Damages Archives - Page 5 of 9

No Statutory Damages Even When Post-Registration Acts Violate a Different Exclusive Right from Pre-Registration Acts

The US Court of Appeals for the Fifth Circuit has reversed a district court ruling awarding statutory copyright damages for pre-registration infringements, explaining that the statute bars such an award even when the post-registration infringement of exclusive rights of the copyright holder is different from the pre-registration act(s). Southern Credentialing Support Services, LLC v. Hammond Surgical Hospital, LLC, Case No. 18-31160 (5th Cir. Jan. 9, 2020) (Costa, J.). This case analyzes § 412 of the US Copyright Act, which bars an award of statutory damages for infringements commenced prior to registration of a copyright.

Credentialing is a process doctors must complete to practice at hospitals, and credentialing service providers verify the information doctors provide. Southern Credentialing Support Services (SCSS) began providing credentialing services to Hammond in 2010, and designed two packets of custom forms for credentialing uses by Hammond. After SCSS stopped providing services to Hammond in 2013, Hammond contracted with another provider for credentialing services and continued to use some of the forms developed by SCSS. By 2017, the new provider for Hammond had also made the SCSS forms available online. SCSS did not obtain copyright registration for its forms until 2014, after learning that Hammond was still using some of the SCSS forms. After the parties failed to resolve the dispute amicably, SCSS sued Hammond for copyright infringement.

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Slipping Through the Cracks of the § 271(e)(1) Safe Harbor

The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.).

EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO manufactured by Hospira infringed various claims of these patents.

Hospira appealed.

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