In an unprecedented PTAB decision involving Spectrum Solutions LLC and Longhorn Vaccines & Diagnostics, the Board found all five challenged patents invalid and imposed sanction against patent owner Longhorn for failure to meet the duty of candor and fair dealing. The board determined that Longhorn selectively disclosed testing results to
Dr. Fangli Chen is a partner in the Litigation Department and vice 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, messenger RNA therapy, gene therapy, 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.
The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality, many in the pharmaceutical and biotechnology industries received the opinion under a cloud of uncertainty and concern for exclusivity rights broad enough to both protect clinical candidates and deter competitors. While the patent bar may remain apprehensive, the Supreme Court kept the door open to genus claims. The impact of the decision may not be as far-reaching as feared.
Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”. Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997) Findings of infringement under DOE, particularly in biotechnology related cases, have often been considered an exception rather than the rule. One such exception is the recent Federal Circuit nonprecedential decision in Jennewein Biotechnologie GmbH v. International Trade Commission, September 17, 2020, Chen, R. (Glycosyn LLC, the patent owner, joined as an Intervenor). The Federal Circuit affirmed an exclusion order from the International Trade Commission (ITC) relying on an application of DOE to find infringement supported by substantial evidence.
Over the last seven years there has been commotion in Obviousness-type Double Patenting (“ODP”) practice. One of the latest cases to spur a considerable amount of interest is Mitsubishi Tanabe Corp. v. Sandoz, Inc., which is currently on appeal to the Federal Circuit (“CAFC”). While a detailed review of this case is not the intent of this post, as a fair number of practitioners have provided insightful coverage, an historical overview is helpful for framing the decision and issues that need clarification from the CAFC.
Allele v. Pfizer – The Basics. On April 23, 2021, Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement complaint filed by Allele Biotechnology and Pharmaceuticals, Inc. (“Allele”) in the Southern District of California. The patent at the center of the case is U.S. Pat. No. 10,221,221 (“the ’221 Patent”) which covers Allele’s mNeonGreen, a monomeric yellow-green fluorescent protein notable for its intense brightness. On May 4, 2021, the court denied the motion to dismiss, leaning heavily of the Federal Circuit’s 2008 decision Proveris Science Corp. v. Innovasystems, Inc. As this case continues to develop it could help shed light on an unsettled issue – are “research tools” categorically excluded from the 35 U.S.C. § 271(e)(1) Safe Harbor?