From the Desk of Patent Circle: Is Dasatinib Order Contravenes Bolar-Provision?

Continuing from our earlier post, we will now focus on another issue whether the Delhi HC Dasatinib order contravenes bolar-provision? However, before going further into details of this let us briefly discuss what is bolar-provision?

Bolar-provision, also referred as Regulatory-use exemption is a statutorily created exemption from the patent infringement under Sec. 107A (1) of the Patents Act, 1970 which states –

(a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product;

In simple words, the exclusive right conferred under Sec. 48 does not extend to prevent third party from any act specifically and reasonably necessary in the development and submission of information required under regulatory laws in India or any other country. The bolar-provision is of high importance to generic manufacturers to conduct certain trials on patented drug needed to generate data to demonstrate bioequivalence prior to the expiry of the patent. The purpose of bolar-provision is to ensure that the generic drugs are on the market immediately after the patent expiry – we again emphasize immediately after the patent expiry, not during the lifetime of the patent. In other words, the bolar-provision allows generic manufacturer to use and make patented drug for conducting necessary trials to generate data to demonstrate bioequivalence and to prove the drug is similar to the reference product (as needed by the Drug Regulatory agencies) without the consent of the patentee. However, exemption under Sec. 107A (1) does not extend to use of patented drug to obtain the license to manufacture and distribute the generic drug before the patent expiry.

We would like to add a word of caution that the bolar-provision exempts use of patented product (drug) to generate necessary regulatory data, not use of patented product to obtain license to manufacture and distribute the drug before the patent expiry and not even to induce willful patent infringement. Usually applicability of the bolar-provision comes in use just couple of years before the patent expiry not at least 10-12 years before the expiration.

Now coming back to our main issue – whether the Delhi HC Dasatinib order contravenes Bolar-provision? Considering (1) the scope of Sec. 107A (1) allows “the use” of patented product to generate bioequivalence data and (2) Hetero while seeking generic drug approval would have generated and submitted the same to the DCGI, it seems there is no contravention of “bolar-provision” by the Delhi HC Dasatinib order. In fact, if the DCGI gives Hetero the approval for marketing and Hetero possibly launches the drug before patent expiry then in such case none of Hetero’s action will be exempted under Sec. 107A (1) and will definitely lead to a case of blatant willful infringement. It is quite unfortunate that exemption under Sec. 107A (1) is distortedly portrayed as statutory go-ahead for willful infringement.

On the lighter note, if Hetero has already conducted bioequivalence studies without having a bona fide intention to launch the generic drug after the patent expiry then Hetero cannot seek immunity under Sec. 107A (1) and has already made a case of patent infringement, possibly willful …