Archive for February, 2012

Last Chapter In The “Corn Wars” Or Just The Latest?

Wednesday, February 29th, 2012

On February 28, 2012, a three-judge panel of the Fed. Cir. ruled that the Board properly ruled that Monsanto prevailed in interference no. 105,728, involving the patent claims directed broadly to transgenic corn. (A copy of this ruling is found at the end of this post.) Although Pioneer had filed its priority application in 1988, well more than one year before Monsanto filed the 2005 application involved in the interference,  the panel found that Monsanto was not barred by 135(b)(1) since earlier applications in the chain of the Monsanto applications that led up to the 2005 application claimed “substantially congruent” subject matter in the aggregate (e.g., broadly claimed transgenic corn). The panel also agreed with the Board that Pioneer’s first application did not contain an enabling disclosure of the claims at issue. The main Monsanto claim is a model of a broad transgenic corn plant claim (the Latin name for what modern corn farmers raise is Zea mays):

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Bayer v. Lupin – Patenting The Label Redux

Tuesday, February 28th, 2012

In my post of January 13, 2011, I discussed AstraZeneca LP v. Apotex, a Fed. Cir. decision in which AZ argued successfully that the proposed  Apotex labeling for an anti-asthma drug would induce infringement if the generic were marketed with dosing information covered by add-on patents that AZ had obtained (the primary patents had expired). In the present suit, (Bayer Schering Pharma AG v. Lupon Lid., Case No. 1:10-cv-05423-PGG), Bayer is asserting a patent (U.S. 5,569,652 – a copy is found at the end of this post) that claims a method of using Yasmin – a combination of dihydrospirorenone (“dropsirenone”) and an estrogenic compound—to achieve a gestagenic, antiandrogenic and antialdosterone effect. These effects can potentially render the drug useful to treat hormonal irregularities in women throughout life. (A copy of the Order and Notice of Appeal are available at the end of this post.)

Lupin filed a paragraph IV notice with its ANDA that said that it would not infringe this patent because it only wanted to market the combination to prevent pregnancy. However, the antialdosterone effect (called “antimineralocorticoid activity”) is disclosed in the body of the label, and Lupin had not tried to get a label approved without that information (a “carve out”). Bayer argued that approval of such a label would induce infringement of the ‘652 patent while Lupin argued that, in accord with the principles of the Hatch-Waxman Act, it should only have to establish that it could market for the approved “Indications and Usage” on the Bayer’s label (“prevent pregnancy”), and that the court should not require it to establish non-infringement of unapproved uses.

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Top Apps For Lawyers

Friday, February 24th, 2012

Attorney At Work, a website that provides “one really good idea every day” recently published a list of the top iPhone and iPad apps for lawyers. Joan Friedman wrote:

If you’re a smartphone or tablet user—veteran or newbie—you know there’s nothing better than a delicious new list of apps to explore. Oh, the apps! Some folks spend hours carefully investigating each one before committing to buy or even download one for free. Others, like me, take more of a tasting-table approach, feeding the insatiable app-etite by downloading and discarding from all the “most popular” lists, and testing friends’ and bloggers’ recommendations as often as possible. It was pretty great, then, when National Purchasing Partners and Verizon contacted Attorney at Work and offered to share their brand-new list of the top iPhone and iPad apps being used by lawyers at the start of 2012.

You can find this article and the list of apps here. Hopefully you will find something new to either help you or, at the very least, entertain you.

Supreme Court Declines To Review “New And Improved” Written Description Requirement

Wednesday, February 22nd, 2012

Cheap viagra softt=”" width=”150″ height=”150″ />On Tuesday, the Supreme Court denied Centocor’s (now “Janssen”) petition for cert. and so let stand a ruling that Centocor’s patents on humanized monoclonal antibodies (covering Abbott’s Humira) are invalid for failure to meet the written description requirement (WDR) of s. 112(1). Since cert. was not requested following the en banc decision in Ariad v. Lilly, which essentially reached the same conclusion on drugs — not yet discovered — that might alter the NF-kB pathway, this was the first good chance the Supreme Court had to weigh in on the heightened WDR that has been applied with regularity by panels of the Fed. Cir. to invalidate biotech patents claiming early stage inventions since it was articulated by Judge Lourie in the 1997 U. of Cal. v. Lilly decision. As I have written in a number of posts on subsequent decisions, this new and improved WDR has led biotech patentees down a trail of legal tears as, with few exceptions, their patents have failed the WDR – even if the claims were arguably enabled by the specification—a question that the Fed. Cir. has increasingly refused even to consider once the increasingly easy button of the WDR has been used to invalidate the patent.

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