Posts Tagged ‘court of appeals’
Tuesday, September 25th, 2012
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)).
(more…)
Tags: biotechnology, biotechnology law, court of appeals, Federal Circuit, ip, Outside The Box, patent attorney, Patent Law, patents, Ricardo Moran, Travel Caddy, Warren Woessner
Posted in Inequitable Conduct/Rule 56 | 1 Comment »
Tuesday, June 26th, 2012
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.
(more…)
Tags: biotechnology, biotechnology news, court of appeals, Eli Lilly, Federal Circuit, intellectual property, ip, Myriad, patent attorney, Patent Law, patents, Supreme Court, Warren Woessner
Posted in Patentable Subject Matter | Comments Off
Thursday, April 26th, 2012
When a three judge panel of the US Court of Appeals for the D.C. Cir. dismissed a preliminary injunction obtained by plaintiffs in April 2011, and the lower court judge then dismissed plaintiffs’ suit to block the Administration’s guidelines permitting funding for embryonic stem cell research as violative of the Dickey-Wicker amendment banning funding that might destroy or harm a human embryo, I thought the issue had been laid to rest. However, plaintiffs – not the Government – have now appealed to the appeals court, arguing that the prior ruling overturning the injunction banning hESC research is not binding on the present panel.
The earlier panel had ruled that the Dickey-Wicker amendment, that is tacked onto some bill sure to pass Congress each year, is ambiguous in view of the more precise policies urged by the Administration and the NIH, regulating hESC research. The plaintiffs argued that the earlier panel ruling simply involved injunctive relief and should not be “the law of the case” regarding the merits of their suit. Defendants and amici argued that the panel effectively analyzed the merits of the suit: the conflict or congruence between Dickey-Wicker and the NIH policy resuming funding for stem cell research.
If the current panel does not agree that it is bound by the earlier panel’s analysis and sides with the (anti-hESC research) plaintiffs, this case will wend its way to the Supreme Court. However, if the Administration changes in November, and a new Administration reinstates the “Bush ban,” the appeal will be moot. Those who support hESC research should hope that the stem cell researchers can get some grants funded and new cell lines approved in the next six months or so. A pro-science door that has been open for about three years may be about to close.
Read the article from Regenerative Medicine Forum
Prior posts on this subject can be found here:
July 28, 2011
May 2, 2011
Tags: biotechnology, biotechnology law, biotechnology news, court of appeals, dickey-wicker, Federal Circuit, hESC research, intellectual property, ip, Patent Law, patents, sherley, stem cell research, stem cells, Supreme Court, Warren Woessner
Posted in Stem Cells/Cloning | Comments Off
Saturday, December 31st, 2011
I spent a day or two looking back over the breaking IP news that resulted in posts on Patents4Life. I wrote most of them, but want to take a pause to thank regular contributors Paul Cole, Ron Schutz and Stefan Danner for their help. Patents4Life was originally intended to be a “blawg” focused on IP developments affecting the Life Sciences and, as 2011 comes to a close, I have put together a “top ten” list of stories to which attention had to be paid – by all of us in most cases – litigators, prosecutors and tech transfer professionals in the U.S. and abroad. The single most-apparent trend in IP last year was the increasing globalization of IP law – consider inter-office work-sharing and the prosecution highway. But I don’t want this column to go on into 2012, so here, in reverse order, are the “legal events” that dominated the netwaves in 2011. (I apologize for what I hope will be minor errors of fact and spelling – I am writing this from notes I made while back-tracking through the year.)
10. The Stem Cell Suits. In Sherley v. Sebelius, the district court finally dismissed the suit which had resulted in a ban on Federal funding for stem cell research, after the Court of appeals reversed its initial decision. (See Post, July 28th). However, in October, the Court of Justice of the EU ruled that claims to embryonic stem cells or even to cells that could become sources for embryonic stem cells were not patentable. (See post, Oct. 18th). Some types of gene therapy were indicated to be allowable. The future of embryonic stem cells is cloudy with a chance of further retreats like Geron’s.
9. On October 18th, Saint-Gobain petitioned for cert., urging the Supreme Court to answer a burden of proof question that comes down to: “Does holding a patent on an improvement on a patented invention that does not literally infringe insulate the accused infringer from infringement under the doctrine of equivalents?” This question has been simmering under the surface of infringement law for decades, the Fed. Cir. is clearly divided and the Supreme Court might bite. See Post of March 8, 2011 as well as October 14th post.
(more…)
Tags: AIA, America Invents Act, AMP, ANDA, Bayh-Dole Act, biotechnology, biotechnology law, biotechnology news, caraco, court of appeals, Dr. Stefan Danner, European patent, Federal Circuit, intellectual property, ip, microsoft v i4i, Myriad, Patent Law, patents, Paul Cole, Pharmaceutical law, Prometheus v. Mayo, saint-gobain, Schutz, sherley, Stanford v Roche, Supreme Court, Therasense, USPTO, Warren Woessner, WDR
Posted in Miscellaneous | Comments Off
