Posts Tagged ‘Kubin’

Happy Birthday Patents4Life – We Are 2!

Thursday, March 3rd, 2011

Well almost. The first posts on Patents4Life were dated March 24, 2009. One was on a fairly obscure decision, SRI International (the prior art effect of internet postings), but the other two were on the Fed. Cir.’s summary affirmance of the district court’s finding of invalidity in Classen (applying Bilski as they saw it) and on the Board’s decision ex parte Kubin (that went on to invalidate a DNA patent as obvious to try in the wake of KSR). These decisions were just the first ripples of the tidal wave of judicial decisions at all levels that have limited the scope of patent protection. While the Supreme Court in Festo facially rejected the absolute bar to the application of the doctrine of equivalents endorsed by the Fed. Cir., no one would have picked it as the high water mark of pro-patent case law in our time. The presumptive surrender of access to the DOE has proven daunting to the use of the DOE in practice. But compared to most of the later decisions on central issues of patent law, Festo looks like a beacon of hope.  If you have been reading this blog (or any number of others) over the last two years, the number of “anti-patent” decisions that have been handed down is simply overwhelming.

Now some of them are not yet carved in judicial stone, being at various stages of appeal, but the sum of KSR,  Bilski (well, I guess it was more pro-patent than the strict M or T test it replaced with a test yet-to-be-determined), Ariad v. Lilly (WDR grows up), Lilly v. Sun,(broadened base for obviousness-type double patenting), Centocor v. Abbott (WDR rules),  Microsoft v. i4i (lower evidentiary bar to patent invalidation), Janssen v. Teva (no utility for hypothetical bioactivity), Stanford v. Roche (weakens Bayh-Dole Act), Myriad (DNA and diagnostics are natural phenomena), Therasense v Becton Dickinson (more ways than ever to show inequitable conduct), and the WARF stem cell reexamination (WARF lost at the Board) do not bode well for the system Jefferson hoped would help modernize the young republic.  The only bright spot on this judicial trial of tears was the Fed. Cir.’s affirmance in Prometheus v. Mayo in December that methods of medical treatment and monitoring past muster under Bilski.  And yet, even this modest decision may be reconsidered by the Supreme Court.

Still, the last time the full court addressed the issue of patentable subject matter was in 2001 in Pioneer v. JEM Ag Supply, in which the patent eligibility of plants was affirmed, and the Court refused to back down from Chakrabarty.  The issuance of the Chakrabarty patent was 30 years ago this month and most would agree that granting biotech patents has done our society a lot more good than it has rained evil upon us. Except, perhaps for the folks who are trying to block Obama’s order permitting funding for stem cell research. Or the Myriad plaintiffs. But they are in the minority. Aren’t they?

AUTM Panel To Address A “Myriad” Of Challenges

Thursday, February 24th, 2011

Robert S. MacWright, J.D., Ph.D., the new head of tech transfer at the Salk Institute, will moderate a panel at the 2011 Annual Meeting of the Association of University Technology Managers (AUTM) on March 1st in Las Vegas.  The panel, entitled, “The Ever Changing Kaleidoscope of U.S. Patent Law,” will examine what MacWright terms “a decade of meddling by the legislature and the courts.” The “panel of experts” – that will include, Sandra Kuzmich of Frommer Lawrence, Gonzalo Merino, J.D., Ph.D., of Columbia and me – will review the current state of affairs and “with considerable risk of error, [we] will also make predictions about other changes that may lie ahead.”

Apart from encouraging you to attend this session (Tuesday, D1 on the program), the trend of judicial decisions at all levels to weaken patent protection for pharma/biotech inventions is alarming. The big losses like KSR (which eliminated the rigorous TSM test for obviousness), Merck v. Integra (expanded safe harbor for drug research), Ariad (“Yes, Virginia, Section 112 does contain a written description requirement”), and Myriad (No patent protection for DNA or for diagnostics used in personalized medicine) have tended to overshadow smaller but still significant anti-patent decisions like In re Kubin (Deuel reversed), In re Fisher (ESTs and SNPs lack utility) and In re Alonso (good-bye to the “monoclonal antibody exception”).

