Archive for October, 2010

Myriad Weighs In At The Federal Circuit

Friday, October 29th, 2010

On October 22d, Myriad, represented by a Jones Day team, weighed in – literally – at the Federal Circuit with a 63 page brief supporting its appeal of Judge Sweet’s decision that claims directed to isolated DNA sequences are unpatentable products of nature and the cancer screening claims fail the machine or transformation test or are unpatentable as abstract ideas. Oddly, Myriad chose to spend 40 pages of their brief arguing that the claims to the isolated BRCA DNA molecules are patentable compositions of matter. They ably argued that “products of nature” should not be categorically unpatentable as “natural phenomena” and, as I have argued at length in previous posts, relied heavily on language from Bergy:  If pure strain microorganisms are patentable when isolated and cultured as useful  compositions of matter (to produce drugs), certainly DNA molecules of defined sequence and manifest utility are patentable compositions of matter. “Indeed, the claimed molecules here are not only purified ; they are chemically extracted (breaking their covalent bonds) and isolated from the native DNA as well, resulting in a new composition that is structurally and functionally different from native DNA” [Brief at page 36]. This is well-put, and in case you have not been following my posts on this saga, I don’t think Myriad can lose on this point.

Myriad also burned a legal “straw man” by arguing that “[t]he district court erroneously divined from Chakrabarty a legal standard requiring a claimed invention to be ‘markedly different’ from a naturally occurring product in order to be patent eligible.” Whether or not the Supreme Court intended to provide a test for when a natural product has been sufficiently changed from its natural state to qualify as a new “composition of matter”(which was not at issue in Chakrabarty), emphasis on this aspect of Judge Sweet’s opinion did not seem necessary in view of the preceding pages of argument relying on cases like Bergstrom, Bergy and Kratz that “these isolated molecules are new chemical compositions, which were unavailable to the public until [the Myriad inventors] discovered and isolated them.” [Brief at page 34].In my opinion, almost any emphasis on the old “purification” decisions is too much, and plays into the legal hands of plaintiffs, who are arguing that the DNA is not “markedly changed’ from its structure or function in its natural state.

The Myriad team even addressed Judge Dyk’s separate opinion in Intervet v. Meriel (2010), discussed in an earlier post, that an argument might be made that leaves might be patentable because they can be isolated in pure form from a tree. Myriad argued that the leaves “might fail under the logic of Funk Brothers, because the plucked leaf would have exactly the same properties as the unplucked leaf—unlike here, where isolated DNA molecules possess significantly different structural and functional characteristics from native DNA. In the words of Chakrabarty, the picked leaves would not be ‘a product of human ingenuity.’”[Brief at page 45].

Was surprised me the most was that the brief spends only 9 pages arguing that the claimed diagnostic methods are patentable subject matter. The Myriad team decided to try to finesse Judge Sweet’s abstract idea rationale by arguing that all of the screening claims meet the machine or transformation test. The heart of the argument is that “[t]he claims involving ‘analyzing’ and ‘comparing’ DNA sequences require extraction and processing of human tissue or blood samples” and are thus as transformative as the “determining” steps in Prometheus v. Mayo.:

“Under a proper claim construction, the claims require a transformation of a human sample, and the transformation of the specific BRCA molecules in that sample…the cells of the tissue sample must be broken open, and a sample of the DNA or RNA extracted. Sequencing is accomplished using a diagnostic probe or primer to hybridize to the target DNA or RNA to initiate a sequencing reaction. Second the DNA or RNA of the tissue sample is transformed when a primer or probe is used to bind to and ‘hybridize’ the DNA or RNA (etc.)”[Brief at page 57].

This is an argument that the recitations in the claimed diagnostic methods that the test subject’s DNA come “from a tissue sample” or is “in a tissue sample”, inherently require that the tissue sample and the DNA be transformed before the comparison with the standard sequence can occur. I have not studied the specification and prosecution histories in detail, to decide for myself if there is any basis to find these limitations in the claims, but claim 1 of the ‘857 patent follows:

“A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA1 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA1 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.”

I don’t see any sample, sampling or sequencing in this claim. Likewise, claim 2 of the ‘857 patent recites comparing the germline sequence of the BRCA2 gene…in  a tissue sample from said subject” with the wild-type sequence. I think an argument based on clam interpretation is asking a few words to do a lot of heavy lifting of processing steps from the specification into the claims, particularly when what is recited is that the gene sequence simply exist in the tissue sample of the subject. I am not saying that this approach does not have merit. I think I am disappointed that the Myriad team chose to duck rebutting the  argument that such claims are patent-ineligible as “abstract ideas”. If the Federal Circuit chooses not to interpret the claims as involving a physical transformation of DNA, it has little upon which to base a holding that the diagnostic claims are sufficiently concrete to escape the “abstract idea” bar. Just one paragraph:

“While the method claims are transformative, and thus patent-eligible, it bears noting that Bilski removed any suggestion that the rigid “machine-or-transformation” test provides the exclusive test for patent eligibility, particularly as applied to ‘Information Age’ technologies like advanced diagnostic techniques claimed in the Myriad patents. Thus, even apart from the [M or T] test, these methods satisfy 101.: Under the plain statutory language, these methods are ‘new and useful process[es]” …and these extraordinarily useful (indeed lifesaving) methods are not mere ‘concepts,’ or ‘unpatentable abstract idea[s],’ as was the method of hedging ruled ineligible in Bilski, 130 S. Ct. at 3231. They are very real ways of diagnosing and treating cancers…Patents representative of this ‘Information Age’ id., should not be invalidated because they involve the use of information.”

