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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.

Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

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. 

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CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent

In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s  Cimzia® (certolizumab pegol), a humanized antibody fragment that treats inflammatory conditions such as rheumatoid arthritis and Crohn’s disease, does not infringe a monoclonal antibody patent owned by Yeda Research and Development Co., Ltd..  (Fed. Cir. No. 2015-1957, September 8, 2016).  Based on actions taken during prosecution, the Federal Circuit agreed that Yeda was “estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed” in its patent.  

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Disclosure Requirements Under the BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.”  In determining the standard and appropriate level of detail required by the disclosures pursuant to the patent dance, looking to analogous disclosure requirements in the Hatch-Waxman context provides helpful guidance.  Gleaning from the Hatch-Waxman context, “detailed statement” disclosures under the BPCIA should have a reasonable basis and establish a prima facie case of invalidity or non-infringement.  Moreover, as in the Hatch-Waxman context, filing “baseless” non-infringement or invalidity positions may risk sanctions as an “exceptional case” that may warrant attorney fees under 35 U.S.C. § 285.

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Supreme Court's Decision in Commil v. Cisco: Big Win for Pharmaceutical Industry

On May 26, 2015, the Supreme Court reversed the Federal Circuit’s decision in Commil USA, LLC v Cisco Systems, Inc. and held that a defendant’s belief regarding patent validity is not a defense to an induced infringement claim.  The Supreme Court’s Decision is a big win for the pharmaceutical industry, where method of treatment patents provide important protection for innovative medical therapies.  The Federal Circuit’s good-faith belief in invalidity defense gutted liability for inducing infringement of such patents.  The Supreme Court’s reversal allows these valuable patents to be enforced against the companies that induce infringement.  It also deters “at risk” launches prior to a district court decision on the validity of the patents.  

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Navigating Protective Order and Prosecution Bar Issues in BPCIA Litigation

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. 

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Impact of Supreme Court’s Commil v. Cisco?

On March 31, the Supreme Court heard oral argument in Commil USA LLC v. Cisco Systems Inc.  The Supreme Court considered the Federal Circuit’s holding that a belief in a patent’s invalidity is a defense to inducing infringement under 35 U.S.C. § 271(b).  The Justices posed tough questions to both sides.  But the ultimate outcome of this case should not impact litigation under the BPCIA where inducing infringement of method of treatment and manufacturing patents offers important protection to innovators since the validity of such patents is typically determined prior to launch of a biosimilar product.

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