In another setback for diagnostic method patents, the Federal Circuit rejected efforts by patent owner/appellant Cleveland Clinic[1] to avoid 35 U.S.C. § 101 by restyling diagnostic method claims as “techniques” for detecting a correlation between protein levels and a disease state. Cleveland Clinic Found. v. True Health Diagnostics LLC, No. 2018-1218, 2019 WL 1452697, at *4 (Fed. Cir. Apr. 1, 2019) (“Cleveland Clinic”). The court’s unwillingness to accept the patent eligibility of diagnostic method claims – even those claims that are rephrased as a process of detection rather than the product or natural correlation per se – directly contradicts the position taken by the United States Patent and Trademark Office (USPTO) in the agency’s May 2016 Subject Matter Eligibility Guidelines (USPTO Guidelines). Cleveland Clinic, although designated as a non-precedential opinion, deepens the growing divide between administrative and judicial interpretations of 35 U.S.C. § 101 and is sure to be an unwelcome development for practitioners who have been modeling diagnostic method claims on the USPTO Guidelines since 2016. Continue Reading
The Federal Circuit Deals Another Blow to Diagnostic Method Patents
Posted in Patent
For the second time in as many weeks, the Federal Circuit has reversed a district court’s finding of patent ineligibility under Section 101 in the life science space, this time concluding that claims directed to methods of treating pain in renally impaired patients are patent-eligible. In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit again attempted to narrow the Supreme Court’s holding in Mayo and strengthen its own precedent that method of treatment claims are directed to patent-eligible subject matter.[1], [2]
On April 15, 2019, the Supreme Court will hear arguments on whether dirty words and vulgar terms may be registrable as trademarks – and if so, what is the test? Section 2(a) of the Trademark Act currently provides that the Trademark Office may refuse registration of a mark that “[c]onsists of or comprises immoral… or scandalous matter.” Erik Brunetti, the owner of the FUCT brand of clothing, filed applications to register his mark. He almost got one registered – it was approved, but the approval by the Trademark Office was withdrawn after the Matal v. Tam decision. The issues now before the Court are whether (1) the statutory prohibition against registration of a “immoral” or “scandalous” marks is facially invalid; and (2) the statute as applied to the registration of “immoral” or “scandalous” marks is constitutionally vague under the First and Fifth Amendments.
“We live in a natural world, and all inventions are constrained by the laws of nature . . . we must be careful not to overly abstract claims when performing the Alice analysis.”[1] These are the promising words from the Federal Circuit in its recent decision in Natural Alternatives v. Creative Compounds, in which the court held that dietary supplements, methods of treatment using the same and methods of manufacturing the same are directed to patent-eligible subject matter.
On Feb. 1, 2019, the Venezuelan Ministry of National Commerce sent a notification that patent and trademark fees shall be paid in the Venezuelan cryptocurrency “PETRO.” HOWEVER, the United States government, by Executive Order 13827 (March 19, 2018), expressly prohibits such transactions by U.S. persons, including individuals and companies, relating to any digital currency, digital coin or digital token issued by, for or on behalf of the government of Venezuela on or after Jan. 9, 2018. Accordingly, at this time we cannot pay for renewal or registration of your trademarks or patents in Venezuela. We do not know if or when this may be resolved. If you have something coming up for renewal in Venezuela, it may not be possible to pay the fees. Stay tuned.
Oral argument before the Supreme Court was held on February 20 in the much-watched and even more intensely discussed trademark dispute Mission Product Holdings, Inc. v. Tempnology, LLC.[i] The case presents the difficult and multifaceted question: Does bankruptcy law insulate the right of a trademark licensee to continue using the licensed mark despite the bankrupt trademark licensor’s decision to “reject” the remaining term of the trademark license?
In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC,[1] the Federal Circuit affirmed the district court’s ruling that claims covering methods for diagnosing neurological disorders by detecting autoantibodies are directed to a natural law together with conventional steps, and are therefore invalid under 35 U.S.C. § 101. Although the claims at issue were said to be directed to patent ineligible subject matter, the court offered further guidance for applicants in the diagnostic space. 
This week, the Supreme Court issued a decision holding that a secret sale qualifies as prior art. At issue was whether the America Invents Act (AIA) changed the “on sale” bar to patentability to exempt secret sales as prior art.[1] The case, Helsinn Healthcare v. Teva Pharmaceuticals USA, arose out of agreements entered into by Helsinn and MGI Pharma, to which Helsinn granted the right to sell a treatment used to reduce nausea caused by chemotherapy. The agreements included a provision requiring MGI Pharma to keep confidential any proprietary information received under the agreements. Approximately two years after execution of the agreement, Helsinn filed four provisional patent applications covering the treatment.
