Pharmalot: Why is this case being seized on as an issue for access to medicines? Baker: Because this is a big drug company taking a shot at the heart of India’s strict patent regime. Basically, Novartis is undertaking a continuing effort to undermine the country’s interest in limiting evergreening. It’s dangerous, though, because it’s a cancer drug. If India’s patent act is limited (by the outcome of this case), then India will have the kind of successive multiple patents where they are lengthened over and over again for companies. If that happens, generic drug makers won’t be able to compete, unless compulsory licenses are used. Basically, they would be selling to rich people or at least those who can afford the medicines. It’s a rational business decision for pharma companies perhaps, but a poor health outcome for people who can’t afford the medicines.
Pharmalot: What’s the history here? Baker: The first time this came up, Novartis basically tried to repeal what is known as section 3d of the Indian Patents Act and claimed this contained restrictions on patentability beyond those permitted by an international agreement called TRIPS. Novartis also claimed the provision violated the Indian constitution. That case went to the Chennai High Court in India and was basically thrown out. The case was decided in the summer 2007 and the court said this was a lawful attempt by India to enact strict standards and was permitted under public policy and, under TRIPS, it was lawful to restrict evergreening. It helps to know that, in 2005, India had amended its patent law to comply with the TRIPS agreement. And remember that section 3d of the Indian Patents Act wouldn’t grant a follow-up patent on a minor varation of an existing medicine unless it showed a significant enhancement in efficacy.
Pharmalot: The upcoming hearing refers to a different legal attempt, yes? Baker: The second case concerns their pending application for a patent on the new form of Gleevec. Basically, Novartis used two strategies to attack – the first, which was already decided, took the constitutional tack against section 3d of the patents act. The second tack was actually going on concurrently. This time, though, Novartis is trying to say that section 3d doesn’t require as much to meet the standard of enhanced efficacy and also argues that it was already established anyway in its application. Again, in the first case, the court that held (the patent act) was not unconstitutional and also partially interpreted the phrase ‘enhanced efficacy,’ by saying this is a term that is well understood in pharmaceutical practice – it’s not vague or irrational. It has meaning.
Pharmalot: So Novartis argues this section 3d is too rigorous? Baker: Novartis wants to make increased efficacy a much looser standard. One argument they make is that Gleevec has 30 percent better bioavailability than the earlier chemical on which it was based. There have actually been several decisions , including one by the patent office in India, which decided that the new form of Gleevec was not a novel entity, just a routine discovery, and that this obvious to people ‘skilled in the arts’ to do this kind of work, which is coming up with another variation in the chemical. The patent office was basically saying that it requires more than simply greater bioavailability or better solubility or better shelf life. The court interpreted the patent act to mean that a patent should be granted not for regular or routine improvement, but something that has a meaningful therapeutic impact that was well beyond what was found in the original product.
Pharmalot: So how did we get to the Supreme Court? Baker: Novartis appealed that decision by the patent office to an appellate body and a court sent it to the Intellectual Property Appellate Board, which made what I think is inferior decision. This board held that the variation was novel and involved an inventive step, but nonetheless upheld the decision by the patent office based on section 3d of the patent act, which is that this newer form of Gleeved doesn’t satisfy the standard of enhanced efficacy because it’s not a significant improvement. Then Novartis appealed that IPAB decision to the Supreme Court in India. That’s why I call this a second bite at the apple. Novartis is trying to get the Supreme Court to rule that a toothless interpretation of increased efficacy should apply.
Pharmalot: What happens if Novartis doesn’t win? Wouldn’t that preclude generic drugmakers from selling lower-cost versions of the new form of Gleevec and limit access, anyway? Baker: With Gleevec, generics have been selling completely therapeutic versions before the patent act was enacted and producing it at about 1/15th of the cost for years. If these minor modified medicines aren’t patented will that somehow break down access? No, the generics can reverse engineer the unpatented medicine if it is made (by Novartis) and so it would be available…