Category: PTO Trial Proceedings
On Wednesday, February 15, 2017, the Patent Trial and Appeal Board (“PTAB”) ruled in favor of the Broad Institute of MIT and Harvard in a closely watched patent fight with UC Berkeley over the breakthrough CRISPR genome-editing technology. The PTAB concluded that the Broad Institute’s later-filed patents for using CRISPR in eukaryotic cells did not interfere with Berkeley’s earlier-filed patent application that disclosed the use of CRISPR technology in vitro and claimed the use of CRISPR technology in general.
It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the Supreme Court, and the number of IPRs has greatly exceeded expectations, making the Patent Trial and Appeal Board one of the most important and busiest forums for patent validity litigation in the US. IPRs were intended to help high-tech innovators besieged with suits from patent trolls to efficiently and cheaply invalidate dubious patents and focus on innovation. But the impact of these proceedings goes far beyond electrical and computer fields as they have had a major impact on biotech and pharmaceutical patents as well. The PTAB proceedings for U.S. Patent No. 6,331,415 (better known as the “Cabilly II patent”) – one of the most litigated biotech patents in the US – offer key insights into IPRs and why they are widely used across technologies.
Supreme Court Affirms Cuozzo – Leaving in Place BRI and Judicial Review Limitation for IPR Proceedings
In Cuozzo Speed Technologies, LLC v. Lee, No. 15-446, the Supreme Court affirmed the Federal Circuit’s holdings that an alleged defect in the PTO’s institution of an inter partes review (IPR) was not subject to judicial review even on appeal of a final decision, and that the PTO can apply the “broadest reasonable interpretation” claim construction standard in IPR proceedings. Over 30 amicus briefs were filed in this case, with pharma/biotech innovators urging the Court to reverse the Federal Circuit.
Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of Zarxio (filgrastim-sndz), the only biosimilar launched in the US to date, is also first in line with an Enbrel biosimilar in the US. Last October, Sandoz announced that FDA accepted its regulatory application for a proposed Enbrel biosimilar for review. Sandoz is seeking marketing approval for all of Enbrel’s medical indications. But Sandoz’s proposed Enbrel biosimilar brought litigation under the US biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
Despite mixed results, biosimilar makers continue to turn to inter partes review (IPR) proceedings in order to challenge innovator patents protecting some of the most important biologics.
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.
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.
Protective orders preventing litigation counsel from participating in the prosecution of litigation-related patents are commonplace. These restrictions, however, could prejudice brand companies in light of the increasing trend among generic and biosimilar applicants to file IPR proceedings on the same patents that are at issue in litigation. In such cases where “the PTO and district court are just two fronts in the same battle,” courts have been liberal in allowing litigation counsel to participate in IPR proceedings, post-grant proceedings, and reexaminations.
Welcome to the Biologics Blog, which will track and analyze developments in intellectual property law related to biologic medical products as well as regulatory and legislative changes. Our impetus for starting the blog is the recent onset of regulatory activity and litigation under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created a new regulatory and legal framework for biosimilar and interchangeable biologic products.