Edwards Life Sciences Corp. et al. v. Meril Life Sciences PVT. LTD. et al.

Docket No. 2022-1877 (https://cafc.uscourts.gov/opinions-orders/22-1877.OPINION.3-25-2024_2290338.pdf)

LOURIE, STOLL, CUNNINGHAM

March 25, 2024

Brief Summary:  DC grant of SJ to Meril based on determination of 271(e)(1) safe harbor affirmed. Summary:   Edwards appealed DC grant of summary judgment (SJ) finding “Meril’s act of importation of the two transcatheter heart valve systems fell within the safe harbor provision of 35 U.S.C. § 271(e)(1).” Meril is an India-based company that started clinical trials for its system (“Myval”) in India in October 2018 and was approved for sale in the European Economic Area in April 2019.  In early September 2019.  Meril started working preparing its FDA premarket approval and later than month “sought out potential clinical researchers for FDA clinical trials at the 2019 Transcatheter Cardiovascular Therapeutics Conference in San Francisco (‘TCTC’)” and “had a booth at TCTC from September 26 through September 28, 2019.”  Meril instructed its employees attending the conference that they could not make any offers for sale in the US market but could offer sales for other countries.  An employee brought two sample systems to San Francisco with a “written declaration stating” those were for “demonstration purpose only” and “not for sale” and to TCTC “where the bag was kept in a storage room overnight” and “never taken out of the bag or shown to anyone.”  Meril presented information on the systems at TCTC, including discussing the systems “with several U.S. doctors to identify potential clinicians for its premarket approval application” but did not include pricing or commercial promotions.  The first employee gave the samples to a second employee to take to Europe on Sept. 30.  In Dec. 2019, Meril submitted its premarket approval submission to the FDA, the FDA responded in Feb. 2020 requiring Meril to include at 50% human test subjects to be at US clinical sites, with which Meril complied by May 2020.  Edwards filed suit in Oct. 2019.  The FC panel wrote that the question presented here is whether Meril’s importation to TCTC “was reasonably related to recruiting investigators for a clinical trial to support FDA approval”, and held that it did.  The FC panel explained that “[t]he safe harbor “provides a wide berth for the use of patented [inventions] in activities related to the federal regulatory process” (Merck KGaA (US 2005) (reasonably related to the development and submission of any information)) and “is not limited temporally” (“irrespective of the stage of research and even if the information is never ultimately submitted to the FDA”) (Amgen, FC 2019 (“reasonable basis for believing”); Momenta, FC 2015 (“extends even to activities the ‘actual purpose’ of which may be ‘promot[ional]’ rather than regulatory, at least where those activities are ‘consistent with the collection of data necessary for filing an application with the [FDA]”); AbTox, FC 1997).  And within 271(e)(1), the FC panel explained, “‘solely’ modifies ‘for uses’” (i.e., “only for acts or uses that bear a reasonable relation to the development and submission of information to the FDA”).  Here, the FC panel found, the DC correctly granted SJ based on its determination that Meril’s importation was reasonably related to obtaining FDA approval.  Judge Lourie dissented, arguing that the safe harbor is only for the “development of information for the FDA.”

Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel…

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.