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« AstraZeneca Pharmaceuticals LP v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009) | Main | Biogen Idec Receives Method-of-Use Patent on Human ß-Interferon »

September 29, 2009

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Comments

Don,

If "lack of utility" is the issue here, why isn't this based on 35 USC 101? The majority would also be on much firmer ground on "lack of enablement" with regard to the sparse disclosure of how to carry out the claimed method, including enablement of the claimed scope, i.e., all dosage ranges. And Judge Gajarsa has a valid point if the district court failed to evaluate whether the spec (not the prior art) would tell one skilled in the art that the claimed method had utility and was enabled for the claimed scope.

In my view, this was a failure of written description. What did I miss? JBS

Dear EG:

This is the old 101:112 shuffle - 112 has a utility requirement embedded in it ("make and use" the claimed invention) and so the Office can always use 112 to make a utility argument, especially in the context of inoperative embodiments that make the practice of the invention require undue experimentation - a very efficient way to make the rejection. The other way to say this is that 112 and 101 are alternative ways of making the rejection, and when enablement is an issue the Office tends to make the 112/utility rejection. Here, it was a District Court but the rationale is the same.

Thanks for the comment.

Dear JBS:

I think the specification disclosed the drug, the disease, ways to administer the drug to treat the disease, and prophetic examples of animal/in vivo experiments to demonstrate operability. I think the court imposed the old "unbelievable utility" arguments that used to be thrown at cancer and AIDS treatments. Alzheimer's disease today can elicit those rejections, so this specification dating from 1986 was even more at risk for this treatment. I think the lesson from the case is that if the utility is sufficiently unbelievable, the fact that you "guessed right" by setting out a disclosure without evidence that the invention was operative is prima facie undue experimentation. This seems to elevate the unpredictability prong of the Wands test to undue supremacy, but that appears to be the basis for the decision.

Thanks for the comment.

I've struggled to understand the law with respect to this scenario quite a bit.

I understand that enablement under 112 incorporates a utility component. However, I had always thought that the threshold for meeting this component is fairly low provided you teach how to make and use the invention (done here) and at any rate I thought that if you later demonstrated that the invention works as claimed that was sufficient to demonstrate enablement.

Here, the court seems to be saying that enablement is strictly judged as of the time the application was filed. If that's the case, why would later filed evidence ever work to demonstrate enablement? Is it because in this case the evidence was never filed?

Also, it seems to me that based on this case and KSR, you could never really file a prophetic application in the biological/chemical arts and expect to have a valid patent. The arguments that the patentee made in this case seem to me to beg the court to find the invention obvious.

Thoughts?


Great decision.

"it seems to me that based on this case and KSR, you could never really file a prophetic application in the biological/chemical arts and expect to have a valid patent. "

I think it would depend on exactly what was described in the prophetic examples.

But there is an interesting policy issue lurking there. To the extent that certain patent bulls insist that without patent protection new therapies won't be developed and people will die, should the abandonment of an application with a prophetic example of a therapeutic life-saving treatment be considered a criminal act? After all, the treatment will no longer be patentable (it's anticipated or obvious) and so will never be developed, effectively killing the patients in need of the treatment.

The court's attempt to distinguish Brana are disingenuous. How can it matter whether supporting data wad submitted "during prosecution"? Either the specification can be supplemented after the filing date or not. And what if the PTO had not questioned enablement so the Applicant never had a reason to submit more data? If this decision has "legs" pharmaceutical cases based on thin provisional applications or prophetic examples could be in jeopardy.

Dear Less:

There has never been any obligation to commercialize an invention, so your liability issue is ephemeral. It is no greater than the liability of policymakers (including judges) whose decisions prevent commercialization - although you could argue that the latter have a greater responsibility.

The real problem is that if the decisions from the Federal Circuit continue to be inconsistent with prior precedent and increasingly panel-dependent, where is the rationale for having a Federal Circuit in the first place?

Thanks for the comment.

Dear Courtney:

Hard cases make bad law. It's clear that the court believed that "guessing" shouldn't be patentable, but their logical basis is weak at best. The court seems intent on raising the question of whether their continued existence, or at least exclusive jurisdiction over patent matters, is either necessary or desirable.

Thanks for the comment.

This opinion is internally inconsistent. The majority explicitly states that invalidity is based on the failure to describe a utility under 112 but then states that the understanding of an person of ordinary skill does not matter here because the invention lacked utility in the first place in Fn. 12. That sleight of hand aside, how can this invention lack utility, if FDA approved the drug and generics companies are fighting to sell it.

That said, perhaps this case can be limited to "pure guess" situations where there is no experimentation of any sort between prior art and the invention. Prophetic applications are okay, as long as there is a experimental step that (1) resolves a previously uncertain question (to avoid KSR) and (2) convinces the person of ordinary skill that the invention works (to avoid In re '318).

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