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Pharmaceutical Patents in Singapore
29 July 2013
AstraZeneca is not getting all its own way in asserting a Singapore patent against Sanofi-Aventis Singapore.
The present case was precipitated by Sanofi’s application to the Health Sciences Authority of Singapore (HSA) for a product license to allow Sanofi to market a competing product (the application). The HSA required Sanofi to notify Astra of its application as Astra’s patent, Singapore Patent No. SG 89993, was relevant to the competing product.
The patent relates to a pharmaceutical composition comprising rosuvastatin as an active ingredient and an inorganic salt in which the cation is multivalent. The pharmaceutical composition in the patent is used to treat high cholesterol.
From the time Astra issued proceedings, a statutory moratorium of 30 months automatically kicks-in to allow Astra to obtain a declaration of infringement. This process is often referred to as patent linkage.
Astra obtained discovery of product description documents from Sanofi, arguing they were required to understand how the competing product infringed the patent. This disclosed the chemical composition of the competing products and the amount and weight of the active pharmaceutical ingredients and excipients.
Then, Sanofi went on the attack – having revealed its product details, it requested “further and better particulars” from Astra of how it alleged Sanofi’s product infringed the patent.
Astra refused, so the matter came to Court again.
Sanofi’s Application for Further and Better Particulars from Astra
The Court decided in favour of Sanofi that certain particulars should be provided by Astra.
The Court examined English case law and noted a change of position over time both for and against requiring particulars because of the risk that a patentee may be wrongly forced at an early stage to construe their patent claims.
The modern position was found to be that in exceptional cases, particulars of infringement may extend to claim construction depending on the facts of the case. The Court adopted this approach and found there were exceptional circumstances because:
1. The action involved a pharmaceutical patent, and the precise patent infringement(s) may not be easily observable without the conduct of experiments.
2. Such experiments are expensive and, without particularization at an early stage, there may be wasted costs.
3. The action was brought under the Medicines Act and all that was required to trigger the 30-month moratorium was an action for prospective infringement.
The provision of more particulars at an earlier stage of the proceedings was therefore found necessary. The Court then assessed the particulars requested to decide which requests were legitimate.
Generally, particulars:
• were not ordered where they were subject matter for expert evidence or not necessary for Sanofi to know the case against it
• were ordered where they could have an impact on the measurements to be taken during experiments (to avoid unnecessary costs and expense).
The first request was wide ranging – identification and further particulars of how each of the 27 claims of the patent would be infringed “to identify the specific component(s)/characteristic(s) of the Defendant’s products that reads on each element of each claim identified.”
Astra said this would essentially require construction of the patents’ claims.
However, although it was acceptable for Astra to rely on all the patent claims, this did not absolve Astra from informing Sanofi of the case against it.
It was insufficient for Astra to simply state that all 27 claims had been infringed despite obtaining Sanofi’s product description documents, and it would be highly onerous for Sanofi to prepare to meet every possible case against it on each of the 27 claims.
Lessons From the Case
Where a claim has serious consequences to the public and to a defendant’s legitimate business, as a matter of good practice, the plaintiff should be required to give proper particulars of its claim.
The Court appreciated that the availability of the 30 month moratorium could be used to delay the launch of medicinal products by competitors, hindering public access to products.
The Court found that the same concerns and considerations that apply to actions for breaches of confidence should apply in patent actions – that extra care must be taken to ensure “clear particularization” and ensure that such claims are not used to oppress and harass competitors.
patrick mirandah co. (s) pte ltd
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Singapore 179903
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