DCT
1:10-cv-00681
Allergan Inc v. Apotex Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Allergan, Inc. (Delaware) and Duke University (North Carolina)
- Defendant: Apotex Inc. (Canada) and Apotex Corp. (Delaware)
- Plaintiff’s Counsel: Spilman Thomas & Battle, PLLC
- Case Identification: 1:10-cv-00681, M.D.N.C., 09/08/2010
- Venue Allegations: Plaintiffs allege venue is proper in the Middle District of North Carolina because Defendants conduct substantial business in the district, including selling over $51 million worth of products in 2009, and have previously filed lawsuits in the district.
- Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs’ Latisse® product constitutes an act of infringement of three patents related to methods of enhancing hair growth using prostaglandin analogs.
- Technical Context: The technology involves the use of specific prostaglandin-related compounds, particularly bimatoprost, for the cosmetic treatment of hypotrichosis (inadequate hair, specifically eyelashes).
- Key Procedural History: This action arises under the Hatch-Waxman Act. Defendants filed ANDA No. 201894 seeking FDA approval to market a generic bimatoprost solution. In a letter dated July 26, 2010, Defendants provided a Paragraph IV certification stating that U.S. Patent Nos. 7,351,404 and 7,388,029 are invalid, unenforceable, and/or not infringed. The letter also stated that U.S. Patent No. 6,403,649 is "not relevant."
Case Timeline
| Date | Event |
|---|---|
| 1992-09-21 | Earliest Priority Date for ’649 Patent |
| 2000-03-31 | Earliest Priority Date for ’029 Patent |
| 2002-02-04 | Earliest Priority Date for ’404 Patent |
| 2002-06-11 | U.S. Patent No. 6,403,649 Issues |
| 2008-04-01 | U.S. Patent No. 7,351,404 Issues |
| 2008-06-17 | U.S. Patent No. 7,388,029 Issues |
| 2010-07-26 | Date of Apotex's notice letter regarding its ANDA filing and Paragraph IV certification |
| 2010-09-08 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,388,029 - "Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued June 17, 2008
The Invention Explained
- Problem Addressed: The patent describes hair loss as a common problem for which existing treatments have safety concerns and limited efficacy (’029 Patent, col. 1:22-55). It notes that while prostaglandins have been proposed for hair growth, their use can be impractical due to side effects like inflammation and pain, which arise from their activity at multiple receptor types (’029 Patent, col. 3:3-8).
- The Patented Solution: The invention provides compositions and methods for treating hair loss using specific "non-naturally occurring" prostaglandin F analogs that selectively activate the FP receptor, which is associated with hair growth, without activating other receptors that cause undesirable side effects (’029 Patent, col. 3:13-24). This targeted approach aims to promote hair growth while minimizing adverse reactions.
- Technical Importance: This technology represents a shift from using general-purpose compounds to using highly selective pharmacological agents designed to interact with a specific biological receptor (FP) implicated in the hair growth cycle.
Key Claims at a Glance
The complaint does not specify which claims are asserted but alleges infringement of at least one claim (Compl. ¶32). Independent claim 1 is representative of a method of use:
- A method of treating hair loss comprising administering to a mammal a composition comprising:
- A) an active ingredient selected from the group consisting of a prostaglandin F analog having a structure selected from two specified general formulas;
- pharmaceutically acceptable salts, hydrates, biohydrolyzable amides, esters, and imides thereof; and
- optical isomers, diastereomers, and enantiomers thereof.
U.S. Patent No. 7,351,404 - "Method of Enhancing Hair Growth," issued April 1, 2008
The Invention Explained
- Problem Addressed: The patent background describes "male pattern baldness" (alopecia) as the most common type of hair loss, for which there was no known cure (’404 Patent, col. 1:25-29). It details the shortcomings of existing treatments, including the cost and pain of hair transplantation and the limited, often disappointing, results from various drug therapies (’404 Patent, col. 2:19-48).
- The Patented Solution: The invention is based on the discovery that bimatoprost (sold as Lumigan® for glaucoma) caused notable eyelash growth in patients (’404 Patent, col. 6:62-col. 7:10). The patent claims a method of enhancing hair growth, including stimulating the conversion of fine vellus hair to thicker terminal hair, by topically applying a class of cyclopentane heptanoic acid derivatives, of which bimatoprost is the preferred embodiment, to mammalian skin (’404 Patent, Abstract; col. 6:40-54).
