Microsoft word - ip_news_18_in re montgomery.doc

In re Montgomery
The U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) decision of In re Montgomery provides some illustration on the issue of anticipation by inherency in the therapeutic context. With its decision, the Federal Circuit sheds some light on the difficult doctrine of inherency, specifically on the potential importance of claim language and The U.S. patent application at issue was U.S. Patent App. No. 11/118,824. The application was related to inhibitors of the rennin-angiotensin system (“RAS”), which plays a role in regulation of blood pressure and salt and water metabolism. RAS inhibitors have typically been used to treat hypertension. The three claims at issue were the following: 42. A method for the treatment or prevention of stroke or its recurrence, wherein said method comprises administering, to a patient diagnosed as in need of such treatment or prevention, an inhibitor of the rennin-angiotensin system, said inhibitor having a ClogP of greater than about 1. 43. The method as claimed in claim 42, wherein the inhibitor of the rennin-angiotensin system comprises at least one inhibitor of angiotensin-converting enzyme. 45. The method as claimed in claim 43, wherein the inhibitor of angiotensin-converting enzyme comprises ramipril. Specifically, claim 42 was construed by the U.S. Patent and Trademark Office (USPTO) Board to have two elements; “to administer an inhibitor of the rennin-angiotensin system” and “the patient population receiving the inhibitor . . . encompasses patients diagnosed as required stroke treatment or prevention.” It was noted that the Board appeared to have implicitly assumed that the administration be effective at treating or preventing a stroke. Although four references were cited in the USPTO rejection, the Federal Circuit focused on one in particular, the Heart Outcomes Prevention Evaluation (“HOPE”) study. This study described a large, simple randomized trial of ramipril and vitamin E for the prevention of myocardial infarction, stroke, or cardiovascular death administered to over 9000 patients at high risk for cardiovascular events. It was contested whether or not the administration of ramipril was “for the treatment or prevention of stroke or its recurrence.” The Federal Circuit examined whether or not the claim had “an efficacy requirement” in the language and came to the conclusion that it did not; the language “expressed a purpose rather than require a particular result.” The Federal Circuit found that this construction was supported by the lack of experimental data in the patent application specification. But, this issue was not necessary for the ruling because they found efficacy to be inherent in carrying out the claim steps. Notably, “newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.It matters not that those of ordinary skill heretofore may not have recognized the inherent characteristics of the prior art.” HOPE inherently anticipates the claim because it discloses a protocol for the administration of ramipril to stroke-prone patients, and administering ramipril to stroke-prone patients inevitably treats or prevents stroke. It does not matter whether or not the trial was actually carried out at the time of filing because anticipation only requires an enabling of disclosure not actual creation of practice. Although an invitation to investigate should not necessarily be considered inherent disclosure, the HOPE reference provided a detailed protocol that was “far from an abstract theory.” In all relevant respects, HOPE is identical to the patent Judge Lourie dissented and tried to emphasize the care that should be taken when applying the doctrine of inherency. Although the goal is to prevent subject matter being removed from the public domain, it should not be applied when it would withhold patent protection from something that the public knew nothing about until a later discovery. A check against inherency should be an analysis of whether or not the invention is inevitable; a later-claimed invention must have necessarily resulted from the practice of a prior art reference. In this regard, Judge Louire believed the HOPE reference fails. The study describes administration of ramipril and vitamin E, which reflects only a hope of success. “Inherency follows from the carrying out of an activity that inherently produces what is claimed; inherency does not arise from a plan whose description does not indicate its realization.”

Source: http://www.staasandhalsey.com/files/ip/IP_News_18_In%20re%20Montgomery.pdf