Merck owns the '329 patent, which teaches a method of treating and preventing osteoperosis through less than daily (i.e. weekly) administration of biophosphonate compounds and is marketed under the name Fosamax. Teva asserted that the patent was obvious under 35 U.S.C. § 103. The '329 patent was filed on August 14, 1998.
The prior art at issue, referred to as the "Lunar News articles," were a series of articles published in 1996 that recommended weekly doses (as opposed to daily doses) of alendronate (a biophosphate compound) to treat osteoporosis.
Both the articles and the '329 patent focused on GI problems that occur with daily dosing and the amount of the dose. The Federal Circuit found that the only difference between the articles and the '329 patent was the recommended dosage amount:
The district court also had problems with the probative value of the Lunar Articles, because they were not peer reviewed and not authored by someone of skill in the art. The Federal Circuit countered, disagreeing with both views:
The Federal Circuit finally addressed secondary considerations – evidence of (1) commercial success, and (2) some causal relation or “nexus” between an invention and commercial success of a product embodying that invention can be probative of whether an invention was nonobvious. (The thinking being that if it is commercially successful, someone else probably had tried to invent it earlier and failed). However, the Court found that Fosamax's commercial success had minimal probative value:
Why were others barred from testing out the ideas? Because Merck had another patent and an exclusive license through the FDA.
The prior art at issue, referred to as the "Lunar News articles," were a series of articles published in 1996 that recommended weekly doses (as opposed to daily doses) of alendronate (a biophosphate compound) to treat osteoporosis.
Both the articles and the '329 patent focused on GI problems that occur with daily dosing and the amount of the dose. The Federal Circuit found that the only difference between the articles and the '329 patent was the recommended dosage amount:
For the Lunar News articles to render claims 23 and 37 obvious, the district court need only have found a suggestion or motivation to modify the dosages from those in the articles to those in the claims. But as noted above, Merck’s own inventors admit the difference in dosing amount is obvious. (internal citations omitted).
The district court also had problems with the probative value of the Lunar Articles, because they were not peer reviewed and not authored by someone of skill in the art. The Federal Circuit countered, disagreeing with both views:
Although these indicia of reliability – whether a study is peer-reviewed, and the credentials of the author – properly go to weight when the trial court has not excluded evidence as unreliable and irrelevant, the district court’s reliance on these factors to distinguish Merck’s claimed invention is, again, misplaced. First, as noted above, these factors provide no relevant distinction between the articles and the claimed invention because the '329 patent also fails to explain how its higher dosing would overcome these dose-related side-effects. Second, as explained below the district court’s finding the author of the Lunar News articles not skilled in the relevant art is inconsistent with the court’s own definition of the relevant art.
The Federal Circuit finally addressed secondary considerations – evidence of (1) commercial success, and (2) some causal relation or “nexus” between an invention and commercial success of a product embodying that invention can be probative of whether an invention was nonobvious. (The thinking being that if it is commercially successful, someone else probably had tried to invent it earlier and failed). However, the Court found that Fosamax's commercial success had minimal probative value:
Although commercial success might generally support a conclusion that Merck’s claimed invention was non-obvious in relation to what came before in the marketplace, the question at bar is narrower. It is whether the claimed invention is non-obvious in relation to the ideas set forth in the Lunar News articles. Financial success is not significantly probative of that question in this case because others were legally barred from commercially testing the Lunar News ideas. Dr. Mazess, for example, could not put his ideas to practice in 1996 – he could only exhort Merck to try it. They did.
Why were others barred from testing out the ideas? Because Merck had another patent and an exclusive license through the FDA.
No comments:
Post a Comment