Archive for April, 2009

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Kubin Analysis Continued

Wednesday, April 8th, 2009

My last post began a rather selective analysis of In re Kubin, which the Federal Circuit decided on April 3, 2009 (see previous post for citations to this and related decisions). Kubin’s claims to DNA molecules encoding sequences including that of the NAIL protein were found to be obvious over a patent (“Valiente”) that did not disclose either the amino acid sequence of the NAIL protein or the nucleotide sequence of the NAIL gene. However, Valiente also had not isolated either the protein or the gene, and only contained a general discussion of how this might be accomplished. Therefore, Valiente clearly could not have claimed either NAIL or the DNA sequence encoding it. Such claims would fail the written description requirement. See Lilly v. UC, 119 F.3d 1559 (Fed. Cir. 1997). However, a reference (or combination of references) must be enabling to the extent that a later invention is legally placed in the hands of the public. In re Hoeksema, 399 F.2d 269 (CCPA 1968). The Kubin panel clearly believed that Valiente, taken with the Sambrook cloning manual (from 1989(!)), met this standard.

This leaves a “patent gap” in the advance of biotechnology that could effectively halt progress in some areas where more progress might be a good thing. Valiente issued in 1997 and was apparently the closest prior art. So at some point Valiente et al. (at the Wistar Institute) stopped working on this project, and Kubin and Goodwin (apparently at Amgen) started. Now Kubin and Goodwin have been stopped by obviousness. According to the Fed. Cir., their successful cloning and sequencing was only “some minor advance in the art”. But without a patent on the NAIL protein or the gene, there is much less incentive to keep on working on finding direct or indirect uses for them. O’Farrell et al. cut themselves off by publishing early work (called “pioneering” by the Court) more than a year prior to filing on their more useful, but ultimately obvious, method. While they had only themselves (or their attorney) to blame, Kubin and Goodwin had every reason to believe they could pick up where Valiente et al. left off.

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Federal Circuit upholds Board In re Kubin – Resurrects O’Farrell Test of “Obvious to Try”

Monday, April 6th, 2009

On April 3, 2009, a three judge panel of the Court of Appeals for the Federal Circuit unanimously affirmed the decision that the Board of Patent Appeals had reached in Ex Parte Kubin. The Board’s decision is discussed in the case note posted below, as are the precursor cases In re Deuel and the leading written description requirement decision, Lilly vs. UC. Keyboards of commentators more august than I will be overheated discussing this decision, but two aspects stand out as particularly notable about In re Kubin, 2008-1184 (Fed. Cir. April 3, 2009)(Serial No. 09/667,859). (A link to a this decision is available at the end of this post.)

The first is that the Federal Circuit faced up to the criticism that the Supreme Court had leveled at the Fed. Cir.’s “obvious to try” test, as the Fed. Cir. had applied it to find a novel DNA sequence unobvious In re Deuel more than twenty years ago. The Supreme Court had concluded: “In that instance [the art worker pursuing “known options” that would lead to “anticipated success”] the fact that a combination was obvious to try might show that it was obvious under s. 103.” The Fed. Cir. wrote: “Under KSR, it’s now apparent ‘obvious to try’ may be an appropriate test in more situations than we previously contemplated.”

But under what circumstances? The panel managed to give the Federal Circuit a pat on the back by falling back on a decision in the appeal of a biotech application that was twenty years old, In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988), stating: “The Supreme Court’s admonition against a formalistic approach to obviousness in this context actually resurrects this court’s own wisdom in In re O’Farrell, which predates the Deuel decision by some seven years. The Kubin panel then went on to extensively discuss O’Farrell, in which Judges Markey, Rich and Nies found the second generation method of cloning method claims obvious over the inventors’ own art.

The Kubin panel revived “obvious to try” rebuttal in the two situations in which the O’Farrell panel endorsed its use: when arriving at the invention would require undue picking and choosing from a plethora of “parameters” and “choices” so that the end result would be, in effect a patentable “invention of selection” (as our EP colleagues might say). The second situation is when the art only provides what has been referred to as an “invitation to experiment” with no, or only very general guidance as to how to succeed in reaching the invention.

