In lengthy hearings conducted by the Senate Subcommittee on Intellectual Property (of the Committee on the Judiciary) on June 4th and 5th (Parts I and II; Part III will be held on June 11th), the Subcommittee, chaired by Senators Tillis and Coons, 30 IP thought leaders testified on the draft legislation to amend ss. 101 and 112. I blogged on the draft legislation on May 24th: The draft bill would eliminate the requirement for novelty in s. 101 and defines the word “useful” as meaning “any invention or discovery that provides specific and practical utility in any field of technology through human intervention.” So, the only questions to be answered when determining if a claim patent eligible is whether or not the claim is directed to a process, machine, manufacture or composition of matter and whether or not it is “useful.” The definition of “process” was not changed. Oh, “PAIN” is my abbreviation for “phenomenon of nature, abstract idea and natural product,” categories ruled not to be patent-eligible in Chakrabarty. It’s interesting that the “Additional Legislative Provisions” accompanying the draft legislation states that “all cases establishing or interpreting [PAIN] are hereby abrogated.”
The testimony of the witnesses and their full names titles are given at the Subcommittees website, so I won’t give them in full to save time and apologize in advance for any errors. My challenge is how to summarize the extensive, though often duplicative, testimony. I think I will try to identify some notable points and take-aways.
Guest Post from the Chisum Patent Academy.
Join us this Summer in beautiful Seattle, Washington for Critical Patent Law Updates!
Registration is now open for our remaining advanced patent law seminar of 2019. August 8 (Thurs) – August 9 (Fri)
For complete details and registration information, click here.
On Wednesday, Senators Tillis and Coons, along with Reps. Collins, Johnson and Stivers released a draft, bipartisan bill to amend ss.100 and 101 to void the “judicial exceptions” to patent eligibility. Section 112(f) was also amended to tighten up the language (“for a combination” was eliminated).
On April 18th, I posted the “Draft Outline of Section 101 Reform.” I noted that the draft attempted to define “exclusive categories of statutory subject matter which alone should not be eligible for patent protection.” However, the draft’s proposed categories included “products that exist solely and exclusively in nature”- but did not mention claims reciting naturally-occurring processes, such as diagnostic tests. This was especially troubling since the draft outline would blacklist “mental activities” and the courts and the PTO routinely disregard steps in method claims that involve thinking, such as the mental activity of the actor who interprets the results of the test as indicative of a medical condition.
The “draft bill text” rejects this definitional attempt to define patent-ineligible subject matter. It amends s. 101 to eliminate the requirement that the patent eligible invention or discovery be “new,” and adds section 100(f) that states: “The term ‘useful’ means any invention or discovery that provides specific and practical utility in any field of technology through human intervention.”
In Novartis Pharm. v. West-Ward Pharm., Appeal no. 2018-1434 (Fed. Cir., May 12, 2019), a three judge panel of Stoll, Plager and Clevenger affirmed the district court’s ruling that the claims of Novartis’ U.S. Pat. No. 8,410,131, directed to using a rapamycin analog 40-O-(2-hydroxyethyl) rapamycin (“everolimus”) to treat renal cell carcinoma (RCC) were valid over two prior art Novartis patents disclosing this analog and disclosing that it is generally useful to treat “tumors” and two papers disclosing phase I studies of another rapamycin analog, temsirolimus, which showed some efficacy against RCC.
The panel held that the district court erred in finding that the POSA “would have been motivated to pursue everolimus as one of several potential treatment options for…advanced RCC.” The panel continued:
“This finding should have affirmatively answered the question whether there would have been a motivation to combine. Yet, the district court continued its analysis and found that West-Ward ‘failed to prove by clear and convincing evidence that a POSA would have been motivated to select everolimus.’ The district court erred in applying this heightened standard. ‘[O]ur case law does not require that a particular combination must be the preferred, or the most desirable combination described in the prior art in order to provide motivation for the current invention.”