Horizon Medicines LLC v. Alkem Laboratories Ltd.

Docket No. 2021-1480 (https://cafc.uscourts.gov/opinions-orders/21-1480.OPINION.11-16-2021_1865455.pdf) (Non-precedential)

DYK, O’MALLEY, HUGHES

November 16, 2021

Brief Summary:  DC refusal to change inventorship, finding of obviousness and no infringement of Horizon’s patents affirmed.

Summary:  Horizon appealed DC finding claims 1, 8, 11 and 14 of US 8,067,033 invalid for obviousness and claims 1-3 and 8-10 of US 8,067,451 not infringed.  Horizon’s product is DUEXISTM (the ‘033 and ‘451 patents are two of six listed on the Orange Book) and Alkem filed a paragraph IV ANDA for a generic product.  Horizon’s patents are directed to combinations of ibuprofen and famotidine that “exhibit exceptional stability under forced degradation conditions” (detailed in the claims).  The ‘451 claims also refer to “the use of OpadryTM White YS-1-7003 as a barrier layer to further improve stability.”  The DC “found that Horizon narrowed the claim scope of the ’451 patent by specifying a barrier layer of YS-1-7003, describing it by listing the ingredients”, “construed the ‘barrier layer’ limitation in the ’451 patent to mean ‘consisting essentially of’ the ingredients in YS-1-7003” even though the claim recites “comprising”, found no infringement, and the FC panel did not disagree with the DC based on the prosecution history.  The DC found the ‘033 claims invalid in view of US Pat. Appln. Pub. 2007/0043096 A1, and the ‘033 patent claims the “combination dosage form disclosed in the ’096 publication”.  The ‘096 publication has a Feb. 22, 2007 priority date and lists inventors Golombick and Tidmarsh, while the ‘033 patent has a Nov. 30, 2007 priority date and lists Tidmarsh but not Golombick as an inventor.  Horizon argued the ‘096 publication is not prior art to the ‘033 patent under pre-AIA 102(a) (“known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent”) and unsuccessfully attempted “to correct the inventorship of the ’033 patent by adding Golombik as an inventor pursuant to 35 U.S.C. § 256 so that Golombik and Tidmarsh would be listed as inventors on both the ’033 patent and the ’096 publication” in front of the DC.   The FC panel explained that “[t]he court looks to “not merely the differences in the listed inventors, but whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity” (Riverwood, FC 2003).  It also found no error in the DC’s decision as it must find “clear and convincing evidence” which cannot be inventor testimony alone (Caterpillar, FC 2004; EmeraChem, FC 2017 (must be evidence corroborating inventor testimony); Medichem, FC 2006) and its “cases are clear that inventing something in an earlier patent or patent application does not automatically make one an inventor of patents that incorporate the earlier invention” (Eli Lilly, FC 2004).  Horizon also unsuccessfully argued against the DC’s obviousness finding of “a reasonable expectation of success to achieve the claimed degree of stability”, but the FC panel found no error in the DC’s decision, citing Alkem’s expert testimony.  Given its invalidity finding, the FC panel did not reach the infringement issue.  The DC decision was therefore affirmed.

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.