by Dennis Crouch

The Federal Circuit's recent decision in Astellas v. Sandoz emphasized the importance of the "party presentation principle" -- that, for the most part, courts should rely upon the parties to frame the issues that need a ruling.  Visiting Delaware, Nebraska District Court Judge Bataillon had issued a sua sponte ruling that certain pharmaceutical patent claims were invalid under 35 U.S.C. § 101 -- even though the defendant had not moved for such a ruling.  On appeal, the Federal Circuit has vacated and remanded -- "trusting" that on remand Judge Bataillon "will take an objective, measured, and thorough look into the legal issues and evidence of record to resolve only those disputes that exist between the parties."

Judge Bataillon's colorful opinion language asserted that the branded and generic pharma companies have colluded to pervert the intent of Hatch-Waxman.  On remand, it may be substantially drier.

by Dennis Crouch

The Supreme Court's landmark decision in eBay v. MercExchange dramatically changed the patent landscape by eliminating the potential of injunctive relief for many patent holders, even in the face of ongoing infringement. The Patent Act indicates that injunctions may be awarded "in accordance with the principles of equity," 35 U.S.C. 283, and in eBay, the Court found this required usage of a "four-factor test historically employed by courts of equity."  The central factor in the test for permanent relief is whether the infringement constitutes irreparable harm against the patent holder.  Prior to eBay, courts had seen infringement as indicative of irreparable harm, but altered their approach after eBay so that today a judgment of infringement comes with no presumption or indication that those tortious acts constitute irreparable harm.

A recently filed appeal before the Federal Circuit seeks to alter this new status quo -- particularly by providing an extensive historical analysis of how traditional courts of equity analyzed irreparable harm in the context of injunctive relief.  The new case is at the preliminary injunction stage, but the preliminary injunction test includes the same irreparable harm clause.

by Dennis Crouch

The Federal Circuit is set to hear oral arguments in November 2024 in Teva v. Amneal, No. 24-1936, a case that could significantly impact Orange Book patent listing (and delisting) practices under the Hatch-Waxman Act (formally known as the Drug Price Competition and Patent Term Restoration Act of 1984).  Hatch-Waxman established a framework for generic drug approvals in the United States. It aims to balance incentives for pharmaceutical innovation with mechanisms to facilitate faster generic drug entry, including provisions for challenging patents listed in the FDA's Orange Book and offering a 180-day exclusivity incentive for first generic entrants.  The Orange Book listing also comes with a powerful 30-month stay -- pausing generic entry - if the patentee sues a generic seeking FDA approval.

At issue are five patents related to Teva's ProAir HFA (albuterol sulfate) Inhalation Aerosol, a metered dose inhaler (MDI) product. The patents claim various aspects of the inhaler device and dose counter, but do not expressly recite the active ingredient albuterol sulfate. Teva listed these patents in the FDA's Orange Book for ProAir HFA.  The big-money question in the case is whether these device patents are properly listed -- recognizing that the Orange Book is particularly for patents that claim either the drug or a method of using the drug.

by Dennis Crouch

The Supreme Court's October 2024 term begins a day early this year. On September 30, the Court will meet for what has become known as the "long conference" -- passing judgment on dozens of petitions that have been briefed over the summer break.  The long conference is primarily a time to deny a large swath of petitions with very few certiorari grants.  Petitioners are usually simply hoping for a relist -- holding over their case for some future conference and a more complete consideration.

A number of patent cases will be reviewed that day.  The following are patent cases scheduled for the Long Conference, listed roughly in the decreasing order of likelihood of being granted certiorari (in my estimation):

by Dennis Crouch

I have been reading a good number of PTAB decisions recently to try to get my head wrapped around the current state of the obviousness and eligibility doctrines within the USPTO.  The Board's recent decision in Ex parte Annakov is on point.  The case involves a distributed service-and-transaction system for aircraft passengers, and the examiner rejected the claims both for lack of eligibility under § 101 (all the claims) and as obvious under § 103 (most of the claims).  On appeal, the Board reversed on eligibility, but affirmed on obviousness -- leaving a handful of claims ready for issuance.

by Dennis Crouch

Many of us feel the daily pull toward coffee, and perhaps likewise toward PTAB decisions about coffee makers.

I found interesting a recent pair of IPR decisions successfully brought by the Swiss Nespresso against German competitor K-Fee.  This post delves into these cases and what I call the 'glove doesn't fit' fallacy in patent law obviousness doctrine; it also provides a discussion of how written description continues to be a risk, even in inter partes review (IPR) proceedings.

by Dennis Crouch

On September 11, 2024, the Federal Circuit issued three separate orders denying petitions for writs of mandamus related to venue transfer decisions. These cases highlight a trend that I previously recognized of the court stepping-back from its prior aggressive mandamus docket.  The cases here all include the similar procedural posture where the district court ordered transfer under the convenient venue statute 1404(a), and the patentee unsuccessfully petitioned the Federal Circuit to reverse the transfer.

Coming up just before the big IPO conference in Chicago, Emory Law in Atlanta will be hosting the 2nd Innovator Diversity Pilots Conference.  This event looks excellent, and I wish I could attend. (I'll be in the woods at a "ManKind Project" retreat).

Details: Friday, September 20, 2024, 8:45 a.m. - 5:30 p.m.  In person or online. https://law.emory.edu/impact/conferences/innovator-diversity-pilots-conference.html.

USPTO Dir Kathi Vidal and other Biden Administration officials have been very open to trying well designed pilot programs that offer some promise to effectively increase participation and engagement of underrepresented groups within the innovation ecosphere.  Although many of the pilots focus on gender and race/ethnicity, the mindset of most really seems to be thinking about ways to make sure that everyone feels that patent-incentive -- adding fuel to the fire of genius.  I expect that the pilots that really work will be rolled-out as deliverables to everyone.

Key topics:

- Lessons learned from recent innovator diversity pilots
- Practical insights from the Diversity Pledge and other law firm diversity initiatives.
- The future of patent drafting and prosecution in the age of AI
- Strategies for retaining diverse talent in the patent profession

It is a mix of academic research presentations and practical discussions.