Is The Tide Turning for Patent Owners?

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 switch to a Phillips claim construction and increased feedback from the Federal Circuit are driving welcome changes at the PTAB for Patent Owners.

Please join me for an interactive webinar discussion of these changes next Monday, August 20th @1PM (EST). Register (here).  The webinar will identify key takeaways from these changes, especially for Bio/Pharma Patent Owners, and offer insights and discuss possible further practice changes that will occur in the weeks/months ahead.  My co-presenter for this webinar will be Charlotte Jacobsen, a partner in Ropes & Gray’s life sciences intellectual property litigation practice.

The formal portion of the webinar will begin at 1PM Eastern and will last for approximately 50-60 minutes. After the presentation there will be a Q&A period. To attend the free webinar please sign up via the link above. You will receive a registration confirmation email immediately. One hour prior to the webinar you’ll receive another email with a link and instructions for joining the presentation. CLE credit will be provided (CA, NYC, VA).

Federal Circuit Denies Tribal Sovereign Immunity from PTAB Proceedings

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?

Senator Hatch Proposes PTAB Exception for Orange & Purple Book Patents

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

Key Bio/Pharma Assets at the 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 Filko Prugo conducted a study that examines institution rates and final written decision outcomes for each Orange and Purple Book-related PTAB petition filed since the inception of the PTAB to May 1, 2018, as well as every validity decision rendered by a federal district court in Hatch-Waxman litigation between Jan. 1, 2013 and May 1, 2018.

I hope you find these insights helpful.

You can find the full study (here)