The Federal Circuit Deals Another Blow to Diagnostic Method Patents

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 Cleveland Clinic, although designated as a non-precedential opinion, deepens the growing divide between administrative and judicial interpretations of 35 U.S.C. § 101 and is sure to be an unwelcome development for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

Is it ‘anything goes?’ – The US expansive view of trademarks supports a wide variety of ‘nontraditional trademarks.’

“Trademark” is broadly defined in Section 45 of the Lanham Act, 15 U.S.C. §1127, as “any word, name, symbol, or device, or any combination thereof” that identifies and distinguishes goods and indicates source. The same definitional breadth applies to service marks, certification marks and collective membership marks. The Supreme Court has supported such breadth where it stated in Qualitex Co. v. Jacobson Prods. Co., 514 U.S. 159, 162 (1995) “ … since human beings might use as a ‘symbol’ or ‘device’ almost anything at all that is capable of carrying meaning, this language, read literally, is not restrictive.” [Emphasis added].

Is this a case of “anything goes” in the U.S. Patent and Trademark Office (USPTO) for registration of nontraditional marks? The answer appears to be in two parts: “almost,” given the broad range of nontraditional marks the USPTO has registered, and “not quite,” as the spectrum of distinctiveness applies and marks must not be functional. Continue Reading

Federal Circuit Holds That Claims Directed to Methods of Treating Pain in a Renally Impaired Patient Are Patent-Eligible Under Section 101

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]

Endo Pharmaceuticals Inc. (Endo) owns U.S. Patent No. 8,808,737 (the ’737 patent), which claims methods of treating pain in a renally impaired patient. The ’737 patent purports to disclose the discovery that the bioavailability of controlled-released oxymorphone can be increased in patients with renal impairment, especially in patients with moderately to severely impaired kidney function.[3] This increased bioavailability is said to result in a higher level of oxymorphone in the blood of those patients than in the blood of healthy patients receiving the same dose, which can lead to harmful effects if the dose is not decreased.[4] Armed with these findings, the inventor is said to have developed a new method of treating pain relief in patients with renal impairment.[5]  Continue Reading

Protected or Unprotected: The Supreme Court Hears Iancu v. Brunetti

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.

The Supreme Court, in Matal v. Tam, 137 S. Ct. 1744, 198 L. Ed. 2d 366 (2017), held that the particular language in Section 2(a) refusing registration of a trademark on grounds that the mark may “disparage or … bring them into contempt or disrepute” was facially invalid under the First Amendment as viewpoint discrimination. Tam was a plurality opinion, which is subject to the narrowest of interpretations. Marks v. United States, 430 U.S. 188 (1977). While all members of the Court held the disparagement clause of Section 2(a) to be facially invalid, the Court was divided over the level of scrutiny generally to be applied to free speech challenges to the Trademark Act. As Justice Kennedy stated in Tam, “We leave open the question whether this is the appropriate framework for analyzing free speech challenges to provisions of the Lanham Act.” 137 S. Ct. at 1768 (Kennedy, J.). No one addressed “immoral” or “scandalous” terms. Continue Reading

The Federal Circuit Opens the Door Wider for the Subject Matter Eligibility of Methods of Treatment, Compositions and Methods of Manufacturing

“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.

Natural Alternatives owns a number of patents that relate to the use of beta-alanine in a dietary supplement designed to increase the anaerobic working capacity of muscles and other tissues. Beta-alanine is a naturally occurring amino acid that, together with histidine and their methylated analogues, forms certain dipeptides that are present in the muscles of humans and other vertebrates.[2] The patents at issue claim methods of treatment, dietary supplements and methods of manufacturing the dietary supplements containing beta-alanine. On a Rule 12(c) motion (judgment on the pleadings), the district court held that the claims at issue are directed to patent-ineligible subject matter under Section 101. The Federal Circuit reversed and remanded. This decision is favorable for patent owners in the life science field. Continue Reading

Patent and Trademark Fees in Venezuela

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.

Mission Products v. Tempnology: Is Bankruptcy the End for Trademark Licenses?

dictionary macro with focus on BankruptcyOral 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?

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Federal Circuit holds that claims directed to diagnosing neurotransmission or developmental disorders are invalid for failing to recite patent eligible subject matter

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. Continue Reading

Supreme Court Unshrouds the ‘On Sale’ Bar as Applied to Secret Sales

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.

Helsinn asserted its patents against Teva, which sought to market a generic version of the treatment. Teva raised a defense contending that Helsinn’s patents were invalid under the “on sale” provision of the AIA. The District Court sided with Helsinn and held that the “on sale” provision did not apply because the public disclosure of the agreements did not disclose the specific dose of the treatment. On appeal, the Federal Circuit reversed and held that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements.

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The ‘Integrated Into a Practical Application’ Test of the 2019 Revised Patent Subject Matter Eligibility Guidance

On Jan. 4, 2019, the USPTO announced revised guidance relevant to Section 101 rejections (“2019 Revised Patent Subject Matter Eligibility Guidance”). The 2019 Revised Patent Subject Matter Eligibility Guidance explains that a claim that recites a judicial exception is not “directed to” the judicial exception if the judicial exception is “integrated into a practical application” of the judicial exception. The procedure, referred to as “revised Step 2A,” changes how examiners should apply Step 2A of the Alice/Mayo test, which asks whether the claim in question is “directed to” a judicial exception. This article considers the effect of the new integrated into a practical application test and offers practical tips for applicants.

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