In the case of AstraZeneca AB (SE) v Sanofi-Aventis Singapore Pte Ltd, the High Court allowed the request by Sanofi-Aventis Singapore Pte Ltd and ordered AstraZeneca AB (SE) to furnish further and better particulars of that were requested by Sanofi-Aventis Singapore Pte Ltd.
AstraZeneca AB (SE) (hereinafter referred to as “the Plaintiff”) is the proprietor of Singapore Patent No. SG 89993 (“the Plaintiff’s Patent”) which relates to a pharmaceutical composition with Rasuvastatin as an active ingredient and an inorganic salt in which the cation is multivalent. Sanofi-Aventis Singapore Pte Ltd (hereinafter referred to as “the Defendant”) submitted applications to the Health Sciences Authority (HSA) for product licenses in respect of its Rosucard Film-Coated tablets (hereinafter referred to as “the Defendant’s Products”). The Defendant also served a notice to the Plaintiff, pursuant to the Medicines Act, notifying the Plaintiff that the Defendant had submitted the applications to the HSA.
The Plaintiff alleged the Defendant’s Products as having a prospect of infringing the Plaintiff’s patent; thereby under the Medicines Act, a 30-month moratorium to be set in place to process the product license applications for the Defendant’s Products. The Plaintiff further argued, by means of an application, that it needed the Defendant’s Products description to verify whether the Defendant’s Products infringe the Plaintiff’s Patent or not. Upon allowance by the High Court, the Defendant furnished the details to the Plaintiff which included the chemical composition of the Defendant’s Products and the amount and weight of the active pharmaceutical ingredients.
Subsequently, the Defendant requested for further and better particulars from the Plaintiff, which the Plaintiff denied stating that the Defendant was not entitled to such particulars since the requests made by the Defendant related to issues of construction of the Plaintiff’s Patent. The High Court admitted that the particulars of pleadings serve to inform the other party of the nature of the case that has to be met, so as to prevent the other side from being taken by surprise at trial, and also to enable the other side to know what evidence it ought to prepare for the trial.
The High Court cited several English case decisions that demonstrated the need and the developments that have occurred in the legal principles governing the office of the particulars of infringement. The High Court noted that the English developments in this particular area of law range from the traditional position where the office of particulars of infringement did not permit any form of claim construction to the position where the particulars of infringement including claim construction were mandated. The current position in the English law was that in exceptional cases, the office of the particulars of infringement may extend to claim construction depending on the facts of the case.
The High Court acknowledged that the Plaintiff’s claim of infringement did not provide any details to aid the Defendant in identifying how the Defendant’s Products were alleged to infringe the claims of the Plaintiff’s Patent and consequently the Defendant had made seven requests demanding further particulars.
The Defendant requested the Plaintiff to identify how the specific components of the Defendant’s Products would read out on each element of each claim; thereby requesting the Plaintiff to show how each of the Patent’s claims would be infringed. The Plaintiff argued that such request would essentially require the Plaintiff to construe the Plaintiff’s Patent claims. The High Court rejected the Plaintiff’s argument stating that the Plaintiff needed to inform the Defendant of the case against him. The High Court further stated that it would not be impossible for the Plaintiff to furnish such details since the Plaintiff had already sought discovery of the Defendant’s Products to mount its case of infringement.
Next, the Defendant requested the Plaintiff to specifically define the term ‘inorganic salt’. The High Court disallowed the request stating that defining the term ‘inorganic salt’ appeared to be the work suited for expert evidence at the later stage of proceedings, and was not necessary required at the stage of pleadings.
The Defendant further requested the Plaintiff to clarify whether the inorganic salt was directed solely to performing a stabilizing function. The Plaintiff argued that there was no mention of the any “stabilizing function” in the Plaintiff’s Patent claims and as such, the request should not be granted. The High Court found out that the specification of the Plaintiff’s Patent indicated that the inorganic salt be incorporated as a stabilizing agent. The High Court further noted that the Plaintiff had confirmed that the inventive step for the Plaintiff’s Patent was the stabilizing function. The High Court adjudged that the Plaintiff needed to specify whether the inorganic salt in the Defendant’s Products performed a stabilizing function or not, so that the Defendant can conduct experiments accordingly. As such, the High Court allowed the Defendant’s request.
Further, the Defendant requested the Plaintiff to define the terms ‘pharmaceutical composition’ and ‘pharmaceutical tablets’ and whether such terms included a ‘coating’. The High Court rejected the Plaintiff’s need to define the terms stating that the Defendant had not shown that he required such definitions to know the case against him. However, the High Court allowed the Defendant’s request to inquire whether the composition and tablets included ‘coating’ stating that such a request was inclusive in nature and would not require the Plaintiff to limit its claims.
Lastly, the Defendant requested for particulars of the means by which the inorganic salt was incorporated into the compound and whether the method of incorporation was that of admixture. The Plaintiff argued that the Plaintiff’s Patent contained some examples of admixtures, but the Patent claims did not limit incorporation by way of admixture only. Hence, the High Court rejected the Defendant’s request on the grounds that such request appeared to be the work suited for expert evidence at the later stage of proceedings, and was not necessary required at the stage of pleadings.
Consequently, the High Court partially allowed the Defendant’s request for particulars of infringement.
The High Court also stated that the availability of the 30-month moratorium, whilst possibly intended to encourage settlement of patent infringement claims before the allegedly infringing products enter the market, can be used to delay the manufacture, importation and sale of medicinal products by competitors of the patentee, and may further have the effect of hindering public access to the competitor’s products. Hence, where a claim has serious consequences to the public and to a defendant’s legitimate business, the plaintiff should be required to furnish proper particulars of its claims to save considerable amount of time, energy and expense being wasted.