Archive for August, 2010

Court Blocks Obama’s Stem Cell Order

Wednesday, August 25th, 2010

In December of 2009, I argued that President Obama’s Executive Order 13505, that lifted President Bush’s 2001 Order banning the use of federal funds for embryonic stem cell (ESC) research, should be a Top Biotech Story of 2009. The Bush Order had banned all federal funding for ESC research except for research on a small number of lines that existed prior to his order. Obama’s substitute order permitted agencies like NIH to fund research on cell lines produced after the Bush ban, so long as the funding was not used to produce the lines by the destruction of embryos. NIH went on to develop guidelines for approving fundable new cell lines.

In the December 2009 post, I noted that Congress had annually enacted the so-called Dickey-Wicker amendment that banned federally-funded research that harms or destroys human embryos. The Administration tried to argue that Order 13505 did not permit funding of obtention of ESCs from embryos, but the Judge found this a distinction without a difference.

Questions remain. While Judge Lamberth (D.C.D.C.) stated that the decision was intended to restore the status quo, the status quo, e.g., the Bush Order, is long gone. Research projects using newly approved lines have been started. Even if they can be continued with private funding, it is far from clear that these “illegal” cell lines can be used at all.  But what if the lines were produced abroad and sent to a U.S. lab? Would even the limited research permitted under the Bush order be fundable now? What is supposed to happen to ongoing projects that cannot find non-federal funds to keep the laboratory lights on? With patent protection for ESCs uncertain at best, the future of this research in the U.S. is cloudy at best.

Read New York Times Article on Judge Lamberth’s Decision.

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

Thursday, August 12th, 2010

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.

Australian Patent Office Grapples With “Obvious To Try”

Tuesday, August 10th, 2010

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.


Monday, August 9th, 2010

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.