Fresh salvo in the turf battle between innovator & generic drug makers

Every business has the right to adopt legitimate practises to protect their own interest. Right? But a recent article argues that going beyond the patent act, which permits research and development during the life of a patent, some innovator drug companies are busy trying to block this. All, in a bid to delay development of generic drugs and inturn their eventual launch after the patent expiry of the innovator's drug. The article titled 'New Frontiers of Divide: Competition vs Exclusivity' that has been published in CPhI Annual Industry Report 2017, has been authored by D G Shah, Secretary General of the Indian Pharmaceutical Alliance (which has some of the leading Indian Pharma companies as its members).

He is also the CEO of Vision Consulting Group. It argues that Innovator companies are exploring new avenues to keep generic drugs and biosimilars at bay. For instance, it says that some innovators are using distribution safety protocol, known as Risk Evaluation and Mitigation Strategy (REMS), to impede generic/biosimilar drug development. Some of the senior officials and business leaders from the Indian pharmaceutical companies also complained about this though none of them wanted to be quoted. The REMS are restricted distribution programs that the Food and Drug Administration (FDA) forces companies to establish when it approves drugs that have adverse reaction profiles of concern. But then generic drug makers do need these samples to perform bioequivalency studies, which typically is the initial stage on the path to filing for an abbreviated new drug application (ANDA).

One of Shah's key arguments, and a serious one at that, is that with the judiciary becoming "more circumspect in its evaluation of alleged patent infringement, the innovator companies are seeking new ways of blocking generics. Till now, they used to block generics after the companies applied for regulatory approval. Now, they seek to block generics at the development stage itself. This gives them multiple opportunities to delay or block the entry of generics." How?

" The modus operandi," he says, " is not only unethical but is abusive. In India, the innovator companies turned to obtaining commercially sensitive information from the office of the drug regulator. They hired a third-party to seek information about generic companies that have applied for import of samples of patented products for development. A law which allows citizens "right to information" on matters of public importance, is thus abused to seek private information." But then, the Right to information act does not provide for trade secrets to be shared. So, how can this be possible. That is precisely what is being raised and he says, "we have already taken this up with the CDSCO and ministry of law, DIPP and even with the Department of Pharmaceuticals."

This is not how innovator companies seem to see it and argue that it is just not possible because the Right to Information Act applies only to public institutions and not private entities.

The Drug Controller General of India (DCGI) however maintains that the Indian regulator has always been against any unfair practice and infact G N Singh, the DCGI, says "the government has been taking measures and today the overall regulatory landscape has changed ensuring that the regulatory environment is conducive for everyone.  Shah and some of the head honchos of pharmaceutical companies therefore says they are hinging all hopes on the competition authorities and drug regulators in playing a key role in preventing abusive anti-competitive practises.

On what Shah calls the "more prevalent practice of not providing samples for bioequivalence," he says: "The U.S. Federal Trade Commission (FTC) has intervened in legal disputes between generic and innovator companies for not providing their products for testing. In 2014, FTC backed Mylan's REMS Antitrust Lawsuit against Celgene for bioequivalence testing. There may not be many such cases, but they could be economically significant. This practice has also attracted attention of the US law makers. The US recently reintroduced a bill: Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (CREATES Act).

It speaks for the innovators' abusive practises. Though CREATES Act allows generics to sue innovators for not providing sufficient quantities of REMS products, experts doubt if it would provide optimum solution to the issue. It is possible that under the current regime in the USA, the innovator companies may behave differently to avoid glare of the President. They may also not flout laws to pursue longer period of exclusivity, having regard to the new Administration's focus on raising competition to reduce drug prices in the US."

In India, Shah says, in some cases for biosimilars there have been instances where innovator companies challenge the decision of the drug regulatory authority and argues that the "points to note are innovator companies' recourse to litigations to prevent/delay entry of biogeneric and generic companies' reliance on the competition authority.'

He points out that the "litigations involving competition authority at the development stage have so far been few. Not because abuses do not take place. They occur all the time. But, generic companies are hesitant to take them up for two reasons. Firstly, they do not want their competitors to find out their product development focus and strategy. Secondly, many of them have some form of commercial alliance with the innovator companies. And, they do not wish to adversely impact their commercial alliance."