AstraZeneca v Sanofi-Aventis: Patent Infringement, Medicines Act s12A, Product Licensing

AstraZeneca AB (SE) sued Sanofi-Aventis Singapore Pte Ltd in the High Court of Singapore on 19 January 2012, alleging potential patent infringement related to Sanofi-Aventis's application for product licenses for Rosucard Film-coated Tablets. AstraZeneca based its claim on section 12A of the Medicines Act, arguing that Sanofi-Aventis's products would infringe its patent (Singapore Patent No. 89993). Sanofi-Aventis applied to strike out AstraZeneca's claim, arguing that section 12A of the Medicines Act did not provide a separate cause of action. The court dismissed Sanofi-Aventis's application, holding that section 12A of the Medicines Act does provide an independent cause of action.

1. Case Overview

1.1 Court

High Court

1.2 Outcome

Application dismissed

1.3 Case Type

Intellectual Property

1.4 Judgment Type

Grounds of Decision

1.5 Jurisdiction

Singapore

1.6 Description

AstraZeneca sues Sanofi-Aventis over potential patent infringement related to product licensing under the Medicines Act. The court dismissed Sanofi-Aventis's application to strike out AstraZeneca's claim.

1.7 Decision Date

2. Parties and Outcomes

Party NameRoleTypeOutcomeOutcome TypeCounsels
AstraZeneca AB (SE)PlaintiffCorporationApplication to strike out claim dismissedWon
Sanofi-Aventis Singapore Pte LtdDefendantCorporationApplication dismissedLost

3. Judges

Judge NameTitleDelivered Judgment
Chan Wei Sern PaulAssistant RegistrarYes

4. Counsels

Counsel NameOrganization
Lee Ai MingRodyk & Davidson LLP
Alvin LimRodyk & Davidson LLP
Sandeep MenonRodyk & Davidson LLP
Vignesh VaerhnAllen & Gledhill LLP
Tan LijunAllen & Gledhill LLP
Eunice LimAllen & Gledhill LLP

4. Facts

  1. AstraZeneca owns Singapore Patent No. 89993 for a pharmaceutical composition comprising Rosuvastatin Calcium and an inorganic salt.
  2. Sanofi-Aventis applied to the HSA for product licenses for Rosucard Film-coated Tablets containing Rosuvastatin Calcium.
  3. Sanofi-Aventis declared to the HSA that its products would not infringe AstraZeneca's patent because they do not contain an inorganic salt.
  4. AstraZeneca commenced an action under section 12A of the Medicines Act, seeking a declaration that Sanofi-Aventis's products would infringe its patent.
  5. AstraZeneca stated it did not believe Sanofi-Aventis's claim of non-infringement.
  6. Sanofi-Aventis applied to strike out AstraZeneca's claim, arguing that section 12A does not provide a separate cause of action.

5. Formal Citations

  1. AstraZeneca AB (SE) v Sanofi-Aventis Singapore Pte Ltd, Suit No 416 of 2011 (Summons 5001/2011/M), [2012] SGHC 16

6. Timeline

DateEvent
Section 12A of the Medicines Act enacted
Sanofi-Aventis submitted product license applications to the Health Sciences Authority
Sanofi-Aventis served notice to AstraZeneca
AstraZeneca filed its original Statement of Claim
Sanofi-Aventis filed SUM 5001 to strike out the action
Judgment reserved

7. Legal Issues

  1. Patent Infringement
    • Outcome: The court did not rule on whether patent infringement would occur, but held that an action could be brought under section 12A of the Medicines Act to determine potential future infringement.
    • Category: Substantive
    • Related Cases:
      • [1988] FSR 1
      • [1969] RPC 367
  2. Cause of Action under Section 12A of the Medicines Act
    • Outcome: The court held that section 12A of the Medicines Act provides a cause of action separate and independent from a patent infringement action under the Patents Act.
    • Category: Substantive

8. Remedies Sought

  1. Declaration of Patent Infringement
  2. Injunction to restrain patent infringement

9. Cause of Actions

  • Potential Patent Infringement (Section 12A of the Medicines Act)

