Pharmaceutical Patents

News & Analysis as of

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more

Sudden Impact

I was once interviewed live on Bloomberg radio at some god-awful hour in the morning, following a 30% drop in the share price of Ely Lily resulting from a negative decision in a patent case by the U.S. Court of Appeals in the...more

Putting Structure and Function Into Context for USPTO Patent Subject Matter Eligibility Guidance

The USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in...more

Court Report -- Part II - July 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc. 1:14-cv-00789; filed June 20, 2014 in the District Court of...more

An Unsuccessful Reach for the STELARA, Written description of generic biomolecule claims

AbbVie owns US 6,914,128 (’128), which covers a variety of anti-IL12 monoclonal antibodies. AbbVie markets an anti-IL12 monoclonal (viz. Humira®) as a treatment for a variety of auto-immune disorders, including psoriasis....more

Court Report - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Panacea Biotec, Ltd. 1:14-cv-01064; filed June 26, 2014 in the Southern District of...more

Federal Circuit Looks for a Different Kind of Unexpected Results in BMS v. Teva

In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more

June 2014: Life Sciences Litigation Update

Combination Drug Product Patent Validity. Pioneer pharmaceutical companies may have been reluctant to make the significant research and development investments required to bring combination drug products to market based on...more

Court Report - June 2014 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al. 1:14-cv-00777; filed June 19, 2014 in the District Court of...more

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

Court Report - June 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cephalon Inc. v. Actavis Laboratories FL Inc. et al. 1:14-cv-00776; filed June 19, 2014 in the District Court of...more

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from...more

BIO International Convention 2014 Preview - BIO and World-Wide Intellectual Property Protection

The 2014 BIO International Convention begins next week in San Diego. If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting. Therefore,...more

Court Report - June 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Glenmark Generics Ltd. et al. v. Ferring, B.V. 3:14-cv-00422; filed June 9, 2014 in the Eastern District of...more

Braintree Laboratories, Inc. v. Novel Laboratories, Inc. (Fed. Cir. 2014) - Whither the Meaning of "a" as a Claim Term

Every once in a while a Federal Circuit panel construes a common claim term contrary to how it has been construed in prior precedent, usually based on the particular situation or circumstance the Court is addressing and...more

UK High Court confirms jurisdiction to grant cross-border declaration of non-infringement

In Actavis Group HF v. Eli Lilly & Co. the UK High Court has granted a declaration of non-infringement in the UK, France, Italy and Spain. A jurisdictional challenge in relation to the French, Italian and Spanish...more

Purgation Case Still Held Up

Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc. Case Number: 1:12-cv-06851-AJN (Dkt. 69) - Judge Nathan approved the parties’ proposal to maintain the case on administrative hold pending...more

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more

Guest Post -- Obvious To Try My Patience: Federal Circuit's Evolving Measure of Obviousness under 35 U.S.C. § 103

When I was your age, and Pluto was a planet, "obvious to try" was not the standard for evaluating patentability under 35 USC § 103. In KSR v. Teleflex, the US Supreme Court qualified this by rejecting the Federal Circuit's...more

Court Report - June 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amarin Pharma, Inc. et al v. Teva Pharmaceuticals USA, Inc. 3:14-cv-03558; filed June 4, 2014 in the District Court of...more

What Is “a Patient?”

Braintree Labs, Inc. v. Novel Labs, Inc. - On appeal from summary judgment, the U.S. Court of Appeals for the Federal Circuit construed “a patient” to mean “a population of patients,” overturning the district court’s...more

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v....more

Recent 340B Orphan Drug Decision May Have Widespread Implications

In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the...more

FTC’s Reporting Rule for Pharmaceutical Patent Transfers Upheld

On May 30, 2014, the U.S. District Court for the District of Columbia ruled in favor of the Federal Trade Commission (FTC) in a dispute with the Pharmaceutical Research and Manufacturers of America (PhRMA) regarding the...more

Patent Filings for June 4, 2014

Petions Filed - Mylan Pharmaceuticals Inc..filed a petition IPR2014-00885 challenging U.S. Patent No. 5,922,695 assigned to Gilead Sciences, Inc. Mylan Pharmaceuticals Inc..filed a petition IPR2014-00886 challenging...more

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