Litigation Details for Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (D. Del. 2023)

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (D. Del. 2023)

Docket		Date Filed	2023-02-10
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To
Patents	10,071,977; 10,149,829; 11,285,129; 8,785,492; 8,846,112; RE46,604
Link to Docket	External link to docket

Details for Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc. (D. Del. 2023)

Date Filed	Document No.	Description	Snippet	Link To Document
2023-02-10				External link to document
2023-02-10	53	Opinion	, 2018) (adding U.S. Patent No. 10,071,977); see Def. Br. at 5 (noting 15 patents asserted in total). …5. Vanda holds multiple patents relating to tasimelteon. The suit for patent infringement underlying …motion to transfer concerns U.S. Patent No. 11,285,129 (the ’129 patent), which issued on March 29, 2022…related patents. 2 See Compl. ¶¶ 22-39, Vanda Pharms. 2 Vanda originally asserted six patents but added…later-issued patents to the Delaware litigation, Vanda would not assert any additional patents against Teva	External link to document
2023-02-10	86	Brief - Opening Brief in Support	the patents asserted by Vanda were U.S. Patent Nos. RE46,604 (“the RE604 patent”) and 10,149,829 (“the…pleadings that claims 1-3 of U.S. Patent No. 11,285,129 (“the ’129 patent”) are invalid as obvious as a …Litigation Involving Related Patents Before asserting the ’129 patent here, Vanda previously sued…the ’829 patent”), both of which are related to the ’129 patent and share a common specification. Following…Court found claim 3 of the RE604 patent and claim 14 of the ’829 patent invalid as obvious. See Vanda Pharm	External link to document
2023-02-10	94	Complaint - Amended	of U.S. Patent No. RE46,604 (“the RE604 patent”) and claim 14 of U.S. Patent No. 10,149,829 (“the ’829…’129 patent was not asserted in the prior litigation, the patentable weight and/or patentability of the…’129 patent was not asserted in the prior litigation, the patentable weight and/or patentability of other…Complaint for infringement of U.S. Patent No. 11,285,129 (the ’129 patent) against Defendant Teva Pharmaceuticals… THE PATENT-IN-SUIT The ’129 Patent 11.	External link to document
2023-02-10	99	Brief - Opening Brief in Support	the patents asserted by Vanda were U.S. Patent Nos. RE46,604 (“the RE604 patent”) and 10,149,829 (“the…pleadings that claims 1-3 of U.S. Patent No. 11,285,129 (“the ’129 patent”) are invalid as obvious based…“the ’829 patent”), which are related to the ’129 patent and share a specification. Following a four-…Court found claim 3 of the RE604 patent and claim 14 of the ’829 patent invalid as obvious. Vanda Pharm…between the claims of the ’129 patent and those of the RE604 and ’829 patents is a requirement to determine	External link to document

Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc.: A Comprehensive Litigation Summary and Analysis

Background of the Case

Vanda Pharmaceuticals Inc. filed a lawsuit against Teva Pharmaceuticals USA, Inc. and Apotex Inc. and Apotex Corp. (collectively, “Apotex”) alleging patent infringement. The dispute centers around Vanda’s patents related to the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) using the drug tasimelteon, marketed as Hetlioz.

Patents in Question

The litigation involves four patents owned by Vanda Pharmaceuticals Inc. These patents pertain to methods of treating Non-24 with tasimelteon. The specific claims under scrutiny include those from the ’487, ’829, ’910, and RE ’604 patents[1][2][4].

District Court Ruling

The district court, presided over by Chief Judge Colm F. Connolly of the United States District Court for the District of Delaware, conducted a thorough analysis and held that all the asserted claims of Vanda’s patents were invalid due to obviousness. The court applied the well-settled standard for assessing obviousness as outlined in Graham v. John Deere Co. and KSR International Co. v. Teleflex Inc. The court found that all elements of the asserted claims were known in the prior art and that a person having ordinary skill in the art would have had a reasonable expectation of success in combining these elements to achieve the claimed methods[2][4].

