Posts Tagged ‘Bilski’

Prometheus’s Brief – Don’t Confuse Us With “LabCorp”

Monday, November 21st, 2011

It took me a while to get around to reading Prometheus’s brief to the Supreme Court in Mayo v. Prometheus Labs., No. 10-1150 (S. Ct. Oct. 31, 2011), because I was pretty sure how it would read and, in fact, there are no major surprises. Prometheus argues that their claims must be considered as a whole, and that section 101 does not categorically exclude processes that end by providing useful information – what I called a “thinking step” in an earlier post. Prometheus argues that “Mayo’s categorical rule that all claims must end with an action step would just multiply byzantine claim drafting…This Court has routinely recognized that patents can properly leave ample room for ‘the judgment of the operator.” Res. Brief at 35. Prometheus also reaches into the Bilski opinion for one of the few helpful quotations: “Nothing in Bilski was intended to ‘create uncertainty as to the patentability of …advanced diagnostic medicine techniques.’ [130 S. Ct. at 3227[ let alone all processes provided valuable information.” Res. brief at 36.

Prometheus also takes the reader along the well-worn path of Morse, Benson, Flook and Grams to argue that the monitoring patents do not preempt all practical use of any “relevant principle” but then neatly circles back to Tilghman, 102 U.S. at 709, to argue that the patent in question “wholly preempted the ‘natural phenomenon’ that water applied at high temperature and pressure would have the stated effect on fatty bodies. But it did not preempt the broader natural principle that high temperature and pressure tend to break chemical bonds, and it did not preclude the use of other methods to separate fat acids and glycerine from fatty bodies, such as sulfuric acid distillation or steam distillation.”

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Classen Immunotherapeutics v. Biogen Idec: Corrected Opinion Likely?

Friday, September 2nd, 2011

On August 31, 2011, a three-judge panel of the Fed. Cir. (Rader, Newman, Moore) revisited the court’s 2009 summary affirmance that the claims of three Classen patents were not directed to patentable subject matter. (A copy is at the end of this post.) This reconsideration was a result of a GVR from the Supreme Court in the wake of the Bilski decision (130 S. Ct. 3218 (2010); GVR, 130 S. Ct. 3541 (2010)). The Bilski decision rejected the M or T test as the sole test by which to evaluate the patent-eligibility of a process, and the Fed. Cir. had based its earlier affirmance of the district court’s ruling on the failure of the claimed processes to accomplish a transformation (304 F. App’x 866 (Fed. Cir. 2008). In March 2009, one of the first posts on this blog was a note I co-authored, criticizing the court for not recognizing that the recited immunization steps accomplish the biotransformation of an animal from a nonimmune state to an immune state. On December 17, 2010, I posted a note on the court’s affirmance of its earlier decision in Prometheus v. Mayo, that the disputed method claims were directed to patentable subject matter, and I suggested that the original Classen decision should be “fixed.” Judges Rader and Newman agreed that 2/3 patents in suit—the ‘739 and the ‘139 patent—claimed patentable subject matter, while a third patent, U.S. Pat. No. 5,723,283 fell into the “abstract ideas” exception to s. 101.

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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.