10. Practice Areas

  • Intellectual Property Litigation
  • Pharmaceutical Law

11. Industries

  • Pharmaceuticals

12. Cited Cases

Case NameCourtAffirmedCitationJurisdictionSignificance
The Upjohn Company v T. Kerfoot & Co. Ltd.N/AYes[1988] FSR 1N/ACited for the principle that applying for a product license is not an infringing act.
Rodi & Wienenberger AG v Henry Showell LtdN/AYes[1969] RPC 367N/ACited to explain the two-step process involved in ascertaining if an alleged infringing product falls squarely within the claim of the patent.
First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd and another appealN/AYes[2008] 1 SLR(R) 335SingaporeCited regarding the theoretical infringement requirement.
Contour Optik Inc v Pearl’s Optical Co Pte LtdHigh CourtYes[2002] SGHC 238SingaporeCited regarding the theoretical infringement requirement.
Gabriel Peter & Partners (suing as a firm) v Wee Chong Jin and othsCourt of AppealYes[1997] SLR(R) 649SingaporeCited for the standard which must be satisfied before pleadings can be struck out.
Tan Ah Thee and another (administrators of the estate of Tan Kiam Poh (alias Tan Gna Chua), deceased) v Lim Soo FoongN/AYes[2009] 3 SLR(R) 957SingaporeCited for the principle that the High Court has the power to make binding declarations of right whether or not any consequential relief is or could be claimed.
Salijah bte Ab Latef v Mohd Irwan bin Abdullah TeoN/AYes[1995] 3 SLR(R) 233SingaporeCited for the boundaries within which the power to grant declarations should be exercised.
Nokia Corp v Interdigital Technology CorpN/AYes[2007] FSR 23N/ACited as an example of a case in which it was found that the plaintiff had a “real commercial reason” for seeking a declaration of non-infringement even though the patentee-defendant did not make a claim against the plaintiff.
Re Clay, Clay v BoothN/AYes[1919] 1 Ch 66N/ACited for the suggestion that it is a requirement before a declaration of right is granted for the defendant to have asserted a claim of right.
Gouriet v Union of Post Office WorkersN/AYes[1978] AC 435N/ACited for the modern position on the power to grant a declaration.
Wyko Group Plc v Cooper Roller Bearings Co LtdN/AYes[1996] FSR 126N/ACited for the guidelines laid down by Lord Dunedin in Russian Commerical and Industrial Bank v British Bank for Foreign Trade, [1921] 2 AC 438 (at 448) in its determination of whether to grant a declaration of non-liability.
Nokia Oyj v IPCOm GmbH & Co KGN/AYes[2010] EWHC 3249N/ACited for the suggestion that the court’s inherent jurisdiction to grant declarations does not include the power to grant declarations about future events.
Tan Eng Khiam v Ultra Realty Pte LtdN/AYes[1991] 1 SLR(R) 844SingaporeCited for the court’s reluctance to summarily strike out a claim.
Hubbuck & Sons v Wilkinson, Heywood and ClarkN/AYes[1899] 1 QB 86N/ACited for the view that it is only in plain and obvious cases that the power of striking out should be invoked.
Russian Commerical and Industrial Bank v British Bank for Foreign TradeN/AYes[1921] 2 AC 438N/ACited for the guidelines laid down by Lord Dunedin in its determination of whether to grant a declaration of non-liability.

13. Applicable Rules

Rule Name
Rules of Court (Cap 322, R 5, 2006 Rev Ed) O. 18, r. 19
Rules of Court O. 87A, r. 2(2)

14. Applicable Statutes

Statute NameJurisdiction
Medicines Act (Cap 176, 1985 Rev Ed) s12ASingapore
Medicines Act (Cap 176, 1985 Rev Ed) s5Singapore
Medicines Act s20Singapore
Patents Act (Cap 221, 2005 Rev Ed) s66Singapore
Patents Act (Cap 221, 2005 Rev Ed) s67Singapore
Patents Act s78Singapore
Supreme Court of Judicature Act (Cap 322, 2007 Rev Ed) s18Singapore

15. Key Terms and Keywords

15.1 Key Terms

  • Patent Infringement
  • Medicines Act Section 12A
  • Product Licence
  • Rosuvastatin Calcium
  • Inorganic Salt
  • Pharmaceutical Composition
  • Stabiliser
  • Health Sciences Authority
  • Prospective Infringement

15.2 Keywords

  • Patent
  • Infringement
  • Medicines Act
  • Product Licence
  • Pharmaceutical
  • Rosuvastatin

17. Areas of Law

Area NameRelevance Score
Patents90
Pharmaceutical Law85
Medicines Act70
Administrative Law30
Contract Law15

16. Subjects

  • Intellectual Property
  • Patent Law
  • Pharmaceuticals
  • Civil Procedure