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« Biotech/Pharma Docket | Main | Ariad v. Lilly: Ariad's Reply Brief »

December 09, 2009

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Dear Readers:

As you will notice, sometimes I have been able to identify the judge who asked a question (Judge Rader's voice is very distinctive, and Judges Newman, Prost and Moore are all distinguishable), but other times I have just said "the court" when I didn't know who was speaking. If anyone can "fill in the blanks" of the court's statements as I have quoted them, please feel free to let me know (either by a comment or by e-mail).

Thanks.

Thanks so much for this posting. I have been dying to know how the oral arguments went. A *very* thorough analysis and description.

Nice post - thanks for taking the time.

Can someone fill in a rather large blank and post a link to Ariad's reply brief, as "there were significant differences in the positions taken in Ariad's opening brief and its reply brief." ?

Kevin,

I wish I could help you on the other "male judge" voices but I can't.

I was surprised at how many questions from the panel were directed to issues peripheral to the two to be addressed: (1) is there a separate and distinct "written description" requirement?; and (2) what does it mean? In fact, in listening to the oral argument recording, I zoned out during the latter part of Whealan's argument.

Frankly, it's hard for Ariad to argue against a separate and distinct "written description" requirement. For example, the 1991 case of In re Alton says it's separate and distinct in unequivocal terms from "enablement" and "best mode." In rebutting the early SCOTUS cases such as Evans v Eaton, Ariad could have pointed out that a separate and distinct "written description" requirement was important then because the old-style claims look very much like those in design patents ((e.g., "a device substantially as shown and described"). Now, the language of the claim itself describes the metes and bounds of what is protected. In other words, the original reason for a separate and distinct "written description" requirement no longer applies.

You're correct that the panel questions seemed to dodge around the more important issue, namely what does the "written description" requirement mean, whether it's separate and distinct or not. In particular, have cases like University of California v. Eil Lilly imposed what appears to be a separate and discriminatory prong to the "written description" requirement in biotech cases which I call "adequate description." In other words, just calling it human DNA that codes for insulin doesn't tell you what that human DNA is, i.e., doesn't "adequately describe" what the chemical composition of that human DNA is. It will be interesting to see how a majority of the panel comes out on that (and I predict there'll be several concurring and even dissenting opinions which could make it difficult to determine what the "majority opinion" is).

Noise:

We recently obtained a copy of Ariad's reply brief and will be posting a summary and link to the brief later today.

Don

Kevin - I believe that you are labeling Chief Judge Michel's voice and Judge Rader's voice both as Judge Rader. E.g., Chief Judge Michel asked about the law/fact distinction, the jury instructions, and the number of written description rejections; Judge Rader asked about whether the older cases are really written description cases or rather enablement cases.

Dear Readers:

Professor Oskar Liivak of Cornell Law School attended the oral argument, and has been kind enough to supply me with the proper identifications for the judges who asked questions during the argument. (Unfortunately, I over-estimated how distinctive Judge Rader's voice was, so some of the comments and questions attributed to him were in fact Chief Judge Michel's. We are also correcting those citations.)

For those unable to resist trying to fathom which way the court may rule based on the oral argument, we believe the proper identification is important (plus, we like to get the story right, after all). We expect these corrections will be made by later today.

Sorry for the delay, and thanks for reading our blog.

Dear Ordinary:

Yes, Professor Liivak kindly let me know that I recognized Judge Rader's voice less well that I thought. Thanks for letting us know; we are revising ASAP.

Thanks for the comment.

Kevin,

I misidentified In re Alton as a 1991 case; it's actually a 1996 case.

BTW, I thought that questions you attributed to Judge Rader were Chief Judge Michel's (his voice is very distinctive to me). I'll never forget when Michel told an advocate in oral argument to "next time, wear a tie."

With all the "identifying the judges" aside, this was a great summary of an oral that went off into way too many side alleys that had nothing to do with the 2 questions at issue.

"I zoned out during the latter part of Whealan's argument."

everyone did. that's because it was him going off the deep end in a fashion that nobody would have perferred to see him go.

All, first of all forgive me for commenting from a purely common sense perspective. I am not trained in law in any way...but, this seems to be such a cut and dried case in favor of Ariad that I struggle with how it can be at this level in our court system today. My comments come from the layman reading of 112 and not from the oral arguments outlined here, which I believe missed the mark on either side and it seems as though the court may have intentionally (strong word) eluded the basic argument hoping for a Supreme Court date later on to settle it once and for all.
My only point is that the written description and enablement are identical in 112. Reading it carefully and even going as far as trying to read a separate WD into it doesnt help either......there just aren't 2 separate requirements no matter how you read the language. The only question is how in depth does the Enablement language need to be to satisfy..(those in the art)? Bottom line Ariad enabled others through specific "enough" language for others to make use. End of story.
Thanks for the outstanding work on this forum.

Dear George:

It is often the case that what is plain to one person is not so plain to another. So while I appreciate that the equivalence of the written description and enablement requirements is plain to you, it is just as clear that it isn't to others (and not just in an outcome determinative way).

It is certainly the case that there needs to be a provision in the law for determining whether an applicant is entitled to a claim for specific embodiments of a generically-disclosed invention. It would be inequitable to permit someone to disclose vaguely and then sit back and wait until competitors produced specific embodiments, and then either assert the broad claim or try to patent a more narrowly-tailored claim to fit the competitor's product. That has always been the province of the portion of the statute that requires a written description. And enablement is not enough, because it is frequently the case that a disclosure enables a certain combination of substituents that is not contemplated by the original inventor.

The principal provisions of the Patent Act are (as they must be) directed towards "promoting the progress" of the useful arts. By this, patent disclosures are intended not only to reward the patentee but to inform the public what has been invented and provide the basis for future invention. In order for the system to work, later inventors must be able to rely on what the original patentee said was her invention, in her claims. Hence the "priority policeman" role.''

The problem is that once you admit that the statute has this function, then there must be a requirement over and above enablement. Now, Ariad's argument is that this function is limited to priority, and that an originally-filed claim satisfies the requirement provided the subject matter is enabled. Not an easy call in this case, since the court is really just determining where to draw the line of "how much" must to described to give "how much" scope of exclusion. It is easier for nucleic acid claims, where there really is not conception until an actual reduction to practice.

I will say that there is a policy argument against permitting inventions regarding basic biological phenomena to preclude drug companies from producing therapeutics unrelated to the basic invention that happen to work by a mechanism involving the phenomenon. To illustrate, it might be a different matter if a pharma company used a cloned and patented gene to screen for binding to a recombinant receptor and then marketed the resulting product. Here, there is no evidence that Lilly was aware of, used or needed an understanding of the Harvard invention to identify Xigris or the other accused product.

Thanks for the comment and the kudos. Have a great New Year.

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