2019 (4) TMI 1626 - HC - Indian Laws

Interpretation of statute - Section 107A of the Patents Act, 1970 - Bolar provision - availability of a competitor's product immediately after the expiry of patent in the Indian market without having to wait for regulatory approval post patent expiry - HELD THAT - It is, therefore, clear that whilst there is one rule generally speaking, use of a term or expression in a statute, carries upon it to be interpreted in the same manner in all provisions of that statute, the rule is neither inflexible admitting no exception nor of universal application. The object of the concerned provision is one of the important factors which weigh in while interpreting whether the same meaning has to be attributed to all parts of the statute. Given these circumstances, this Court is of the opinion that exports is used in different contexts in Sections 84, 90 and 92A. Section 84 is the provision which enables compulsory licensing of certain conditions. Section 84(7) spells out what are reasonable requirements of the public. These are deemed not to have been satisfied if under Section 84(7)(a)(iii), a market for the patented article manufactured in India is not being supplied or developed. Section 90(1)(vii) is in a sense, complimentary to Section 84 and has to be read with it it guides the Controller to ensure inter alia that the license granted under Section 84(7)(a)(c)(iii) is with the predominant purpose of supply to the Indian market and that the licensee may also export the patented product. Having regard to all these factors, it cannot be held that the Parliament intended to per se exclude exports from the sweep and width of the term sale in Section 107A regard being had to the disparate and differing objectives of Sections 84, 90 and 92A all of which in some way or the other primarily deal with compulsory licensing and on the other hand, Section 107A is the only provision that allows an exception to be used- construction and sale of a patented article only for research purposes and subject to fulfillment of the conditions specified therein. The court is of the opinion that there is no question of treating Section 107A(a) as an exception to Section 48. Its history of interpretation by TRIPS, the discussion in the Parliamentary Joint Committee Report, all clearly point to its being a special provision that deals with the rights of the patented invention for research purposes.

Issues Involved:
1. Interpretation of Section 107A of the Patents Act, 1970 (Bolar provision).
2. Whether the term "sale" in Section 107A includes "export."
3. Applicability of Section 107A to exports for regulatory purposes.
4. Relationship between Section 107A and other provisions of the Patents Act, such as Section 48 and Section 84.
5. The burden of proof in cases involving the Bolar exemption.
6. The scope of judicial review in matters involving the Bolar exemption.

Detailed Analysis:

1. Interpretation of Section 107A of the Patents Act, 1970 (Bolar provision)
The judgment addressed the interpretation of Section 107A, commonly known as the Bolar provision, which allows certain acts related to patented inventions for the purpose of developing and submitting information required under any law. The court emphasized that this provision is not an exception or proviso to Section 48 but an independent provision designed to facilitate research and development.

2. Whether the term "sale" in Section 107A includes "export"
The court examined whether the term "sale" in Section 107A includes "export." It concluded that the term "sale" does encompass "export," especially in the context of developing and submitting information required by regulatory authorities in other countries. The court rejected Bayer's argument that "sale" should be interpreted narrowly to exclude "export."

3. Applicability of Section 107A to exports for regulatory purposes
The court held that the sale, use, and construction of patented products for regulatory purposes, including exports, are authorized under Section 107A. This interpretation aligns with the global understanding of the Bolar exemption, which aims to ensure that generic versions of patented drugs are available immediately after patent expiry.

4. Relationship between Section 107A and other provisions of the Patents Act, such as Section 48 and Section 84
The court clarified that Section 107A operates independently of Section 48 and Section 84. While Section 48 defines the rights of a patentee, it is subject to other provisions of the Act, including Section 107A. The court emphasized that Section 107A is not subordinate to Section 48 but a special provision facilitating research and development.

5. The burden of proof in cases involving the Bolar exemption
The court discussed the burden of proof in cases involving the Bolar exemption. It held that the party relying on the exemption must prove that their activities are reasonably related to the development and submission of information required by law. This includes providing details about the quantity of the product, the end use, and compliance with regulatory requirements.

6. The scope of judicial review in matters involving the Bolar exemption
The court noted that disputes involving the Bolar exemption are not ordinarily the subject of public law proceedings. Such disputes should be addressed through civil suits where the full range of reliefs can be granted based on the evidence presented. The court also highlighted that directing executive authorities to ensure compliance with the Bolar exemption is beyond the scope of judicial review.

Conclusion
The court affirmed that the Bolar exemption under Section 107A of the Patents Act includes the sale and export of patented products for regulatory purposes. It clarified that Section 107A operates independently and is not subordinate to Section 48. The burden of proof lies with the party claiming the exemption, and such disputes should be resolved through civil suits rather than writ petitions. The judgment underscores the importance of balancing patent rights with the need for research and development to ensure public access to generic drugs immediately after patent expiry.

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