Pharmaceutical Patents

News & Analysis as of

Plausibly Alleging Non-monetary Settlements as Reverse Payments After Actavis

In In re Lipitor Antitrust Litigation, No. 12 Civ. 2389 (D.N.J.), U.S. District Judge Peter G. Sheridan has confirmed his prior ruling that under the Supreme Court’s decisions in Twombly, Iqbal, and FTC v. Actavis, Inc., 133...more

The ACLU, Working for the Man

The ACLU championed its efforts in the AMP v. Myriad case as being another instance of the group fighting for the rights of the many and the powerless against corporate America and the oligarchical few. In a paradox, it now...more

Going All In

Functional limitations and Senju Pharm. v. Lupin Pharm. Last year in Senju Pharma. v. Apotex Inc., 746 F.3d 1344 (Fed. Cir. 2014), Senju and Allergan were blocked from suing Apotex on a re-examined set of claims under...more

District Court Denies Amgen's Bid to Block Sale of Blockbuster Biosimilar Drug

On March 19, 2015, Judge Seeborg of the Northern District of California handed a significant victory to Sandoz's efforts to bring the first biosimilar product to market by denying Amgen's partial judgment on the pleadings and...more

Court Strikes Expert Opinions, No Punishment Intended

Order Granting Takeda’s Motion to Strike, Takeda Pharmaceutical Co. LTD., et al., v. TWi Pharmaceuticals, Inc., Case No. 13-cv-02420-LHK (Judge Lucy H. Koh) - The Northern District Patent Local Rules are specifically...more

The Tyranny of the Judiciary

There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more

Judge Finds Biosimilar Patent Procedures Optional

Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more

Court Report - March 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Co. v. Mylan Pharmaceuticals, Inc. 1:15-cv-00049; filed March 19, 2015 in the Northern District of...more

Enzo Biochem Inc. v. Applera Corp. (Fed. Cir. 2015)

When can a district court's factual findings related to the extrinsic evidence in a claim construction determination not be given deference by the Federal Circuit? At least one situation is when the findings do not...more

Biosimilars in the US: still at the starting line?

Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create a framework for the introduction of biosimilar and interchangeable drugs into the US market. Like the predecessor Hatch-Waxman Act,...more

Court Report - March 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Otsuka Pharmaceutical Co., Ltd. v. Sandoz Inc. et al. 1:15-cv-01716; filed March 9, 2015 in the District Court of New...more

The Supreme Court's New Standard of Appellate Review for Claim Construction

On January 20, 2015, the United States Supreme Court redefined the standard of appellate review for claim construction. In Teva Pharm. USA, Inc. v. Sandoz, Inc., the Supreme Court vacated well-established Federal Circuit...more

Court Report - March 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech, Inc. et al. v. Celltrion Healthcare Co., Ltd. et al. 1:15-cv-10698; filed March 6, 2015 in the District...more

POSITA Motivated to Pursue Clinical Development of Therapy Disclosed in Prior Art Despite Potential Safety and Efficacy Hurdles

The PTAB recently held that the challenged claims in two patents assigned to Genzyme and one patent assigned to Duke University on methods for treating Pompe disease are invalid. ...more

PTAB Rejects Attempts to Expand the Scope of CBM Review - Par Pharm., Inc. v. Jazz Pharm., Inc.

Addressing for the first time a request for covered business method (CBM) review by a generic drug maker facing an infringement suit under the Hatch-Waxman Act, the U.S. Patent and Trademark Office’s (PTO’s) Patent Trial and...more

Direct Purchasers and End Payors Accuse Brand Pharma of Delaying Generic Entry

Americans want access to inexpensive pharmaceutical drugs. This demand must be balanced with the fact that brand-name, innovator pharmaceutical companies typically invest tremendous resources to research and develop new...more

Guest Post: $2.6 Billion Per Drug: Is Your Patent Portfolio Strong Enough to Protect Your Investment?

Late last year, the Tufts Center for the Study of Drug Development (CSDD) released a number that would cause jaws to drop all around the healthcare world.  The estimated cost for developing a new drug was an astounding $2.558...more

The Top 5 Trends in Canadian Intellectual Property Law for 2015

Last year promised significant changes in Canadian IP law; some of which will be realized in 2015. As the first quarter draws to a close, this year’s trends in IP law are emerging. Canada’s international trade negotiations...more

IP Newsflash - February 2015 #3

FEDERAL CIRCUIT CASES - Federal Circuit Throws Out $2 Million Award to Nvidia and Sony - Despite the Supreme Court's Octane Fitness decision making it easier to award attorneys’ fees, the Federal Circuit has...more

Federal Circuit Review - February 2015

More Deference to District Courts in Claim Construction - In TEVA PHARMACEUTICALS USA, INC. v. SANDOZ, INC., No. 13-854, the Supreme Court held that factual findings underpinning claim construction rulings are reviewed...more

Court Report - March 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Shire LLC v. Par Pharmaceutical, Inc. et al. 1:15-cv-01454; filed February 25, 2015 in the District Court of...more

FTC Looks to Accelerate Oncology Drug Growth by Requiring Novartis to Divest Two Protein Inhibitors in Its Clinical Development...

The Federal Trade Commission (“FTC”) on Monday completed its review of Novartis AG’s (“Novartis”) proposed $16 billion acquisition of GlaxoSmithKline’s (“GSK”) oncology drug portfolio with an announced consent decree that...more

Glenmark Generics Ltd. v. Ferring B.V.,

Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment...more

Pfizer Inc. v. Mylan Pharms. Inc.

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., Civ. No. 10-528-GMS, 2014 U.S. Dist. LEXIS 150283 (D. Del. Oct. 22, 2014) (Sleet, J.) (When a POSA would have to undertake significant guesswork to vary the parameters of...more

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

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