Given that the Bilski claims were invalidated by the Supreme Court as abstract ideas (nearly copying Judge Rader’s dissent), and that Judge Sweet specifically rejected this claim interpretation-based “M or T “ argument and ruled that the diagnostic claims were attempts to patent abstract mental processes, the decision of the Myriad team to focus on the transformative aspects of the claims feels a little like watching your hockey team pull its goalie when the game is tied.

Myriad Brief of Appellant

ACI 12th Advanced Forum on Biotech Patents

Thursday, October 28th, 2010

This well-known meeting/master patent drafting class will be held in Boston, MA from November 30 to December 2.  On December 1, Warren Woessner will be speaking on the topic, “Are Genes Patentable?  Examining the Potential Ramifications of Myriad and Developing Practical Strategies to Protect Your IP”.  Other panelists include Hans Sauer of BIO, Stephen G Albainy-Jenei of Frost Brown & Todd, Jennifer Gordon of Baker Botts and Lesley Rapaport of Borden Ladner Gervais.  The “Esteemed Co-Chairs” are Brian Coggio of F&R, and Immac J Thampoe of Merck.  The Keynote speaker will be Sharon Barner, Deputy Director of the USPTO.

For more information on the ACI Biotech Conference, please click here.

US Patent Law – Discouraging an International Business Model?

Thursday, October 28th, 2010

In the recent decision of Solvay S.A. v. Honeywell International, Inc. (2009-1161, Fed. Cir. 2010), the Federal Circuit held that despite both being first to possess an invention in the U.S. and practicing reasonable diligence prior to filing, Honeywell did not receive priority under 35 U.S.C. § 102(g)(2), because the invention was first made in Russia by an agency under a contract with Honeywell (then Allied Signal).  As a result, despite Solvay being the second to invent, the District Court’s finding of invalidity of Solvay’s U.S. Patent No. 6,730,817 was reversed, and the finding of infringement by Honeywell was affirmed. 

Even if a goal of 35 U.S.C. § 102(g)(2)’s requirement that “before such person’s invention thereof, the invention was made in this country by another inventor…” is to protect and favor U.S. businesses, it seems like the wrong result when a U.S. company creates an invention abroad via a contractual business relationship and is not awarded priority over another company that independently invents the same invention second in time. 

Honeywell had not publically disclosed the invention; it was kept secret within the company.  Thus the provision of 35 U.S.C. § 102(a) that “the invention was known or used by others in this country…” did not apply.  As discussed in the M.P.E.P. at 2132.01(I), “known or used” in § 102(a) means publicly known or used.  If Honeywell had disclosed or used the invention this way, then § 102(a) would have applied, but it would have started the § 102(b) clock as well.  Additionally, and perhaps more importantly, such a disclosure would have resulted in the loss of foreign filing rights in most countries. 

The business relationship between Honeywell and the Russian agency didn’t allow Honeywell to successfully argue that a business organization located in the U.S. made the invention first, and 35 U.S.C. § 102(g)(2) requires the invention to be made “in this country”.  For companies that choose to outsource inventing activities abroad, a solution is to rapidly file a PCT application designating the U.S., perhaps preceded by a national stage filing in the country in which the invention was made.  By treaty, a PCT filing in English designating the U.S. is treated like a regular U.S. filing for priority purposes.  However, this clearly gives companies that invent in the U.S. an advantage, as they can seek the protection of § 102(g)(2), and can thus potentially withhold an invention from the public for a longer period of time with less worry.  The U.S. inventor will need to be vigilant to ensure no § 102(b) disclosures occur, but otherwise they need only be reasonably diligent prior to filing.  This could allow companies that invent in the U.S. to be more selective about what they ultimately seek to patent, and to bring an invention to a more highly finished state at the time of patenting, which can increase the quality and corresponding value of granted patents.  Even a slight time advantage can be extremely important for inventions that bring in the highest profits near the end of their patent term, such as pharmaceuticals. 

But with the tremendous amount of outsourcing of traditional U.S. business of late, with cost savings at the root, perhaps we should be happy with interpretations of U.S. Patent Law that counteracts  this outward flow? 

Guest post written by Nicholas Lanzatella, associate attorney at Schwegman, Lundberg & Woessner, P.A. 

The opinions expressed herein are those of the author and not necessarily those of the firm or any of its members, and are presented for educational purposes only.

KSR Panel at AIPLA Annual Meeting

Monday, October 25th, 2010

Thanks to all of you who attended (or tried to attend) the panel presentations on KSR Tuesday morning at the AIPLA Annual Meeting. We apologize, but were pleasantly surprised, that the room was too small to accommodate all who wished to attend. Al

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though it is available at the AIPLA website, I have attached the paper I submitted: “Adjusting the Rearview Mirror – Blocking Impermissible Hindsight Rejections.” It also touches on the state of “non-analogous art” and “picking and choosing.” I think that KSR unleashed/freed/encouraged Examiners to make obvious to try rejections which involve blatant picking and choosing from laundry lists of known elements, and that are only supported by the “common sense” or “ordinary creativity” of the POSA (read “the Examiner”). If I felt that anything was lacking in the panel, it might be the lack of a speaker on the importance of identifying prior art disclosures teaching away from the claimed invention.