By Kevin E. Noonan --
The Supreme Court today entered orders denying certiorari in all five cases having petitions on subject matter eligibility, including Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC; Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc., and Berkheimer v. HP Inc.
It can only be concluded that the Court is comfortable with the state of diagnostic method patenting (i.e., it does not exist in the U.S.). There are members of the Court who have expressed skepticism or outright hostility to such claims, fearing that they will inhibit the practice of medicine, as well as statements (some of dubious provenance) that diagnostic methods are unlike pharmaceuticals and don't need patents (mostly from legal academics and economists). Although Bilski was a business method patent case, some of the Justices there seemed unimpressed with method claims more generally, and this prejudice may be affecting their certiorari behavior. And there is the animus many of the Justices have voiced about the Federal Circuit over the past 15-20 years, which may have made the Court less inclined to come to their rescue.
Or maybe the Court believes that this decision (not to decide) will motivate Congress to change the law; after all, in Mayo, Justice Breyer said something along the lines of "if you disagree with us, go to Congress." And genuinely, the Court may be facing up to the reality that, even if its concerns are real, the Justices don't have a solution to the problem, in which case Congress is the only answer.
What needs to be done (although it won't be) is for the PTO and courts to distinguish in individual cases the application of the Mayo/Alice cases to come to a determination of patent eligibility. The Court can speak in generalities all it wants, but if pressed by advocates who point out the economic consequences of the recent jurisprudence there is a chance the Court will moderate its views. After all, the Court certainly does not want the business section of the Wall Street Journal to run the headline "Supreme Court Destroys U.S. Industry, Public at Risk, Healthcare Costs Sure to Rise."
On the bright side, by denying cert. in Vanda, the Court kept alive the glimmer of hope that there is a way to draft enforceable claims related to diagnostics leading to real world therapeutic interventions, as well as in Berkheimer, which increases the burden on patent challengers and may inhibit plenary dismissal on eligibility grounds.
And in view of the Court's denial of certiorari in Regents of the University of Minnesota v. LSI Corp., maybe the Court believes that the other petitioners have more compelling interests in the Court's disposition of their cases than patentees have. This sentiment would not be inconsistent with the Court's views on patent law enunciated in many cases over the past decade.
"After all, the Court certainly does not want the business section of the Wall Street Journal to run the headline "Supreme Court Destroys U.S. Industry, Public at Risk, Healthcare Costs Sure to Rise.""
I share the sentiment, but neither the WSJ nor any inferior newspapers like the NYT will run such a headline: the increase in healthcare costs will be due to the lack of new medicines (e.g. an increase in antibiotic resistant infections and a lack of new antibiotics to fight them), and the continued inability to diagnose, and no one is going to attribute that to SCOTUS's jurisprudence. Most people aren't capable of connecting the dots.
Posted by: Atari Man | January 14, 2020 at 05:15 AM
I'll tell you what inhibits the practice of medicine. A lack of approved diagnostic tests, because funding was not available for projects without patent protection. To do list - letter to Thom Tillis.
Posted by: Carl B. Massey, Jr. | January 14, 2020 at 08:27 AM
Hey Kevin,
On Athena Diagnostics, a sadly expected, but frustrating response by Our Judicial Mount Olympus. Frankly, they've mucked up 101 thoroughly with their brazen judicial overreach, applying a standard of statutory construction ("implicit exceptions") unique to patent law. They're also too arrogant (or cowardly, take your pick) to admit they made a mistake, one that puts the US (as European amicus briefs have pointed out) in serious danger of violating its treaty obligations under TRIPS. The only Justice I currently respect is Neil Gorsuch, especially for his dissent in Oil States where the majority of SCOTUS (again) brazenly mischaracterized patent rights as a "public franchise." (I especially despise Breyer's, as well as Thomas' views, on patent law jurisprudence, by the way.) Is it any wonder that most of the patent bar generally has no respect for Our Judicial Mount Olympus? (My late and dear patent attorney father had a similar, extremely jaded view of SCOTUS.)
If you're expecting the Federal Circuit and especially Congress to fix this mess in 101, you're truly hoping for a pipedream, a miracle. The current Chief Judge (Prost) is generally spineless in my opinion. Only once did she (and 9 other Federal Circuit judges) in the Limelight remand unanimously dare to SCOTUS' challenge when offered the opportunity (at least thank goodness for that) to salvage 271(a) as to "whomever" meaning "more than one" infringing actor. Now that SCOTUS has made it clear its up to them or Congress (I thoroughly cringe at the thought of Congress ever doing anything but making this 101 mess worse) to push back. But I'm (pessimistically) not holding my breath for either to do what needs to be done.
Posted by: EG | January 15, 2020 at 06:29 AM
Dear Kevin,
My apologies: "dare to SCOTUS' challenge" should read instead "dare to challenge SCOTUS' offer."
Posted by: EG | January 15, 2020 at 06:33 AM