Yesterday, U.S. Senators Chris Coons (D-Del.),Thom Tillis(R-N.C.), Dick Durbin (D-Ill.), and Mazie Hirono (D-Hawaii) introduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (here). Also yesterday, some of the very same senators introduced the Patent Eligibility Restoration Act of 2023.
The co-introduction of these bills suggests a plan to drive compromise on patent eligibility.
Late last week the USPTO issued an Advanced Notice of Proposed Rulemaking (ANPRM) that floated numerous rule proposals and requests for feedback — too numerous. Proposals addressing current 314(a) and 325(d) practices were not only expected, but long overdue. While these expected proposals were included in the sprawling Notice, the rule-making process will undoubtedly be bogged down by the remaining collection of controversial ideas and administrative over-reach.
Keep in mind that 314(a) Fintiv practices could soon be struck down as improper circumvention of APA rule-making. Stalling the issuance of those rules for at least another 12-18 months – if not longer – seems like a bad idea. My guess is political pressure from outside the agency led to the laundry list of additional proposals. Especially as they relate to for-profit entities in the wake of the Open Sky debacle.
Regardless, of how or why the expansive ANPRM came to be, I’ll walk through each proposal/idea in detail below (ANPRM here)
Continue Reading PTAB Rule Ideas – The Good, The Bad, & The Ugly
Senator Patrick Leahy (D) VT and Senator John Cornyn (R) TX have jointly drafted a new bill entitled the “Restoring the America Invents Act.” The Bill proposes to roll-back recent directives and policies of former USPTO Director Iancu, most notably discretionary denials of AIA trial proceedings in view
Well, the wait was not that long after all. Senator Leahy -VT (D) (with co-sponsor Senator Cornyn – Tx (R)) has today released the draft bill entitled “Restoring the America Invents Act.” The bill includes most of what I expected, with a handful of additional tweaks.
Below is a brief overview of all of the proposed changes.
Continue Reading Restoring the America Invents Act – What You Need to Know
Back in July, I predicted that competitor standing in PTAB appeals was a debate destined for cert petition. That petition was filed last Wednesday in Gen. Elec. Co. v. United Techs. Corp. (“GE”)
As a reminder, in GE the Federal Circuit held that for the competitor standing doctrine to apply in appeals from the PTAB, the government action must change the competitive landscape by, for example, creating new benefits to competitors (citing its earlier decision in AVX Corp. v. Presidio Components, Inc.). The Court further explained that the government action with respect to a unique property right like a patent, militates in favor of a narrower application of the precedent. The holding in GE drew a concurrence from Judge Hughes (as bound by precedent), which explained his differing views on the Court’s competitor standing jurisprudence.
GE has pressed the views of Judge Hughes in its cert petition.
Continue Reading Competitor Standing in PTAB Appeals Pursued to SCOTUS
A perceived lack of Article III standing in appeals from the Patent Trial & Appeal Board (PTAB) to the Federal Circuit can doom an appeal. More recently, the Court has had an opportunity to explore “competitor standing” as a potential avenue for standing of close competitors. But, the Court has applied a patent-specific view to distinguish from controlling precedent on the impact of the “government action” of competitor standing.
A few weeks back in Gen. Elec. Co. v. United Techs. Corp., (hereinafter “GE”) the court made clear that for the competitor standing doctrine to apply, the government action must change the competitive landscape by, for example, creating new benefits to competitors. Building on its earlier decision in AVX Corp. v. Presidio Components, Inc., the Court found that the government action with respect to a unique property right like a patent, militates in favor of a narrower application of the precedent, drawing competing views from the Court.
This debate seems destined for cert petition.
Continue Reading Competitor Standing to Evolve for PTAB Appeals?
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co. (here), the Federal Circuit was poised to explore the level of biosimilar legwork that could satisfy Article III standing for appeal from an adverse Patent Trial & Appeal Board (PTAB) decision. But, business developments of Momenta since the 2017 oral argument have now spoiled all of the fun.
The question as to how much investment/business exploration is enough in the biosimilar context for Article III standing remains an open question.
Continue Reading BPCIA & FDA Steps as Article III Standing from the PTAB?