As Southeast Asia grows as a manufacturing base and sales market for pharmaceuticals, it is becoming more important for life sciences IP professionals to factor the region into their strategies and to monitor important legal developments across its numerous national jurisdictions. Below is a guide to the most important patent-related decisions to be issued by Southeast Asian courts so far in the 2020s.
The patent linkage provisions enacted following the Free Trade Agreement with the US on 1 January 2004 sparked two rounds of patent litigation concerning the cancer drug bortezomib. This series of cases stretched began in 2019 and concluded in 2023. Under the patent linkage system, an applicant for marketing authorization needs to disclose third-party patents that are related to a drug for which marketing authorization is applied.
In the first round of litigation – in Millennium v Zyfas ([2020] SGCA 84) – the generic’s marketing authorization was revoked by the Singapore Court of Appeal for failing to disclose patents “related to the drug” which include the patented manufacturing process, even though the generic drug applicant believed that the generic drug was not the result of the patented process. Though patents protecting the drug itself had already expired, Millennium owned in-force patents covering manufacturing processes used to make the product.
The Court of Appeal affirmed the lower court’s that the generic drug applicant needed to disclose the patented process “related to” the drug in its marketing authorization application, even if it did not believe that the generic drug was produced using the patented process. It is then for the Health Science Authority to decide if the generic applicant needs to give notice of the application to the patent holder, the Court of Appeal held. If the patent holder does not file legal action within 45 days, only then will the Health Science Authority grant the marketing authorization.
The second round of litigation between the same parties concerned infringement and validity. The generic drug distributor succeeded in having one of the process patents revoked and, with respect to another process patent, convinced the Singapore High Court ([2023] SGHC 360) that infringement was not proven.
An interesting aspect of this decision was the patentee’s failure to invoke Section 68(1) of the Patents Act for the burden of proof to be reversed which means that the defendant was presumed to have implemented the patent process unless it could prove that it uses a different process.
In order to successfully invoke Section 68(1), it was necessary for the plaintiff to establish the following:
1. That a substantial likelihood exists that the product is made by the process; and
2. That the proprietor of the patent had been unable, through reasonable efforts, to determine the process that was actually used.
The substantial likelihood element was not met because the court found that there were differences in the manufacturing processes of the defendant’s products. Also, the plaintiff could not satisfy the court that it had made reasonable efforts to determine the process used by the defendant. An additional factor that the court considered was that Dr Reddy’s (the supplier of Zyfas’ generic drug) offered the patentee an opportunity to inspect its plant, which the plaintiff rejected.
In October 2023, Novartis finally concluded its eight-year-long litigation case against Vietnamese drug manufacturer relating to a diabetes patent drug with the active ingredient – vildagliptin.
Novartis had to go through two rounds of appeal before it succeeded in 2023. The lower court – the People’s Court of Binh Duong Province, where the defendant was located – declared that the defendant infringed the patent during the patent validity and ordered it to terminate all infringement acts, pay damages and make a public apology. The defendant filed an appeal against this judgement to the High People’s Court of Ho Chi Minh City. The appellate court annulled the first judgement, raising the need to clarify the infringement assessment, and the case was returned to the lower court for re-trial.
In its second infringement assessment, the lower court maintained the same conclusion. The defendant filed another appeal. The final judgement of the appellate court ordered the defendant to pay damages and make a public apology.
While the case was ongoing, the patent expired in 2019 and the local manufacturer continued with the production of the drug during the litigation. Currently, the number of patent litigation cases in Vietnam is still limited and the level of patent awareness among Vietnamese drug companies is low. Many Vietnamese drug companies still think that a drug marketing authorization granted by the Drug Administration of Vietnam will protect all business activities regarding the drug. Nevertheless, the 2023 decision demonstrates to generic manufacturers the need to respect patent rights.
In 2020, the Indonesian Court refused to enforce a second medical use claim patent (blood disorder drug deferiprone) belonging to Apotex against an Indonesian generic company Novell. The reason given was that there was prior art referencing the possibility of using the drug to alleviate the effect of excess iron as a result of blood transfusion for thalassemia patients. This was a confusing move given that there was no validity challenge under consideration. It was also confusing because the claim in the patent was directed at treating a more severe type of this blood disorder than covered by prior art.
On 25 June 2021, the Intellectual Property Office if the Philippines’ Bureau of Legal Affairs issued a decision finding Suhitas Pharmaceutical liable for infringing Boehringer Ingelheim’s telmisartan patent and ordering the payment of P5M Pesos (about USD 90,000) in damages.
