In Taiwan, the enforceability of a patent during its term extension is limited to the effective ingredients and uses specified explicitly in the regulatory approval upon which the drug patent extension is based. A dispute recently arose regarding whether a patent during its extended term can be enforced against the import of the active pharmaceutical ingredient (API) of a patented drug.

  Bristol-Myers Squibb (BMS) is the holder of patent I320039 titled “Lactam-containing compounds and derivatives thereof as factor Xa inhibitors.” Filed in 2002 with two US priorities in 2001 and 2002, the ‘039 patent's original term started on February 1, 2010 and ended on September 9, 2022. However, the patent term was subsequently extended to May 23, 2026 based on the associated regulatory approval. Claim 1 of the ‘039 patent relates to a compound called Apixaban, marketed under the brand name Eliquis, which is an anticoagulant primarily used to treat thromboembolic disorders by preventing blood clot formation.

  New Chiens Biotech, a pharmaceutical trader, obtained import licenses from the Taiwan Food and Drug Administration (TFDA). BMS accused New Chiens of infringing the ‘039 patent by importing Apixaban into Taiwan. In its defense, New Chiens explained that an API is distinct from a medicinal preparation or a finished generic drug product; APIs as a raw material cannot be directly used to treat disorders in patients. Although the import license stated the imported substance’s field for pharmaceutical indication as “anticoagulant,” New Chiens emphasized that it merely described the pharmacological effect of the substance and was not a therapeutic indication in a medical context. Additionally, the enforceability of a patent does not extend to research and trials necessary for obtaining drug registration and regulatory approval as required by the law.[1] New Chiens added that its overseas procurements of Apixaban were subject to exemption since the imports thereof were solely for the potential research activities of other generic drug makers with an aim to obtain marketing approvals; thus, the importation should not be covered. Moreover, the enforceability of the ‘039 patent was strictly limited to the use of Apixaban in treating the indications specified in BMS’s regulatory approval, on the basis of which the ‘039 patent was granted an extension. When Apixaban as a mere API cannot be prescribed by hospitals or clinics to treat any of the medical conditions stated in the regulatory approval, the API should not fall within the scope of the extended ‘039 patent.

  On December 29, 2023, the Intellectual Property and Commercial Court rendered a first-instance judgment rejecting BMS’s complaint.[2]

  Procedurally, the Court first resolved the plaintiff’s standing to sue. Although the ‘039 patent had previously been licensed to BMS Taiwan, a separate entity from the controlling company BMS Holdings registered in Ireland, this license was not exclusive in nature. After BMS Taiwan later granted the license to Pfizer, neither did BMS Taiwan and Pfizer become the exclusive licensees. That said, the BMS Holdings retains the full capabilities to sue.

  On the merits of the case, the Court held that the disputed API did not fall within the scope of the extended ‘039 patent. As the Court highlighted, an API is not a finished preparation capable of treating disorders, and the technical data on New Chiens’ import license merely represented a pharmacological classification, not a medical indication validated in a human clinical trial report for the drug's biosafety and efficacy. As an API trader with a main business engagement in the import, sales and agency of active ingredient materials from an overseas partner, New Chiens is not capable of the manufacture or sale of a finished product in Taiwan. The Court reaffirmed that the enforceability of a drug patent during its extended term was limited to only the effective ingredients and uses specified in its associated regulatory approval. Since an API is not an administrable drug for patient treatment, it was not covered by the extended patent right.

  BMS further argued that Taiwan's patent term extension law mirrored the US legislation[3], suggesting a broader patent coverage that is inclusive of APIs as ruled in US case laws. However, the Court denied this argument, stressing that Taiwan's extended patent enforceability was restricted to only indications corresponding to the regulatory approval, whereas an extended patent in the US can be enforceable against “all” medically approved uses (or indications) of the active ingredient. The US and Taiwan's statutory foundations differed, so the reasoning of the foreign case law was not applicable here.

  BMS went on to insist that Claim 7 of the ‘039 patent—concerning the use of Apixaban to manufacture anticoagulants—was within the extended scope of the patent right. However, the Court again clarified that the extended scope was limited to—as literally stated in the reissued patent certificate—the use of the active ingredient Apixaban in preventing stroke […] in adult patients with […] at least one of the following risk factors: (1) previous stroke or transient ischemic attack; (2) age greater than or equal to 75 years; (3) hypertension; (4) diabetes, and; (5) symptomatic heart failure (NYHA Class≧II). None of the foregoing statement related to the specific use of the manufacture of a medicament recited in Claim 7. BMS’s argument was deemed to be fallacious.

  To briefly conclude, the import of the disputed API Apixaban did not fall within the enforceable scope of the extended ‘039 patent. The Court found no infringement as a result of New Chiens' import of Apixaban; hence, the Court did not continue to hear New Chiens’ counterclaim against the decision to grant the ‘039 patent’s term extension. BMS's claims for damages and injunctive reliefs were rejected. The case remains appealable.