DCT
1:19-cv-00012
Japan Tobacco Inc v. Mylan Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Japan Tobacco Inc. (Japan)
- Defendant: Mylan Pharmaceuticals Inc. (West Virginia)
- Plaintiff’s Counsel: Schrader Companion Duff & Law, PLLC
- Case Identification: 1:19-cv-00012, N.D. W. Va., 01/24/2019
- Venue Allegations: Venue is alleged to be proper based on Defendant's residence in the district, as it is incorporated in West Virginia and has a principal place of business there, and has allegedly committed acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the HIV treatment Stribild® constitutes an act of infringement of a patent covering a combination therapy of three specific anti-HIV compounds.
- Technical Context: The technology relates to combination antiretroviral therapies, a cornerstone of modern HIV management, which is a highly significant and competitive area in the pharmaceutical market.
- Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification for a generic drug product. The complaint states that Defendant’s certification alleged invalidity of the asserted patent claims but did not allege non-infringement. This lawsuit was filed within the 45-day statutory window following Plaintiff's receipt of the notice letter, which triggers a 30-month stay of FDA approval for the Defendant's ANDA product.
Case Timeline
| Date | Event |
|---|---|
| 2004-05-21 | '219 Patent Priority Date |
| 2005-03-22 | JT licenses elvitegravir technology to Gilead |
| 2012-08-27 | Gilead's Stribild® receives FDA approval |
| 2014-01-21 | '219 Patent Issued |
| 2018-12-12 | Mylan's Paragraph IV Notice Letter sent |
| 2019-01-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,633,219 - "Combination Therapy"
- Patent Identification: U.S. Patent No. 8,633,219, "Combination Therapy", issued January 21, 2014.
The Invention Explained
- Problem Addressed: The patent's background describes the challenges in treating HIV, including severe side effects from existing pharmaceutical agents and the emergence of drug-resistant viral strains, which is a particular problem for single-agent therapies and can also occur with multi-drug combinations ('219 Patent, col. 2:4-10). The patent notes a desire for novel anti-HIV agents that operate via new mechanisms, such as the inhibition of integrase, an enzyme essential for HIV replication ('219 Patent, col. 2:11-17).
- The Patented Solution: The invention is a combination therapy that pairs an integrase inhibitor, identified as "Compound A" (elvitegravir), with at least one other anti-HIV agent, such as a reverse transcriptase inhibitor or a protease inhibitor ('219 Patent, Abstract). By combining drugs with different mechanisms of action, the therapy aims to reduce the required dose of each component, thereby lowering potential toxicity, while also creating a more robust treatment that is less susceptible to the development of viral resistance ('219 Patent, col. 5:5-18). The specification specifically contemplates combining elvitegravir with other known HIV drugs ('219 Patent, col. 11:1-25).
- Technical Importance: The development of integrase inhibitors represented a significant advance in HIV treatment, offering a new class of drugs to use against a virus known for its ability to develop resistance to established therapies ('219 Patent, col. 2:11-17).
Key Claims at a Glance
- The complaint asserts independent claims 1 (a method of treatment) and 5 (a composition), as well as dependent claim 2 (Compl. ¶13, ¶22).
- Independent Claim 1 (Method) recites a method for treating HIV by administering a combination of:
- (a) an effective amount of (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (elvitegravir);
- (b) an effective amount of tenofovir disoproxil fumarate; and
- (c) an effective amount of emtricitabine.
- Independent Claim 5 (Composition) recites a composition for treating HIV comprising effective amounts of the same three compounds listed in Claim 1.
- Dependent Claim 2 adds the limitation to Claim 1 that the three compounds "are formulated together and administered as a single therapeutic composition."
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Mylan's ANDA Product," a fixed-dose combination tablet for which Mylan is seeking FDA approval (Compl. ¶17).
