Divide and Rule: Companies File ‘Divisional’ Applications to Avoid Oppositions Against HIV Drug Patents

Press Release 30 May 2009

In our previous posts, here and here, we alerted you to Abbott re-filing the same application for its heat stable ritonavir, ritonavir/lopinavir formulation under the guise of a divisional application. Given the loose wording in section 16 of the Indian Patents Act, we began to wonder whether other companies were using the right to file a further divisional application as a continuation application in order to avoid pre-grant oppositions filed against their parent applications. Our concerns appear to be well founded.

Take for example the patent application for the HIV drug atazanavir, which patient groups had opposed. In August 2007, reports circulated that Novartis had abandoned its application for the drug atazanavir after the patent office had released a letter to that effect. A copy of the patent office letter confirming the abandoning of the parent application 805/MAS/1997 can be viewed here. We ran a post at the time wondering whether this was true, or if Novartis had another application in the system.

It turns out that Novartis does still have a pending application for atazanavir in India. More worrying is that Novartis adopted the same strategy that Abbott is attempting with its patent application. On 17 February 2007, Novartis filed a ‘divisional’ application to its parent application 805/MAS/1997. The new application number is 310/CHE/2007 (‘310) and was published on 28 November 2008. The publication notice for ‘310 can be viewed here. We have reviewed the new application and it makes the same claims as the parent application, plus a few more.

Gilead Sciences has also resorted to the same strategy with respect to its applications for tenofovir disoproxil (originally filed as 2076/DEL/1997) and tenofovir disoproxil fumarate (originally filed as 896/DEL/2002). These applications were also opposed by patient groups – see here for more details. The original application 2076/DEL/1997 was divided out to 602/DEL/2007 on 20 March 2007 and makes the same claims. Similarly 896/DEL/2002 was re-filed as a divisional on 29 May 2007, with the new number 1135/DEL/2007. Both publication notices can be viewed here and here.

There are two issues of grave concern arising from these developments.

The first is whether oppositions that patient groups filed against the parent applications in the above cases will still be applicable against these so called ‘divisional’ applications. Considering that all the ‘divisional’ applications make the same claims that were opposed by patient groups, one would think that in the interests of justice the patent office would still apply the oppositions during examination. Otherwise, the purpose of the pre-grant opposition system becomes defunct.

The other worrying factor is the Indian patent office, whether intentionally or not, is allowing applicants to re-file the same or essentially the same patent application under the guise of a divisional. One could accept divisional applications that claim subject matter that was disclosed in the original patent specification, but not previously claimed. However, this is not what is happening. What is happening is applicants are filing what are akin to continuation applications as permitted in the U.S. (For those of you not familiar with how continuation applications work in the U.S., see Mark Lemley and Kimberley Moore’s paper ‘Ending Abuse of Patent Continuations’ available here).

If such practices are allowed to flourish, the patent system in India is going to become the subject of abuse  by applicants. Provisions like section 3(d) and the pre-grant opposition procedure will serve little purpose as applicants will be able to continuously file ‘divisional’ applications every time they run up against an opposition or rejection by an examiner.

The administrative and financial cost of all this to the patent office, interested opponents and especially those who are in need of affordable medicines will be significant.

The Indian Patent Office needs to realise quickly what is going on and curb the abusive practice of these continuation type applications.

 

Join us to stay updated
and help make lifesaving medicines accessible to all