- Technical Importance: The invention identifies a new and unexpected use for an existing therapeutic compound, repurposing a glaucoma treatment as a method for cosmetic hair growth enhancement.
Key Claims at a Glance
The complaint does not specify which claims are asserted (Compl. ¶32). Independent claim 1 is representative:
- A method for stimulating hair growth in a mammalian species comprising the application to mammalian skin of an effective amount of a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by a specific formula (Formula I);
- wherein the variables (A, B, X, Z, R1, R2, etc.) define a class of chemical structures.
Multi-Patent Capsule
U.S. Patent No. 6,403,649 - "Non-Acidic Cyclopentane Heptanoic Acid,2-Cycloalkyl Or Arylalkyl Derivatives As Therapeutic Agents," issued June 11, 2002
- Technology Synopsis: This patent addresses the treatment of ocular hypertensive conditions, such as glaucoma, which are characterized by increased intraocular pressure (’649 Patent, col. 2:37-43). While certain prostaglandins were known to be effective, they were associated with side effects like ocular surface hyperemia (’649 Patent, col. 2:46-53). The invention discloses a class of non-acidic cyclopentane heptanoic acid derivatives that are potent ocular hypotensives but cause significantly less hyperemia (’649 Patent, col. 3:12-21).
- Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶1, Prayer for Relief ¶a).
- Accused Features: The filing of ANDA No. 201894 for a generic bimatoprost solution is the alleged act of infringement (Compl. ¶55). Apotex's notice letter stated this patent was "not relevant" (Compl. ¶55).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendants’ proposed "generic Bimatoprost Topical Solution 0.03%" (Compl. ¶34).
Functionality and Market Context
- The product is the subject of ANDA No. 201894, filed with the FDA to obtain approval for commercial manufacture and sale in the United States (Compl. ¶34, 41). The complaint alleges this product is a generic version of Allergan's commercially successful Latisse® product, which is an FDA-approved treatment for hypotrichosis of the eyelashes (Compl. ¶1, 34). The act of infringement alleged under 35 U.S.C. § 271(e)(2) is the submission of the ANDA seeking approval to market this generic drug for a use claimed in the patents-in-suit prior to their expiration (Compl. ¶41, 48, 55).
IV. Analysis of Infringement Allegations
The complaint pleads infringement under 35 U.S.C. § 271(e)(2), where the infringing act is the filing of an ANDA for a drug claimed in a patent. The complaint does not contain a detailed claim chart, but alleges that the proposed generic product, if approved, would infringe. The following tables summarize the infringement theory for representative claims.
No probative visual evidence provided in complaint.
’029 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating hair loss | The proposed generic product is intended for the same indication as Latisse®, the treatment of hypotrichosis (inadequate eyelashes), which constitutes treating hair loss. | ¶1, ¶34 | col. 3:13-14 |
| comprising administering to a mammal a composition comprising: | The ANDA seeks approval to market and sell a drug composition for administration to humans. | ¶34, ¶38 | col. 3:13-14 |
| A) an active ingredient selected from the group consisting of a prostaglandin F analog... | Apotex’s proposed product contains Bimatoprost Topical Solution 0.03%, which is alleged to be a prostaglandin F analog covered by the patent's structural formulas. | ¶34 | col. 7:42-col. 8:43 |
’404 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for stimulating hair growth in a mammalian species | The proposed generic product is for treating hypotrichosis, which is a method of stimulating hair growth. | ¶1, ¶34 | col. 4:11-18 |
| comprising the application to mammalian skin of an effective amount | The proposed product is a topical solution for application to the skin at the base of the eyelashes. | ¶30, ¶34 | col. 5:63-67 |
| of a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by the formula I... | Apotex's ANDA product contains bimatoprost, which is alleged to be a compound falling within the scope of Formula I, with bimatoprost being the patent's preferred embodiment. | ¶34 | col. 6:35-40 |
Identified Points of Contention
- Validity: The central dispute will likely concern the validity of the asserted claims. Apotex’s Paragraph IV letter explicitly alleges the ’029 and ’404 patents are invalid and/or unenforceable (Compl. ¶35). The case will therefore involve an examination of whether the claimed inventions were novel and non-obvious over the prior art at the time of filing.
