The YASMIN Case: Is it Conceivable (or Not) that Hatch-Waxman Method Patent Infringement Lawsuits are Limited to Information in the “Indications and Usage” Drug Labeling Section?

February 22, 2012

By Kurt R. Karst – 
Following the Federal Circuit’s recent precedential decision in AstraZeneca Pharms. v. Apotex et al. (Case No. 2011-1182) (in which the Court held that an ANDA sponsor who submits a “section viii” statement with respect to an Orange Book-listed method-of-use patent and does not seek approval for the patented use cannot be found liable under 35 U.S.C. § 271(e)(2) for patent infringement – see Orange Book Blog and Patent Docs posts), and as we all patiently await a decision from the U.S. Supreme Court in the patent use code counterclaim case, Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S (Docket No. 10-844) (see our previous post here), we thought we’d tee up another case, pending before the Federal Circuit, that represents a middle ground of dispute of sorts between AstraZeneca and Caraco: Bayer Schering Pharma AG v. Lupin, Ltd. et al. (Case No. 2011-1143; Oral Argument held Dec. 7, 2011).  

The case involves U.S. Patent No. 5,569,652 (“the ‘652 patent”), which is listed in the Orange Book for the contraceptive drug YASMIN (drospirenone 3 mg/ethinyl estradiol 0.03 mg) Tablets (NDA No. 021098; approved on May 11, 2001) with a “U-1” patent use code defined as “PREVENTION OF PREGNANCY.”  

Depending on who you ask, Bayer Schering Pharma AG v. Lupin, Ltd. et al. is either a run-of-the-mill Hatch-Waxman patent infringement dispute under 35 U.S.C. § 271(e)(2), or a high-stakes case with significant implications for future Hatch-Waxman infringement litigation concerning method-of-use patents.  The question before the Federal Circuit is whether the U.S District Court for the Southern District of New York erred when it granted, in September 2010, a Judgment on the Pleadings in favor of the ANDA sponsors (Defendants-Appellees) determining that the ‘652 patent does not claim an FDA-approved use for YASMIN because the patented use does not appear in the “Indications and Usage” section of the YASMIN labeling, but rather in the “Clinical Pharmacology” section of the labeling. 

Claim 11 of the ‘652 patent, which is at the center of the dispute, asserts the following method-of-use claim for YASMIN:

A method of simultaneously achieving, during pre-menopause or menopause, a contraceptive effect, an anti-androgenic effect, and an antialdosterone effect in a female patient in need thereof comprising administering an effective amount of dihydrospirorenone and an effective amount of an estrogenic compound, wherein said effective amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, anti-androgenic effect, and an anti-aldosterone effect in said female patient.

Plaintiffs-Appellants argue that FDA approved the ‘652 patent’s claim of simultaneous gestagenic, anti-androgenic, and anti-aldosterone effect, and that that approval is found in the “Clinical Pharmacology” section of the YASMIN labeling, which states in relevant part:

Drospirenone is a spironolactone analogue with antimineralocorticoid activity.  Preclinical studies in animals and in vitro have shown that drospirenone has no androgenic, estrogenic, glucocorticoid, and antiglucocorticoid activity.  Preclinical studies in animals have also shown that drospirenone has antiandrogenic activity.

Based on Federal Circuit precedent – i.e., Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) and Allergan Inc. v. Alcon Labs., 324 F.3d 1322 (Fed. Cir. 2003), which have been used to support the proposition that a method-of-use patent infringement claim against an ANDA sponsor cannot stand where that use is not approved by FDA – district court precedent – i.e.Alcon Labs. v. Allergan, Inc., 256 F. Supp. 2d 1080 (C.D. Cal. 2003) – and FDA’s labeling regulations at 21 C.F.R. § 201.57(c), which state in part that “[i]ndications or uses must not be implied or suggested in other sections of the labeling if not included in this section,” the New York District Court determined that “the FDA-approved use of a drug is governed by the “Indications and Usage” section of its label. . . .”

In their briefs (here and here), Plaintiffs-Appellants argue that the district court ignored basic principles of administrative law in coming to its September 2010 decision.  Citing FDA’s Hatch-Waxman patent listing regulations, Plaintiffs-Appellants argue that the court’s ruling is in direct conflict with those regulations.  Those regulations “confirm that a patented method need not appear just in the Indications section.”  Moreover, write Plaintiffs-Appellants, “[c]onsistent with these regulations, the Orange Book contains numerous [patent] use codes sourced outside of the Indications section.  The district court’s holding would render unenforceable in Hatch-Waxman proceedings the method of use patents underlying these use codes.”  Plaintiffs-Appellants also argue that the district court ignored other evidence of FDA approval of the ‘652 patented method, including DDMAC’s pre-clearance of certain promotional pieces “featuring the ‘652 patented method,” and a declaration from a former FDAer responsible for the clinical review of YASMIN. 

Defendants-Appellees argue in their brief that the district court got it right when it concluded that the only approved use for YASMIN included in the product’s labeling is contraception.  They counter that Plaintiffs-Appellants go too far in characterizing the scope of the district court’s decision.

Bayer repeatedly mischaracterizes the District Court’s opinion as going far beyond its actual holding that the FDA approved Yasmin for contraception only. . . .  Bayer insists that the District court held, far more broadly, that “a patentee can only assert method patents if those methods appear in the Indications section of the approved labeling.”  Bayer does not even attempt to cite to specific language in the District Court’s opinion in order to support its mischaracterization of the breadth of the court’s holding.  Rather, it simply sets up a straw man argument, and then devotes many pages of briefing to knocking it down.  In fact, the District Court’s holding was appropriately limited to the ‘652 patent claims, the scope of the FDA’s approval of Yasmin, and the consequences vis-a-vie Appellees’ ANDAs for their respective generic versions of Yasmin.  The court’s decision from which Bayer appeals . . . is a straightforward, narrow ruling, and is amply supported by the record.

Hatch-Waxman junkies will surely be watching this case closely.  Clearly, the Federal Circuit’s decision will be an important one regardless of how the Court ultimately rules.  Indeed, the case is so important that even PhRMA filed an amicus brief