Allergan Sales LLC v. Aurobindo Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Allergan Sales, LLC (Delaware); Allergan USA, Inc. (Delaware); and Forest Laboratories Holdings, Ltd. (Ireland)
  • Defendant: Aurobindo Pharma USA, Inc. (Delaware) and Aurobindo Pharma Ltd. (India)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:18-cv-00118, D. Del., 01/19/2018
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation.
• Core Dispute: This is a Hatch-Waxman Act case in which Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the hypertension drug Bystolic® constitutes an act of infringement of a patent covering a specific mixture of nebivolol stereoisomers.
• Technical Context: The technology relates to pharmaceutical compositions for treating hypertension using a specific racemic mixture of two stereoisomers of the active ingredient nebivolol.
• Key Procedural History: The complaint notes that the patent-in-suit, U.S. Patent No. 6,545,040, was the subject of an ex parte reexamination at the USPTO, which confirmed the patentability of the asserted claims. It also notes that the Patent Trial and Appeal Board (PTAB) denied institution of an inter partes review (IPR) petition challenging the patent, finding the arguments were substantially the same as those already considered by the USPTO. The patent’s term was extended under 35 U.S.C. § 156.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,545,040 - “Method of Lowering the Blood Pressure”

• Patent Identification: U.S. Patent No. 6,545,040, “Method of Lowering the Blood Pressure,” issued April 8, 2003.

The Invention Explained

• Problem Addressed: The patent background suggests that while certain 2,2'-iminobisethanol derivatives were known to have beta-adrenergic blocking properties, it was discovered that a specific class of isomers could potentiate the activity of blood pressure reducing agents ('040 Patent, col. 1:15-19).
• The Patented Solution: The patent claims pharmaceutical compositions and methods for treating hypertension. The core of the invention is a composition containing a specific combination of two enantiomers (mirror-image stereoisomers) of the compound nebivolol: the [2S,αR,2'R,α'R] isomer (also known as the SRRR- or d-nebivolol isomer) and the [2R,αS,2'S,α'S] isomer (also known as the RSSS- or l-nebivolol isomer) ('040 Patent, Abstract; col. 12:1-23). The patent teaches that these isomers can be combined with a pharmaceutically acceptable carrier to create a drug for lowering blood pressure ('040 Patent, col. 5:56–col. 6:24).
• Technical Importance: The invention provides a specific chemical formulation for nebivolol, a beta-blocker used in the treatment of hypertension, a widespread medical condition ('040 Patent, col. 12:28-35).

Key Claims at a Glance

• The complaint asserts infringement of claims 2-6 (Compl. ¶30).
• Independent Claim 2 (Composition Claim):
  • A pharmaceutical composition consisting of a pharmaceutically acceptable carrier and, as active ingredients:
  • The blood pressure reducing compound [2S,αR,2'R,α'R]-α,α'-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] (the SRRR-isomer).
  • The compound [2R,αS,2'S,α'S]-α,α'-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] (the RSSS-isomer).
• Independent Claim 5 (Method Claim):
  • A method of treating hypertension in warm-blooded animals.
  • Comprising administering an effective amount of the pharmaceutical composition of claim 2.
• The complaint asserts dependent claims 3, 4, and 6, which further limit the composition (e.g., specifying a 1:1 molar ratio) or method of use (Compl. ¶30).

III. The Accused Instrumentality

Product Identification

• "Aurobindo’s ANDA Products," specifically generic nebivolol tablets in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths, for which Aurobindo seeks FDA approval via ANDA No. 211053 (Compl. ¶22).

Functionality and Market Context

• The accused products are generic versions of Plaintiffs' branded drug, Bystolic® (Compl. ¶6). The complaint alleges that Bystolic® is indicated for the treatment of hypertension and that its active ingredient, nebivolol, is a racemic mixture of the SRRR- and RSSS-stereoisomers (Compl. ¶12). The complaint includes a visual depiction of the chemical structures for both the SRRR- and RSSS-isomers of nebivolol hydrochloride. (Compl. p. 5, Figure).
• The complaint alleges that by filing its ANDA, Aurobindo seeks approval to market these generic products in the United States before the expiration of the ’040 Patent (Compl. ¶6, ¶23).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart but alleges that the product described in Aurobindo’s ANDA will infringe. The infringement theory is based on the allegation that Aurobindo’s generic product is a copy of Bystolic®, which embodies the claimed invention.

’040 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The complaint states that Aurobindo's notice letter does not dispute infringement but instead alleges invalidity (Compl. ¶24). This suggests the primary legal battle may concern validity. However, a potential infringement question for the court is whether the product detailed in Aurobindo's confidential ANDA submission corresponds exactly to the composition required by the claims.
  • Technical Questions: A factual question for the court will be to confirm, through discovery of the ANDA's contents, that Aurobindo's proposed generic product is indeed a pharmaceutical composition containing both the claimed SRRR-isomer and the claimed RSSS-isomer as its active ingredients.

V. Key Claim Terms for Construction

• The Term: "consisting of"
• Context and Importance: This transitional phrase appears in independent claim 2, defining the components of the pharmaceutical composition ('040 Patent, col. 12:1). Practitioners may focus on this term because, unlike the open-ended term "comprising," "consisting of" is a closed term. Its construction is critical because it limits the claim's scope to compositions containing only the recited ingredients (the carrier and the two specified nebivolol isomers) and any impurities ordinarily associated with them. If Aurobindo's product were found to contain an additional, unlisted active ingredient, it could potentially fall outside the scope of the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent does not appear to provide evidence that would broaden the generally accepted, closed-ended meaning of this term.
  • Evidence for a Narrower Interpretation: The patentee's choice to use "consisting of" in Claim 2, as opposed to the more common "comprising," is strong intrinsic evidence of an intent to draft a narrow claim covering only the specified active ingredients ('040 Patent, col. 12:1). The specification’s description of the invention as a combination of these specific components further supports this narrow reading ('040 Patent, col. 12:1-23).

VI. Other Allegations

• Indirect Infringement: The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b), asserting that Aurobindo's proposed product labeling will instruct physicians and patients to use the generic product for the treatment of hypertension, the method claimed in the ’040 Patent (Compl. ¶30-31). It also alleges contributory infringement under § 271(c), stating the product is especially made or adapted for an infringing use and is not a staple article of commerce (Compl. ¶34).
• Willful Infringement: The complaint alleges that Aurobindo acted with full knowledge of the ’040 Patent and its relevance, based on the patent's listing in the FDA's Orange Book and the statutory ANDA notification process (Compl. ¶21, ¶32, ¶37). It further alleges that this conduct makes the case "exceptional," seeking enhanced damages and attorneys' fees (Compl. ¶37, Prayer for Relief ¶F).

VII. Analyst’s Conclusion: Key Questions for the Case

1. A central issue will be one of validity: The ’040 Patent has previously survived both an ex parte reexamination and a denied IPR petition. A key question for the court will be whether Aurobindo’s invalidity defense, which the complaint alleges is duplicative of prior-rejected arguments, presents new evidence or legal theories sufficient to overcome the patent’s heightened presumption of validity (Compl. ¶17, ¶20, ¶25).
2. A secondary question is one of compositional identity: While infringement appears to be a less contentious issue, the case will depend on whether discovery confirms that Aurobindo's proposed generic product contains, as its active ingredients, only the specific SRRR and RSSS isomers recited in Claim 2, thereby meeting the strict "consisting of" limitation.