- Claim Scope and Relevance: A key question for the ’649 patent is its relevance. Apotex claims it is "not relevant," while Allergan asserts it (Compl. ¶37, 55). This raises the question of whether a patent directed at treating "ocular hypertension" and "glaucoma" (’649 Patent, col. 2:37-53, claims 2-3) can be construed to cover a product indicated for eyelash growth. The analysis may depend on whether the product's active ingredient, bimatoprost, is itself covered by the ’649 patent’s compound claims, regardless of the indicated use.
V. Key Claim Terms for Construction
The Term: "treating hair loss" (’029 Patent) / "enhancing hair growth" (’404 Patent)
Context and Importance: These terms define the fundamental purpose of the patented methods. The scope of these terms will be critical to the infringement analysis. Practitioners may focus on whether these terms are limited to specific types of hair (e.g., eyelashes vs. scalp) or specific conditions (e.g., alopecia vs. cosmetic enhancement), which could impact both infringement and validity arguments.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The background of the ’404 patent discusses "male pattern baldness" and hair loss on the "scalp" extensively, suggesting the invention is not limited to eyelashes (’404 Patent, col. 1:20-col. 2:12). The ’029 patent broadly refers to "hair loss in mammals" without anatomical restriction (’029 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specific examples and discoveries detailed in the patents focus on eyelash growth observed during glaucoma treatment (’404 Patent, col. 6:62-col. 7:22; FIG. 1). An argument could be made that the invention's true scope is limited to the context in which it was discovered and demonstrated, i.e., enhancing eyelash growth.
The Term: "non-naturally occurring prostaglandin" (’029 Patent)
Context and Importance: This term distinguishes the claimed compounds from natural prostaglandins and is central to the patent's assertion of novelty. The definition will determine which specific chemical structures are covered by the patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides numerous and varied chemical structures as examples of suitable non-naturally occurring PGF analogs, suggesting the term encompasses a wide range of synthetic modifications (’029 Patent, Tables 1-2, col. 9-40).
- Evidence for a Narrower Interpretation: The patent emphasizes selectivity for the FP receptor as a key feature of the invention (’029 Patent, col. 3:13-24). A defendant might argue that to be a "non-naturally occurring prostaglandin" within the meaning of the patent, a compound must not only be structurally distinct but must also demonstrate this specific functional selectivity, potentially narrowing the group of covered compounds.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Apotex knew or should have known that its proposed generic product will be used to infringe, and that its actions will actively induce infringement by end-users (Compl. ¶44, 51, 58). It also alleges contributory infringement, stating the product is especially made or adapted for an infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶45, 52, 59).
- Willful Infringement: The complaint does not use the word "willful" but requests treble damages and attorneys' fees for an exceptional case (Prayer for Relief ¶e, f). The basis for this claim appears to be Apotex's knowledge of the patents, which it identified in its ANDA submission to the FDA, prior to the filing of the lawsuit (Compl. ¶43, 50, 57).
VII. Analyst’s Conclusion: Key Questions for the Case
- Validity over Prior Art: A primary issue will be one of validity. Given Apotex’s Paragraph IV certification, the case will likely focus on whether the claimed methods of using bimatoprost and related compounds for hair growth are invalid as obvious or anticipated by prior art related to prostaglandins and their various known biological effects.
- Scope and Relevance of Asserted Patents: A second key issue will be one of claim scope. This has two dimensions: (1) Can the term "enhancing hair growth" in the ’404 patent, which was based on observed eyelash growth, be broadly construed to cover other types of hair loss, such as on the scalp? (2) Is the ’649 patent, which is directed to treating ocular hypertension, legally relevant and enforceable against a product indicated for a cosmetic purpose, a question directly raised by Apotex’s "not relevant" assertion.
- Claim Construction: The dispute will depend heavily on the construction of chemical terms. The outcome may turn on the precise structural definitions provided in the claims and whether Apotex’s generic bimatoprost formulation falls squarely within the scope of those definitions as properly interpreted by the court.