In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit.
The decisions illustrate the utility of the new IPR process before the PTAB, implemented under the America Invents Act (AIA), as a parallel venue in which patent litigation defendants can challenge the patentability of claims asserted against them in litigation, more expeditiously and less costly than in court proceedings.
The three patents, U.S. Patent Nos. 7,713,698 (the ’698 patent), 7,790,869 (the ’869 patent), and 8,088,575 (the ’575 patent), were three of five patents-in-suit at issue inTrustees of Columbia University & Intelligent Biosystems v. Illumina, Inc., 1:12-cv-00376-UNA, pending in federal court in the District of Delaware. (Illumina did not file petitions for IPR of Columbia’s U.S. Patent Nos. 7,635,578 and 7,883,869, which were also asserted in the court case). The five asserted patents cover technology relating to “sequencing DNA by synthesis,” (SBS) which is used in next generation sequencing. After Columbia sued Illumina on March 26, 2012, alleging infringement of the five patents, Illumina filed petitions for inter partes review of selected claims in the ‘698, ‘869 and ‘575 patents on September 16, 2012 and October 3, 2012—within the 1 year deadline for instituting inter partes review following service with “a complaint alleging infringement of the patent.” 35 U.S.C. § 315(b).
In response to the Petitions, the PTO instituted inter partes review on March 12, 2013, and within 18 months of the petitions, the PTAB issued its final written decisions canceling the challenged claims (claims 1-3 and 6 of the ’575 patent, claims 1-7, 11, 12, 14, 15 and 17 of the ’698 patent, and claims 12, 13, 15-17, 20-26, 28, 29, 31 and 33 of the ’869 patent) as either being anticipated or as unpatentably obvious in view of cited prior art.
In an interesting turn of events, when Illumina counterclaimed for patent infringement against Columbia and Intelligent Biosystems (IBS) in the litigation, IBS took its cue from Illumina and successfully petitioned for inter partes review of Illumina’s three asserted patents, U.S. Patent Nos. 7,057,026, 7,785,796, and 8,158,346. According to a Joint Report submitted to the district court following the PTAB’s decisions in the IPR proceedings for Columbia’s patents, the PTAB trials on Illumina’s patents are scheduled to take place between April 23, 2014 and October 10, 2014. Meanwhile, the parties have stipulated to conduct limited ongoing fact discovery while awaiting the results of the IPR of Illumina’s patents.
Although the successful cancellation of claims in Columbia’s three SBS patents mark some of the first successful IPRs of biotech patent claims in parallel with litigation, it is interesting to note that Columbia’s “Axel Patent,” U.S. 6,455,275—directed to certain transformed Chinese Hamster Ovary cells and methods of producing proteins using the cells—was similarly successfully challenged in another venue, a re-examination proceeding conducted in parallel with multi-district litigation in the District of Massachusetts. See In Re Columbia University Patent Litigation, 330 F. Supp.2d 12 (D. Mass. 2004) (denying in part Columbia’s motion to stay the case pending re-examination, but proceeding with litigation of the issue of obviousness type double patenting); see also Ex Parte Reexamination Certificate for U.S. Patent 6,455,275 (stating that Claims 1-19 and 20 are cancelled).
IPRs—A Second Strategy for Later Filing Generic Drug Companies
Petitions successfully instituting IPR challenges in parallel with ongoing litigation have also been successfully filed by generic drug companies who were not first-to-file, in anticipation of, or in parallel with ANDA litigation filed by the branded drug company. See, e.g., Kappers et al., Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, IPR2013-00371, and IPR2013-00372 (PTAB), AIPLA Biotech Buzz, available at http://www.aipla.org/committees/committee_pages/Biotechnology/ptab/Shared%20Documents/PTAB_Buzz_201401.pdf. At least two other generic drug companies have also filed petitions for IPR of patents that were the subject of ANDA litigation.
A generic drug company that is first to file an abbreviated new drug application (ANDA) containing a “Paragraph IV” certification that one or more of the branded company’s patent claims are invalid, unenforceable and/or not infringed secures 180 days of generic drug market exclusivity if the branded drug company files an ANDA litigation, and the first-to-file generic drug company wins its challenge in court. First-to-file generic drug companies may therefore be reluctant to petition for IPR and jeopardize a chance for 180-day market exclusivity.
However, use of IPR proceedings remains a viable option for later filing generic companies. For example, when the branded drug company files suit against an ANDA-filer, it triggers a 30-month stay of FDA approval of the generic drug. Generic drug entry into the market can be accelerated if the later-filing generic successfully petitions for IPR of the patents-in-suit in the ANDA litigation and the IPR proceedings conclude favorably before the end of the 30-month stay. Filing for IPR may also provide leverage in settlement discussions.
- Consider inter partes review as a second line of defense when defending against allegations of patent infringement in federal district court. IPR is a less costly and more expeditious venue than a litigation proceeding in federal district court.
- Be cognizant of the 1 year deadline for filing the petition for inter partes review, following service of a complaint alleging infringement, and note that PTAB has held that the 1 year statute of limitations also applies to allegations of infringement brought in counterclaims. See, e.g., Kappers et al., St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., IPR2013-00258 (PTAB) (reporting PTAB’s denial of a petition for inter partes review filed more than one year after a counterclaim alleging infringement was made). Moreover, PTAB has held that the one-year bar from service of the complaint applies even where the petition challenges claims amended by a reexamination certificate issued after service of the complaint. See, e.g., Kappers et al., BioDelivery Sciences Int’l, Inc. v. MonoSol RX, LLC, IPR2013-00315 (PTAB).
- Although first filing generic companies gain 180-day exclusivity by invalidating a patent in ANDA litigation, inter partes review remains a viable option for later-filing generic drug companies to challenge asserted patent claims.
- Use of IPR proceedings by a later filing generic could accelerate generic entry into the market where PTAB issues a favorable final written decision which is affirmed before the end of the 30-month stay, and may also provide leverage in settlement discussions.