Pharmaceutical Industry Patents

News & Analysis as of

FDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed

The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese...more

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more

Pfizer’s strategic response to the threat of generic competition upheld by the Federal Court

On 25 February 2015, the Federal Court handed down its much-anticipated judgment in the matter of ACCC v Pfizer Australia Pty Ltd. In dismissing the Australian Competition and Consumer Commission’s (ACCC) allegations, Justice...more

Markman Opinion Is Supplemented Following Evidentiary Hearing

Andrews, J. The court previously entered a Markman opinion on January 20, 2015. Declarations by experts were submitted on January 16, 2015 and an evidentiary hearing took place on January 23, 2015 regarding how a POSA would...more

Federal Circuit Patent Updates - April 2015

Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

Amgen v. Sandoz Update -- Amgen's Continuing Efforts to Obtain Preliminary Injunction

Amgen is once again seeking a preliminary injunction in the Amgen v. Sandoz case, this time at the Federal Circuit while that Court resolves the issues on appeal from the District Court. Sandoz has only agreed to stay off...more

Court Report - April 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et el. 3:15-cv-02841; filed April 22, 2015 in the...more

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

March 2015 Recap

March 2015—like January and February—saw decisions on a variety of fronts from ND Cal judges. ND Cal judges demonstrated their willingness to apply the Supreme Court’s decisions in Nautilus and Alice to invalidate patents on...more

Court Report - April 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Gilead Sciences Inc. et al. v. Watson Laboratories Inc. et al. 1:15-cv-00289; filed April 1, 2015 in the District...more

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute [Video]

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc. (Fed. Cir. 2015)

The Federal Circuit availed itself of another opportunity to demonstrate that the Supreme Court's recent decision in Teva v. Sandoz may be relevant in cases that are the exception rather than the rule. The Federal Circuit's...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

Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional

The biologics industry has been closely monitoring Amgen Inc.’s (“Amgen’s”) lawsuit against Sandoz Inc. (“Sandoz”) for refusing to engage in the BPCIA’s “patent dance” with respect to Sandoz’s application for Zarxio®, a...more

District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...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

Supreme Court: Patent Claim Construction – Two Standards Of Review

The Supreme Court recently decided a patent case involving a significant procedural issue. In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (1/20/15), the question before the Court was whether the Federal...more

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

Business Litigation Report - February 2015

- Firm News: - Main Article: ..Traversing the Breach: Why You Need to Prepare for Data Breaches and How to Do It - Noted With Interest: ..Direct Purchasers and End Payors Accuse Brand Pharma of...more

The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of...more

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