Put another way, it is time for Jones Day to click their well-polished heels and go home. Today, the U.S. Government filed an amicus brief largely supporting the arguments by AMP/ACLU that isolated DNA is essentially the same molecule after isolation as it is in vivo – in other words that it is not a “new composition of matter.” The amicus brief (a copy is found at the end of this post) – that was not co-signed by the PTO – conceded that cDNA was changed sufficiently by the hand of man that it should remain patentable. This is the position that the Solicitor took when Myriad’s appeal was argued before the Federal Circuit, and is likely to carry substantial weight at the Court. The Court may well not draw any such distinction.
Posts Tagged ‘patent attorney’
On Friday, Oct 5th, the Supreme Court granted cert. to review the Fed. Cir.’s decision in Monsanto Co. v. Bowman, App. no. 2010-1068 (Fed. Cir. September 21, 2011). (A copy of the decision is at the end of this post.) Bowman, a soybean farmer, had purchased commodity (mixed -source) seed from a local grain elevator to plant as a “second crop” since he did not want to pay the higher cost that a licensed seed grower would charge. All sales to growers of the Monsanto seeds in question – these particular seeds are transgenic in that they carry, and pass on, the trait of resistance to glyphosate – are subject to a “standard form limited use license,” the “Monsanto Technology Agreement,” that licensed the two patents-in-suit to growers under the conditions, inter alia, that they would use the crop for planting only in a single season, not to resell the seed, and not to save seed for replanting. The growers can sell the seed to grain elevators as a commodity – e.g., for use as food or feed.
The following is a guest post from Schwegman Lundberg & Woessner’s associate Ricardo Moran.
The issues on appeal were whether Travel Caddy, Inc. had committed inequitable conduct for: (i) not disclosing the existence of the litigation on U.S. Patent No. 6,823,992 (“the ‘992 patent”) during the prosecution of the application that matured into U.S. Patent No. 6,991,104 (“the ‘104 patent”; the ‘104 patent is a CON of the ‘992 patent; the ‘104 patent was filed shortly before the ‘992 patent issued); and paying small entity fees, even though Travel Caddy was not entitled to claim small entity status. (PDFs of both patents are available at the end of this post.)
Non-disclosure of the ‘992 patent litigation
To establish unenforceability based on inequitable conduct in the U.S. Patent and Trademark Office (PTO), it must be shown that (i) information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, with (ii) the intent to deceive or mislead the patent examiner into granting the patent. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290-92 (Fed. Cir. 2011) (en banc). Withholding of material information and intent to deceive or mislead must be established by clear and convincing evidence. Id. at 1287 (citing Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008)).
Following its reversal of the Fed. Cir.’s decision in Mayo v. Prometheus (“Mayo”), the Supreme Court GVR’d in response to AMP’s (read: ACLU’s) appeal of Myriad’s claims to isolated DNA sequences and to a method of screening potential anti-cancer drugs using cells transformed with BRCA DNA (“claim 20”). I have reviewed a number of the amicus briefs that were filed prior to the June 15th deadline (oral hearing at the Fed. Cir. is set for July 20th) and they prompted me to reflect on the magnitude of what has been lost and the potential for future judicial limits on patentable subject matter.
First, a quick look back at what was lost in Mayo. Certainly, going forward no one is going to draft claims like the main claims to giving an AZA-type drug, measuring the level of the 6-MP metabolite and drawing a conclusion about whether to adjust the dose. However, because the Prometheus claims were method-of-medical treatment claims in disguise, it seems to me that claims to dosing regimens of all types, for any purpose, are no longer patentable subject matter. Such claims are often used by NDA holders to obtain add-on patents, that are listed in the Orange Book as methods of using the approved drug. The Fed. Cir. has invalidated such claims as inherently anticipated or as obvious in view of the primary use of the drug, e.g., an effective dose treats cancer, but the court’s job just got a lot easier.