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« Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work for Follow-on Biologics | Main | BIO Meets the Press »

February 26, 2009


"Mr. Burrill does not seem to share the concerns of many that biomarker patent protection may be weakening in the wake of the Classen Immunotherapies decision by the Federal Circuit."

Classen isn't a biomarker patent. It's just a terribly drafted application and nobody should be particularly worried why it is invalidated.

A better question is: why would the biotech industry benefit from the issuance of Classen's claims? I can think of nothing worse for biotech patenting than a finding by the PTO or any court that Classen's claims are valid.

Do biotech prosecutors want to become the next laughing stock of the patent bar?

Dear Heart:

Since many biomarkers will be unpatentable as being disclosed in Human Genome Project databases, there may only be method claims available. I was using the Classen case/claims as a shorthand for claims "correlating" an observation with a biological consequence. Those types of claims seems to be at risk under the Bilski/Labcorp dissent analysis.

Since you expressed the "laughingstock" opinion, I put it to you: assuming the composition of matter/kit claims are not available, and you have a method of detecting some change in a biomarker that correlates with a disease state, how would you write a "better" (i.e., patentable) claim? Enlighten us.

Thanks for the comment.

For starters, one might include a step of reporting the result to a third party, or a step of treating a certain subclass of the tested subjects.

You know the drill, Kevin.

My laughingstock comment was directly at Classen's claims specifically. The fact is that the PTO continues to issue "detect then correlate" claims that are based on actual discoveries. While some of these claims may have LabCorp issues, it is misleading to lump them in with Classen which is, quite simply, one of the most ridiculously awful biotech claims most practitioners have ever seen.

By the way, did you see this?


"We are counsel to Classen Immunotherapies in the recent 12-19-08 CAFC decision on section 101 post Bilski. We filed our Petition for rehearing yesterday and are seeking amicus briefing. We are only seeking to reverse that part of the opinion that states that immunization is not a transformation."

Huh. I don't remember the opinion saying that "immunization is not a transformation." I also don't recall that Classen's invention transformed anything. Classen invention was a method for "determining" something. Other than that allegedly new determination, nothing else was required (in spite of what the claim recited -- anybody can drop a "transforming" step into their claim but if it's just a preceding event that is old in the art, then it's smoke that it is perfectly fair to ignore).

Dear Heart:

More later, but one of the problems with the treatment step is that it may raise a Muni Auction problem, i.e. require joint tortfeasors to infringe without either being under the direction or control of the other.

There are also suggestions to include a display limitation and other machine tying steps. All of which limit the claim in ways that I think are easy to practice without infringing.

Thanks for the comment.

Well, I was asked to address the patentability issue.

The concerns you raise in your last comment address something much more political than legal, i.e., when a person identifies a relationship between (1) a chemical or its levels in a human body and (2) a previously identified condition in humans, should that person be granted exclusive rights to all substantial uses of that relationship?

If you believe the answer is yes, the question is: why? The freshman answer is that without that incentive, people will stop looking for relationships or the rate at which such relationships are identified will slow.

I think that answer bears as much consideration as arguments that companies need to pay their CEOs tens of millions of dollars a year or else the companies won't be able to compete, i.e., it's a self-serving myth.

Dear Heart:

I don't think an inventor should have rights to ALL substantial uses of the relationship.

The Labcorp case illustrates the point. There, elevated homocysteine levels were correlated with a vitamin deficiency, and that was the claimed method. We also know that elevated homocysteine levels are correlated with increased risk of heart disease, but that isn't covered by the Metabolite claim. It is analogous to the use of the Arrhenius equation is the claim in Diamond v. Diehr, which was recited in the claim for a specific use in curing rubber but did not preclude the use of the Arrhenous equation in other applications.

A claim reading "A method of diagnosing a disease or disorder in a human comprising the step of detecting an elevated level of homocysteine in a blood sample from the human" would be more like the claim you describe, and may very well be unpatentable. I don't think the situation is as clear with the claim in the Labcorp case.

Thanks for the comment.

Dear Heart:

One more thing. I don't think that people will stop researching the correlations between biological phenomena and disease. I think there will be less incentive to translate this knowledge into useful diagnostic tests if we decide that diagnostic method claims (which have existed for quite some time) are not patentable.

The Supreme Court in Festo said that courts should be careful not to "disrupt the settled expectations of the inventing community" by changing the rules. One of the GSK arguments against the new continuation/claims rules was that GSK had made a decision - disclosure - in reliance on the rules as they were when they filed their applications, and that it would constitute an unconstitutional taking to impose the proposed limitations at this point. And I think that disclosure and encouraging disclosure is more important than the short-term profit that diagnostics companies may make in bringing these diagnostic methods to market.

Thanks for the comment.

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