News & Analysis as of

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

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...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

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

Docs @ BIO -- Federal District Court vs. the PTAB

Yesterday, BIO 2014 presented a session entitled "Navigating Patent Challenges Under the America Invents Act" during which the presenters analyzed the differences between patent challenges in Federal District Court and before...more

Judicial Efficiencies and Economy Support Bifurcation of Liability and Damages at Trial

Endo Pharmaceuticals, Inc. v. Actavis, Inc., et al. Case Number: 1:12-cv-08985-TPG (Dkt.55) - Endo brought suit against Actavis, as well as over a dozen other pharmaceutical manufacturers, for allegedly...more

Federal Circuit Issues Decision Affirming Obviousness of a Molecule Patent Claim

On June 12, 2014, the US Court of Appeals for the Federal Circuit issued a precedential opinion affirming the obviousness of a patent claim directed to a drug molecule. Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., ___...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

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

Establishing Personal Jurisdiction Over Foreign Corporations in ANDA Cases

In this BNA Insight, attorney Paul Ragusa examines the impact of a recent U.S. Supreme Court decision on litigation involving foreign corporations and abbreviated new drug applications. He says it may become more challenging...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

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

Combining Two Drugs Is Not Always Obvious

Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc. - Addressing the obviousness of combining two known hypertension medications, the U.S. Court of Appeals for the Federal Circuit upheld a ruling of...more

District Court Upholds HSR Rulemaking on Pharmaceutical Patent Licensing Transactions

The transfer of certain patent rights in the pharmaceutical industry will remain subject to the premerger notification rules under the Hart-Scott-Rodino Act (HSR Act) after a federal judge rejected a challenge brought by the...more

Gilead Warns: Examine Patent Portfolios for Double Patenting Pitfalls

Gilead Sciences, Inc. v. Natco Pharma Ltd. - Addressing invalidation of a patent for obviousness-type double patenting, the U.S. Court of Appeals for the Federal Circuit vacated and remanded a district court’s...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

Court Report - June 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cephalon Inc. v. Breckenridge Pharmaceutical Inc. et al. 1:14-cv-00671; filed May 27, 2014 in the District Court of...more

269 Results
|
View per page
Page: of 11