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WILL THE NIGHTMARE FOR BIOTECH PREP/PROS NEVER END?

I recently gave a talk on patenting biomarkers, and was asked to talk about “push-back” by the courts and the PTO against getting useful patent claims in this emerging area (the gateway to “personalized medicine.” I was struck with how the Federal Circuit has gnawed away at the bundle of “rights” (laws/practices/policies) that formed the foundation of our value-adding profession, over a relatively short time span. In better times, one of my partners once called patent attorneys the “priests of the information age.” Well, if we are, the Federal Circuit must be Henry VIII and we are papists headed for the stake.

In re Kubin – Fed. Cir. holds that a claim to DNA encoding NAIL protein was obvious since the protein was in the prior art (even though it had never been isolated or sequenced). Good-bye Dueul (and that decision only came down in 1995!).

Noelle v. Lederman – Fed. Cir. ends de facto “antibody exception” to WDR, finding that one Ab does not enable a claim to any Ab that binds to a characterized antigen (mouse antigen on activated T cells was disclosed).

In another Ab case, In re Alonso – Fed. Cir., the case explicitly states that making and screening info is not sufficient to meet WDR. You need enough working examples to support the claim scope.

In re Fisher – This is an older (2005) decision, but should not be forgotten. The court affirmed the rejection of claims to five purified corn ESTs. The court found a failure to meet the PTO’s substantial and specific requirement for patentable utility, even though Fisher proposed seven potential uses for such ESTs (probes of protein expression, etc.). The court stated: “the claimed ESTs themselves are not an end of Fisher’s research effort, but only tools to be used along the way in the search for a practical utility.”

About the WDR, don’t even get me started. I am not saying that Ariad v. Lilly was wrongly decided, but if you think you can predict how (or even if) the Fed. Cir. will resolve the tension between the WDR and enablement, you should be picking stocks, not trying to get patents granted.

From past posts on this blog, you know how Bilski has cast a shadow on diagnostic and method of treatment claims. After the clearly wrong decision in Classen (assay involving immunization fails Bilski test), the Fed. Cir. tried to lift the fog a bit, with its decision in Prometheus v. Mayo, in which they clearly stated that methods of medical treatment are patentable (transformative enough, it seems), but this case still may be on its way to the Supreme Court, where three Justices would have decided that diagnostic assays are simply natural phenomena coupled with unpatentable mental steps (LabCorp. v. Metabolite Labs. (2006)). Do all of those elderly gentlemen have normal PSAs?

Finally (and I only stop because I am tired of typing fairly late on Friday), this perfect storm of anti-patent precedent undoubtedly encouraged the Ass’n of Molecular Pathology et al. v. USPTO and Myriad Genetics lawsuit (SDNY May 12, 2009) in which the plaintiffs seek rulings that the PTO is exceeding its statutory authority in granting patents on genes, since they are products of nature, that patenting “the concept of looking at or comparing human genes and [increased cancer risk] violates legal principles barring patents on laws of nature,” and that the Constitutional mandate to promote progress in the useful arts is violated by patents on gene-based screening methods. The PTO has tried without success to get this suit dismissed. If this anti-patent trend continues, we will converge with the Indian patent system in another five years (or less). TGIF.

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