Thursday, December 10, 2015

BMS/Ono Immuno-Oncology Patent In United Kingdom Held Valid, Over Merck Objections

In at least one theater (London) -- in this truly global patent battle -- over immuno-oncology breakthrough products -- Merck has come up a little short. In the United Kingdom, at the trial court level, a sitting patent judge has held that BMS, claiming through an Ono Pharmaceutical Co. Ltd. (Japan) patent license, holds a valid and enforceable U.K. patent. MSD had contended that the subject patent was invalid.

Of course, this is but one shortish scene, in a very long (four hour plus!) play. We will keep you posted, but this link is the decision proper -- just entered after arguments, back in July of 2015. [UPDATED: Merck has now filed to appeal this decision.] And. . . a bit from the trial court:

. . . .64. Ono submits that what Merck calls the prevailing explanation was only one of a number of possible explanations which were part of the common general knowledge at the priority date. Merck responds that while these other possible explanations were in the literature, the second receptor hypothesis was the prevalent theory and the others were not part of the common general knowledge.

65. This is one of the critical issues in the case and a great deal of cross-examination was, appropriately, devoted to it. In the end I was not persuaded that the state of the common general knowledge was in accordance with Merck's submission, for the following reasons.

66. First, there were a number of credible articles published shortly before the priority date which published experiments showing co-stimulatory effects using the ligands PD-L1 and PD-L2. Merck characterised the co-stimulatory results as being from "one group" which I think is correct but the group was well respected, the papers were published in peer reviewed and respected journals and other workers were prepared to discuss them without criticism.

67. Second, important evidence comes from the discussions in the published scientific literature. There is no doubt that the literature universally refers to PD-1 as an inhibitory receptor but the co-stimulatory results associated with the ligands were clearly common general knowledge. There are papers before the priority date which note the discrepancy and suggest they could be explained by the existence of a second co-stimulatory receptor, without mentioning alternative hypotheses. Important examples are the review articles Carreno & Collins (2002) (see p43, top paragraph) and Pardoll (2002) (see Box 2 at p232). This supports Merck's submission that the second receptor was the prevailing hypothesis or primary suggestion to explain the co-stimulatory effects of the ligands. . . .

Onward, then -- with sporatic postings, as year-end draws nigh. . . Filled with approaching holiday spirit -- do travel safe -- and travel light, one and all!

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