Morgan, Lewis & Bockius
Firm overview:
Morgan Lewis is a full-service global law firm with a presence on four continents: North America, Europe, Asia Pacific, and the Middle East. In the US alone, it operates 18 offices.
Morgan Lewis’s global patent team has prepared and prosecuted patents for the world’s largest companies, and many have been successfully enforced in highly publicised litigation.
The firm advises clients on the full range of services, including patent preparation, prosecution, licensing, due diligence, valuation, portfolio management, opinion, and counseling work, as well as post-grant proceedings at the US Patent and Trademark Office (USPTO).
Morgan Lewis’s clients do business in an array of technical industries, such as electrical, computer, software, business methods (ecommerce and financial services), mechanical, life sciences (biotechnology and pharmaceuticals), speciality chemicals, medical devices, diagnostics, semiconductors, consumer products, cleantech, and fintech, among others.
Team overview:
Many of the firm’s patent lawyers and agents have technical and scientific degrees, including doctorates, as well as industry experience and prior careers at the USPTO.
Key contacts at the firm include Louis Beardell in Philadelphia, and Michael Lyons, who leads the Silicon Valley litigation practice. Lyons has secured verdicts for clients totalling hundreds of millions of dollars, and frequently handles adversarial patent office proceedings in addition to litigation.
Key matters:
● Regenxbio and The Trustees of The University of Pennsylvania v Sarepta Therapeutics, Case No. 24-1408, US Court of Appeals for the Federal Circuit, ongoing
Morgan Lewis represents plaintiff-appellant the Trustees of the University of Pennsylvania in this dispute brought by plaintiffs against Sarepta Therapeutics over its alleged unlicensed use of gene therapy technology.
The innovation by plaintiffs (genetically-engineered cultured host cells carrying a recombinant nucleic acid molecule) was found by the US District Court for the District of Delaware to not be patent-eligible, because the recombinant molecule's nucleic acid sequences do not “alter” or “change” their natural form. Under current Supreme Court precedent, compositions of matter that combine natural components are patent-eligible if the composition offers “significant utility” and is “markedly different” from its natural sources.
The plaintiffs have appealed the matter to the Federal Circuit. The outcome of this litigation could substantially impact the biotech industry's ability to patent its innovations.
Representing plaintiff‐appellant Regenxbio are Fish & Richardson attorneys Susan Morrison and Deanna Reichel.
● Salix Pharmaceuticals v Norwich Pharmaceuticals, 98 F.4th 1056, US Court of Appeals for the Federal Circuit, 2024
Morgan Lewis’s William Peterson, assisted by counsel from Venable, argued for Salix Pharmaceuticals in this dispute over Norwich’s proposed generic version of rifaximin.
Rifaximin is the active ingredient in Salix’s commercial product Xifaxan, used to treat hepatic encephalopathy (HE) and irritable bowel syndrome with diarrhea (IBS-D). Salix asserted patents directed to methods of treating HE, patents directed to methods of treating IBS-D, and patents directed to a solid form of rifaximin.
Following a trial in Delaware, the district court found that the HE patents infringed and were not invalid, and that the IBS-D and polymorph patents infringed but were invalid as obvious. On appeal, Salix argued that the district court erred in finding that a person of ordinary skill in the art would have had a reasonable expectation of success in obtaining the claimed rifaximin form.
In its decision of April 2024, Federal Circuit judges affirmed 1) the district court’s holding that various claims of the patents at issue would have been invalid as obvious; 2) the district court’s order setting the effective approval date of Norwich’s ANDA to be no earlier than the date of expiration of the last to expire of the HE patents; and (3) the district court’s denial of the motion to modify the final judgment.
Axinn attorneys led by Chad Landmon represented Norwich. Counsel from Kramer Levin represented amici curiae Regeneron Pharmaceuticals and Ocular Therapeutix, and McDermott Will & Emery counsel represented amicus curiae Vanda Pharmaceuticals.
Clients:
Salix Pharmaceuticals, Trustees of the University of Pennsylvania.
