Posts Tagged: "Mayo v. Prometheus"

On June 7, 2018, the USPTO issued new guidance to its examining corps in the form of a memorandum discussing the Federal Circuit’s April 13, 2018 decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Circ. 2018). The memo indicates that it is intended to “addresses the limited question of how to evaluate the patent eligibility of ‘method of treatment claims’ in light of the Federal Circuit decision in Vanda” and also states, perhaps in a nod to the leadership of new USPTO Director Andrei Iancu, that “[t]he USPTO is determined to continue its mission to provide clear and predictable patent rights in accordance with this rapidly evolving area of the law, and to that end, may issue further guidance in the area of subject matter eligibility in the future.”

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks.

In Exergen Corporation v. Kaz USA, No. 16-2315 (March 8, 2018), the Federal Circuit, in a split non-precedential opinion, affirmed a holding that Exergen’s claims directed to methods and apparatuses for detecting core body temperature were directed to patentable subject matter under 35 U.S.C. § 101… The majority held that the district court did not clearly err in finding that it was unconventional to use temperature scanning technology to measure arterial temperature beneath the skin… Judge Hughes dissented, arguing that the majority erred by relying on the natural law in determining inventiveness at step two… Judge Hughes seems to suggest that the correct step-two inquiry should be whether, assuming the natural phenomenon were known, it would have been conventional to combine that phenomenon with existing technology to practice the asserted claims.

A group of six patent law professors filed an amicus brief with the Court of Appeals for the Federal Circuit in Cleveland Clinic v. True Health Diagnostics. The professors’ brief urges the Federal Circuit to reverse a finding by the lower court invalidating patents asserted by Cleveland Clinic covering diagnostic methods for atherosclerotic cardiovascular disease. According to the brief, the district court’s invalidation of Cleveland Clinic’s patents represents an improper application of 35 U.S.C. § 101, the basic threshold statute governing the patentability of inventions.

In a research project funded by the Austrian Science Fund (FWF), evidence emerged that a higher expression of the GIRK1 protein in malignant tissue samples was linked to higher relapse and mortality rates in breast cancer patients who have gone through surgery. The novel use of the GIRK1 protein as a biomarker could have a great impact on breast cancer diagnostics and treatments and further research could yield more discovery on the interdependence of GIRK1 with other important biological pathways critical to cancer management… Unfortunately, discovery of GIRK1 as a biomarker for breast cancer diagnostics would run into 35 U.S.C. § 101, the basic threshold statute for determining patentability of subject matter, under the Supreme Court’s March 2012 ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In that case, the Court held that processes involving correlations between blood test results and patient health is not patent-eligible subject matter because the process incorporates laws of nature. This would seemingly render any processes involving the application of GIRK1 as a biomarker for breast cancer prognoses unpatentable as well as the expression of GIRK1 occurs naturally.

These revisions favor patent owners, according to Palmer, but not everyone is supportive. For instance, Bilski, Mayo, Myriad, and Alice have given several accused infringers an additional tool for fighting non-practicing entities. So. the level of support for these revisions will depend where you fall on this spectrum. That being said, Palmer does not think the Court will change its eligibility analysis in the foreseeable future, and Congress is not likely to take up these anytime soon.

I have always argued that software patent eligibility is a must in a country where patent rights are guaranteed by the Constitution. That is, all fields of innovation should be treated equally under the law such that one field of endeavor (e.g., pharmaceuticals or electronics) is not deemed more “patent worthy” than other fields (i.e., computer science and information technology). This is especially true when one considers how important software is to the U.S. economy… A substantial amount of U.S. commerce is software-dependent and the associated innovation in the field – when novel and non-obvious – deserves stable and predictable patent law protection!

