In OSI v. Apotex, Appeal no. 2018-1925 (Fed. Cir., October 4, 2019), the panel reversed the PTAB and found that the method of treatment claims in U.S. Pat. No. 6,900,221 were not obvious over a primary reference taken with each of two secondary references. The claims were to a method of treating non-small cell lung cancer by administering to a mammal a therapeutically effective amount of erlotinib (Tarceva®). The panel found that the cited combinations of references, Schnur in view of Gibbs or OSI’s Form 10-K as it was presented in its 10-K submission, would not provide a reasonable expectation of success in treating NSCLC to the POSA.
On October 1st, Athena filed a petition for a writ of certiorari to the Supreme Court following the Fed. Cir.’s fractured denial for its petition for rehearing en banc in Amgen v. Mayo. The original request for rehearing en banc posed two questions. In brief, whether the Fed. Cir. now has effectively created a per se rule that claims to diagnostic methods are not patent-eligible (PE) and whether courts may now exclude claim elements that they deem conventional in determining whether a claim is directed to PE subject matter.
This bill has been introduced into both houses of Congress in a bipartisan effort to curb the reach of inter partes review (IPR) proceedings and the broad four-factor analysis for injunctive relief set forth by the Supreme Court in eBay v. MercExchange. I originally posted on this bill and referenced other commentators here on May 25, 2019.
Senator Tillis opened the discussion by asserting that the present high standard for obtaining injunctive relief can discourage “patent trolls”, and that IPR can be an efficient way for small businesses to protect themselves from trolls. However he was concerned about the provisions limiting the number of petitions for IPR that a defendant can file, and the need to choose between conventional infringement litigation and the PTAB’s post-grant procedures called for in the bill. The hearing had six witnesses who were pretty much split on whether or not such broad amendments to the AIA were necessary, but almost all of them testified that some reforms were needed.
In Ino Therapeutics LLC v. Praxair Distrib., Inc., Appeal no.2018-1019 (Fed. Cir., August 27, 2019) a divided Fed. Cir. panel comprising Judges Dyk and Prost, Newman dissenting affirmed a district court decision that a number of INO’s patent claims were patent ineligible as attempts to claim a natural phenomenon. Five method-of-treatment patents were involved, including U.S. Pat. Nos. 8,282,966 and 8,795,741.
The relevant claims were directed to reducing the risk that inhalation of nitrous oxide (“iNO”) by neonatal patients identified having hypoxic respiratory failure, who also are identified as having left ventricular dysfunction, do not receive iNO, due to their increased risk of pulmonary edema. Claim 1 of the ‘741 patent reads as follows: