News & Analysis as of

Generic’s Counterclaims for Non-Infringement are Proper Despite Covenant Not to Sue From Brand

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...more

University of Pittsburgh v. Varian Medical Systems, Inc. (Fed. Cir. 2014)

The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al. 1:14-cv-00387; filed March 26, 2014 in the...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more

House and Senate Bills Would Provide Incentive for Repurposing Old Biologics

Last month, Sen. Richard Blumenthal (D-CT) and Rep. Joaquin Castro (D-TX) introduced legislation in the Senate and House, respectively, that would extend the term of certain patents claiming a method of using a biological...more

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

Senju Pharmaceutical Co. v. Apotex Inc. (Fed. Cir. 2014)

Applying the doctrine of claim preclusion (previously termed res judicata), a fractured majority of the Federal Circuit held that prior ANDA litigation to final judgment precluded reassertion of amended claims in the same...more

Supreme Court Agrees to Take Case Assessing Scope of Review for Claim Construction

The Supreme Court on Monday, March 31, 2014, granted certiorari in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Case 13-854 (Mar. 31, 2014), a case that has the potential to overturn years of precedent leading back to the...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Company v. Apotex Inc. et al. 1:14-cv-00351; filed March 19, 2014 in the District Court of...more

FTC Continues Aggressive Posture On Reverse Payment Settlement Agreements With Reference To Disgorgement

In two recent statements, the FTC reaffirmed its intention aggressively to pursue reverse-payment patent settlement agreements in the pharmaceutical industry. ...more

If Written Description Matches Claim Scope, No § 112 Problem - GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.

The U.S. Court of Appeals for the Federal Circuit affirmed a district court rejection of a written description challenge to patentability, concluding that under either parties’ construction of a disputed claim term the...more

Supreme Court Grants Certiorari in Teva Pharmaceuticals v. Sandoz

Earlier today, the Supreme Court granted certiorari in the Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. case (Supreme Court docket number 13-854). The sole issue on appeal is encapsulated by the question presented...more

Narrower of Possible Claim Constructions Prevails - Takeda Pharmaceutical Co. Ltd. v. Zydus Pharma USA, Inc.

Addressing, among other things, where the upper limit of a claimed range lies for claim construction, the U.S. Court of Appeals for the Federal Circuit overturned a district court ruling that a claimed range included a margin...more

Pharmaceutical Patent Injunction Refused: Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241

Pfizer sought an interlocutory injunction to restrain Apotex from launching its pregabalin products for the treatment of seizures, claiming that the supply would constitute indirect infringement of Pfizer’s patent for...more

Significant Uptick in Royalty and Patent Stream Monetizations (Quorum, March 2014)

One of the areas where Cadwalader has seen a significant pickup in activity levels in 2013 and early 2014 is royalty and patent stream monetizations. In 2013, we helped clients complete 10 royalty and patent monetization...more

Federal Circuit Finds Barr Does Not Infringe But Rejects Enablement and Written Description Defenses

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...more

IPR Update -- The First Biotech IPR Decisions

Earlier this month, on March 6, 2014, the Patent Trial and Appeal Board ("Board") issued three related inter partes review opinions, marking the first set of opinions related to either the Biotech or Pharmaceutical industry. ...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cephalon Inc. v. Sun Pharma Global FZE et al. 1:14-cv-00333; filed March 14, 2014 in the District Court of...more

FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know

On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the...more

Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)

The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Accord Healthcare Inc., USA et al. 1:14-cv-00389; filed March 12, 2014 in the Southern...more

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more

Federal Circuit Finds Easy Solution to Avodart Solvate Written Description Question

Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit...more

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