DCT
1:13-cv-01973
Vanda Pharma Inc v. Roxane Laboratories Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novartis Pharmaceuticals Corporation (Delaware), Novartis Pharma AG (Switzerland), and Aventisub II Inc. (Delaware)
- Defendant: Roxane Laboratories, Inc. (Nevada)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: 1:13-cv-01973, D. Del., 11/25/2013
- Venue Allegations: Venue is alleged based on Defendant manufacturing and selling generic drugs throughout the United States, including within the District of Delaware, and having previously been sued in the district without challenging personal jurisdiction.
- Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic iloperidone tablets constitutes an act of patent infringement under the Hatch-Waxman Act.
- Technical Context: The dispute concerns a pharmaceutical compound, iloperidone, used as an antipsychotic agent for the treatment of schizophrenia.
- Key Procedural History: The patent-in-suit is a reissue of U.S. Patent No. 5,364,866, which suggests a prior engagement with the U.S. Patent and Trademark Office to correct or amend the scope of the original patent claims.
Case Timeline
| Date | Event |
|---|---|
| 1989-05-19 | RE'198 Patent Priority Date |
| 1994-11-15 | Original U.S. Patent No. 5,364,866 Issued |
| 2006-07-18 | Reissue Patent RE'198 Issued |
| 2009-05-06 | Plaintiffs' FANAPT® (iloperidone) Tablets Approved by FDA |
| 2013-10-17 | Plaintiffs Received Defendant's ANDA Notice Letter |
| 2013-11-25 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
Patent Identification: U.S. Reissue Patent No. RE39,198 E, "HETEROARYLPIPERIDINES, PYRROLIDINES AND PIPERAZINES AND THEIR USE AS ANTIPSYCHOTICS AND ANALGESICS," issued July 18, 2006.
The Invention Explained:
- Problem Addressed: The patent's background section describes a need for new antipsychotic drugs for treating conditions like schizophrenia, noting that then-existing neuroleptic drugs often produced significant unwanted side effects, such as extrapyramidal symptoms (e.g., rigidity and tremor) and tardive dyskinesia (RE'198 Patent, col. 1:41-61).
- The Patented Solution: The invention provides a class of chemical compounds, including heteroarylpiperidines, asserted to possess antipsychotic and analgesic properties, potentially with a more favorable side-effect profile (RE'198 Patent, col. 1:56-61). The patent claims the compounds themselves, pharmaceutical compositions containing them, and methods of using them to treat psychoses (RE'198 Patent, Abstract). The specific compound iloperidone is disclosed as an embodiment of this invention (RE’198 Patent, col. 31:57-60).
- Technical Importance: The invention provided a new chemical entity for the treatment of psychosis at a time when therapeutic alternatives with fewer adverse effects were sought by the medical community (RE'198 Patent, col. 1:56-61).
Key Claims at a Glance:
- The complaint alleges infringement of claims covering the iloperidone compound, pharmaceutical compositions, and methods of use (Compl. ¶16). Claim 29 is representative of the compound claims.
- Claim 29 (Independent):
- The compound 1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]ethanone
- or a pharmaceutically acceptable acid addition salt thereof.
- The complaint reserves the right to assert other claims of the RE'198 patent (Compl. ¶23).
III. The Accused Instrumentality
- Product Identification: Defendant Roxane’s iloperidone oral tablets in 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg dosage strengths, as described in its ANDA submitted to the FDA (Compl. ¶17).
- Functionality and Market Context: The accused products are generic versions of Plaintiffs’ FANAPT® tablets and contain the same active pharmaceutical ingredient, iloperidone (Compl. ¶¶12, 17). The filing of the ANDA is an artificial act of infringement under 35 U.S.C. § 271(e)(2) that allows for adjudication of the patent rights before the generic product enters the market (Compl. ¶21). The complaint alleges Roxane seeks approval to manufacture and sell these products before the expiration of the RE'198 patent (Compl. ¶17).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
- Claim Chart Summary: The complaint alleges that by filing an ANDA for a product containing iloperidone, Roxane has infringed claims covering the compound itself.
RE'198 Patent Infringement Allegations
| Claim Element (from Independent Claim 29) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| The compound 1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]ethanone or a pharmaceutically acceptable acid addition salt thereof. | Defendant’s ANDA seeks approval for oral tablets containing the active ingredient iloperidone, which is the chemical compound recited in the claim. | ¶13, ¶17 | col. 114:4-8 |
- Identified Points of Contention:
- Factual Question: The central factual question for infringement of claim 29 is whether the active ingredient in Roxane's ANDA product is, in fact, the chemical compound 1-[4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3-methoxyphenyl]ethanone. Given the nature of ANDA filings, this is typically not a point of substantial dispute.
- Legal Question: The complaint notes that Roxane’s ANDA certification alleges the RE'198 patent claims are "invalid and/or that certain claims will not be infringed," but immediately clarifies that Roxane "did not, however, allege that the RE198 patent claims covering iloperidone will not be infringed" (Compl. ¶18). This suggests the primary legal dispute will not be over non-infringement of the compound claims, but rather over their validity.
V. Key Claim Terms for Construction
The complaint’s allegations focus on infringement by a product containing iloperidone, which is the specific compound recited in claim 29. As claim 29 identifies a compound by its precise chemical name, there are no terms that would typically require judicial construction for the purposes of determining literal infringement. The dispute is more likely to concern issues of patent validity rather than claim scope.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that if Roxane’s ANDA is approved, the administration of the product to patients for the treatment of psychoses will directly infringe method claims of the RE'198 patent. It further alleges that Roxane will actively induce this infringement with knowledge and intent (Compl. ¶24).
- Willful Infringement: The complaint alleges that when Roxane filed its ANDA, it "was aware of the RE198 patent" (Compl. ¶22). This allegation of pre-suit knowledge may serve as a basis for a claim of willful infringement should infringement be found.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of patent validity: Since the infringement analysis for the compound claim appears straightforward, the case will likely turn on Defendant's challenge to the validity of the RE'198 patent. The key questions will be the specific grounds for the invalidity defense (e.g., obviousness, lack of enablement, anticipation) and what evidence from the original patent's prosecution history and subsequent reissue proceeding will support or undermine that challenge.
- A secondary issue may be the scope of relief: Should the patent be found valid and infringed, a key question will be the extent of the relief granted, particularly the court's order regarding the effective date of any FDA approval for Roxane's ANDA, which Plaintiffs request be no earlier than the patent's expiration date (Compl. ¶25).