Pharmaceutical Patents

News & Analysis as of

Federal Circuit Reinvigorates “Original Patent” Requirement of 35 U.S.C. § 251 For Reissue Patents

On November 17, 2014, the Court of Appeals for the Federal Circuit, in Antares Pharma, Inc. v. medac Pharma Inc. and medac GmbH, ruled in favor of Ropes & Gray client Medac and breathed new life into the “original patent”...more

In re: Nexium: Ranbaxy’s Motion for a Mistrial to Be Argued Today

Today, the Nexium district court will hear arguments on the Ranbaxy defendants’ motion for a mistrial. As we have previously reported, In re: Nexium is the first pay-for-delay case to go to trial since the Supreme Court’s...more

Insurance Antitrust Legal News - November 2014 - Volume 3 - Number 6

Plaintiff Files Third Amended Antitrust Claim Against Highmark - A long running antitrust dispute in Western Pennsylvania continued on October 1, when a Pennsylvania hotel (Cole’s Wexford Hotel) filed a third amended...more

Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

Antares Pharma, Inc. v. Medac Pharma Inc. (Fed. Cir. 2014)

When can a sufficient disclosure for patentability purposes nevertheless fail to adequately "describe" the claims of a patent? According to the Federal Circuit in a case issued this week, when the claims are added in a...more

Parties Must “Meet and Confer” Before Requesting Conference Call

Metrics, Inc. v. Senju Pharmaceutical Co., Ltd. - In an order involving two related inter partes reviews (IPRs), the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or the Board) denied a patent...more

Court Report - November 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al. 1:14-cv-07105; filed November 3, 2014 in the...more

Patent Litigation and Generic Drug Companies: How to Avoid Becoming an “Exceptional Case”

2013 brought generic drug companies increased financial and legal hurdles when it came to marketing their products in the U.S. First, substantial new GDUFA “user fees” got levied on generics for access to the FDA. Then, the...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

Court Report - November 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teijin Ltd. et al. v. Unimark Remedies Ltd. 1:14-cv-01356; filed November 4, 2014 in the District Court of...more

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

The High Court takes remedial action in the escitalopram battle

In the long-running escitalopram patent battle, which has been fought all over the world, Australia’s highest court has affirmed the general remedial power of Australia’s extension of time provisions as they apply to...more

Judge Sheridan Dismisses More Plaintiffs in Lipitor Antitrust Case

Late last week, District Court Judge Peter Sheridan (D.N.J.) dismissed with prejudice the complaint for antitrust injury by the so-called "End Payor Class Purchasers" against the parties in previous ANDA litigation in the...more

Nexium District Court Takes Pioneering Approach to Preliminary Jury Charge

How does a court explain the complicated area of law at the intersection of patent settlements and antitrust law to a group of lay-jurors in the wake of Actavis? The district court’s approach to preliminary jury instructions...more

Court Report - October 2014 #5

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases Amgen Inc. v. Sanofi et al. 1:14-cv-01349; filed October 28, 2014 in the District Court of Delaware. • Plaintiff: ...more

President and Fellows of Harvard College v. Lee (Fed. Cir. 2014)

One of the most iconic inventions of the biotechnology era is the "Harvard Oncomouse" invented by Philip Leder and Timothy Stewart in the early 1980's. One of the first transgenic mice transformed with DNA encoding something...more

Examination of Myriad-Mayo Guidance Comments -- University Community Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Patent Owners: Better Address All Obviousness Arguments Raised by Petitioner

Pharmatech Solutions, Inc. v. LifeScan Scotland Ltd. - In a final written decision addressing an obviousness challenge, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB, the Board) found the...more

Oral Argument In Teva Pharmaceuticals: Supreme Court To Decide Federal Circuit’s Standard Of Review Of District Court Claim...

On October 15, the Supreme Court heard oral argument in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (No. 13-854). The issue presented in the case is “Whether a district court’s factual finding in support of its...more

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Federal Circuit Judges Disagree on Use of Post Filing Date Evidence of Nonobviousness

On October 20, 2014, the Federal Circuit issued an order denying the petition for rehearing or rehearing en banc filed in Bristol-Meyers Squibb Co. v. Teva Pharmaceuticals, USA, Inc. While the order itself may not be...more

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