The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. § 271(e)(1). The Federal Circuit’s ruling, and the subsequent denial of Edwards’s petition for rehearing en banc, underscores the breadth of the safe harbor, putting to bed the question of whether “solely” means “only” in the context of the safe harbor.

Read the full post on Proskauer’s Minding Your Business blog.

Posted in Commercial Litigation, Patents
Tags: Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., FDA, Federal Circuit, Hatch-Waxman Act, Intellectual Property, life sciences patents, Patent Infringement, Safe Harbor Provision, U.S. Food and Drug Administration (FDA)
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Photo of Fangli Chen Fangli Chen

Dr. Fangli Chen is a partner in the Litigation Department and chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively identifies…

Dr. Fangli Chen is a partner in the Litigation Department and chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively identifies and transforms technological developments into valuable intellectual property assets for her clients and specializes in the strategic development of complex IP portfolios for companies that align with their business goals.

Fangli’s practice also focuses on post-grant review before the USPTO, oppositions, pre-litigation and litigation strategy, due diligence investigations, freedom-to-operate, non-infringement and invalidity analysis, licensing and other IP matters in connection with commercial transactions. She handles a variety of technology areas including biochemistry, molecular and cell biology, immunotherapy, enzyme replacement therapy, nucleic acid based technologies including messenger RNA therapy, gene therapy, gene editing, antisense and oligonucleotides based therapies, vaccines, bioinformatics, and small molecule compound drugs.

Fangli also has a wealth of experience in the following areas:

  • Post-grant challenges: representing clients in inter partes review interference and various foreign opposition proceedings.
  • Technology transactions & licensing: advising clients on matters relating to technology or material transfer, licensing and research collaborations.
  • Investment or acquisition counsel: assisting investors in assessing the technology and intellectual property assets and risks for potential target investments and counseling companies on intellectual property matters in connection with public offering or acquisition.

Fangli has been repeatedly noted for her top-tier work by industry publications, including being listed as a World’s Leading Patent Practitioner by IAM Patent 1000 and recognized as one of the Top 250 Women in IP nationwide by Managing Intellectual Property. In 2019, she was named Patent Strategy & Management Attorney of the Year in Massachusetts by LMG Life Sciences. She has also been recognized by Best Lawyers in America, Client Choice, Legal 500, Massachusetts Lawyers Weekly and Massachusetts Super Lawyers. Prior to joining Proskauer, Fangli was a partner at a leading Boston law firm.

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Photo of Erik Milch Erik Milch

Erik Milch is a partner in the Litigation Department and a member of the Intellectual Property, Patent Law and Trials group.

Erik brings more than 20 years of experience litigating in key jurisdictions across the U.S., as well as before the International Trade…

Erik Milch is a partner in the Litigation Department and a member of the Intellectual Property, Patent Law and Trials group.

Erik brings more than 20 years of experience litigating in key jurisdictions across the U.S., as well as before the International Trade Commission and the U.S. Patent and Trademark Office. As a first-chair trial lawyer, Erik litigates complex matters involving medical devices, life sciences instrumentation, pharmaceuticals, electrical and computer technology, and consumer products. He regularly counsels clients in a range of industries in connection with patent procurement, development of patent portfolios, patent licensing, valuation of patent portfolios in business transactions and transactional diligence.

Erik has extensive experience in all aspects of patent litigation from pre-filing through appeal, including enforcement of patents against competitors and defense of patent infringement allegations. His technical background includes microfluidics, lab automation, optical imaging instruments, wound closure, surgical instrumentation, orthopedics, autoinjectors, tissue resection and sealing, pharmaceuticals, haptic feedback systems, computer software, consumer products, fluid mechanics applications, automotive engines and mechanical and electrical components, aerospace propulsion and control systems, weapons systems, and telecommunications.

Erik has been consistently recognized in Chambers USA and IAM Patent 1000 for his significant expertise in patent litigation. He was also recognized as a “Top Lawyer” by The Washingtonian.

Prior to pursuing a legal career, Erik earned a bachelor’s degree in mechanical engineering from Georgia Tech, where he developed a deep appreciation for cutting-edge technology and its potential to drive progress. His background in engineering equips him with a unique ability to comprehend intricate technical concepts. This enables him to effectively navigate the intricate world of patent litigation, combining his legal skills with technical know-how to provide comprehensive and strategic counsel to his clients.

In addition to his academic accomplishments, Erik served as an officer in the United States Navy. His military background instilled in him a strong sense of discipline, leadership, perseverance, and attention to detail; qualities that continue to guide him in his legal practice.

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Photo of Nicholas C. Prairie Nicholas C. Prairie

Nicholas Prairie is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. He works with life science and pharmaceutical clients of all sizes in the preparation and prosecution of patent applications.

Prior to joining Proskauer, Nicholas was…

Nicholas Prairie is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. He works with life science and pharmaceutical clients of all sizes in the preparation and prosecution of patent applications.

Prior to joining Proskauer, Nicholas was an associate at another Boston firm, where he worked with corporate clients of all sizes. He drafted and prosecuted U.S. and foreign patent applications, and assisted in district court litigation and Inter Parte Reviews. Nicholas’s technical expertise includes small molecules, peptides, and protein conjugates.

Before law school, he worked as a chemist at Ipsen (Biomeasure, Milford, MA) where he synthesized a variety of pharmaceutically interesting compounds including; small molecules, peptides, peptide-drug conjugates, proteins, and protein-polymer conjugates. As a graduate student his research focused on natural product synthesis.

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