USA Trends and Developments Contributed by: Steven Lieberman and Nicole (Nikki) DeAbrantes, Rothwell, Figg, Ernst & Manbeck PC
Trends in Biologic-Biosimilar Litigations In the last two years, the U.S. has seen a dra- matic increase in patent litigation under the United States Biologics Price Competition and Innovation Act of 2009 (BPCIA). From mid-2022 to the present, a total of nineteen new BPCIA suits have been filed against biosimilars. Seven- teen of those lawsuits involve six new innovator biologics that had not previously been litigated: • Denosumab;
would have been motivated to modify the pri- or art design to create the same overall visual appearance as the claimed design.” Id. at 1299 (quoting in part Campbell Soup, Co. v Gamon Plus, Inc. , 10 F.4th 1268, 1275 (Fed. Cir. 2021)). In the LKQ case, the Federal Circuit vacated the PTAB’s determination of non-obviousness and remanded the case to the PTAB to assess non- obviousness of GM’s design patent under the new standard. The Federal Circuit’s decision to overturn the Rosen-Durling test marks a pivotal change in design patent law that reverberates not only in district court litigation but also to prosecution. Shortly after this decision, the USPTO issued Updated Guidance and Examination Instructions for Making a Determination of Obviousness in Designs, which incorporates the Federal Cir- cuit’s standard. The Graham approach encourages fact-specific analyses and allows courts and examiners to better consider the knowledge of an ordinary designer. On the other hand, by lowering the standard and removing the “basically the same” require- ment, the Federal Circuit drastically broadened the field of potentially invalidating prior art. As a result, there will likely be heightened scrutiny by examiners during the prosecution process. The new standard will likely make it more diffi- cult for companies to obtain and enforce design patents. It will also be easier for patent chal- lengers to invalidate design patent claims at the district court. Design patentees and applicants should closely consider their enforcement strat- egies moving forward and assess the strength of any design patents under the new obviousness standard.
• Aflibercept; • Eculizumab; • Ustekinumab; • Natalizumab; and • Tocilizumab.
In comparison, in the eight years from late 2014 through mid-2022, there were a total of only forty BPCIA litigations filed against biosimilars – all of which involved one of nine other innovator biologics. These new lawsuits provide further insight into the trends that patent professionals
can glean from BPCIA litigations. Accelerated Schedules and Quick Resolutions
Thus far, most BPCIA litigations have reached early resolutions and few have made it past the discovery stage. Only a small handful of cases have proceeded to trial. Those cases include Amgen Inc. v Hospira , Inc., No. 15-cv-839 (D. Del.), which proceeded to a jury trial where the jury found that Hospira’s epoetin alfa biosimi- lar infringed Amgen’s patent covering its Epo- gen product. See Dkt. 326. In Immunex Cor - poration et al. v Sandoz Inc ., No. 16-cv-1118 (D.N.J.), the court held a bench trial on validity and upheld both of Immunex’s two asserted pat- ents. In Amgen Inc. v Apotex Inc ., Nos. 15-cv- 61631, 15-cv-62081 (S.D. Fla.), the court held a bench trial and ruled that Apotex’s process for
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