Boehringer Ingelheim Pharm. et al. v. Mylan Pharmaceuticals Inc.
Docket No. 2019-1172
DYK, MOORE, HUGHES
March 16, 2020
Brief Summary: DC decision of ineligibility under 101 for method of treatment claims reversed; invalidity for double-patenting and obviousness affirmed.
Summary: Boehringer appealed DC judgement that certain claims of US 8,853,156 are directed to ineligible subject matter under section 101, and the other claims of US 9,173,859 and 8,673,927 are invalid for obviousness-type double patenting and obviousness over the prior art. The patents relate to treatment of type 2 diabetes using DPP-IV inhibitors (e.g., linagliptin).
The ‘156 claims, directed to “[a] method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate…comprising orally administering to the patient a DPP-IV inhibitor” were found ineligible for being “directed to an ‘abstract idea,’ namely ‘the act of administering the DPP-IV inhibitor to the target patient population” and did not “recite an inventive concept”. The FC panel reviewed the DC ineligibility decision de novo (SAP, FC 2018) and explained that “the Supreme Court has cautioned…we must be careful in this analysis as ‘too broad an interpretation of this exclusionary principle could eviscerate patent law’” (Natural Alternatives, FC 2019). Boehringer argued “that the claims are directed to a ‘method of treating a specific disease…for specific patients…using a specific compound…at specific doses…to achieve a specific outcome” and were therefore patent eligible. The FC panel agreed since “the claims are directed to a particular method of treatment under step one” (of Alice, US 2014) “and are therefore patent eligible” (Vanda, FC 2018 (Patent eligible since “[b]ased on the results of that test, a particular dose of iloperidone was selected and internally administered….While we acknowledged that the inventors had recognized the underlying relationships, we explained that those were not what was claimed.”); CellzDirect, FC 2016 (the “natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability”)). This part of the DC’s decision was therefore reversed.
The ‘859 and ‘927 patents were held invalid for obviousness-type double patenting over Boehringer’s earlier expiring US 8,178,541, and obvious in view of the PCT ‘510 publication (the ‘541 patent priority document). The DC “determined that because ‘the claimed invention’s doses of linagliptin in 2.5 mg and 5 mg fall within the ‘510 publication[’]s disclosed range of 1-100 mg,’ there is a presumption of obviousness” and “a skilled artisan would ‘have a reasonable expectation of arriving at the claimed 2.5 mg and 5 mg dosages’ through routine experimentation”, citing Tyco (FC 2011) and based on expert testimony (e.g., “one would be guided through that information of looking at the lowest end of the dose range for the most potent compound”). The FC panel found no clear error with this conclusion or with the DC’s secondary consideration analysis, and affirmed these obviousness conclusions.