Pharmaceutical Industry

News & Analysis as of

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

Lupin Appeals Fine Imposed by European Commission in “Pay-For-Delay” Crackdown

In July of this year, the European Commission imposed fines on French pharmaceutical company Servier and five generic drug makers, including Lupin Ltd., totaling €427.7 million. The fines were the result of a five-year...more

The M&A Outlook in the Middle East: A Look Back at 2014 and Beyond

The Megatrends in Mergers & Acquisitions conference held in October 2014 focused on the evolving M&A landscape, promoting inbound and outbound M&A in the Middle East, and general industry trends. Among the speakers at the...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

Preliminary Injunction Precludes Actavis from Pulling Current Version of Namenda off the Market

Yesterday, Judge Robert Sweet granted the New York Attorney General’s request to block Actavis and its New York-based subsidiary Forest Laboratories LLC from pulling Namenda, a dementia drug commonly used to treat...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

Patent Trial and Appeal Board Issues First IPR Decisions on Orange Book-Listed Patents

On December 9, 2014, the Patent Trial and Appeal Board (PTAB) issued final decisions in three inter partes review (IPR) proceedings filed by Amneal Pharmaceuticals challenging three patents listed in the Orange Book for...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

Top Ten International Anti-Corruption Developments for November 2014

For busy in-house counsel and compliance professionals, we have tried to summarize the most important international anti-corruption developments in the past month with links to primary resources. November was definitely a...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

District Court Allows Monopolization Claims to Move Forward on Allegations of Direct Evidence of Monopoly Power

Traditionally, plaintiffs asserting claims under Sections 1 and 2 of the Sherman Act allege the existence of one or more product markets relevant to the defendants’ anticompetitive conduct and the defendants’ shares of those...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

Sophisticated Hackers Target Insider Information

A security consulting firm has discovered a sophisticated hacking campaign that has targeted more than 100 public companies, investment banks and law firms. In a report released December 1, cybersecurity firm FireEye...more

Court Allows “Product Hopping” Claims to Proceed in Suboxone Litigation Based on Allegations of Removal of Prior Formulation and...

We’ve previously discussed antitrust claims related to “product hopping”—allegations that pharmaceutical manufacturers have reformulated or otherwise altered their products to prevent automatic generic substitution. Earlier...more

Growth Of The 340b Program: Past Trends, Future Projections

The 340B program provides certain healthcare providers (referred to as “covered entities”) access to deeply discounted pharmaceuticals for outpatient use. Congress created the program in 1992 to help uninsured and vulnerable...more

UK: World Anti-Doping Agency announce global collaboration agreement with Pfizer

On 3 December 2014, the World Anti-Doping Agency (“WADA”) announced a global collaboration agreement with American pharmaceutical corporation Pfizer Inc....more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

December 2014: Life Sciences Litigation Update: MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft®...

MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft® Products Liability Litigation. This summer, the U.S. District Court presiding over a multi-district products liability litigation issued a pair of...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

FDA Draft Guidance Clarifies Criteria and Process for Obtaining Rare Pediatric Disease Priority Review Vouchers

On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Criminal Global Cartel Focus on Generic Pharmaceuticals

The Antitrust Division is nearing the end of its largest, record-setting criminal cartel investigation – global auto parts suppliers. It has been a sprawling investigation that has leaped from product-to-product in the auto...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

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