This morning, in Nautilus, Inc. v. Biosig Instruments, Inc., the Supreme Court rejected the Federal Circuit’s formulation of the definiteness requirement under 35 U.S.C. § 112, para. 2. Under the now-abandoned iteration of the definiteness test, claims were deemed to have satisfied the statutory requirement so long as they were “amenable to construction” and “not insolubly…
In a previous post, we wrote about developing trial themes early. In this post, we explore the importance of using depositions to support that trial theme. In ANDA cases, particularly those with multiple defendants, we have noticed a trend. Attorneys are not taking the time to adequately prepare for depositions or to think strategically about their…
In the recent Braintree Labs v. Novel Labs, the Federal Circuit may have limited the value of composition for methods of treatment claims. The patent-in-suit related to compositions for preparing the bowels of a patient ready for colonoscopy. In particular, the claims were to a bowel prep composition “for inducing purgation of the colon of…
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…