Fish & Richardson

Post-Approval Conduct and the Hatch-Waxman Safe Harbor


After the Federal Circuit’s decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), one might conclude that post-approval conduct is immune under the Hatch-Waxman safe harbor as long as the accused conduct is “for uses reasonably related to the development and submission of information to the FDA.” 35 U.S.C. § 271(e)(1). This result would most certainly be true if the conduct under consideration occurred before FDA-approval. But the case law, including Momenta itself, suggests that a more stringent test may be applied in analyzing whether post-approval conduct is protected by section 271(e)(1).
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In The Headlines

TayganPoint Consulting Group

Business Transformation, the New Norm for Biopharma


There is no question the Biopharma Industry is undergoing significant change.  From an industry and regulatory perspective there are many driving factors such as health care reform, data transparency and security, precision medicine, and new forms of competition to name a few.  The impact of these industry trends are forcing executives to re-evaluate their strategies in search of new, innovative ways to generate revenue, improve productivity and ensure compliance with ever changing regulatory guidelines. These evolving strategies are leading executives to consider fundamentally transforming their entire business model.  In the past, companies addressed these challenges with narrow improvement efforts managed within functions.  Today, an increasing number of companies are holistically transforming their business and unlocking significant profits that historically were hidden in functional silos and old operating models.
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Topic of Discussion

What to Look for in a Chief Compliance Officer


The hiring of a Chief Compliance Officer (CCO) is critical in any business organization. However this role is not one that lends itself to the traditional skills of a Chief Legal Officer. This is because the greatest challenge for any CCO is how to influence the conduct and actions in a corporate environment, particularly as compliance is viewed as non-revenue generating and usually does not exist simply to protect the company, which is how the legal department is often viewed. Because the role is very different than that of a General Counsel (GC), a CCO needs to bring another skill set to bear to do his or her job.
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