Posts Tagged ‘Hatch-Waxman’

In re Rosuvastatin Calcium Patent Litigation – Making “Therasense” out of Confusion

Thursday, December 20th, 2012

Recently, a divided three judge panel sorting out a multi-party Hatch-Waxman suit, ruled that the patentee, Shinonogi, had not committed inequitable conduct in obtaining the patent that was subsequently reissued so as to obtain narrow claims focused on Rosuvastatin, or Crestor®, the popular cholesterol lowering drug. The majority of the panel also held that the patent was properly reissued due to error without deceptive intent. Although the deceptive intent element has been removed from the reissue statute by the AIA, it will remain relevant to earlier-filed reissues for some time to come. The opinion was subtitled AstraZenca UK Ltd v. Aurobindo Pharma Ltd, 2010-1460 to 1473 (Fed. Cir., December 14, 2012) and involved multiple “generic company” defendants. (A download is available at the end of this post.)

After finding the Crestor claim non-obvious over a Sandoz reference that disclosed a sulfonylated analog, the panel spent 7 pages discussing IC and 10 pages discussing whether or not the reissue application was properly filed. In terms of IC, Fed. Cir. panels continue to be reluctant to find IC in cases in which multiple parties create “a string of mishaps, mistakes, misapprehensions and misjudgment,” particularly if the “purported culprits” are “inexperienced and overworked,” to use the language of the district court, that also found no IC. It probably helped that the only two “purported culprits” were both Japanese patent attorneys apparently working in Japan, although it is hard to fathom how they carried out the prosecution of a U.S pharma application and then reissued the resulting patent with no input from U.S. counsel, but none are mentioned. The Japanese attorneys had failed to file an IDS during prosecution of the ‘440 patent, and then filed for reissue, listing the two references on an IDS, and obtained the ‘314 reissued patent with claims essentially limited to Crestor.

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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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Legal Challenge To “ObamaCare” Threatens Generic Biologicals

Thursday, March 29th, 2012

What should not be lost on pharma/biotech patent attorneys or their clients, amidst all the attention given to the Supreme Court’s review of the “Patient Protection and Affordable Health Care Act” – public law 111-48, is that it contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. As I wrote here on March 26, 2010, Title IV of the law is “Improving Access to Innovative Medicial Therapies” – Subtitle A and is referred to as the “Biologics Price Competition and Innovation Act of 2009.” It can be most easily be followed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590. The Act amends section 351 of 42 USC 262 and 35 USC 271(e). In my March 26th post I reviewed many of its Hatch-Waxman-like features.

Since enactment, there have been many seminars, workshops and symposia about how best to implement these procedures at the FDA/USPTO, and the FDA has finally begun to work with the stakeholders to provide a regulatory pathway for generic biologicals. Without such a pathway –as currently – a generic biological has to endure the same NDA route to approval as any other new drug. Questions of what degree of “biosimilarity” should be required and what the market exclusivity period should be for the first generic biological to be approved have been hotly debated.

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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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