The applicant, Arrow, had entered into an agreement with Pharmac (New Zealand’s pharmaceutical purchasing agency) for the supply of clopidogrel.  This pharmaceutical was widely used for the treatment and prevention of vascular disorders.  Clopidogrel was known to exist in two polymorphic forms - Form 1 and Form 2.  The respondent, Sanofi-Aventis, held a patent for Form 2 but its patent for Form 1 had expired. 

Arrow sought a declaration under s75 Patents Act 1953 that the making, use or sale by any person of the applicant’s oral pharmaceutical product containing clopidogrel hydrogen sulphate Form 1 (“the Arrow product”) did not or would not constitute an infringement of any claim of Sanofi-Aventis’ Form 2 patent.

Sanofi-Aventis opposed the declaration on two grounds:

1. Arrow had failed to show that the product it proposed making and selling would not infringe the patent; and 
    
2. Arrow had failed to supply Sanofi-Aventis with particulars of the product in accordance with the statutory requirements for commencing the proceeding.

The evidence filed by Arrow showed that samples of Arrow’s clopidogrel product were clopidogrel Form 1.  Evidence from Sanofi-Aventis was that the process was capable of inducing changes in the polymorphic form so that Arrow’s product could contain Form 2.  Arrow’s evidence was that there was no detectible amount of Form 2.  But Sanofi-Aventis countered this by noting that the samples tested were from a developmental batch and not full scale production. 

Sanofi-Aventis also opposed the declaration on the basis that s75 required the applicant to have supplied full particulars in writing of the process or article and that this was a prerequisite to the issue of proceedings.  Arrow contended that there was no such prerequisite. 

Held, granting a declaration:

(1)  The onus is on the applicant to establish that it is entitled to the declaration sought.

Mallory Metallurgical Products Limited v Black Sivalls and Bryson Inc[1977] RPC 321 CA; Rohm & Haas Co v Collag Limited [2001] FSR 28 (upheld on appeal Rohm & Haas Co v Collag Limited [2002] FSR 28) referred to.

(2)   The Court has a discretion as to whether to make the declaration or not; but if the applicant establishes that there is or would be no infringement, the Court will ordinarily grant the declaration. 

Mallory Metallurgical Products Limited v Black Sivalls and Bryson Inc[1977] RPC 321, 345 referred to.

(3)   It is not necessary for the article to have been produced but, if so, the description of the article must be sufficiently clear and precise to enable the Court to declare that an article corresponding with the description would not constitute an infringement.

Mallory Metallurgical Products Limited v Black Sivalls and Bryson Inc[1977] RPC 339, 345, 347 referred to.

(4)   In this case the issue was not whether the product to be manufactured might infringe, but whether a product that complied with the description might infringe.  There was no reason why a declaration should not be made before an article comes into existence as long as the description is sufficiently clear and precise.  Here a clear and precise description was readily achieved. Only an article containing as its active ingredient clopidogrel Form 2 would infringe the patent.  It followed that a drug containing as its active ingredient only clopidogrel Form 1 would not infringe.  Arrow proposed to sell an article conforming to that description. The fact that it was yet to manufacture it in commercial quantities, and the possibility that the process could lead to the presence of clopidogrel Form 2, should not disentitle it to a declaration. 

(5)   If the declaration sought embraced products or processes that would or might involve infringement, a declaration should be refused.  Here a declaration in appropriate terms would not afford any protection to a clopidogrel product that contained Form 2.

(6)   As to the preconditions to the making of a declaration, there was nothing in s75 to suggest that the conditions must be satisfied before proceedings were issued.  Accordingly, it could only mean that it must be shown at the hearing that the conditions had been met.

Niche Generics Limited v Lundbeck A/S [2004] FSR 20; Nokia Corp v Interdigital Technology Corp [2007] FSR 23 CA; MMD Design and Consultancy Limited’s Patent [1989] RPC 131 referred to.