Article
Source: Pharmaceutical Patent Analyst
Article
By Patrick A. Doody,
02.09.17
After Cuozzo, the patent challenger will not be precluded from arguing differing claim interpretations in district court litigation and the Patent Trial and Appeal Board (PTAB), as differing standards are clearly permissible and contemplated under the law. Accordingly, the lower standard of proof and broader claim construction standards before the PTAB should inure to the benefit of the patent challenger, making inter partes review an attractive avenue for generic companies seeking to challenge the validity of bio/pharma patents.
Cuozzo Speed Technologies, LLC v. Lee
In 2011, Congress enacted the America Invents Act (AIA), creating three new post grant proceedings, including inter partes review (IPR).1 IPR was a new proceeding, intended to replace inter partes reexamination proceedings, in which third parties could challenge the validity of issued patents before the Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office (PTO). The 20 June 2016 decision of the Supreme Court in Cuozzo Speed Technologies, LLC v. Lee, confirmed the viability of IPRs for generic-drug makers to challenge patents owned by brand name pharmaceutical companies, instead of, or in conjunction with pursuing costly Hatch–Waxman litigation.2 The Cuozzo decision affirmed the constitutionality of IPRs, and promotes the notion that using IPR to challenge patent validity often proves advantageous over pursuing the alternative: costly and time-consuming district court litigation. The Cuozzo Court therefore paved the way for generic pharmaceutical companies to challenge issued patents in a more efficient and cost-effective manner.
1Leahy-Smith America Invents Act (AIA), Pub. L. No. 112–29, 125 Stat. 284. (2011).
2Cuozzo Speed Techs., LLC v. Lee, 579 U.S., _____. (2016).