In part 1 of my analysis, I offered a brief summary of the Delhi High Court’s judgment imposing strict conditions on the sale of the biosimilar version of Roche’s breast cancer drug, Trastuzumab, by Biocon and Mylan. Before I delve into the findings of the single judge, I should point out that, as one of the commenters to my previous article noted, the decision has been stayed by a Division Bench and the matter is listed to be next heard on 10.05.2016.
Scope of the court’s review power and legal relevance of the Biosimilar Guidelines:
After holding that the suit was maintainable in the High Court, the Court delved into the issue of ascertaining the legal force of the Biosimilar Guidelines, 2012 (“the Guidelines”) and the scope of its powers to intervene in case of a failure to comply with the Guidelines. 3 observations of the Court are relevant for this purpose.
First, citing prior case law in favour of its view, the Court held that it was a well settled principle that even if the Guidelines did not have the same character as a statutory instrument, they could not be regarded as being of a non-binding character so long as they merely supplemented, as opposed to supplanting, the provisions of the Drugs and Cosmetics Act (“the Act”) and the Drugs and Cosmetics Rules (“the Rules”).
Second, the Court held that the Guidelines put in place a robust regulatory pathway for the marketing of biosimilar drugs by prescribing the need for clinical trials, quality comparability studies, putting forth other clinical data for the grant of approvals, etc. Since the Guidelines came into force on 15.09.2012, they were fully applicable to the approval granted to Biocon and Mylan.
Finally, judicial intervention would be permissible, the Court held, in case the procedure followed for the grant of the approval was fundamentally at odds with the prescribed procedure or if the modus operandi of granting the approval was completely contrary to the public purpose underpinning the Guidelines.
Legal tenability of the approval:
As the Court noted in para 171, the determination of this issue turned on two main questions:
A. Was the approval granted in a manner consistent with the Act and Rules?
B. Was it mandatory for the defendants to conduct the first two phases of clinical trials and could they have short-circuited the process by merging the tests in one phase into a subsequent phase?
Insofar as compliance with the Rules is concerned, the Court had to decide whether it was permissible for the Drugs Controller General of India (“DCGI”) to treat the defendants’ approval application, which was filed for the approval of a new drug, as an application for the manufacture/importation of a drug already approved in India.
Holding that it was not open to the DCGI to follow the summary procedure for the approval of marketing/importation of drugs already approved in India, the Court held that there was nothing on record to suggest that the defendants’ biosimilar drug had been approved in India prior to the application dated 15.10.2013.
The Court’s conclusion was further fortified by the fact that, if the DCGI had intended to follow the summary procedure, it would never have asked the defendants as to why they had not conducted the first two phases of clinical trials as the same was not required in the summary procedure. Further, Biocon also stated in its application that it sought approval for the “permission to market a new drug” and not for the “subsequent approval to manufacture an already approved drug.”
As regards question 2, the Court held that paragraph 1(1)(iv)(a) of Schedule Y to the Rules makes it unequivocally clear that all phases of clinical trials have to be conducted in cases like the one under contemplation, so it was impermissible for the DCGI to grant an approval to the defendants even though they did not conduct the first two phases of clinical trials. Stating that combining various phases of clinical trials would “render redundant the underlying logic of sequential testing”, the Court held that no abbreviated pathway could have been sanctioned without recording reasons for the same in writing.
Use of plaintiffs’ INN:
On the question of whether it was permissible for the defendants to use the International Non-proprietary Name (“INN”), Trastuzumab, which was granted to the plaintiffs, the Court held that conducting all requisite clinical trials and fulfilling all protocols under the Act, Rules and Guidelines are the sine qua non for a party to be able to use the INN granted to another party.
If this threshold is not met, the INN can only be used while indicating some mark of distinction in order to avoid any possibility of deception with the INN of the innovator. On this basis, the defendants were directed to use the INN Trastuzumab in combination with their name i.e. Biocon’s Trastuzumab or Mylan’s Trastuzumab.
Representations on package insert:
The Court took note of the fact that Biocon had made a number of misleading assertions in its package insert, such as stating that its drug had been tested in 3 phases of clinical trials even though it had just been tested in one phase.
Holding that it was legally unacceptable for a party to make false claims on its package insert, the Court ruled that, while it was permissible to use appropriate data of the innovator drug, the same could not be wrongly used in such a way as to make it appear that the biosimilar possessed every attribute of the innovator drug.
On the issue of whether or not the defendants were allowed to use the plaintiffs’ data available in the public domain for developing Trastuzumab’s biosimilar and its marketing material, the Court held in para 300: “No doubt, defendant No.2 is entitled to rely upon the plaintiffs’ published data relating to the plaintiffs’ Trastuzumab which can be used by defendant No.2 for conducting comparative tests and thereby establishing biosimilarity…”
Curiously, however, the Court notes in para 303: “After having considered the arguments of the parties, I am of the opinion that unless Government of India frames policy to declare as to whether after expiry of patent, the data in public domain can be used as pathways or not, the regulatory authority can neither disclose nor rely upon the first applicant’s data at the time of granting marketing approval to the subsequent applicants.”
Notwithstanding the fact that the judgment is fairly comprehensive, there are some questions that it leaves unanswered.
First, even though the Court repeatedly highlights the fact that there is no law with respect to data exclusivity in India and even takes note of the fact that it was nobody’s argument that the defendants could not use the data of Trastuzumab on the expiry of the patent, its capaciously-worded observation that the data of the innovator drug cannot be used/disclosed while considering an application for the grant of approval to a biosimilar is difficult to fathom. This observation also flies in the face of the Court’s repeated enunciation of the proposition that accurate representation of the data is the only condition precedent to its use by Biocon.
Second, thinly veiled criticism of the DCGI permeates the 227 pages of the judgment; at one point, the Court even goes so far as to say that an error of judgment by the DCGI is unacceptable since the drug in question can be the difference between the life and death of a patient. However, in a move that can be construed as a tacit recognition of the importance of affordable cancer medication, the Court does not, in fact, prohibit Biocon or Mylan from manufacturing or marketing the biosimilar of Trastuzumab. if the Court does not see anything wrong in exercising its discretion in a manner that helps promote access to affordable medicine, one wonders why what’s good for the goose cannot be good for the gander.
Finally, if this preliminary finding of the Court is reaffirmed in the final judgment after trial, there can be no two views about the fact that it would further exacerbate the problem of lack of affordable life-saving medication by making it much harder for companies to produce and market biosimilar drugs. While some may argue that the safeguards built into the regulatory approval process are necessary for ensuring the safety of patients, it must be equally remembered that regulators and courts have to balance that imperative with the need to create an environment in which generic and biomedicine producers feel invested in the system.