The Federal Circuit’s holding in Prometheus v. Mayo was one of the few bright spots (methods of screening for drug efficacy and medical treatment are patentable – yea!) but even this decision may be reviewed by the  Supreme Court – again (it granted cert. once). And while it is difficult to see the Supreme Court’s Bilski decision as a good thing, at least an entire category of patentable subject matter was not eliminated. If the “M or T” test had been affirmed, the Federal Circuit would have been required to invalidate most of the Myraid diagnosis claims. Now Judge Rader has to figure out how to support a holding that the Myriad “comparing DNA sequence” claims are less abstract than Bilski’s claims to hedging commodity risk. And he is the judge that the ACLU is trying to recuse as prejudiced in favor of biotech! It’s going to be an interesting year.

Federal Circuit Mows Down Bean Patent – Reading Between the Rows

Wednesday, July 15th, 2009

On July 10, 2009, the Court of Appeals for the Federal Circuit in In re Pod-Ners, Appeal No. 2008-1492, affirmed the Board’s rejection of all of the claims of U.S. Pat. No. 5,894,079. The Board had rejected as obvious claims to, inter alia, a pinto bean plant producing yellow beans of a certain color, as well as claims to the beans themselves, which had been deposited in the ATTC. The claims were rejected over a publication argued to disclose the same yellow bean, in view of another non-prior art publication relied upon as demonstrating that the claimed bean and the “well known” yellow bean are gentically identical.

While only six pages long, and eminently predictable given the fact that the Mexican government had alleged theft of their biological heritage, the decision feels muddled. To begin with, the panel clearly would have preferred to invalidate the patent as anticipated by the “well-known” yellow bean, “Azufrado Peruano 87.” The law is well-settled that non-prior art publications can be relied upon to show that a prior art reference is, in fact, anticipatory. But whether anticipated by, or obvious in view of, the prior art publication, it seems that the panel should have acknowledged that the prior art publication which, after all, disclosed a plant variety, was enabling. Historically, a printed publication could not per se place a plant variety in the possession of the public; the public was believed to, in fact, need to have access to the plant. This gap was simply filled by the panel by noting that the older variety was “well known.” This is getting pretty exotic, but I seem to recall a decision which held that evidence of the commercial sale of a plant described in a printed publication was sufficient to render the publication enabling. This decision validated the PTO’s examination policy then in effect. Does anyone but me remember that decision?

Finally, the decision has an odd anti-biotech air about it that I don’t think I am imagining. In April, the Fed. Cir. overturned In re Dueul and In re Bell finding a previously unisolated and unexpressed cDNA sequence obvious, primarily because it would have been obvious to use known techniques to isolate the “gene” and to express it as a protein that was known to exist, but had not itself been isolated. In re Pod-Ners, the panel concluded:

“The Board correctly held that the subject matter of the ’079 patent – yellow beans, the plants they produced and a method for reproducing such plants by cross-breeding – would have been obvious to one [of] ordinary skill in what POD-NERS identifies as the “breeder-grower” art. … [Appelant] does not contend that he devised or applied new or unexpected techniques in reproducing the beans.”

Now substitute “cDNA encoding the NAIL protein, the NAIL protein produced thereby and a method for cloning the DNA” for the description of the holding of the Board given above, and you have the Kubin decision. The patentee in fact had isolated yellow beans (the DNA sequence) from a bag of beans of various colors (the genome) and bred (“cloned”) them so that they became a unique cultivar.

The panel affirmed the invalidity of the claims to the cultivar, which was recited to have a “yellow coat described as within a narrow range of shades of yellow on a particular color chart” without ever stating that the “prior art” bean was the same color. In fact, the panel conceded that the beans may only have been “substantially the same”. If patentee had obtained a Plant Patent instead of a utility patent, the opponents and the court would have had to find that the cultivars were indistinguishable in appearance in order to invalidate the patent. However, Plant Patents are not available for plants that reproduce via seed. My comment is becoming as long as the decision, as I try to turn it into a fable, but it is adamantly not “Jack and the Beanstalk.” These beans did not bring their owner a pot of gold. In the end, the patent wasn’t worth a hill o’ beans.

Pod-Ners Decision
ETCGroup

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.