United States: What Amounts To Significantly More?

The two-part Alice/Mayo test includes an analysis involving three questions, one of which is: "Does the claim recite additional elements that amount to significantly more than the judicial exception?" This question is asked in Step 2B in a flow chart published by the USPTO in the Federal Register, 79(241), 74618-74633 (2014). Courts have been left to grapple with what constitutes "significantly more," creating uncertainty about what is patentable and what is not. Since the Alice/Mayo decisions, challenges and defenses claiming invalidity of claims under 35 U.S.C. § 101 have increased and patent examiners have not hesitated to reject claims under Section 101. Some recent district court decisions provide a few more guideposts in our journey of discovering what "significantly more" means.

In Oxford Immunotec Ltd. v. Qiagen, Inc. et al., 15-cv-13124-NMG (Mass. Dist. Ct. 2015), Oxford filed a claim of infringement against Qiagen asserting a number of patents related to tuberculosis (TB) tests. On August 31, 2016, the magistrate judge allowed in part and denied in part Qiagen's motion to dismiss. Qiagen argued that Oxford's claims in the asserted patents are invalid as directed to patent ineligible subject matter. The claims in question may be represented by claim 7 of U.S. Patent No. 7,632,646 and claim 1 of U.S Patent No. 8,507,211.

Claim 7 of the '646 patent recites a kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses ESAT-6, comprising a panel of eight peptides represented by SEQ ID NOS: 1 to 8. The eight peptides recited in claim 7 occur naturally but were synthesized in the lab. Oxford argued that the peptides functioned differently than the naturally-occurring peptides. However, the court found that the kit claims are directed to a product of nature and that the peptides had not been modified beyond the naturally-occurring peptides. Although the peptides were synthesized in the lab and the peptides perform differently than their naturally-occurring counterparts, the court concluded that the kit claims are invalid under Section 101.

Claim 1 of the '211 patent recites a method for identifying Mycobacterium tuberculosis-specific immediate effector T cells in a subject. The method includes providing a sample from a patient, exposing the sample to peptides, and determining if the T-cells in the sample are activated by measuring cytokine production. The court determined that the method claims were directed to a law of nature and continued to Step 2B of the Alice/Mayo test. Pursuant to Step 2B, the court found that claim 1 contained enough to qualify as "significantly more." The court pointed out that "the patented invention improves on existing methods for diagnosing TB by making diagnosis more convenient, less dependent on a physician's subjective interpretation of results, and more accurate." Oxford Immunotec Ltd. v. Qiagen, Inc. et al., 15-cv-13124-NMG, pages 11-12, (Mass. Dist. Ct. 2015).

In Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., 13-cv-01973 (D. Del. 2013), Vanda Pharmaceuticals Inc. and Aventisub LLC alleged infringement by Roxane of several U.S. patents. Roxane is seeking to make and sell the drug iloperidone - an antipsychotic drug. Vanda sells FANAPT® (iloperidone), which is approved for treating patients with schizophrenia. Roxane contended that the claims in asserted U.S. Patent No. 8,586,610 are invalid under Section 101.

Claim 1 of the '610 patent is directed to a method of treating a patient with iloperidone by adjusting the dosage based on whether the patient has a CYP2D6 poor metabolizer genotype. Roxane argued that the relationship between the patient genotype and the drug's metabolism is a natural law and that adjusting the dosage of iloperidone to reduce adverse effects amounted to "routine and conventional" activities. Vanda conversely argued that the tests to determine the claimed dosage adjustments were not routine, noting Novartis's attempted clinical trial of iloperidone that failed to determine a relationship between adverse effects and CYP2D6 metabolism. The court concluded that the asserted claims amount to significantly more than just a natural law in view of Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., No. 2015-1570, 2016 WL 3606624 (Fed. Cir. July 5, 2016) (valid claims may depend upon a natural relationship if the claims contain a particular combination of steps.)

The USPTO, in its 2014 Interim Guidance to Examiners, advised that valid claims may contain a specific limitation that is not routine or conventional that limits the claim without pre-empting the use of the natural law or natural product. In Vanda, the patent owners successfully showed that the claim contained "significantly more" by arguing that using a genotyping assay to determine dosage was not routine or conventional as evidenced by the failure of others to do so. In Oxford, the court found that, in relation to the asserted method claims, the in vitro aspect of the TB test is an "inventive concept" because it improves on existing methods for diagnosing TB by making diagnosis more convenient, reducing diagnostic error, and increasing accuracy.

In light of recent court decisions, claims must be carefully evaluated to ensure that the claimed invention amounts to "significantly more" than just a natural law or a natural productto withstand anticipated Section 101 challenges.

This article is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Gilson & Lione lawyer.

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