Posts Tagged: "Hospira"

On January 9, the Court of Appeals for the Federal Circuit (CAFC) affirmed a decision of the U.S. District Court for the Northern District of Illinois, holding claim 6 of U.S. Patent No. 8,648,106 (the ‘106 patent) invalid as obvious. The ‘106 patent, owned by Hospira, Inc. (Hospira), is one of many patents covering Hospira’s dexmedetomidine products under the brand Precedex, such as the ready-to-use Precedex Premix product. Hospira sued Fresenius Kabi USA LLC (Fresenius) for infringement of claim 6 of the ‘106 patent, over its filing of an Abbreviated New Drug Application (ANDA) regarding its ready-to-use generic dexmedetomidine product.

Yesterday, in an opinion authored by Judge Moore, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s decision that: 1) U.S. Patent No. 5,856,298 (the ‘298 patent) belonging to Amgen was infringed by Hospira and not invalid; 2) 14 batches of drug substance for Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provision of 35 USC § 271(e)(1); and 3) Amgen had proven that it was entitled to a jury verdict of $70 million in damages. Additionally, the CAFC affirmed the jury’s verdict of noninfringement of U.S. Patent No. 5,756,349 (the ‘349 patent).

While the claims-in-suit had previously survived validity challenges in an inter partes review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB) and in a District of Delaware case, Aly credited additional testimony and evidence in this case with leading Judge Pallmeyer towards finding that the claimed advance was inherent to the invention in the prior art. “In IPR, there’s a limited record so there’s not a lot of testing to examine, and two tests were submitted in the Delaware case,” Aly said. While that could have been enough, he noted that, in the Fresenius Kabi case, multiple companies had done more than 20 tests, all of which showed that the claimed advances were inherent to the stable product.

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery in the district court. The Court also found that Amgen failed to meet the requirements for mandamus relief. Amgen Inc. v. Hospira, Inc., (Fed. Cir. Aug. 10, 2017) (Before Dyk, Bryson, and Chen, J.) (Opinion for the court, Dyk, J.)… When filing a BPCIA paragraph (l)(3) list of patents that could potentially be infringed by a biosimilar, all patents that could reasonably be infringed, based on available knowledge without discovery, should be included on that list. In an interlocutory appeal, the Federal Circuit lacks “collateral order” jurisdiction to compel a district court to order discovery concerning non-listed patents, nor is mandamus warranted, because relief is available on appeal from a final judgment.

The Federal Circuit, sitting en banc, unanimously reversed the prior panel, holding that MedCo was not barred from seeking its patents due to a commercial sale under § 102(b). The sale of manufacturing services by a contract manufacturer to an inventor to create an embodiment of a patented product for the inventor does not constitute a “commercial sale” of the invention. Further, “stockpiling” a product prior to the bar date is not a “commercialization” that would trigger § 102(b). Instead, the transaction must be one in which the product is “on sale” in the sense that it is commercially marketed.

The sole modification in the figure amended was to change one of the 13 amino acids in the structure of daptomycin from an L-stereoisomer to a D-stereoisomer of asparagine. At the time of the invention, it was universally believed that daptomycin included the L-stereoisomer. Not until years later did Eli Lilly discover the error. In any case, the certificate of correction did not affect the validity of the patent, because daptomycin had been described in numerous ways in the application, including by referencing another application that described how to make daptomycin, which would have inherently included the D-stereoisomer.

The Federal Circuit disagreed, holding that “record evidence establishe[d] a genuine dispute over whether a person of ordinary skill would have been motivated to add a vent to Hoang’s disinfecting cap.” The Court also held that “the tradeoff between the desire to retain cleaning agent and the patents’ disclosure regarding drying is a factual matter left to the factfinder.”

In this issue of the Federal Circuit Review: (1) Damages for Lost Profits May Not Be Based On Extraterritorial Services Performed by an Infringer’s Customers Under § 271(f); (2) Federal Circuit Invalidates Claims Under the On-Sale Bar for Commercial Exploitation of the Invention Before the Critical Date; and (3) The PTO’s 180-Day Filing Deadline of the Optional Interim Procedure for PTA Reconsideration Request Is Not Arbitrary and Capricious.