After the biotechnology patent bar recovered from the shock of seeing recombinant DNA claims found obvious in this still young art, in which nearly every advance had contained patentable subject matter, we latched onto a single paragraph in O’Farrell that appeared in the opinion pages prior to the “obvious to try discussion”, in which the panel discussed the prior art reference: “Polisky contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” (This sentence was also quoted by the Kubin panel.) Many of us called this the O’Farrell tripartite test, and turned it on its head. We would argue that the methodology in a prior art publication was absent or incomplete or even inoperable, that there was no suggestion of the modifications required to arrive at the invention and that there was no reasonable evidence that any modifications would be successful. We would argue that our client’s invention was in an area that was so unpredictable that actual reduction to practice should be required, not just an Examiner’s speculation that the modifications would yield the invention. Those were the good old days of biotech patent prosecution, and while these arguments still have considerable legal weight, those days are far behind us.
In Re Kubin and Goodwin

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Why A Blog? Why Me? Why You?

Monday, April 6th, 2009

I started this blog to begin a conversation about patent law and policy, particularly how it affects those of us involved in “prep/pros” and, more particularly, how it affects examination policy and practice in the USPTO. This blog will have a particular focus on biotechnology and pharma patent law and practice. Of course, I welcome your comments and short casenotes or opinion letters on anything in this area, particularly on anything I have to say. After almost 30 years in practice, I have a fair amount to say, but I wanted to do something by way of introduction. It is one thing to have your photo on a firm website or a blog, with a brief, self-congratulatory bio paragraph that says you can do anything – at least, anything in your particular sub-specialty of IP law. It is quite another thing to ask colleagues and/or clients to read what you have to say about their profession on a regular basis and to have any opinion about it.

So this morning I updated my resume (or C.V. as the academics say). (There is a link to my resume at the end of this post.) Since I am a founding partner of one of the largest patent law firms in the United States, I am not looking for a job, but pulling out meeting programs and journals made me think a lot about what I have been doing recently and how I (and most of you) got started in the first place. Most patent attorneys are what I sometimes refer to as “failed technocrats”. What I mean by that is that if we were such great biologists or chemists (or even M.D.’s in some cases), we would still be doing it at some level, and not writing patent applications and opinions on other people’s work. I have quite a few patents naming me as a co-inventor – see U.S. Pat. No. 4,149,017 – but none of them ever made a dime as far as I know. I left my job at Miles Laboratories in 1978 to go to law school, and never looked back.

I think a beginner patent attorney needs three things to attain success in patent prosecution (I am going to drop the “prep/pros” abbreviation hereafter). She/he needs to be technically proficient, be a good writer and realize that we are all in a service industry. We are not seeing heart patients or doing roofing work or moving furniture, but we depend on a steady flow of new work from old (and new) clients. In a service business, you have to replace about 20% of your clients and the work they give you every year, on average. Client service can and will be the subject of other postings (perhaps yours). Patent attorneys who are missing any one of these three legs of their professional stool are not going to make it.

But can you think of a more interesting profession? If you had to design an interesting job, “biotech/chem patent attorney” might be number one. We get to interact with researchers who are making discoveries that are on the cutting edge of everything – medicine, agriculture, energy, and on and on. Time magazine has put stem cells on its cover more than once. When the human genome was sequenced, Esquire put Heidi Klum on the cover, with the question, “Who Owns This Body?” Now that was a conversation starter at parties. I have a big “university practice”, but even if you do not get to hob-nob with Nobel prize contenders or medical device pioneers, it is “all good” because it is today’s news – or tomorrow’s. I have seen pioneering patents expire before the claimed inventions got close to commercial development. Then, after you “interview” the inventors, you get to go back and write interesting stories about what they are doing. Occasionally, I call patent attorneys “highly paid technical writers”, but that is only when I want to make a point about the need to write well. Writing and filing the application is just the beginning. We then have to deal with administrative law; we are now lobbyists and advocates for our clients before a Government agency, and on a path that can lead to the Supreme Court.

So this post is getting fairly long, and I really have not done much except to give you random thoughts, like Kevin Costner gave Susan Sarandon in Bull Durham, though lacking some of the free-form wit. I did get my resume updated and a link to it is to the right of this post. Patents I have written and/or prosecuted are listed on the firm website. I have had a fair amount of success over the years – including obtaining the first patents on Bt corn and obtaining patents that cover the anti-HIV drug marketed as Abacavir/Ziagen. I have also had some major set-backs – not just patents I didn’t obtain in time or at all, but ones due to failures to “get” what my clients needed or wanted. Well, we all know that “you can’t always get what you want.” This blog is going to be about how you can get what you, and your clients, need.
Woessner Resume

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