Life Sciences Law Blog : Class Action Lawyer & Attorney : Sheppard Mullin Law Firm : Antitrust, Securities, Wage & Hour, Consumer Fraud

By Robert Magielnicki

In a recent interview, Senator Herb Kohl (D-Wis.), Chairman of the Senate Judiciary Committee's subcommittee on antitrust, competition policy and consumer rights, discussed the subcommittee's legislative priorities for 2010. At the top of the list is passage of the Preserve Affordable Access to Generics Act, which would prevent anticompetitive "pay-for-delay" patent settlements in which a brand-name pharmaceutical company pays a generic drug maker millions of dollars in exchange for an agreement to stop selling a generic version of the drug.
 

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By Robert Magielnicki

In a May 24, 2010 speech to the Antitrust in Healthcare Conference, Christine A. Varney, the Chief of DOJ's Antitrust Division, emphasized the importance of antitrust enforcement in preserving vigorous competition in health insurance markets, and of encouraging innovation and efficiency in health care delivery while preserving competitive markets.
 

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By Peter Reichertz

On May 19, 2010, FDA published on its website a series of proposals designed to promote “openness” and “transparency” in government. The document, entitled “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the United States Food and Drug Administration” can be found here.  The document contains 21 specific proposals about changing the Agency’s policies of disclosure of information submitted to it and about interim decisions made by it.
 

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By Jennifer Driscoll-Chippendale

In a Business Review Letter[1] dated April 26, 2010, the U.S. Department of Justice, Antitrust Division (hereinafter, “the Division”) stated that it would not challenge a data sharing program proposed by three health care associations located in California. From the Division’s vantage point, the program posed little risk of facilitating anticompetitive conduct; rather, the most likely effect of the program would be to increase transparency about the relative costs and utilization rates of hospitals that participated in the survey.
 

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By Peter Reichertz

Manufacturers

As part of the recently enacted Patient Protection and Affordable Care Act (“PPACA”) – known to most as Healthcare Reform Legislation, new taxes will be imposed on manufacturers of “branded prescription drugs” and most medical devices. These taxes are in addition to the fees already charged by the Food and Drug Administration (“FDA”) for review of full new drug applications for drugs and 510(k)’s and Premarket Approval Applications for medical devices. And unlike user fees, the taxes will not be paid to FDA but assessed by the Department of Treasury and paid to support health insurance coverage.
 

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By Jennifer Trusso

On March 29, 2010, in the highly publicized and closely watched case of Association for Molecular Pathology, et al v. U. S. Patent and Trademark Office, et al. (real parties in interest patent holders Myriad Genetics and the University of Utah Research Foundation), the District Court in the Southern District of New York granted summary judgment in favor of Plaintiffs and held that 15 claims in Myriad’s 7 patents relating to human BRCA1 and BRCA2 genes (Breast Cancer Susceptibility genes 1 and 2) (collectively “BRCA1/2”) are invalid because they claim non-patentable subject matter.
 

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By Heather Cooper and Jennifer Driscoll-Chippendale

Congress has taken preliminary steps to adopt legislation that would restore the rule that minimum resale price agreements between manufacturers and retailers, distributors or wholesalers, violate the Sherman Act without requiring proof of their anticompetitive effects.
 

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