Posts Tagged: "Supernus Pharmaceuticals"

IP Due Diligence in the Life Sciences: Key Considerations for 2019

The success of a life science product, and thereby the company, rests heavily upon a combination of patent protection, regulatory exclusivity and product life cycle management. A company’s ability to formulate and articulate an integrated strategy is critical to obtaining investments, strategic partnerships and market success. In this two-part series, we will discuss recent judicial developments that affect life science companies’ IP strategies and also outline the four basic principles of an integrated IP strategy on which a company’s intellectual property audit and preparation for third-party diligence should focus. These are: (1) patent prosecution and strategy, (2) rights and ownership, (3) interplay of patent and regulatory exclusivity, and (4) freedom to operate and competitors. Part one will focus on patent prosecution and strategy, as well as rights and ownership.

Federal Circuit Again Considers USPTO Calculation of PTA in Supernus Pharmaceuticals v. Iancu

Last week, the U.S. Court of Appeals for the Federal Circuit reversed a ruling of the U.S. District Court for the Eastern District of Virginia, which had affirmed a patent term adjustment (PTA) calculation of the United States Patent and Trademark Office (USPTO). See Supernus Pharmaceuticals, Inc. v. Iancu, No. 2017-1357 (January 23, 2019). The Federal Circuit held that the USPTO cannot count as applicant delay any period of time during which there was no possible action that the applicant could take to reasonably conclude prosecution. A sensible ruling, and one the panel explained was entirely consistent with both the PTA statute and Gilead Sciences, Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015). “A period of time including no identifiable efforts that could have been undertaken cannot be ‘equal to’ the period of failure to undertake reasonable efforts under the terms of the statute,” wrote Judge Reyna.