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Court Report -- Part II - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc. 1:14-cv-00882; filed July 7, 2014 in the District Court of...more

Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms. Inc. (Fed. Cir.)

Case Name: Sanofi-Aventis Deutschland GmBH v. Glenmark Pharms Inc., 748 F.3d 1354 (Fed. Cir. Apr. 21, 2014) (Circuit Judges Newman, Linn and Wallach presiding; Opinion by Newman) (Appeal from D.N.J., Cavanaugh,...more

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

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

Medical Devices: recent developments in the UK and the US

As it becomes harder for rights holders to control the flow of infringing medical products, Baker Botts’ Neil Coulson and Mark Whitaker review developing case law on both sides of the Atlantic. Whether a company...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

Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2014. ...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

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

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

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