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« Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences Part XI: Agriculture and the Microbiome | Main | Dialware Communications, LLC v. Hasbro, Inc. (C.D. Cal. 2017) »

July 18, 2017


The CAFC created a mess when it expanded its "inherent anticipation doctrine" into the realm of obviousness. I'm relieved not only that this panel reached the correct result, but that the decision will provide helpful guidelines for those defending an "inherently obvious" attack. I wonder, however, what the result would have been had Judge Newman not been on the panel.

Hey Kevin,

Judge Newman is still the best, the Grand Dame of the Federal Circuit. It will truly be heartbreaking if she ever steps down.

@ EG

I could not agree more. If I retain 10% of her ability and intelligence at age 90 I will be delighted. More seriously, she has worked in the chemical arts with a special interest in life sciences and so knows 100% what she is talking about.

Having read through the decision, I'm puzzled about one thing. Claim 31, which was one of the claims at issue, recites the process of lyophilizing bortezomib with mannitol. As far as I can see, the Federal Circuit's decision doesn't address the question of whether or not it would have been obvious to carry out this process. Note the language of the decision:

"However, the prior art does not teach or suggest that lyophilization of bortezomib in the presence of mannitol would produce a chemical reaction and form a new chemical compound, or provide a reason to make this specific new chemical compound, or that this new compound would solve the previously intractable problems of bortezomib formulation. Although mannitol was a known bulking agent, and lyophilization was a known method of drug formulation, nothing on the record teaches or suggests that a person of ordinary skill should have used mannitol as part of a synthetic reaction to make an ester through lyophilization."

The focus is on the lyophilization process as a means to make a new ester. But was it obvious to do the process as a way to possibly formulate the unesterified compound? I don't see where the court addressed that question, and it seems to me the issue should have been addressed, because claim 31 doesn't include a limitation about "as a way to make the ester" or some such. Claim 31 merely recites the process.

To be clear, even if the process *was* obvious, it doesn't follow that the inevitable (i.e. inherent) product of the process is obvious, and I'm pleased that Judge Newman has done her best to try to defeat such assertions, should they be made in the future.

Dear Atari:

Point taken - I think the court was focused on the product claim. But maybe the unexplained rationale is that a process involving selection among several alternatives, that produces a surprising and unexpected result when one alternative is chosen, with no reasoned basis in the art that the alternative chosen should (rather than could) be chosen, and no recognition of the surprising, unexpected and beneficial result to be obtained should that alternative be chosen, renders the method claim non-obvious.

Thanks for the comment.

"To be clear, even if the process *was* obvious, it doesn't follow that the inevitable (i.e. inherent) product of the process is obvious."

Hey Atari Man,

As Kevin noted, a very astute point by you about the potential difference between the obviousness of the product versus the obviousness of the process. Indeed, going way back into my case law memory, I believe there were instances where the product was deemed unobvious (and patentable) by the Federal Circuit/CCPA where the process for preparing that product was deemed obvious (and unpatentable. The distinction made by the Federal Circuit/CCPA was that any "unexpected properties" of the product inured to the benefit of the unobviousness/patentability of the product, but not the process for making it-that distinction always came across to me as weird, but that's chemistry for you (the sometimes "unpredictable" art).


You might be interested in some conversations recently at IPWatchdog concerning the meaning of the word "unpreditable."

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