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?
As we close out 2018, there may be some hope on the horizon for those confounded by the current state of patent eligibility determinations under 35 U.S.C. § 101.
On the legislative side, Senators Coons (D-Del) and Thom Tillis (R-N.C.) will host a closed-door meeting tomorrow, Dec. 12th, to
The Patent Trial & Appeal Board (PTAB) has issued an update to its Trial Practice Guide. The update includes notable practice changes that favor Patent Owners. Going forward, Patent Owners will have the last word in briefing, and at oral argument. These changes, along with the imminent
Last Friday, the Federal Circuit affirmed the Patent Trial & Appeal Board’s (PTAB) denial of tribal sovereign immunity as a patent owner defense to an AIA trial challenge. The decision tracks my November prediction that the Court would follow its reasoning in Ultratec, Inc. v. Captioncall, LLC, 2017, (Fed. Cir. Aug. 28, 2017), which explained that PTAB proceedings were not “trials” in an Article III sense. You can find Friday’s decision in St. Regis Mohawk Tribe v Mylan Pharm., Inc. (here)
The Board noted that the question of state sovereign immunity was left for another day, but was it really?
Continue Reading Tribal Sovereign Immunity Denied, Will State Immunity Hold at the PTAB?
As explained earlier this week in a study by my partner Filko Prugo, Orange & Purple Book patents fare no worse at the PTAB than in the courts. That said, some believe that the ability to challenge such patents in a faster, cheaper expert forum upsets the balance of power in the existing drug innovator landscape.
Today, Senator Orrin Hatch (R-UT), the Chairman of the Senate Republican High-Tech Task Force and co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to in his words “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” Senator Hatch’s amendment, the Hatch-Waxman Integrity Act of 2018, is argued to prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design. It is also argued to ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications.
Continue Reading Senate Moves to Exclude Orange & Purple Book Patents from PTAB
Through more focused strategy, patent owners have ensured that Patent Trial and Appeal Board (PTAB) proceedings are not overwhelmingly fatal to Orange and Purple Book patents. In fact, patent invalidity rates at the PTAB now rival those in district court litigation.
Ropes and Gray’s IP Litigation (Life Sciences) Chair