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The FTC gets activist post-Actavis

In 2013, the FTC left its mark on the pharmaceutical industry when the Supreme Court ruled in FTC v. Actavis that settlement agreements for patent infringement suits between branded and generic drug companies are not immune...more

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Supreme Court 2014 Patent Preview

On average, the U.S. Supreme Court historically hears fewer than one patent case each term. For example, in the 14 years between 1982 and 1995, the Court decided only five patent cases. In the seven years between 1995 and...more

For the First Time PTAB Upholds Validity of Pharma Patents

On December 9, 2014, the Patent Trial and Appeal Board (“PTAB”) upheld the validity of three Supernus Pharmaceutical’s patents relating to once-daily formulations of doxycycline. The trio of decisions is significant because...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

IP Newsflash - December 2014: DISTRICT COURT CASES: A Contrary Construction from Reexamination Is No Basis to Reconsider a...

On December 10, 2014, the Southern District of New York denied plaintiff’s motion to reconsider a 2006 claim construction ruling and vacate a related summary judgment order. Plaintiff requested the relief following a contrary...more

PTAB Update -- Hatch-Waxman-Watch Edition

The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...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

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

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

Court Report - October 2014 #4

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. 8:14-cv-01710; filed October 23, 2014 in the Central...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

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

United Therapeutics Corp. v. Sandoz, Inc.

Nature of the Case and Issue(s) Presented: UTC claimed that Sandoz induced infringement of the ’007 patent by instructing physicians to dilute its product for use intravenously. The asserted claim required a particular...more

Supreme Court: Should Appeal Give Deference to Lower Courts on Claim Construction?

On October 15, the Supreme Court heard oral argument in Teva Pharmaceuticals USA Inc., et al. v. Sandoz Inc., et al., case number 13-854. At issue is the level of deference that the Court of Appeals for the Federal Circuit...more

Guest Post: Nature's Indelible Marker - Naturally abundant, stable isotopes have already protected the identity and origin of $1.5...

The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products...more

Supreme Court Preview -- Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. -- The End of Cybor Corp.?

The Supreme Court will begin its 2014-2015 term next Monday. Last year, the Court heard a record number of patent law cases, at least for recent history. Nevertheless, it is scheduled to hear another one on October 15. ...more

Expect Focus - Regulators Are Watching: New Products, New Opportunities, New Risks - Volume III, Summer 2014

In This Issue: - IN THE SPOTLIGHT ..Standard CGL Policy Form Adds Data Breach Coverage Exclusion - LIFE INSURANCE ..Class Claims Against Lincoln National Barred in Section 419 Action – Again ...more

Court Report - September 2014 #6

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cadence Pharmaceuticals Inc. et al. v. InnoPharma Licensing LLC et al. 1:14-cv-01225; filed September 24, 2014 in the...more

In re Lipitor Antitrust Litigation (D.N.J. 2014)

In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more

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