Does Bolar exception apply only to generic drugs?

By Tang Huadong, Merits & Tree Law Offices
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Article 69 of the Patent Law provides that, “the manufacture, use or import of a patented pharmaceutical or patented medical device, or the manufacture or import specifically on a party’s behalf of a patented pharmaceutical or patented medical device, for the purpose of providing the information required for administrative approval” is not deemed patent infringement. This provision is commonly known as the “Bolar” exception to pharmaceutical infringement. The question is, does the Bolar exception apply only to generic versions of patented drugs?

Tang Huadong
Partner
Merits & Tree Law Offices

The Case Handling Guidelines for Administrative Decisions in Patent Infringement Disputes, of the National Intellectual Property Administration, state that the legislative intent of such a provision is to overcome the delays in the marketing of a generic drug or medical device after the expiration of the term of a patent brought on by the review and approval system of the drug marketing, thereby avoiding a disguised extension of the protection period for patents on relevant drugs and medical devices. If one keeps to this interpretation, it would seem that only generic drugs would benefit from the Bolar exception.

Article 5 of the latest version of the Provisions for Drug Registration specifies that the classification of chemical drugs for registration purposes includes classification based on new chemical drugs, modified new chemical drugs, generic drugs, etc. The classification of biologics for registration purposes includes classification based on new biological products, modified new biological products, and already marketed biological products (including biosimilars).

In fact, during the course of providing the information required for the administrative review and approval of new drugs, or modified new drugs, there are many instances that involve the manufacture or use of patented drugs. For example, for an innovative biological product, it is possible that, in the course of the research and development of an antibody drug conjugate (ADC), an already marketed monoclonal antibody drug needs to be used as a raw material, with further conjugation carried out on that basis. During the production process, it is possible that the patent for the monoclonal antibody sequence or preparation method will be implemented.

As another example, for a modified version of a patented chemical pharmaceutical, it may be necessary, on the basis of a known active ingredient, to manufacture or use the active ingredient from an already marketed chemical pharmaceutical in the research conducted to optimise the structure, dosage form, formulation process, means of administration, indications, etc., and there is a possibility that the patent on the chemical pharmaceutical’s compound or preparation method will be implemented.

Accordingly, it is of great significance to clarify whether the Bolar exception is applicable to the implementation of an existing pharmaceutical patent, for purposes of providing the information required for administrative review and approval, in the course of the research and development of an innovative drug.

First, neither the existing Bolar exception provision, nor the provisions of the guidelines, specify that the Bolar exception applies only to administrative approvals for generic drugs, and does not apply to administrative approvals for innovative drugs.

Second, pursuant to article 1 of the Patent Law, the legislative objectives of the Patent Law are encouraging invention and creation, promoting the application of inventions and creations, enhancing innovation capabilities, and promoting scientific and technological progress and socioeconomic development as a whole, while protecting the lawful rights and interests of patent holders.

If the Bolar exception is limited so as not to apply to innovative drugs, it would also cause the existence of prior patents to hinder the research, development and marketing of innovative drugs, and reduce the accessibility of drugs, thereby running counter to the legislative objectives of encouraging invention and creation, and promoting scientific and technological progress and socioeconomic development.

Third, the term “generic drug” in the guidelines should be understood in a broad sense, not understood as specifically referring to the proper noun “generic drug” in the Administrative Measures for the Registration of Drugs, but as the act of copying and producing patented drugs.

In this regard, as long as the copying of a patented drug occurs in order to provide the information required for administrative approval in the course of the research and development of an innovative drug, the Bolar exception is applicable, and the defence of non-infringement can be raised.

Of course, this does not mean that as long as the purpose is the provision of information required for administrative approval, pharmaceutical research and development is protected by an amulet, and the risk of infringement disappears. The National Intellectual Property Administration further specifies in the guidelines that, “pharmaceutical patents worked for the purposes of providing information required for administrative approval not only include patents for the drugs themselves, but also patents for the active ingredients of drugs, drug preparation method patents, and pharmaceutical active ingredient preparation method patents”.

If the patented technology of a third party is used in the course of pharmaceutical research and development, and such technology is not an active ingredient patent, preparation method patent, etc., that is directly related to the above-mentioned prior patented drugs, it is still necessary to pay attention to the risk of patent infringement.

In short, in the absence of an express limitation in law, the author understands that, if the purpose is “to provide information required for administrative approval”, the Bolar exception is equally applicable to innovative drugs and generic drugs.

Tang Huadong is a partner at Merits & Tree Law Offices

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