. Lighting Ballast Control, LLC v. Philips Elecs. et al. (No. 2012-1014) (Fed. Cir. Feb. 21, 2014). The de novo review standard has […]
A three judge panel of the Federal Circuit recently affirmed the District of Delaware’s judgment of infringement and validity related to U.S. Patent No. 6,197,819 (owned by Northwestern University and licensed to Pfizer) covering the drug Lyrica, which treats seizures and certain types of nerve pain. The decision effectively prevents a generic version of Lyrica […]
Politicians have begun talking about the damage caused by “patent trolls” and how to deal with it. On March 7, 2014, Carlson Caspers is hosting a CLE discussing non-practicing entities, public responses to them, and how your company can respond to non-practicing entities (or monetize its own portfolio). Agenda Background: This will explain the recent […]