Archive for April, 2012

Sherley v. Sibelius – The Undead Threat To Stem Cell Funding

Thursday, April 26th, 2012
Green Energy Sources

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

Eurand v. Mylan –A “School Of Obviousness”

Friday, April 20th, 2012

How to teach preschool children/>When I read the April 16th decision (App. No. 2011-1399, -1409 (Fed. Cir. April 16, 2012)) (a copy is available at the end of this post) in which a Fed. Cir. panel of Newman, O’Malley and Reyna reversed a district court’s finding that two Aptalis patents on a controlled-release form of a muscle relaxant were obvious, I expected a routine recitation of the KSR “standards” and not much more. Therefore, I was pleasantly surprised to find that Judge O’Malley had authored one of the clearest and most thorough explications of the obviousness inquiry that I have ever read in an opinion. Every patent attorney should read this decision and so should every examiner.

The claims in question are thick with “pharmacokinetic values” and the question confronted by the court was whether or not it would have been obvious to “ascertain the correct pharmacokinetic/ pharmacodynamic (‘PK/PD’) profile” wherein the “determination of a PK profile is a quantitative exercise. The determination of PD, or therapeutic effectiveness, however is a qualitative exercise.” Of course the holding was ultimately “no,” and the panel may have been a bit snowed by the technical arguments, but the explanation of the s. 103 standards mandating reversal are what gives this opinion its force.


Major Changes to IP Law in Australia Enacted

Thursday, April 19th, 2012

This guest post by Tom Gumley, PhD, a partner in the well-known Freehills Patent and Trademark firm provides a lengthy guide to the changes wrought by Australia’s new patent law, that was enacted on April 15, 2012. The law brings Australia closer to the US in many of its legal standards and, like the AIA, goes into effect at various times in the future.


We are pleased to provide Freehills’ guide to Australia’s new patent law [available at the end of this post] that was signed into law on April 15, 2012.

This new law will have far-reaching consequences for those seeking and enforcing patent rights in Australia, and ultimately will establish a class of new Act patents to which higher validity standards required by the new law will apply, and old Act patents to which relatively lower validity standards established by the old law will apply.

There will also be important consequences regarding exemption from infringement for patentees and alleged infringers with the codification of experimental use provisions, and a broadening of old law exemptions to cover acts done for seeking regulatory approval of any product for which approval is required for marketing.

If you or your clients have business interests in Australia, it is very important that you come to an understanding of the new law sooner rather than later, as in many instances, the opportunities to be had and the risks to be mitigated under the new law will require you to take relevant action now.

Given the complexity of the new law, our commentary is necessarily of a general nature and we strongly advise you to contact us should you require professional advice on any particular issue.


Tom Gumley PhD
Freehills Patent and Trade Mark Attorneys

Guide to Australia’s new patent law

Supreme Court Reverses In Caraco Appeal

Tuesday, April 17th, 2012

Today, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, in an opinion authored by Justice Kagan (a copy can be found at the end of this post), the Court reversed the Fed. Cir.’s divided 2010 decision that an ANDA filer (a “generic drug company”) sued in para. IV litigation cannot assert a counterclaim that the NDA holder (“the innovator”) listed a use code in the FDA Orange Book that is overly broad. This question is important because during litigation, Novo had broadened its use code to cover uses Caraco alleged were not within the claims of the listed patents, but which Caraco wanted to be able to include in its labeling. So the question presented was:

“Whether an ANDA applicant may assert a counterclaim under Section 355(j)(5)(C)(ii)(I) by alleging that the brand name manufacturer’s patent information [the use code] does not accurately and precisely describe the method of use claimed by its patent.”