Introduction
The litigation between Shire Development LLC and Apotex, Inc. revolves around the validity and infringement of Shire's patent for lisdexamfetamine (LDX), a prodrug of amphetamine marketed as VYVANSE. Here is a detailed summary and analysis of the key points in this litigation.
Background
Shire Development LLC holds Canadian Patent No. 2,527,646 (the 646 Patent) which covers LDX, compositions containing LDX, and uses of LDX. This patent is crucial for Shire's product VYVANSE, approved for treating Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder in adults[1][4].
Prohibition Application and Invalidity Action
In 2018, Shire applied under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex for its LDX product. This application was consolidated with Apotex's action seeking a declaration of invalidity and non-infringement of the 646 Patent[1].
Court Decision
Justice Fothergill of the Federal Court granted Shire's application, issuing an order of prohibition until the expiry of the 646 Patent. The court dismissed Apotex's action for impeachment of the 646 Patent and Shire's counterclaim for infringement, based on Apotex's experimental or regulatory use defense. The court found that the 646 Patent was valid, rejecting Apotex's arguments of insufficiency and obviousness[1].
Validity Analysis
Apotex argued that the 646 Patent was insufficient because it did not teach that only certain forms of the hydrochloride salt of LDX could be isolated, and only the mesylate salt was likely useful for solid oral dosage forms. However, the court disagreed, stating that the skilled person could make the compounds by following the patent without needing specific instructions on scale-up synthesis or particular crystal forms of LDX[1].
Obviousness
Apotex also contended that the claims were obvious, arguing that the inventive concept should be narrowly focused on the subject matter of the claim. However, the Federal Court of Appeal (FCA) upheld the lower court's decision, stating that the inventive concept could be understood by considering the specification, especially when the claims are to bare chemical compounds. The FCA held that the inventive concept of a sustained release formulation of amphetamine resistant to abuse was not obvious[4].
Infringement Counterclaim
Shire's counterclaim for infringement was dismissed because Apotex successfully argued that its use of LDX was for experimental or regulatory purposes. Despite producing a large number of capsules, Apotex provided evidence that the inventory would be used for research and demonstration batches and not sold commercially[1].
Appeals
Apotex appealed the Federal Court's decision to the Federal Court of Appeal, which upheld the lower court's findings on the validity of the 646 Patent and the prohibition order. The Supreme Court of Canada later denied Apotex's leave to appeal, solidifying the Federal Court of Appeal's decision[4].
International Context
The Canadian court declined to rely on foreign proceedings addressing the validity of corresponding patents, emphasizing the need to decide issues based on Canada's own laws and the factual record presented[1].
Impact on Pharmaceutical Industry
This litigation highlights the importance of patent protection in the pharmaceutical industry. The validity of Shire's patent ensures that VYVANSE remains a proprietary product, protecting Shire's investment in research and development. It also underscores the complexities and challenges generic manufacturers face when seeking to enter the market with similar products[1][4].
Key Takeaways
- Patent Validity: The 646 Patent covering LDX was found valid by the Federal Court and upheld by the Federal Court of Appeal.
- Prohibition Order: The Minister of Health was prohibited from issuing a NOC to Apotex for its LDX product until the expiry of the 646 Patent.
- Infringement: Shire's counterclaim for infringement was dismissed due to Apotex's experimental or regulatory use defense.
- Obviousness: The court rejected Apotex's argument that the claims were obvious, allowing for a broader interpretation of the inventive concept.
- Appeals: The Federal Court of Appeal and the Supreme Court of Canada's denial of leave to appeal have finalized the decision in favor of Shire.
FAQs
Q: What is the main product at the center of the litigation between Shire and Apotex?
A: The main product is VYVANSE, which contains lisdexamfetamine (LDX), a prodrug of amphetamine.
Q: What was the outcome of Shire's prohibition application against Apotex?
A: The Federal Court granted Shire's application, prohibiting the Minister of Health from issuing a NOC to Apotex for its LDX product until the expiry of the 646 Patent.
Q: Why was Apotex's action for impeachment of the 646 Patent dismissed?
A: The court found that the 646 Patent was sufficient and not obvious, rejecting Apotex's arguments.
Q: What was the basis for dismissing Shire's counterclaim for infringement?
A: The court accepted Apotex's evidence that its use of LDX was for experimental or regulatory purposes.
Q: Did Apotex successfully appeal the Federal Court's decision?
A: No, the Federal Court of Appeal upheld the lower court's decision, and the Supreme Court of Canada denied Apotex's leave to appeal.
Cited Sources
- JD Supra: "Shire's VYVANSE patent valid, prohibition order issued" - July 31, 2018.
- LegalMetric: "Individual Judge Report" - August 10, 2010.
- Casetext: "Shire Development, LLC v. Watson Pharmaceuticals, Inc." - June 3, 2015.
- Smart & Biggar: "Federal Court of Appeal upholds Federal Court decision finding Shire's VYVANSE patent valid" - March 30, 2021.
- UniCourt: "Shire Development LLC et al v Apotex, Inc et al" - Case Summary.
