It is not uncommon in the biotechnology and pharmaceutical fields to file new patent applications based on results of a clinical trial or discovery of a newly appreciated feature of a compound. However, results-based claim language, such as pharmacokinetic or drug release profiles, may not confer patentable weight, as shown in a recent IPR decision.
In Generico, LLC v. Dr. Falk Pharma GMBH (IPR2016-00297), the challenged patent (US 8,865,688) is drawn to a method of maintaining remission of ulcerative colitis for at least six months by administering a formulation of a known compound (granulated mesalamine) to patients. During the course of prosecution, a claim limitation was introduced reciting the drug release profile “wherein 85% to 90% of the mesalamine reaches the terminal ileum and colon,” regions of the small intestine and large intestine that are affected by ulcerative colitis. This amendment aimed to distinguish the claimed method from the patent licensee’s own press release prior to the priority date of the patent, which described initial results from a phase III clinical trial using the same formulation that also resulted in at least six months of remission.
In the IPR, the prior art press release was relied on to show that the “wherein” clause was met, even though the press release only expressly stated a portion of what was recited in that clause. It showed that the formulation was designed to release the drug in the small and large intestines, but not the specific release profile of “85% to 90% …reaches the terminal ileum and colon.” The petitioner was able to bridge this gap by arguing that the formulations of the patent and those described in the press release were the same (which was not disputed). As a result, one would necessarily expect that the methods described in the prior art press release have the same drug release profile as described (and claimed) in the patent.
Here, the Board relied on the specification of the patent itself for attributing the drug release profile to the specific formulation, thereby establishing the release profile as an inherent or necessary property of the formulation. Importantly, the release profile was not a result of any of the additional administration features or steps of the claimed method.
In this case, the Board found that reciting an inherent property of the formulation was not sufficient to establish non-obviousness of the known formulation. When new results are achieved or properties are newly appreciated, it is important to make clear if the results or properties are due to another aspect of the invention rather than an inherent feature of the formulation itself.
For petitioners, the specification of the challenged patent itself can provide a way to connect the dots between features of a formulation and a potentially inherent property.
For patent applicants/owners, be aware when drafting applications that statements in the specification may be construed as attributing properties as inherent to a formulation. Newly appreciated features and results may be used to promote patentability; however, it is important to consider how to use this information in a claim.
Finally, in this case, one of the critical pieces of prior art was a press release from the patent’s licensee. Though press releases are used as business and investment communications, they can also be used as prior art, so disclosing, even if details of the technology are withheld, may undercut patentability.