Functionality and Market Context
- The product is a generic equivalent of the branded drug Stribild® and is intended for the treatment of HIV-1 infection (Compl. ¶15, ¶17). The complaint alleges Mylan's ANDA product is a fixed-dose combination tablet containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate (Compl. ¶17). The act of infringement alleged in this Hatch-Waxman case is the filing of the ANDA itself, which seeks approval to market the product before the expiration of the ’219 Patent (Compl. ¶20).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’219 Patent Infringement Allegations
| Claim Element (from Independent Claim 5) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for treating an HIV infectious disease in a human patient comprising: | Mylan's ANDA Product, if approved, will be a composition for treating an HIV infectious disease. | ¶23 | col. 26:5-7 |
| (a) an effective amount of ... [elvitegravir] ... | The ANDA product is a composition that contains an effective amount of elvitegravir. | ¶17, ¶23 | col. 26:8-10 |
| (b) an effective amount of tenofovir disoproxil fumarate, and | The ANDA product contains an effective amount of tenofovir disoproxil fumarate. | ¶17, ¶23 | col. 26:11-12 |
| (c) an effective amount of emtricitabine. | The ANDA product contains an effective amount of emtricitabine. | ¶17, ¶23 | col. 26:13 |
- Identified Points of Contention:
- Validity vs. Infringement: The complaint alleges that Mylan's notice letter challenged the validity of the asserted claims but did not allege non-infringement (Compl. ¶18). This suggests the primary legal battle may center on the patent's validity (e.g., obviousness) rather than on infringement.
- Technical Question: Mylan's ANDA product is alleged to contain cobicistat, a fourth active ingredient, in addition to the three recited in the asserted claims (Compl. ¶17). This raises the question of whether a product containing an additional, unrecited active ingredient can infringe a claim using the transitional phrase "comprising." The open-ended nature of "comprising" typically allows for the presence of additional elements without avoiding infringement, but this could become a point of legal argument.
V. Key Claim Terms for Construction
- The Term: "comprising"
- Context and Importance: This transitional phrase is central to the infringement analysis because the accused product allegedly contains a fourth active pharmaceutical ingredient (cobicistat) not recited in the claims (Compl. ¶17). The interpretation of "comprising" will determine whether the presence of this additional ingredient allows the accused product to fall outside the scope of the claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Patent law precedent establishes "comprising" as an open-ended term meaning "including at least the following elements, but not excluding others." The patent specification supports this interpretation by repeatedly framing the invention broadly, for instance, as a combination of Compound A "with at least one other anti-HIV active substance" ('219 Patent, col. 5:46-48). The claims themselves consistently use this standard, open-ended language ('219 Patent, col. 26:50, col. 26:5).
- Evidence for a Narrower Interpretation: A defendant might argue that in the specific context of a pharmaceutical formulation, the recitation of a specific list of active ingredients implies the exclusion of other unlisted active ingredients that materially alter the product's characteristics. However, the complaint and the patent itself do not appear to provide explicit support for such a narrowing interpretation, which would deviate from the generally accepted meaning of the term.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Mylan will induce infringement of method claims 1 and 2 upon approval of its ANDA product (Compl. ¶24). This allegation is based on the assertion that the product's label will contain instructions directing medical professionals and patients to administer the drug in a manner that practices the patented method, and that Mylan will encourage this infringement with knowledge of the ’219 Patent (Compl. ¶24).
- Willful Infringement: While the complaint does not contain a separate count for "willful infringement," it establishes a basis for such a claim by alleging that Mylan filed its ANDA with awareness of the ’219 Patent (Compl. ¶21). This allegation of pre-suit knowledge could be used to support a later request for enhanced damages if infringement is found.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue appears to be one of patent validity. Given the complaint's assertion that Mylan's notice letter challenged validity but not infringement, the case will likely focus on whether the claimed three-drug combination would have been obvious to a person of ordinary skill in the art at the time of the invention.
- Should infringement be contested, a key legal question will be one of claim scope: can the term "comprising," as used in claims reciting a three-component composition, be interpreted to read on an accused product that contains those three components plus a fourth active pharmaceutical ingredient?