Inter partes review (IPR) proceedings were introduced by the America Invents Act on September 16, 2012. IPRs were intended to provide a rapid, low-cost alternative to litigation. They allow any party to challenge the validity of an issued patent based on published prior art.
In the pharmaceutical and biotech industries alone, there have been 268 IPR requests to date, indicating widespread use. IPRs make it easier to invalidate patents compared to Federal district court litigation because: (1) the challenged patent is not presumed valid; (2) the burden of proving invalidity is lower in IPRs than in litigation, and (3) the standard for interpreting claim terms is “broadest reasonable interpretation” and thus is more inclusive. However, rather than making the life science industry more predictable, IPRs have introduced increased uncertainty and strategic gamesmanship:
- IPRs are relatively new proceedings and the
rules are still evolving.
- To date, very few requests to amend patents during IPR proceedings have been granted, but the USPTO is now encouraging claim amendments.
- Substantive testimonial evidence, including expert testimony, is no longer prohibited in preliminary responses from patent owners.
- While the intent of IPRs was to provide an alternative to litigation, practically they provide alleged infringers with an additional chance to invalidate a patent: after nearly a year in litigation, the alleged infringers often file an IPR close to the deadline so that both proceedings run concurrently.
- IPRs and litigations sometimes produce inconsistent outcomes. For example, two patents protecting Novartis’s Exelon® patch survived Federal district court litigation and Federal Circuit appeal, but were invalidated in the IPR proceedings.
- Second ANDA filers sometimes strategically use IPR proceedings to interfere with the settlement dynamics established by the Hatch-Waxman litigation scheme.
- Creators of the IPRs did not foresee that financial challengers with no plans to introduce generic drugs would sometimes file for IPRs while shorting the stocks.
- The rate of IPR institutions varies by judge and suggests personal biases.
In the next quarter, these upcoming IPR decisions may be of interest to people monitoring biotech and pharma industries:
- Adcirca (Eli Lilly)
- Copaxone (Teva)
- Effient (Eli Lilly)
- Inomax (Ikaria)
- Prolensa (Bausch + Lomb)
- Xyrem (Jazz)