Federal Circuit Appeal

Vanda Pharmaceuticals Inc. appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit affirmed the district court’s ruling, upholding the invalidation of Vanda’s patent claims due to obviousness. The appellate court reiterated that obviousness does not require certainty but rather a reasonable expectation of success[1][4].

Supreme Court Petition

On January 12, 2024, Vanda filed a petition for a writ of certiorari to the Supreme Court, seeking review of the Federal Circuit’s decision. Vanda argued that the obviousness standard should require a showing of “predictable” results rather than just a “reasonable expectation of success.” This argument contrasts with the established precedent that obviousness requires only a reasonable expectation of success[4].

Key Arguments and Counterarguments

Vanda’s Arguments

Vanda contended that the district court and the Federal Circuit erred in their application of the obviousness standard. They argued that the clinical trials and other evidence presented did not provide a sufficient basis for concluding that the use of tasimelteon to treat Non-24 was obvious. Vanda also emphasized the long-felt need for a treatment for Non-24 and the significant effort and expense involved in their clinical studies[2][4].

Defendants’ Counterarguments

Teva and Apotex argued that the district court and the Federal Circuit correctly applied the obviousness standard. They pointed out that Vanda’s patents were invalid because all the elements of the claimed methods were known in the prior art, and a person of ordinary skill in the art would have been motivated to combine these elements with a reasonable expectation of success. The defendants also noted that Vanda’s petition to the Supreme Court introduced a new argument that was not raised in the lower courts, making it forfeited and meritless[2][4].

Legal Standard for Obviousness

The case highlights the ongoing debate over the legal standard for obviousness. Vanda’s petition seeks to clarify whether obviousness requires a showing of “predictable” results or merely a “reasonable expectation of success.” The Federal Circuit and the district court have consistently held that a reasonable expectation of success is sufficient, aligning with the precedent set by KSR International Co. v. Teleflex Inc.[2][4].

Impact and Implications

The decision in this case has significant implications for patent law and pharmaceutical innovation. If the Supreme Court were to adopt Vanda’s proposed standard, it could potentially raise the bar for proving obviousness, making it more challenging for generic drug manufacturers to enter the market. However, the Federal Circuit’s affirmation and the defendants’ arguments suggest that the current standard is well-settled and consistent with existing precedent[2][4].

Key Takeaways

• Obviousness Standard: The case reaffirms that obviousness does not require certainty but rather a reasonable expectation of success.
• Patent Invalidity: All asserted claims of Vanda’s patents were held invalid due to obviousness.
• Supreme Court Petition: Vanda’s petition seeks to clarify the obviousness standard, but it introduces a new argument not raised in lower courts.
• Impact on Pharmaceutical Innovation: The decision could influence the balance between innovation and generic competition in the pharmaceutical industry.

FAQs

What is the main issue in Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc.?

The main issue is whether the patent claims related to the treatment of Non-24 with tasimelteon are invalid due to obviousness.

What standard for obviousness did the district court and Federal Circuit apply?

The courts applied the standard that requires a reasonable expectation of success, as established in Graham v. John Deere Co. and KSR International Co. v. Teleflex Inc.

What is Vanda’s argument in their Supreme Court petition?

Vanda argues that the obviousness standard should require a showing of “predictable” results rather than just a “reasonable expectation of success.”

Why did the Federal Circuit affirm the district court’s decision?

The Federal Circuit affirmed because the district court correctly applied the obviousness standard, finding that all elements of the claimed methods were known in the prior art and that a person of ordinary skill in the art would have had a reasonable expectation of success.

What are the implications of this case for pharmaceutical innovation?

The case could influence the balance between innovation and generic competition by potentially affecting the standard for proving obviousness in pharmaceutical patents.

Cited Sources

1. VANDA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC., No. 23-1247 (Fed. Cir. 2023).
2. In the Supreme Court of the United States, Vanda Pharmaceuticals Inc. v. Apotex Inc. et al, No. 1:23-cv-00153 (D.Del.).
3. 23-152 - Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals U.S.A., Inc., GovInfo.
4. Clarifying What's Obvious: Vanda Seeks Supreme Court Review of Whether Obviousness Requires Predictability or Reasonable Expectation of Success, Crowell & Moring LLP.