Concerns over software and biotechnological innovations being patent eligible, the omnipresent threat of patent reform that could make it even more difficult to enforce the patent property right, and no clear path to a philosophical or ideological turning point make for little to celebrate this World IP Day in America… If Congress wants to resurrect the U.S. patent system these three decisions would be overturned. As long as these decisions remain in force the U.S. patent system will continue to suffer and will undoubtedly be looking up in the rankings to the likes of Hungary when the Chamber releases its 2018 world IP rankings.

Sections 101 and 112 provide their own separate limitations to the scope of patent protection in ways that are sometimes complimentary and sometimes contradictory… Inventors are motivated to maximize the breadth of their claims. But they may seek to do so by employing imprecise claim language. Both §§ 101 and 112 corral this behavior, although in slightly different ways. Section 101 safeguards against claims that are too abstract or overbroad to be patentable, being concerned with claims that would “wholly pre-empt” any other use of an inventive concept, thereby foreclosing independent innovations or application. Bilski, 561 U.S. at 610 (quotation omitted). Section 112 protects against claims that are not completely and functionally disclosed within the patent specification ensuring that patentees cannot claim more than what they have invented – and shared with the public.

As we approach the fifth anniversary of the Supreme Court’s decision this is what I know — Mayo is a lawless decision by a Court that has become too powerful. Mayo continues to wreak havoc on the patent system and innovators, and has resulted in patent protection being easier to obtain for cutting edge software, biotech, genetic and medical innovations in Europe, Canada, Australia and even China. Mayo is at the root of all of the problems facing the industry relative to patent eligibility, and if I could repeal only one Supreme Court decision in the patent space it would be Mayo. Indeed, the Supreme Court’s decision in Mayo is probably the worst, most wrongly decided case by the Supreme Court in the patent field ever. I say “probably” only because there are so many contenders to choose from that picking only one is truly difficult. Only the Supreme Court’s decision in eBay v. MercExchange comes at all close to Mayo in terms of damage to the patent system. Only the Supreme Court’s decision in Association of Molecular Pathology v. Myriad Genetics comes close to Mayo in terms of intellectual dishonesty.

When addressing the issue of generality vs. particularity, we come across a situation where the inventors described the most crucial aspect of the invention, the classification unit, in general terms in the claim. Consequently, in the PTAB’s assessment, the representative claim did not rise above the threshold test of patentability under section 101. But much of what the PTAB seems concerned about relates to disclosure and there is nothing in the PTAB panel decision in Itagaki to suggest that the PTAB reviewed the specification to determine whether the somewhat generally described terms were given particularized meaning by the applicant. It also raises questions about how the PTAB could have properly conducted an obviousness review if the classification unit was so abstract as to be infirm from a patent eligibility point of view.

This is as straightforward a certiorari candidate as any patent case can be. It is manifestly important: A host of judges and amici have stressed that the result below is untenable— invalidating previously irreproachable inventions and precipitating what Judge Lourie called “a crisis of patent law and medial innovation.” And this is the vehicle this Court needs to provide that clarification: Every opinion below agrees that this case tests Mayo’s uncertain limits by invalidating an otherwise plainly meritorious invention. Here, unlike Mayo, every intuition points towards patent-eligibility. And yet the Federal Circuit felt compelled by Mayo to condemn this meritorious patent—and, a fortiori, the patents underlying an entire, vital field of American healthcare innovation.

While Justice Scalia served on the Supreme Court for nearly three decades, his contributions to the area of intellectual property law were quite limited. Scalia did famously refer to patents as “gobbledegook” during the KSR v. Teleflex oral arguments. Scalia was the only Justice not to sign onto an opinion in Bilski v. Kappos that would have recognized that at least some software is patent eligible. But Justice Scalia did not author any of the major patent decisions considered by the Court during his tenure. The passing of Justice Scalia does not seem likely have much of an impact on intellectual property cases, particularly patent cases. Having said this, I could see legislative history becoming more relevant than anyone would have anticipated just a week ago when the Supreme Court considers Cuozzo Speed Technologies v. Lee.