Biologics Blog

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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.

Mixed Results as IPR Petitions for Biosimilars Soar

Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017. But the results are mixed, with the Patent Trial and Appeal Board denying a high percentage of the petitions. Many of these patents are ultimately litigated in district court under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA). 

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Impact of Nautilus on Biotech and Pharmaceutical Patents

In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court rejected the Federal Circuit’s “insolubly ambiguous” standard for determining whether a patent claim meets the definiteness requirement under 35 U.S.C. §112, ¶ 2, and that “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” In the ensuing one and a half years, the Federal Circuit and several trial courts have applied the Nautilus standard in the biotechnology and pharmaceutical contexts. We discuss three notable decisions.

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Biosimilar Makers’ IPR Strategy Yields Mixed Results

A number of biosimilar makers have turned  to inter partes review (IPR) proceedings to challenge innovator patents prior to submitting their biosimilar applications to FDA.  IPRs have been attractive to biosimilar makers because in addition to offering procedural and substantive advantages for challenging patents they do not require the filing of a biosimilar application.  As a result, they make it possible for biosimilar makers to obtain patent certainty at a time when litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is premature and, depending on the results of the IPRs, may be avoided entirely.  The first such IPRs, however, are yielding mixed results, leaving potential patent disputes for later BPCIA litigation.  

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Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products in advance of submitting their regulatory applications to FDA. Since IPRs, unlike district court proceedings, do not require a case or controversy, they allow biosimilar applicants to resolve potential patent disputes long prior to being able to litigate these disputes in district court and to potentially avoid the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) of 2009 entirely.   

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