Pharmaceutical Patents

News & Analysis as of

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

Braintree Labs., Inc. v. Novel Labs., Inc. (Fed. Cir.)

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. Apr. 22, 2014) (Circuit Judges Dyk, Prost, and Moore presiding; Opinion by Prost, J.; Concurrence-in-part and Dissent by Dyk, J.; Dissent by...more

Court Report - July 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. GlaxoSmithKline LLC et al. v. Glenmark Generics Inc. USA 1:14-cv-00877; filed July 3, 2014 in the District Court of...more

Allergan, Inc. v. Apotex, Inc. (Fed. Cir.)

Case Name: Allergan, Inc. v. Apotex, Inc., No. 2013-1245, -1246, -1247, 2014 U.S. App. LEXIS 10710 (Fed. Cir. June 10, 2014) (Circuit Judges Prost, Reyna and Chen presiding; Opinion by Prost, C.J.; Dissent-in-part by Chen,...more

IPR Update -- The First Pharma IPR Decisions

Late last month, while many of us were getting ready to attend the BIO International Convention in San Diego, the Patent Trial and Appeal Board ("Board") issued four related inter partes review opinions, marking what many...more

BioPharma Patents Quick Tips and News - May/June 2014

QUICK TIPS - 35 U.S.C. 112 Tips: 1) Does your U.S. Examiner assert that not enough representative species are described in the specification? MPEP Section 2163 II.A.3(a)(ii) says that “(t)he written...more

Federal Circuit Holds That Even Functional Claims Require Structural Fence Posts

In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As...more

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

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