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Reactions to In re Kubin: DNA Patents and Obviousness

Earlier this month, the Federal Circuit decided In re Kubin (pdf), invalidating one of Amgen’s DNA patents.  Here’s the short version from ScienceInsider:

“The court declared that an invention owned by Amgen Inc. … was so obvious as to be unpatentable. The invention … was the sequence of a gene for the protein NAIL, important in the human immune response. But those who opposed the patent argued that it took no original insight to work out the gene’s code. The U.S. Court of Appeals for the Federal Circuit agreed with the skeptics.”

Here’s the more patent-y version from Patently-O:

“The Kubin opinion found that the Supreme Court’s KSR decision overturned In re Deuel and its admonition against an ‘obvious to try’ test for obviousness.”

Since the decision has had some time to percolate, I thought I’d collect some of the reactions from around the web (with the able assistance of articling student Dr. Alison Varga)…

Patent Baristas has (as usual) a good run-down of the decision, concluding:

“The only thing that’s certain is that the Patent Office will begin hammering biotech patents on obviousness more than ever — starting immediately.”

Patently-O takes a look at the big picture implications:

“To be clear, Kubin does not hold that an invention that was ‘obvious to try’ was necessarily obvious under Section 103(a). Going forward, however, the question in this long-running debate will be ‘when is an invention that was obvious to try nevertheless nonobvious?’…

KSR moves to Non-Predictable Arts: Biotech has traditionally been thought of as unpredictable. Here, Judge Rader may have dismantled the art-level distinction in holding that KSR applies to the unpredictable arts. The issue rather is if the particular invention in question was predictable.”

Dennis also adds a couple of helpful notes:

– I should note here that the PTO is well ahead of the Federal Circuit. MPEP 2141 indicates that being “obvious to try” is a proper rationale “to support a conclusion of obviousness.”  The big book does hint that such an application would only be proper if the “trying” means “choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.”

– This case makes clear that the level of enablement of the prior art is very important to any obviousness conclusion.  That result is in contrast to the recent Gleave case that found anticipation absent known utility.

Here’s the Biotechnology Industry Organization (BIO) blog post, The Blunders of In Re Kubin:

“[The] U.S. Federal Circuit of Appeals decision  distorts the definition of what a patentable discovery is for the biotechnology industry, but may have a wider impact on all discoveries granted patents in the United States… Hindsight is 20/20… and harmful in determining the patentability of any invention at the time of its discovery.”

Patent Docs is equally disturbed by the ruling and the reasoning, but is more equable about the effects:

“Another reason the sky will not be falling on biotechnology patenting arises from the time in the history of biotechnology in which the decision was handed down. Many (if not most) of the “known” genes in the art have been cloned and patented (or not) over the past 30 years of gene patenting, and many of these patents have expired or are nearing the ends of their terms. In addition, many of these genes were isolated at a time when the technology was much less well developed and when there are sound factual bases for concluding that there was not a reasonable expectation of successfully cloning a cognate gene even for proteins that were well known and well characterized. Turning to the present day, many (if not most) of the genes patented or that have been attempted to be patented were not known prior to their discovery (usually through homology comparisons) as a result of the Human Genome Project (HGP). A fundamental pillar of the Court’s decision in Kubin was that p38 was known; that will not be the case for most of the genes identified since the late 1990’s.”

Holman cites Patent Docs and adds his own take on why the firmament remains fixed:

“Kubin does not mean that any patent claiming a cDNA is necessarily obvious if the encoded protein was known in the prior art. It simply means that we can no longer continue to interpret Deuel as establishing that the cDNA is never rendered obvious under those circumstances. Rather, the inquiry should shift to whether or not there was any kind of suggestion or motivation to clone the cDNA, and if there was, whether there was a reasonable expectation of success. In cases where the patent applicant can bring forth sufficient evidence to show that the cloning of a particular cDNA was more technically challenging, creating a sufficient level of unpredictability with regard to success, the invention should still be patentable under Kubin.”

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One response to “Reactions to In re Kubin: DNA Patents and Obviousness

  1. Joe Manak September 4, 2009 at 1:25 pm

    As many have observed here, there is a fundamental question that the Federal Circuit side stepped in Kubin: Is cloning a routine process when the target protein sequence is known nothwithstanding in re Deuel’s focus on the existence of degeneracy or redundancy? Does Kubin say “maybe” or more? I’d like to know.

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