Earlier this week the Federal Circuit decided In re Cellect, LLC, affirming the PTAB’s cancellation of claims for obviousness-type double patenting (ODP) over reference claims from earlier expiring patents in the same family in which differences in expiration dates were due solely to patent term adjustment (PTA).
For those in the SEP and Bio/pharma spaces, this is a call to action.
The PTAB released two studies on historical petition filing practices this month. One directed to the frequency of so-called serial/parallel petition filings, and the other pertaining to Orange Book/Biologics patents. As with the agency’s earlier studies on these same topics (2021), the refreshed data again demonstrates that Orange Book patents are very rarely subject to AIA trial proceedings, and that abusive, serial petition filings have been effectively outlawed for years now.
Of course anyone that actually practices before the PTAB is well-aware of these realities. So, these empirical studies are primarily directed to the oft repeated criticisms of moneyed lobbyists and disingenuous critics at a time when both Congress and the agency grapple with wildly conflicting narratives.
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
Senator Patrick Leahy has now proposed draft legislation to add Obviousness-Type Double Patenting (OTDP) to IPR jurisdiction. The argument for adding this potential ground is that it is an important control to combat improperly extended drug monopolies (the justification underlying much of the legislative proposal). Whether this provision makes it to law is far from clear given the likely push back from Bio/Pharma.
In the meantime, a Pharma dispute recently argued that OTDP is basically the same PTAB obviousness analysis under a different rubric. An awkward argument given the coming storm.
Continue Reading PTAB Estoppel & Double Patenting?
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
A few years back, the Patent Trial & Appeal Board (PTAB) released a study showing the outcome of proceedings directed to so-called “Orange Book” patents. That study demonstrated that Orange book/Biologic patents were more likely to survive PTAB proceedings relative to other patents. Last week, the 2018 study was updated.
The update shows the performance of Orange Book/Biologic patents at the PTAB since 2012.
Continue Reading Bio/Pharma Patents Fare Best at PTAB
Back in 2018 I noted the current PTO administration had backed away from a dispute on the appropriate 112 standard to apply in AIA trials (after intervention by the previous PTO administration). That is, the initial intervention sought to support the application of the standard enunciated by In re Packard to AIA trial proceedings. After Director Iancu came on board, that Intervenor Brief was withdrawn.
Today, the PTO formally announced (via memorandum) that the Nautilus standard applies to AIA trials – settling an open question….at least for the time being.
Continue Reading PTAB Applies Nautilus 112 Standard to AIA Trials…For Now
The USPTO is hosting a Boardside Chat webinar on Thursday, July 18, from noon to 1 p.m. ET, to discuss its previous PTAB Orange Book patent/biologic patent study and district court pharma litigation study. Acting Vice Chief Judge Michelle Ankenbrand and Judge Jason Repko will discuss these studies.
The
It was easy to miss last week’s introduction of a new patent reform bill on the House side entitled: “Terminating the Extension of Rights Misappropriated Act of 2019” with so much focus on the Senate’s patent subject matter eligibility hearings. The “Term Act of 2019” is described as addressing “the rising cost of prescription drugs by significantly limiting the process known as “evergreening,” whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity and maintain high prices.”
Under the heading “Prevention of Double Patenting” the bill seeks to add a special presumption for Orange Book patents directed to a same drug/biological product.
Continue Reading Bio/Pharma to Face Second Double Patenting Hurdle?
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?