That how many types of new drugs are eligible for listing in the Patent Linkage Registration Platform (“the Platform”) has been like a see saw going up and down since the system was established in Taiwan in 2019. The Ministry of Health and Welfare (“MHW”), as the authority governing the Platform have been holding in a conservative stance to narrowly define that only the drugs of new compositions, new therapeutic compounds and new methods of administration (hereinafter referred to collectively as “category 1”). In December 2022, two trial court’s decisions shed a different light with the opposite opinion and seemly opened the door for more drug types. To some’s regret, however, the Supreme Administrative Court (“SAC”) being the appellate court recently rendered two judgements in November 2023 on the other two cases dictating that drug types other than category 1 are not registrable onto the Platform.[1]

  MSD is the owner for ISENTRESS 600 mg table, an integrase inhibitor in HIV treatments, and Allergan is the developer for LUMIGAN ophthalmic solution 0.01%, an eye drop that helps reduce eye pressure due to glaucoma and other eye diseases. MSD and Allergan (collectively referred to as the “Plaintiffs”) logged in the Platform to register the patents of their respective products. Later in the input review by the maintaining staff of the MHW, it was discovered that the medical product authorization by which the Plaintiffs upload the associated patents directed not to any kind of category 1 but a drug in “new administered dose.” MHW deleted the registrations. In reaction, the Plaintiffs sued for restoration of their registrations by canceling the take-down.

  The definition of a new drug eligible for linkage system was the core of the trial court’s opinion. Patent linkage connects the marketing approval of a new drug and the disclosure of the legal information of its associated patents. It also connects the examination process for generic applications and the resolution of disputes of whether the new drug’s associated patents are infringed. Under the Pharmaceutical Affairs Act, a new drug refers to a medical preparation having new compositions, new therapeutic compounds or new method of administration.[2] The MHW is the competent authority to determine whether a product sent for marketing approval examination is in one of the types in category 1. As for the preparations of new dosage forms, new administered doses and new unit strengths (collectively hereinafter referred to “category 2”), the Regulations for Registration of Medicinal Products only provide that their examination for marketing approval applies in the same process as category 1. No more preferences were endowed to category 2 drugs to afford them the same legal status identical to category 1 drugs. In view of such, category 2 was not new drugs as per the statutes. The Plaintiffs’ attempts to register products of no new drugs were therefore not lawful. Therefore, deleting the registrations of the Plaintiffs’ authorizations for new doses was correct, opined by the trial court.

  With the unfavorable decisions, the Plaintiffs appealed.

  In the appellate judgement, the SAC sided with the trial decision to affirm that the authorizations for new administered dosages are not eligible for the linkage regime. More elaborations were added.

  Investigating the policy goal of the legislation by the time of introducing the linkage system in 2018, the SAC reasoned that the term “drug” clearly referred to the definition of category 1 when the statute was amended in 1993. That is, the legislators in 2018 knew what new drugs in the statute have been since 1993. They intentionally limited the scope of new drug eligible for the linkage system to category 1 only when they enacted the same.

  Being reluctant to yield, the Plaintiffs persisted that the statutes further provided that the definition to a new drug should be resorted to the dedicated Chapter for Patent Linkage where it stipulated only substance, composition or formulation, medical use being registerable on the Platform. The SAC found such argument erroneous. To correctly interpret the law, not only did a patent direct to a substance, a composition or formulation, or a medical use but also its associated marketing authorization must be a product of category 1, SAC analyzed. In other words, the product authorizations and the associated patents have their respective requirement to be met before they can be listed onto the Platform. Thus, a product able to enter the linkage system remained to be a category-1 drug indeed.

  The SAC explained, what kinds of drugs are eligible is determined up to choice of the parliament. Each step of the linkage system, including a patented drug’s listing, a generic challenger’s declaration, the notification to the IP office, the suspension of generic approval issuance, sale exclusivity privilege, etc., hinges on the public welfare, supply and demand, competition strength, and the product prices. Each country has its own sets of conditions and policy goals. Taiwan’s rules and regulations in the linkage system do not have to be consistent in all aspects with other nations. The statute that defined what a new drug is was previously enacted by the parliament in the rule of democracy. For any future changes to the definition or scope of subject matters is ought to be resorted to the reserved power of the legislative branch.

  Lastly, the Plaintiffs argued that the application for registration of patent onto the Platform was automatically received and then post publically on the Platform’s webpage. The statute only endowed the third parties in the general public to challenge any errors rather than the MHW to take down a registration. The SAC opined to the otherwise. The MHW was the head authority for medical and pharmaceutical affairs. It possessed the dictating jurisdiction to regulate the Platform under the law. The MHW is entitled to exercise its discretionary power to validate the lawfulness of a registration. That is to ensure that a listing would not be illegally post and published, despite the public vetting mechanism available.

  To short conclude, the Plaintiffs’ argument in seek of a broader scope of new drug to enter the linkage system was not valid. The SAC affirmed the lower court’s decision and the MHW’s take-down was lawful. The MSD and Allergan’s cases were final.

  The series of litigation histories for the drug type disputes is briefly illustrated in the below table. Note following in later November and early December 2023, there have been two other appellate judgements (CIMA Labs and Novartis) on the same issue were made by the SAC to keep in constancy ruling new dosage not registerable.

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