Wide-Ranging Senate Bill Aims to Streamline Post-Grant Proceedings and Block Trolls

On Wednesday, Senator Coon—of 101 hearings fame—and five co-sponsors introduced the Stronger Patents Act in the Senate (“Support Technology & Research for Our Nation’s Growth and Economic Resilience”). About 22 of the bill’s 40 pages involve amendments to IPR, PGR and ex parte rexamination that limit appeals and clarify overlapping court and PTO actions. These provisions have been ably summarized by Joshua Rich in a post at PatentDocs, but there are other interesting amendments to 35 U.S.C. so I thought I would start toward the last half of the bill.

Section 106 of the bill, entitled “Restoration of Patents as Property Rights,” amends section 283 to require that a court that finds infringement to presume that further infringement would cause irreparable injury and that remedies available at law are inadequate to compensate for that injury. These are the circumstances that encourage the court to issue an injunction against the infringer.

Section 42 of 35 U.S.C. would be amended to end USPTO fee diversion into the general fund by providing that any fees collectable by the Director shall be “available to the Director” and used to operate the PTO. Remaining unobligated funds are to be maintained in the “USPTO Innovation Promotion Account.”

Continue reading

Posted in AIA Patent Reform, Inter Partes Review, Post-issuance procedures | Tagged , , , , , , , , , , | Leave a comment

Federal Circuit Denies En Banc Review of Athena v. Mayo

On July 3rd, the Fed. Cir. denied Athena’s petition for rehearing en banc. The three-page order is a 7/5 denial accompanied by more than 80 pages of concurrences and dissents. Concurring in various combinations are Judges Lourie, Hughes, Dyk, Reyna, Prost, Hughes and Taranto, with Dyk and Chen doing most of the writing. The dissenters were Judges Newman, Moore, Wallach, Stoll and O’Malley with Moore and Newman as the main authors.

I wish I had the staff to provide you with a condensed account of the opinions, but they draw the lines between the Judges who believe that denial was required because they could not distinguish (or did not think that the S. Ct. would distinguish) Prometheus v. Mayo from the facts of Athena v. Mayo and the dissenters who think the Fed. Cir. can and should.

Part I. The Concurrences

One theme, succinctly summarized by Judge Lourie appears to be shared by all of the Judges:

“If I could write with a clean slate, I would write an exception to patent eligibility [“PE”], as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma…etc. I would not exclude uses or detection of natural laws. The laws of [102, 103 and 112] provide other filters to determine what is patentable….because the claims recited only what the [S. Ct.] called a natural law together with well understood, conventional activities, the Court concluded the claims were ineligible under s. 101.”

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , | Leave a comment

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.

Continue reading

Posted in Drug Patent Term | Tagged , , , , , | Leave a comment

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.”

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , | Leave a comment