Among the defences raised by Suhita was that Boehringer’s patent is overly broad and lacks novelty for being anticipated by an earlies patent (Patent No. 17158 for Imidazo (1,2-a) Pyridin-2-YL Carbostyril Derivatives issued in 1984). The BLA rejected this defence since, aside from the bare allegations in Suhitas’s answer and its witness’s judicial affidavit, no other evidence was presented by Suhita to prove their claim. Remarkably, the BLA granted Boheringer’s application for preliminary injunction during the pendency of the case, which is rare in patent infringement cases where issues are technically complex.
Suhitas appealed the BLA’s decision to the IPOPHL Office of the Director General. In 2023 the ODG affirmed Suhitas’ liability for patent infringement.
IP infringement cases in the Philippines may be filed in either the IPOPHL or the courts. IPOPHL is still chosen over the court option because the hearing offices at IPOPHL are usually more knowledgeable on patent matters and may have more technical expertise in deciding patent infringement cases compared to court judges. In addition, the IPOPHL is not strictly governed by technical rules of procedure and evidence and the quantum of proof is only substantial evidence (the standard for administrative cases), as compared to preponderance of evidence in courts.
Where necessary, a patentee may wish to consider seeking a preliminary injunction in view of the delay until the first instance decision. There is an option to apply for a preliminary injunction in IPOPHL proceedings, and this may be granted after the hearing which may take 6 to 8 months from filing.
In January 2024, the Court of Appeal for Specialized Cases issued a decision in H. Lundbeck A/S v Unisun and Medline [case no. 129/2567] to affirm that Unisun and Medline are jointly liable for infringement against Lundbeck’s patent (antidepressant medicine escitalopram for treatment of general anxiety disorders) and were ordered to pay damages of 106,500 in Danish Krone (about US$15,500), fixed legal costs and court fee to Lundbeck.
The case started in June 2020 when Lundbeck filed a civil patent infringement action against two Thai companies: Unisun and Medline. The Danish company owned a Thai product patent and alleged that Unisun and Medline jointly infringed the patent. Lundbeck claimed that not only did Unisun manufacture and sell and Medline as Unisun’s distributor sell and offer to sell the medicine protected by the patent, but also recorded the medicine as a Thai innovation with the National Science and Technology Development Agency (NSTDA) which allowed the two Thai companies to sell and offer to sell the medicine without having to go through the auction process and caused hospitals and/or state agencies to stop ordering Lundbeck’s medicine. Lundbeck demanded over 4 million Danish Krone (about US$584,000) in damages and more, and for the Thai companies to stop the infringement, hand over the remaining infringing medicine for destruction, and withdraw the innovation record with the NSTDA.
The Central Intellectual Property and International Trade Court ruled in favor of Lundbeck and ordered Unisun and Medline to pay 1.1 million in Thai Baht (about $30,100) in the combination of 500,000 Thai Baht (about USD13,700) for Lundbeck’s expenses incurred to enforce its patent rights and 600,000 Thai Baht (about US$16,400) for Lundbeck’s loss of benefit, plus interest and fixed legal costs and court fee. Lundbeck’s other requests were dismissed, presumably because Lundbeck’s Thai patent had expired by then. Both parties appealed, with the Thai companies challenging the awarded loss of benefit in the amount of 600,000 Thai Baht as too high, among other issues. The Court of Appeal for Specialized Cases simply ordered the same amount to be paid in Danish Krone instead of Thai baht per Lundbeck’s original request, upheld the first instance infringement ruling.
This case shows how conservative Thai courts can be in awarding damages.
It is not yet known whether any party appealed to the Supreme Court.
There is no one size fits all patent protection approach. Even though the patentability requirements are similar and most patent offices grant local patents based on the same patent family grants from more developed jurisdictions such as EU, USA, Japan and Korea, each court’s treatment of patent protection is different. This could be due to varied legal traditions – inherited from the past that continue to apply today albeit with some local flavor infused.
Nevertheless, it is still important to be vigilant against generics who are prepared to test originators’ resolve to enforce their patent rights – particularly when patents are nearing their end of protection period. From a generic perspective, the Singapore case is illustrative in dealing with an originator’s attempt at evergreening drug protection – and how a generic company with resolve is able to overcome such attempts.
This article was first published on IAM in July 2024.
