Archive for the ‘Hatch-Waxman’ Category

“We Don’t Need No Stinkin’ Patents” – Antibiotic and Antifungal Drugs Gain Non-Patent Exclusivity

Monday, June 23rd, 2014

Posted on the FDA Law Blog by Kurt Karst on June 19, 2014.

After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms to account for new non-patent marketing exclusivities.  First there was the addition of “NCE*” exclusivity, defined as “NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT),” that FDA created after the approval of NDA No. 204168 for FETZIMA (levomilnacipran) Extended-release Capsules, 20 mg, 40 mg, 80 mg and 120 mg (see our previous post here).  Then there was the addition of “RTO*” and “RTO**” exclusivities, defined as “OTC USE FOR WOMEN AGES 15 AND 16” and “OTC USE FOR WOMEN 14 AND BELOW,” respectively, that FDA created to account for various supplemental approvals under NDA No. 021998 for PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (see our previous post here).  Now that FDA has approved the first drug product designated as a Qualified Infectious Disease Product (“QIDP”), the Agency has once again added to the Orange Book list of exclusivity terms.  The term “GAIN” was added to the Orange Book Cumulative Supplement last week in relation to NDA No. 021883 for DALVANCE (dalbavancin HCl) Lyophilized Powder for Injection, 500 mg.  FDA approved DALVANCE on May 23, 2014 in the treatment of acute bacterial skin and skin structure infections.  With a period of NCE exclusivity that expires on May 23, 2019, but that is extended under the Generating Antibiotic Incentives Now Act (“GAIN Act”) by an additional 5 years to May 23, 2024, the GAIN exclusivity FDA granted for DALVANCE is the latest expiring period of non-patent exclusivity ever listed in the Orange Book (not to mention the longest period of exclusivity that FDA has granted for a drug product in decades – see FDC Act § 505(j)(5)(F)(i)).

To see the full post, go to the FDA Law Blog.

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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Supreme Court Grants Cert. In Caraco

Monday, June 27th, 2011

Today (June 27, 2010), the Supreme Court granted cert. in yet another patent appeal, Caraco Pharm. Labs., Ltd., v. Novo Nordisk, (Supreme Ct. 10-844). Earlier this month, I did an extensive post on the decision below, in which the Fed. Cir. denied Caraco’s counterclaim seeking to strike the broad “use code” that Novo had put on its drug, Prandin (U-968). Even though Caraco would market the generic for a narrower use, the broad use code effectively prevented Caraco from “carving out” the still-patented use(s) from its labeling, thus effectively keeping it off the market.

I took a chance by posting on this one because the Solicitor General’s office recommended review and there was a strong dissent below. However, when the appeal started getting some attention in the press – though the issues were often mischaracterized – it began to look more likely that cert. would be granted. I am not so sure that the Fed. Cir.’s recent streak of affirmances will be left intact.