Posts Tagged ‘IP law tools’

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.”

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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.

New Blog On AIA Aims For Co-Op Approach

Wednesday, January 18th, 2012

With a tidal wave of proposed regulations implementing the AIA poised to hit IP practitioners – ready or not – it seemed worthwhile to point out a new “Blawg” recently launched to help keep our heads above the murky legal waters to come. My firm, Schwegman Lundberg & Woessner, in cooperation with the IP group of the general practice firm Leonard Street and Deinhard, has opened a website, Patent RE-forum – Perspectives on the America Invents Act at http://www.americainventsact.com/. This blog blends the patent prosecution expertise of SLW with the experience of the IP litigation team at Leonard Street, and has already posted a series of short essays on most of the sections of the AIA: “Breaking Down the AIA.” Members of the William Mitchell College of Law IP Institute have also been invited to contribute posts.

Since Patents4Life does not intend to follow the new regulations closely, except as they will affect life sciences/biotech practice, the site should be a good supplement to my musings. For example, on January 6, 2012, the USPTO published 21 pages of proposed regulations  in 77 Fed. Reg. at 982  “simply” to implement the changed requirements for an inventor’s oath and declaration in various applications. There is an entire column on the changes in the oath and declaration requirements in a continuing reissue application (!)  I tried to skim the changes but quickly got bogged down. The most useful nugget I unearthed is that the assignee can execute the oath and declaration on behalf of a deceased inventor. Emotional issues aside, this can be a big help to facilitate continued prosecution in situations in which the inventor’s estate has been closed and the personal representative does not want to reopen it in order to sign for the inventor. Oh, and after September 16, 2012, the assignee(s) can sign the reissue oath and declaration for a broadening reissue application IF the assignee(s) applied for the original patent. Don’t get me started!

Finally, I am  pleased to note that both Patents4Life and Patent RE-forum were recently picked as members of the top 25 Minnesota Blawgs in a survey sponsored by the Minnesota State Bar Association. Not a bad 3rd birthday present for Patents4Life!