The Taiwan Patent Act provides a system for the extension of patent rights for pharmaceuticals and agrochemicals. According to Article 56 of the Patent Act, the scope of an extended patent right approved by the IP Office shall be limited to the active pharmaceutical ingredients (API) and the indications specified on the new drug approvals, submitted for filing and obtaining the extension of patent rights. The Intellectual Property and Commercial Court, in its Judgment rendered on December 29, 2023 on a patent infringement lawsuit, addressed the issue as to the scope of such extended patent right .
The Judgment may offer insight into the Court's interpretation of the provision of Article 56 of the Patent Act.
The patent at issue is a divisional patent which took advantage of the filing date of its parent case, i.e. September 10, 2002. Thus, the durational term of the patent at issue commenced on February 1, 2010, and expired on September 9, 2022.The claims of the patent at issue include compound claims, claims for pharmaceutical compositions containing that specific compound, and medical use claims using the same compound in the treatment of thromboembolic disorders.
Subsequently, a new drug approval from the Ministry of Health and Welfare was issued, based on which the patentee filed a request for an extension of the patent term on October 28, 2014. After examination, the IP Office issued a Certificate of Extension of the Patent Right, which indicates that the patent term was extended by 1,352 days, from September 10, 2022, to May 23, 2026. The approved scope of extension is: "the active ingredient Apixaban for use in adult patients with non-valvular atrial fibrillation who have at least one of the following risk factors for stroke or transient ischemic attack: (1) a history of stroke or transient ischemic attack; (2) age 75 years and over; (3) hypertension; (4) diabetes; and (5) symptomatic heart failure (NYHA Class≧II)”
Based on the extended patent right, the patentee filed a patent infringement lawsuit against a bulk drug trader who has obtained drug approvals, registered as “bulk drugs” of API apixaban with the indication specified as "antithrombotic agents” (hereinafter referred to as the bulk drug approvals) The patentee averred that the defendant's importation and sale of the bulk agent of the active ingredient Apixaban which falls at least within the literal scope of the compound claims of the patent at issue, constituted a literal infringement.
One of the core disputes in this case revolves around whether the protection scope of a patent during an extended period is limited solely to the active ingredients and uses specified on the drug approval (i.e. the one used for filing and obtaining the extension of the patent right), or whether bulk drugs of the same API may be covered by the compound claims relating to the same API.
Regarding this issue, the Intellectual Property and Commerce Court elaborated that, according to Article 56 of the Patent Act, the scope of the extended patent right is limited to the active pharmaceutical ingredients (API) and the indications specified on the drug approval for filing and obtaining the extension of the patent right issued by the IP Office. Therefore, an infringement would be established only when both the active ingredient (Element A) and the indication (Element B) could read on the allegedly infringing product.
Element A: The active ingredient Apixaban
Element B: Used for adult patients with non-valvular atrial fibrillation who have at least one of the following risk factors for stroke or transient ischemic attack (TIA): (1) a history of stroke or TIA; (2) age 75 years and over; (3) hypertension, (4) diabetes; and (5) symptomatic heart failure (NYHA Class≧II)
Regarding Element A, the English trade name on the defendant's bulk drug approvals is Apixaban. Thus, there should be no dispute that the concerned API could be read by Element A.
As to Element B, the defendant's drug approvals are bulk drugs with the indication specified as an antithrombotic agent.
The Court examined the relevant information required for obtaining bulk drug approvals and found that the bulk drugs are not "formulations” and do not have therapeutic purposes in themselves. In addition, it can be understood from the relevant information that clinical trial reports supporting the efficacy and safety of the indications are not required for issuing bulk drug approvals. Those skilled in the art would appreciate that the indications on the bulk drug approvals refer only to the “pharmacological classification” of the bulk drugs, instead of therapeutic indications for clinical treatment with the support by human clinical trial reports in terms of the safety and efficacy. Therefore, the concerned bulk drug could not be read by Element B.
Furthermore, bulk drugs are generally purposed to provide pharmaceutical companies with necessary components for conducting trials for drug approval or as active components in the manufacturing of drug formulations. It is not intended for the manufacturing of drug formulations (finished products) itself. The defendant, as a trader of bulk drugs, belongs to the upstream sector of the pharmaceutical industry in Taiwan. While it acts as a sales agent for major international API manufacturers, and assists local pharmaceutical companies in finding new sources of raw materials, its main products and services involve the import and sale of bulk drugs only. As such, the defendant possesses, in no event, any capability to apply for or obtain a finished drug (formulation) approval, to manufacture or market approved drugs.
The Court further noted that Article 56 of the Patent Act clearly mandates that the scope of extended patent rights is delimited. For a bulk drug that does not have a therapeutic use (upstream industry) and the examination and approval thereof focuses solely on the API's physicochemical properties and synthetic steps without extending to its therapeutic safety or efficacy, it apparently does not fall within the scope of the extended patent right of the patentee.
While the patentee claimed that the scope of the extended patent right should not be limited to the final product (drug formulation) only and that the antithrombotic agent is positively specified on the bulk drug approvals issued to the defendant, the Court held that the indications on the defendant's approvals are merely a "pharmacological classification," not those for clinical treatment which should be supported by clinical trials and proven to be safe and effective for human treatment. Since the concerned patent has expired, the scope of the extended patent right naturally should not cover a scope beyond the combination of the API and the indication specified on the drug approval for filing and obtaining the extended patent right. Therefore, the concerned bulk drug does not fall within the scope of the extended patent right of the patent owned by the plaintiff.
In defense, the plaintiff argued that the purpose of submitting the new drug approval was merely to prove that the concerned patent could not be practiced temporarily due to the filing of an application for drug approval. In response, the Court pointed out that Article 56 of the Patent Act explicitly states the scope of an extended patent right is delimited. For compound/composition claims, the scope of the extended patent right is limited to the API and the indications specified on the drug approval for filing and obtaining the extension of the patent rights. For use claims, the right is limited to the indications specified on the drug approval. As to method claims, it is limited to the method for preparing the API for the indication specified on the drug approval. Therefore, the plaintiff's claim regarding the coverage of patent rights during the extended period is a misunderstanding of the legal text and is unfounded.
From the above, it is crystal clear that the Court has acknowledged the distinctions between the bulk drug approvals and the formulation drug approvals, noting that bulk drugs, as raw materials for drug formulations, do not have therapeutic purposes per se. Even if indications are specified on a bulk drug approval, this is merely a "pharmacological classification," instead of indications for clinical treatment. The Court further restricted the effect of an extended patent right to the components and uses specified on the drug approval for filing and obtain an extension of the patent rights.
This is the first-instance judgment. Whether or not the higher court would adopt the same stance after any appeal and the future development of the case are worthy of further observation.