University IP In The News – Expedited Examination And March-In Request

On July 29th, Rep. Frank Wolf (D.-Va.) introduced H.R. 5980 that would give priority to examination of patent applications filed by U.S. universities and by their “patent holding companies.” The definition of the latter seems a bit vague, but is apparently intended to cover entities like the Wisconsin Alumni Research Foundation (WARF) that finances prep/pros of patents by University of Wisconsin inventors and licenses them to provide income to both entities. The patents are assigned to WARF when they issue. The bill would also limit the early publication of U.S. patents to their abstracts. The bill is clearly an attempt to levy an IP “tariff” on foreign inventors but, for those of us with big university practices, it is an intriguing concept (if not a good idea).

In a somewhat related news  item, a group of patients afflicted with Fabry’s disease have asked The U.S. Department of Health and Human Services (DHHS) to “march in” under the provisions of the Bayh-Dole Act, and permit/require Mt. Sinai School of Medicine, the owner of two patents (U.S. Pat. Nos. 5356804 and 5580757) covering the drug Fabrazyme, to grant additional licenses to manufacture and market the drug. This request is made under the “march in” provisions of the Bayh-Dole act, which founded the entire “industry” of university technology transfer in the 80’s. It is based on the allegation that Genzyme cannot meet the need for the drug, given its recent quality control problems. During the early years of the AIDS epidemic, such requests were made regarding the few anti-HIV drugs that were then available. As far as I know, none of the prior requests were granted.

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Australian Patent Office Grapples With “Obvious To Try”

A note from Bill Bennett of Pizzeys (Australia seems to be adopting the standard from In re O’Farrell just as the US courts are distancing themselves from it):

We have previously flagged that the APO might modify their practice in relation to the “obvious to try” standard.

We have now observed that the examiner’s manual was amended on August 2nd.  (This can be found by clicking here.)

According to the APO, an invention will be obvious to try if there is a “reasonable expectation that the solution might well solve the problem”.

This appears to echo the High Court’s decision in Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59, which expressly endorsed the reasoning of the US Court of Appeals for the Federal Circuit in In re O’Farrell (853 F.2d 894) as the better approach under Australian law.

The Australian Examiner’s Manual now recognises that Australian law includes the requirement that anything suggested as “obvious to try” must carry with it a “reasonable expectation of success” in order to make the invention obvious.  As in US law under O’Farrell, rebuttal of the factual assertion that any anticipated success is “reasonable” may therefore help overcome objections that the invention is obvious because it was “obvious to try”.

In practice, Australian examiners may not be so bold as to assert “obvious to try” as the sole reason for a claim rejection in view of the overarching principle that the skilled person must be “directly led” to the invention for it to be obvious.

Indeed, recent examination reports are asserting that references “provide motivation to make the invention” and “directly lead the skilled person to the invention” and only then stating as a consequence of those direct leadings that a “reasonable expectation of success” has been established.

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MYRAID APPEAL UPDATE: WHO’S RECUSING WHO?

Subtitle: “Who’s Your Amicus, Baby?” On July 19th, various Blogs reported that the ACLU (Plaintiffs’ attorney in the appeal of the district court’s ruling in the case sensibly abbreviated by Hal Wegner as AMP v PTO) filed a motion in the Federal Circuit seeking to recuse Chief Judge Rader on the basis of allegedly pro-DNA comments he made at a symposium at the International BIO Conference in May. The session was chaired by Jennifer Gordon of Baker Botts, who authored BIO’s amicus brief filed in AMP v. PTO at the district court level.  I have read this well-reasoned “law and policy” brief, and it provided an outline for Judge Sweet’s opinion that rejected pretty much every word of it.

More recently, the Federal Circuit Bar Association has raised the visibility of this motion by filing an amicus brief authored by Edward Reines and Amber Rovner of Weil, Gotshal in support of neither party but espousing the standard for recusal based on a judge’s statements at a conference:

“If the Judge’s comments can reasonably be understood as general expressions regarding the law, recusal is not warranted, even if the views expressed are also relevant to particular pending or impending case. Correspondingly, recusal should be considered, based on such comments, only if the objectively reasonable interpretation is that those comments constituted the expression of the judge’s specific views regarding the proper disposition of a particular identifiable pending or impending case, and reflect bias or predisposition (i.e., an unwillingness to consider the case with an open mind.)”

All clear?  Let’s try this, from page 9: “Simply put, participation in an organization’s event does not imply adoption of every position taken by the organization as an amicus or otherwise.  [Unfortunate cite department]: See generally In re Charges of Judicial Misconduct, 404 F.3d at 694….case-specific conferences are the exception, not the rule, however, and in the absence of such unusual circumstances [judge approved funding for conference which included a ‘Hollywood-style pre-screening of the plaintiffs’ case] a judges attendance at a conference or educational retreat should not lead to disqualification.”

Well, I never saw anything at a BIO conference so flamboyant that could be called “Hollywood-style” but neither was the judge attending a CLE course at a scholarly retreat.  This may not be over by a long shot, particularly since the issue on appeal can be summarized in one short sentence (see below).

