My take on the post-trial briefs:
1) INDUCEMENT
The inducement issue hinges on intent. That is, can it be proven that the generics intend to induce prescribers to infringe. The legal standard for intent that applies in this case relates specifically to whether or not the label, considered in its entirety, so much as recommends or suggests that the product be used in a way that infringes on the claims in question. In my view, Amarin's argument on this issue is rock solid. At the core of their argument is the fact that Clinical Studies section of the label effectively instructs (or at a minimum, recommends or suggests) that patients take the drug for at least 12 weeks, and also instructs the doctor with respect to how administration of the drug will affect triglycerides, LDL levels, and ApoB reduction. This role of the Clinical Studies section in guiding how a medication is prescribed is supported by well-established case law (e.g. Sanofi), and real world practice as explained by expert testimony. The defendants' reliance on Grunenthal, Horizon, etc, is irrelevant, as all of those cases included carve-outs where the generics went to demonstrable lengths to avoid infringement, and they did not "encourage treatment of the specific condition that was the subject of the claimed methods", as is the case here.
The question of "substantial non-infringing use" is also irrelevant, as it simply does not apply to a case of induced infringement. Substantial non-infringing uses would only apply in a case of contributory infringement. For induced infringement to be proved, Amarin must only demonstrate that, by following the label in general, and the Clinical Studies section in particular, some doctors will prescribe the drug to some patients for more than 12 weeks, thereby infringing on Amarin's patents. They obviously will.
2) NON-OBVIOUSNESS
While there seems to be a lot going on around the non-obviousness issue, in my view it really comes down to just a couple of key issues. (And keep in mind that the bar for overturning the USPTO decision on Amarin's claims is very high. There must be clear and convincing evidence that the USPTO erred in approving the claims. In my view, the defendants don't come close to clearing that bar.)
The two key issues:
- Does the absence of severe hypertriglyceridemia patients or related findings from prior art render Amarin's claims non-obvious?
Amarin takes the correct position that the severe hypertriglyceridemia population is a distinctly different population from the sub-500 mg/dL population. The same triglyceride therapy will affect the two populations in very different ways. Amarin argues that any prior art that isn't in any way powered to identify how a given therapy works for this specific population (>500 mg/dL) teaches nothing about the efficacy of that therapy for this population. None of the prior art cited by the generics met this criteria, as they were all focused on populations <500 mg/dL. The generics work hard to persuade that one could conclude that the effects on the <500 mg/dL population can be obviously extrapolated to the >500 mg/dL population, but that's wrong on its face, and it's very effectively countered by Amarin. The statistically possible presence of 1 or 2 >500 mg/dL patients in Jelis or other prior art does little to change the argument, as none of their results were individually tracked or recorded, and therefore teach nothing about the effect of the therapy on that distinctly different population.
On the related issue of whether the prior art makes it obvious (i.e. provides a reasonable expectation of success") to a POSA that EPA will have a different effect on LDL levels than other triglyceride lowering therapies (i.e. niacin, fibrates, omega-3 fatty acids), the generics again try to make their case based on much of the same prior art, with the same result. A POSA looking at the prior art at the time would have had no reason to believe that purified EPA, administered to a population of severely hypertriglyceridemic patients, would do anything different from other triglyceride lowering therapies (i.e. raise LDL levels).
- Are the objective indicia supporting non-obviousness persuasive?
The objective indicia supporting non-obviousness are significant, as they were cited by the USPTO examiner as an important factor in the eventual approval of the Amarin claims in question. That, in itself, provides a difficult barrier for defendants to overcome here, and they don't do it. Using objective indicia such as long-felt need, unexpected results, widespread skepticism, widespread praise, and commercial success, Amarin makes an overwhelming case for the non-obviousness of the claims.
There are assorted other issues in the briefs related to non-obviousness, such as internal Amarin communications; REDUCE-IT nexus; late introduction of statin argument by defendants. However, while I think Amarin has the stronger position on most if not all of these issues, I think the key issues I've cited above are what will be the basis for the non-obviousness decision in Amarin's favor.
