Cutting Through the Patent Thicket – The Little Bill that Couldn’t

A bill was recently proposed to “reduce the improper issuance of patents that improperly extend the term of exclusivity afforded a new drug or biological product.” The bill would amend the patent statutes (s. 253 or title 35) for add the following language:

(c) Disclaimer of Drug Patent Term —

  1. In General—Except as provided in para. 2 [of this bill], in a proceeding challenging the validity of patents under section 505(c) of the [FFDCA] (21 USC 355(c)) with respect to a drug, under section 351(1) of the [PHS] (42 USC 262(1)) with respect to a biological product, or a federal district court proceeding involving patents that are the subject of an action under 271(e)(2), [Hatch-Waxman provisions], the patentee shall be presumed to have disclaimed the patent term for each of the listed patents after the date on which the term of the first [listed?] patent expires, subject to the exceptions provided for in subsection (2)… [which says that if a patentee demonstrates by a preponderance of evidence that certain patents described in para. (1) cover patentably distinct inventions from the invention claimed the first such patent to expire, [then “never mind.”].

Of course, this bill effectively puts terminal disclaimers on all of the later-filed patents listed in, e.g., the Orange Book for the drug under attack by the generic drug company. It begins with the “presumption” that all of the later patents are obvious variants of the first “blocking patent.” Even though the patentee has demonstrated that the invention is patentable during prosecution (and even after appeal in some cases), patentee will now have to prove that any patents that patentee did not terminally disclaim over the first-filed patent in the first instance were properly granted.

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Senate Subcommittee Hearing of Patent Eligibility Wrap Up – Now What?

In my first post on the Subcommittee Hearings held last week, I noted the absence of many witnesses from the life science industry, as opposed to groups such as IPO, AIPLA, BIO, ACLU and PhMA. The third and final panel, held yesterday, remedied this absence and then some. This panel included Laurie Hill (Genentech), Gonzalo Merino (Regeneron), Sean George (Invitae), Peter O’Neill (Cleveland Clinics Innovations), David Spetzler (Caris Life Sciences), Corey Salsberg (Novartis) and Robert Deberadine (Johnson and Johnson). The witnesses were rushed, and the written testimony that was submitted provides more thorough accounts of their positions.

Chairman Tillus opened this hearing by summarizing some of his takeaways from the previous hearings, agreeing that the current judge-made law of patent eligibility is a “complete mess”, and that the draft definitions of utility and the amendments to s. 112 (f) as proposed need further work. He also recognized the need for an enhanced experimental use exception to infringement. He criticized the ACLU for advancing a “false narrative” that an individual’s genes would be patent eligible, were the draft bill to become law. He said that he was hopeful that a revised final  bill would be sent to the Judiciary Committee and come up for vote in the Senate.

Apart from the general uncertainty about the effect of the proposed amendments to s. 112(f) (one witness suggested dropping them out of the draft bill at this time), there was a nearly a consensus among the witnesses, both from the info-tech and life sciences areas, on the need to amend section 101. As stated by Dr. Spetzler: “Any invention relying even in part upon the relationship between a gene and disease, or a gene and treatment benefit, may be characterized as an unpatentable ‘natural law.’ And any invention relying even in part upon analyzing large amount of molecular data may be characterized as an unpatentable ‘abstract idea.’” He described the use of “machine learning algorithms” to select therapies when alternative ones are available, and to detect the origin of tumors based on molecular analysis, so as to better choose from treatment options, but stated that “the systems and methods we have developed to inform treatment decisions may be alleged to be unpatentable natural laws, abstract ideas or both.”

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Senate Subcommittee on IP Feels our PAIN

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.

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Chisum Patent Academy – Seattle Seminar, August 2019

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.

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