Pharmaceutical Industry

News & Analysis as of

Is 4-3 the New 3-2? FTC Continues to Target Pharmaceutical Mergers

The Federal Trade Commission (“FTC” or “Commission”) has often stated that merger analysis requires more than a simplistic determination that high market concentration leads to anticompetitive effects. Still, the antitrust...more

University of Pittsburgh v. Varian Medical Systems, Inc. (Fed. Cir. 2014)

The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

A Picture is Worth 1000 Words — Video Depositions

in BioMarin Pharmaceutical Inc. v. Genzyme Therapeutic Products Limited Partnership, IPR2013-00534, Paper 32, IPR2013-00537, Paper 31 (April 11, 2014), the patent owner sought to take video cross examination of the...more

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al. 1:14-cv-00387; filed March 26, 2014 in the...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

Insurance Recovery Law

Suit Alleging Drug Distributor Was a “Pill Mill” Requires Defense - Why it matters: A Kentucky federal court held that the claimed impact in a suit brought by the West Virginia Attorney General – alleging that...more

Public Citizen Wants Black Box on Testosterone Products

There appears to be no shortage of advertising for testosterone products for men to relieve low sex drive and fatigue. But these products remain without any warning on the product labels despite a recent study that showed the...more

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more

House and Senate Bills Would Provide Incentive for Repurposing Old Biologics

Last month, Sen. Richard Blumenthal (D-CT) and Rep. Joaquin Castro (D-TX) introduced legislation in the Senate and House, respectively, that would extend the term of certain patents claiming a method of using a biological...more

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

Senju Pharmaceutical Co. v. Apotex Inc. (Fed. Cir. 2014)

Applying the doctrine of claim preclusion (previously termed res judicata), a fractured majority of the Federal Circuit held that prior ANDA litigation to final judgment precluded reassertion of amended claims in the same...more

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more

Supreme Court Agrees to Take Case Assessing Scope of Review for Claim Construction

The Supreme Court on Monday, March 31, 2014, granted certiorari in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Case 13-854 (Mar. 31, 2014), a case that has the potential to overturn years of precedent leading back to the...more

Stay Off My Turf! How to Protect Field of Use in a Biotechnology License Agreement

To protect a licensor’s rights, a key element of a biotech license is the licensor’s right to restrict the scope of the license by limiting the field of use, often to a particular disease area. But the license agreement only...more

Court Report

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Bristol-Myers Squibb Company v. Apotex Inc. et al. 1:14-cv-00351; filed March 19, 2014 in the District Court of...more

FTC Continues Aggressive Posture On Reverse Payment Settlement Agreements With Reference To Disgorgement

In two recent statements, the FTC reaffirmed its intention aggressively to pursue reverse-payment patent settlement agreements in the pharmaceutical industry. ...more

Summary of Clinical Laboratory Fee Schedule Reform Provisions in the Protecting Access to Medicare Act of 2014

On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more

Medicare OPPS Lab "Packaging" Policy Raises Bundle of Issues

In previous Payment Matters articles, we described a policy included in the 2014 hospital outpatient prospective payment system (OPPS) final rule that would “package” certain clinical laboratory tests into OPPS, and CMS...more

California District Court Holds That Named Plaintiff’s Lack Of Credibility On Key Issue Renders Him An Inadequate Class...

The U.S. District Court for the Central District of California denied class certification in a product mislabeling case after holding that named plaintiff lacked credibility on a material issue and, therefore, could not be an...more

Provisions of Interest to Labs in the Protecting Access to Medicare Act of 2014

The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more

Stopping Bad Legislation -- The Innovation Alliance Speaks Out

On the day before the Senate Judiciary Committee is scheduled to take up S. 1720 (The Patent Transparency and Improvements Act), the Innovation Alliance delivered a letter to Chairman Leahy and Ranking Member Grassley...more

Congressional Hearing on Proposed FDA Rule Change

Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling....more

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