A recent decision in the High Court of Singapore involved yet another dispute in the pharmaceutical industry between an innovator giant and a generic manufacturer. This time, the case refers to a patent litigation battle between Switzerland-based Novartis and its exclusive licensee in Singapore (the Plaintiffs), and Ranbaxy (M) Sdn Bhd (the Defendant).
On the facts, the Defendant had made an application to the Health Sciences Authority on product licences for the product, Starval, to be imported into the Singaporean market.Starval is a generic version of the Plaintiffs’ product, Diovan, a blockbuster drug for treating hypertension. Novartis then brought an action towards the Defendant when the application was made known to them via notice, asserting that the Defendant’s product could possibly infringe the Diovan patent.
The Defendant, in response, filed a counterclaim against the Plaintiffs alleging that the Diovan patent was invalid, on the basis that the invention was not novel because it was anticipated by prior art in a similar field of technology.
In an effort to fend off the Defendant’s attempts to invalidate the Diovan patent, the Plaintiffs then sought to have the claims of the patent amended “to enhance clarity, to highlight the inventive contributions of the patent and to reduce the number of claims, as well as to further distinguish the claims in the patent.”
Key issues arising then were whether or not the amendments to the patent claims would add matter beyond the application as initially filed, and whether there was undue delay on the part of the Plaintiff in taking out the present application which justifies the refusal of leave to amend.
The High Court ruled in favour of the Plaintiffs. The Judge was in view that none of the proposed amendments would add matter which has not already been disclosed in the examples given of preferred embodiments at time the application was filed.
Moving on, the Judge also found that there was “no undue delay or reprehensible conduct”on the Plaintiffs’ part in their application to amend the patent at this juncture. The Judge viewed that it was not fair to state that the Plaintiffs were responsible for undue delay simply because they did nothing in relation to the Singapore patent upon being aware of prior art from as early as 2006, seeing that the Plaintiffs believed they would – and did, in fact – prevail in the opposition proceedings at the European Patent Office (EPO). Further, the Judge dismissed the arguments put forward by the Defendant that the Plaintiffs should have applied to amend earlier in 2006 and in 2009 when opposition/invalidation proceedings were lodged against Plaintiffs’ equivalent patent at the EPO.
The Judge also added that as the Plaintiffs had to determine that amendments were necessary and that the proposed changes were viable before seeking to amend the claims, it would therefore not be reasonable to expect the Plaintiffs to amend their specifications for corresponding patent applications filed in various countries when a prior art objection is raised in one jurisdiction. It was noted that it was based on this reason that the Plaintiffs decided to wait for the amendments to the European patent in relation to the same invention to be granted before proceeding in other jurisdictions.
According to Singaporean law, Novartis had 45 days to take action in asserting its rights under the Diovan patent and to obtain necessary relief from the Court, otherwise the product licences would be granted to the Defendant.
This case illustrates the importance of drafting specifications for a patent which cannot be understated. Claims are the heart of a patent, and must be sufficiently supported in the description, which is the backbone of the subject matter. It must be emphasised that careful and deliberate efforts should be invested in drafting strong claims along with a clear description of the subject matter, as this has been proven to be imperative in the event that it becomes a future matter of contention, especially in litigation.