Vanda Pharmaceuticals Inc. v. Apotex Inc. (Case No. 1:19-cv-02375) represents a protracted legal battle over patent rights for Vanda’s circadian rhythm disorder drug Hetlioz® (tasimelteon). The case centers on Apotex’s submission of an Abbreviated New Drug Application (ANDA) seeking FDA approval for a generic version, which Vanda alleges infringes its patents. Below is a structured analysis of the litigation’s key developments and implications:
Case Background and Procedural History
Vanda initiated the lawsuit in December 2019, alleging Apotex’s ANDA infringed multiple patents, including U.S. Patent No. 10,376,487 (‘487 patent) covering Hetlioz®’s administration protocol[1][10]. This followed similar litigation against Teva Pharmaceuticals, which was consolidated with the Apotex case in 2020[1][5].
Key milestones include:
- 2018–2020: Vanda filed infringement suits against Teva and Apotex, triggering consolidated proceedings in Delaware[1][16].
- March 2022: A bench trial addressed validity challenges, where Teva and Apotex stipulated to infringement of claim 5 of the ‘487 patent contingent on its validity[2][7].
- December 2022: District Judge Colm Connolly invalidated claim 5 of the ‘487 patent and three other patents (RE46,604; 10,149,829; 9,730,910) for obviousness, finding prior art provided a reasonable expectation of success for the claimed dosing regimen[2][7][16].
- 2023 Appeal: The Federal Circuit upheld the invalidity ruling, emphasizing clinical trial disclosures and prior art combinations rendered the patents non-novel[2][8][16].
- June 2024: The court denied Apotex’s motion for early judgment, allowing further discovery and claim construction[4][9][12].
Key Legal Issues and Judicial Analysis
Obviousness Challenges
The district court and Federal Circuit concluded the patents were obvious based on:
- Prior Art Combinations: References dating to 2007–2014 disclosed tasimelteon’s pharmacokinetic profile, 20mg dosing, and circadian entrainment mechanisms[2][7][15].
- Clinical Trial Disclosures: Vanda’s Phase III trial data (publicly reported in 2012) contributed to expectations of success, undermining patentability[8][16].
- Objective Indicia: Courts rejected Vanda’s arguments about long-felt need and unexpected success, noting limited evidence of industry praise tied to claimed methods[2][8].
Infringement Stipulations
While Teva and Apotex conceded infringement of claim 5 of the ‘487 patent, this stipulation became moot after invalidation[2][5][16]. The court declined to rule on infringement of other claims due to their overlapping invalidity[7][13].
Implications and Current Status
- Market Impact: Apotex and Teva may launch generic versions of Hetlioz® as early as March 2035 under settlement terms with Vanda[1][14].
- Litigation Strategy: Vanda’s aggressive patent defense reflects broader patterns, with 15+ lawsuits filed against FDA and generic manufacturers since 2018[6][11].
- Pending Actions: The Delaware court’s 2024 denial of early judgment prolongs discovery, requiring deeper analysis of patent validity under 35 U.S.C. § 103 standards[4][9][12].
Critical Analysis
The Federal Circuit’s reliance on pre-trial clinical data as prior art signals stricter scrutiny for pharmaceutical patents, particularly when innovators disclose methodology before securing IP rights[8][16]. Vanda’s partial settlement with MSN Pharmaceuticals (allowing post-2035 generics) and ongoing FOIA disputes with the FDA further illustrate the complex interplay between patent litigation and regulatory strategy[6][14][16].
While Vanda continues pursuing injunctive relief, the courts’ consistent focus on obviousness thresholds suggests limited prospects for reversing generic competition timelines absent novel patent claims[12][15]. This case underscores the high bar for non-obviousness in dosage regimen patents, particularly when prior art overlaps with publicly disclosed research.
“The disclosure of Vanda’s Phase III trial would also have contributed to a skilled artisan’s expectation of success” [8][16]
This judicial emphasis on pre-existing data undermines attempts to patent incremental dosing adjustments, reshaping ANDA litigation strategies industry-wide.
References
- https://www.sternekessler.com/news-insights/news/fed-circ-wont-bar-generic-sleep-meds-amid-vanda-appeal/
- https://casetext.com/case/vanda-pharm-v-teva-pharm-us-2
- https://insight.rpxcorp.com/litigation_documents/13632065
- https://www.investing.com/news/company-news/court-advances-vanda-pharmaceuticals-patent-case-93CH-3504103
- https://www.supremecourt.gov/DocketPDF/23/23-768/295665/20240112152259752_Vanda.cert.appendix.pdf
- https://www.thefdalawblog.com/2024/10/vanda-lay-litigation-industries-inc-taking-stock-of-vanda-pharmaceuticals-inc-s-big-bets-on-petitioning-and-litigation-against-fda-and-the-federal-government/
- https://www.ipiqblog.com/wp-content/uploads/sites/47/2024/05/23-1247.OPINION.5-10-2023_2124577-Vanda-v.-Teva-2.pdf
- https://fedcircuitblog.com/wp-content/uploads/2023/06/Vanda-Response.pdf
- https://www.investing.com/news/company-news/court-advances-vanda-pharmaceuticals-patent-case-93CH-3504103
- https://www.law360.com/cases/5e0a6c30c919e404036b015d
- https://www.thefdalawblog.com/2024/10/vanda-lay-litigation-industries-inc-taking-stock-of-vanda-pharmaceuticals-inc-s-big-bets-on-petitioning-and-litigation-against-fda-and-the-federal-government/
- https://www.stocktitan.net/news/VNDA/federal-court-allows-vanda-s-hetlioz-r-patent-lawsuit-to-proceed-uxfbnh34025c.html
- https://www.supremecourt.gov/DocketPDF/23/23-768/295665/20240112152259752_Vanda.cert.appendix.pdf
- https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2023cv0629-62-0
- https://fedcircuitblog.com/wp-content/uploads/2023/06/Vanda-Response.pdf
- https://www.sternekessler.com/news-insights/news/sterne-kessler-team-scores-federal-circuit-win-teva-sleep-disorder-drug/
