PTO Releases New Guidelines on Subject Matter Eligibility

On Oct. 17th, the PTO published Guidelines intended to supplement the Jan. 2019 Subject Matter Eligibility Guidelines (“2019 PEG”). The Guidelines and associated Examples are extensive. Only two of the Examples (43 and 44) are concerned with the life sciences. Example 43 is a method of medical treatment claim and 44 is a claim to a packaged natural product, that contains the natural product in a self-injectable patch to control diabetes, or combines it with another natural product.

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OSI v. Apotex – Christmas in October!

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.

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Athena’s “Questionable” Petition for Cert.

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.

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Senate Subcommittee on IP Holds Hearings on SWOT of STRONGER Bill

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.

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