One Fed. Cir. Judge that the ACLU is not going to try to disqualify is Judge Dyk. In Intervet, Inc. v. Merial Ltd., Appeal No. 2009-1568 (Fed. Cir. 2010), the Judge wrote a concurrence-in-part and a dissent-in-part, to emphasize that the issue of whether or not certain of the claims that had been construed by the court had implicitly condoned that “isolated DNA claims” embraced patentable subject matter.  The Judge wrote:

“The question is whether the isolated DNA molecule [apart from its uses] is patentable subject matter. Neither the Supreme Court nor this court has directly decided [this question].  Although we have upheld the validity of several gene patents…none of our cases directly addresses [this question]….I think such patents do in fact raise serious questions of patentable subject matter….allowing the patentability of naturally occurring substances [would] preempt the use by others of substances that should be freely available to the public.”

Please wait one minute, Judge Dyk, the form in which the public uses their DNA (in their chromosomes) remains “freely available to the public.”  No one has seriously argued that a patent on an isolated DNA sequence that is part of the human genome would permit the patentee to go up to a passer-by and demand a royalty because he/she is using the gene in an infringing manner.  In an analogy that could have been drawn by the ACLU attorneys, who have likened isolating DNA from the genome to picking gold nuggets out of a stream: “The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question [Who said it did?].  It would be difficult to argue for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.” Here is a Judge who has never heard of, or read the lyrics of, “Autumn Leaves.” I sure hope he finds time to read the BIO amicus brief before he “reflect[s] bias or predisposition” – again.

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Testing The “Myriad Method Claims” Using The USPTO Interim Guidance – Beyond “M or T”?

In my last post, I discussed the contents of the USPTO’s “Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos.” One of the most intriguing single points for discussion comes at the end of part III of the Notice, before the eight “pro” and “con” factors are listed:

“To date, no court presented with a subject matter eligibility issue, has ever ruled that a method claim that lacked a machine or a transformation was patent-eligible. However, Bilski held open the possibility that some claims that do not meet the “M or T” test might nevertheless be patent eligible.”

Among those courts are the S.D.N.Y. In his decision in Ass’n. for Molecular Pathology v. USTPO et al (the “Myriad case”), Judge Sweet invalidated just such claims. Among them was claim 2 of U.S. Pat. No. 6033857: [shortened by me] A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene…in a tissue sample from said subject with the germline sequence of the wild-type BRAC2 gene, wherein an alteration in the germline sequence of the BRAC2 gene indicates a predisposition to said cancer.”

Claim 1 is more succinct: It is directed to a method for identifying a mutant BRAC2 nucleotide sequence in a suspected mutant BRAC2 allele which comprises comparing the sequence of the suspected mutant sequence with the wild-type [reference] sequence, wherein a difference between them identifies a mutant BRAC2 sequence.

Judge Sweet would have none of this. He distinguished Prometheus as involving actual transformation and stated: “In contrast, the language of the method claims-in-suit and the plain and ordinary meanings of the terms “analyzing’ or ‘comparing’ establish that the method claims-in-suit are directed only to the abstract mental processes of ‘comparing’ or ‘analyzing’ gene sequences.” Judge Sweet refused to read the claims as including the physical transformations associated with sampling and sequencing, but he acknowledged that certain dependant claims – not asserted – contained such “transformative events.” Slip op. at 141-143. However, he concluded: “Even if the challenged method steps were read to include the transformations associated with isolating and sequencing human DNA, these transformations would constitute no more than ‘data-gathering step[s]’ that are not ‘central to the purpose of the claimed process.’” [citing Grams] Slip op. at 145.

These claims are in effect directed to diagnostic assays based on “data mining.” It seems that about every day there is another item of genomic news reporting that a mutation at position x of gene y indicates a predisposition to, if not presence of, some pathology or the ability, or lack thereof, of the subject having the mutation to be helped by a particular drug. This is the foundation of personalized medicine. Pretty soon, most of us will be able to afford to carry the DNA sequences of our individual genomes around on a memory stick. Before a particular treatment or lifestyle change is initiated, the doctor will be able to compare the relevant regions of our genome with reference regions that will let the doctor know if the diagnosis is correct and if the proposed therapy will help. The “testing lab” our DNA data is sent to to will not need to sequence it, and they will already have the reference or benchmark sequences (the “wild-type sequences” of the Myriad claims). They will simply compare the sequences and report the differences they find, and where they are (and probably, what they mean as well). Welcome to the future of medicine.

Claims such as the Myriad process claims do not recite an M or T, but they also do not simply attempt to claim the broad concept that mutations in human DNA indicate presence or propensity for disease (“the concept”). The claims implement the concept in a tangible way, by looking for mutations in a few defined sequences. The performance of the steps is observable and verifiable (presumably, a computer will compare the sequences and identify the specific mutations, if any, that are present. The results had better be verifiable statistically or no one will use the test.)

So how would an Examiner in possession of the Interim Guidance act on the Myriad diagnostic method claims today? The Interim Guidance does disparage method claims based on mental steps, beyond warning against patents on naked concepts. Certainly, the method claims directed to diagnosing a predisposition for breast cancer “describe a particular solution to a problem to be solved” and “Implement the [general] concept in a tangible way.” But what fate for the claims that simply recite identifying a mutant sequence in a BRCA2 gene? Is the “comparing step” enough to avoid the prohibition against “monopoliz[ing] a natural force or patent[ing] a scientific fact?’ For now, you be the judge.

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