The Federal Circuit recently held certain method of treatment claims patent eligible under step one of Alice, reversing a district court’s judgment on the pleadings. In that same case, the Federal Circuit upheld the district court’s obviousness and obviousness-type double patenting determinations invalidating the claims of two other patents because the claimed treatments fell within a prior art dosage range.
Boehringer Ingelheim Pharmaceuticals, Inc. and its related companies (collectively, “Boehringer”) asserted three patents relating to use of DPP-4 inhibitors to treat type 2 diabetes in patients with certain medical conditions against Mylan Pharmaceuticals Inc., its related companies and Aurobindo (collectively, “Mylan”). The inventors of those patents determined that, unlike other diabetes treatments, DPP-4 inhibitors are generally secreted through the liver as opposed to the kidneys. Accordingly, DPP-4 inhibitors are advantageous for use in patients with kidney disease and other similar conditions.
At the district court, Mylan moved for judgment on the pleadings that the claims from one of the asserted patents were unpatentable under 35 U.S.C. § 101. The district court agreed, holding the claims invalid as claiming the abstract idea of “administering the DPP-IV inhibitor to the targeted patient population.” The district court then conducted a bench trial and found the asserted claims of the other two patents invalid for obviousness-type double patenting and invalid as obvious because the claimed invention’s doses of 2.5 mg and 5 mg fall within the prior art range of 1-100 mg.
On appeal, the Federal Circuit reversed the district court’s Section 101 ruling at step one of Alice. In so doing, the court relied on its decision in Vanda Pharmaceuticals, where it held that claims were patentable where they covered a method of treating patients with schizophrenia by performing a genetic test and, based on the results of that test, selecting and administering a particular dose of a drug. Although the Vanda inventors recognized the underlying biological relationships, they did not claim those relationships—they claimed a specific method of treating a specific disease. Similarly, here, although the inventors recognized that certain DPP-4 inhibitors are metabolized by the liver instead of the kidneys, that is not what the claims cover. The claims are directed to a specific method of treating a specific type of patient with type 2 diabetes, and are therefore patent eligible at step one of the Alice test.
In the same opinion, the Federal Circuit affirmed the district court’s determination that claims of two other patents were invalid for obviousness-type double patenting as well as obviousness. Those claims cover administering the DPP-4 inhibitor linagliptin in 2.5 mg and 5 mg doses. The prior art disclosed use of compounds, including linagliptin, within a range of 1-100 mg. Based on this disclosure, the district court applied a presumption of obviousness and found in the alternative that a person of ordinary skill in the art would have obtained the claimed dosages through routine experimentation. The Federal Circuit agreed with the district court’s alternative finding, declining to address the district court’s presumption determination. In reaching this conclusion, the court relied on testimony indicating that dose ranging studies would guide skilled artisans to look at the lowest end of the dose range for a compound like linagliptin, which is known to have a high potency. Accordingly, the court held that, in light of the disclosed 1-100 mg range, a skilled artisan would have had a reasonable expectation of arriving at the 2.5 mg and 5 mg doses through routine optimization, and there was no error in the district court’s obviousness analysis.
Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim Internationl GMBH, Boehringer Ingelheim Corporation, Boehringer Ingelheim Pharma GMBH & Co. KG v. Mylan Pharmaceuticals Inc., Mylan Inc., Mylan Laboratories Limited, Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc. No. 2019-1172 (Fed. Cir. March 16, 2020)
Practice Tip: When analyzing whether a method of treatment claim is patent eligible, consider whether it claims a natural correlation or observation, or whether it claims a specific method of treatment. And, if the claimed treatment covers using a specific dose, consider whether the prior art teaches an overlapping range and a reason why a skilled artisan would likely arrive at the claimed dose.
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