How Sweet Is It?

Takeda Chemical Ind., Ltd. v Alphapharm Pty., Ltd.

After KSR, the Federal Circuit's decision in Takeda Chemical Ind., Ltd. v Alphapharm Pty., Ltd. may feel like a spoonful of sugar to patent holders.  Takeda involved a patent which included claims for a chemical compound for use as an anti-diabetic agent.  The defendant sought to invalidate the patent.  It alleged that, because the compound was chemically similar to another compound - known as "Compound B" - known in prior art, it would have been obvious to derive the claimed compound from the prior art compound.  The primary difference between the two compounds was the placement of an ethyl component in a certain position around the central chemical "ring."  The defendant argued that, starting from Compound B, it would have been obvious to try rotating that component in various positions around the ring to derive the claimed compound.

The Federal Circuit disagreed.  The Takeda court found that the particular placement of the ethyl component in the claimed compound demonstrated the requisite level of innovation necessary to defeat a claim of obviousness.  A reference in an academic publication was critical to that determination.

The article discussed research which showed that Compound B caused both weight gain and toxicity issues.  Here, said the Takeda court, was a textbook example of prior art "teaching away" from the claimed invention.  Compound B's side effects were well-known and acknowledged by experts on all sides.  Hundreds of other potential chemical compounds existed to try and many were identified as lacking Compound B's documented side effects.  For those reasons, the court rejected the defendant's claim that Compound B was an obvious choice as a "lead compound" to investigate.  Instead, the court found it unlikely that a person having ordinary skill in the art would have chosen to pursue Compound B as an anti-diabetic agent.

Additionally, the court focused on the fact that patent holder's specific placement of the ethyl component created unexpected results regarding lack of toxicity.  The concurring opinion focused heavily upon the surprising nature of this result in agreeing with the majority opinion.

Not bad, especially considering the state of the obviousness battleground in the wake of KSR.  We wonder, though, how far Takeda will actually go to sweeten that burnt aftertaste KSR left behind.

From one viewpoint, the Takeda decision can be seen as a sub-set opinion -- influenced by the robust patent law covering chemical compounds and limited, as precedent, to that specific topic.  The Federal Circuit has a long established appreciation of the art of chemical invention.  Takeda may simply be the court's way of weaving KSR's requirements into its own chemical compound jurisprudence.

From another viewpoint, Takeda appears to recognize that, while KSR rejected a rigid application of the "teaching, suggestion, or motivation to combine" test, even that approach doesn't automatically lead to a finding of obviousness, especially when the prior art can fairly be said to "teach away" from the claimed invention.  KSR's emphasis on market realities has raised questions about the continuing vitality of the "TSM" inquiry.  Yet here, strong evidence of prior art "teaching away" from the claimed invention trumped defendants' claims that a design need or market pressure to solve a problem lowered that standard.  On these facts, the court found, Compound B would not have been even "obvious to try."  In short, under these circumstances, the practical impact of KSR was minimized.

Certainly, patentees who can put their hands on prior art that "teaches away" from a particular element in a combination invention will want to keep Takeda top of mind.  While patentees may no longer be able to rely upon the absence of express suggestions, neither can alleged infringers generically rely upon "obvious to try" arguments where the record contains technical reasons which teach away from the alleged combination.

In the end, whether Takeda changes obviousness' blood sugar is a question for the patent bar to chew on.

We plan on checking levels regularly.

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