I-Mak Blog

Brazilian Patent Office Issues Final Refusal for Tenofovir - But Gilead Files Divisional Application

Updating our earlier posts here and here, The Working Group on Intellectual Property (GTPI) of REBRIP and Associação Brasileira Interdisciplinar de AIDS (ABIA) have circulated a press release that on 30 June 2009 the Brazilian Patent Office (INPI) issued a final refusal of Gilead's patent application no. PI 9801145-4 for tenofovir disoproxil fumarate (TDF).

Gilead's only recourse to overturn INPI's decision with respect to application no. PI 9801145-4 now lies with the courts.

However, unsurprisingly Gilead has not left all its eggs in one basket. Under Article 26 of Brazil's Law No. 9279/96, applicants may divide an application out until the end of examination, provided they give specific reference to the original application and do not claim any additional matter. According to our search of INPI's patent database, Gilead filed divisional application no. PI9816239-0 on 31 March 2009. If 30 June was the date INPI issued its final refusal during examination, it would appear that Gilead's divisional application falls within the requirements of Article 26.

Having reviewed the claims of the divisional application (our unofficial translation of which can be downloaded here), it appears that Gilead is still attempting to seek protection on the product related aspects of TDF that could prevent generic competition. For example,despite the preambles to Claims 1 and 2 starting with the words "Use", it seems clear that Gilead is trying to protect the use of a composition that is TDF. In some jurisdictions i.e. the U.S., applicants can act as their own lexicographer for the purpose of defining patent claims. Therefore, Gilead may attempt to give a common word or phrase like "Use" a meaning that is very specific and different from the normal definition of the term. It is also possible that Gilead could amend these claims further during prosecution, by adding in additional product claims provided the subject matter was disclosed ion the original application.

It will be interesting to see how INPI interprets these claims. Also, as Gilead is required under Article 26 to provide reference to the original application that PI9816239-0 was divided from, one would expect that INPI would refuse the divisional claims also.

This situation only re-confirms the existing problems with the current patent system. It shows how divisional applications will be used by applicants to get a second bite of the cherry, avoid patent oppositions/ observations and to keep uncertainty in the market place. We have already discussed these practices by originator companies in India here and here.

It's about time that legislators and patent offices around the world changed patent laws to prevent these "never-ending" patent applications that prevent legitimate competition. The European Patent Office, following the recent EC Competition Report on the Pharmaceutical Sector, has made some improvements in this regard by changing its rules on divisional applications (see here). But more can and should be done. If an application is refused during examination, the applicant should either amend the claims to those that the patent office will allow or lose the application completely without recourse to filing a divisional. As it stands, the patent system is stacked highly in favour of applicants and those with deep pockets.


UK All-Party Parliamentary Group on Aids to Urge Companies to Pool HIV Patents

According to a story in yesterday's Guardian newspaper, the All-Party Parliamentary Group On Aids is set to release its report this week detailing the need for pharmaceutical companies to pool their patents on HIV medicines to counter the "treatment timebomb".

The parliamentary group's report is said to indicate that by 2030, 50 million people will need new HIV drugs, which are currently too expensive, to keep them alive. The report also highlights that only a third of those in need of medicines are receiving treatment, but going forward there is a need to ensure access to the next generation of drugs. By suggesting companies holding patents on HIV drugs pool them for the international drug purchasing facility Unitaid - generic companies will be able to make lower cost versions and new combinations in a single pill of the new generation of treatments.

It will be interesting to see whether GSK and others who have agreed to pool patents on some neglected diseases, but not HIV drugs, for least developed countries will make a u-turn?

Will Abbott Laboratories and Bristol Myers Squibb (BMS)/Novartis be willing to pool their respective patents on the second line drugs ritonavir and atazanavir to allow for a fixed-dose combination of the two - which according to reports here and here, is believed to be considerably cheaper to produce and has similar antiviral efficacy to Abbott's ritonavir/lopinavir (Kaletra) combination. To do so would mean Abbott losing  market share and profits from Kaletra - something that Abbott has aggressively avoided by hiking up the price of ritonavir by 400% to avoid competition from other companies protease inhibitor compounds, notably atazanavir (see Wall Street Journal report).


Parliamentary Standing Committee Releases Report on Improving the Patent and Trade Mark Systems in India

In an earlier post of December 2007, we informed you that The Parliamentary Standing Committee on Commerce embarked on a study of examining ways and means to strengthen and improve transparency of the patent system in India. I-MAK was invited to make submissions to the Committee, which can be read here.

The Committee has now released its Report on the various findings and submissions, which can be downloaded here. The Report goes into some detail about how the current patent and trade mark systems in India are working, including budget allocations and the areas in need of improvement.

From a transparency perspective, we are pleased to see that the Committee has taken on board a number of our recommendations. These include:

  • A fully searchable patent database comprising complete patent information that is available to the public;
  • Repealing s144 of the Patents Act and making available to the public via an online searchable database all examination reports, including amendments to applications that applicants may file during prosecution;
  • Improving the pre-grant opposition system so as to ensure consistent application of the Rules amongst all the Offices. In particular, the Committee has take on board that the Rules for pre-grant oppositons should not be applied in a manner that make it an ex parte procedure.

Some of the other highlights from the Report:

  • Between 2005-2008, approximately 26,000 patents have been granted (albeit this figure is already out of date);
  • The pre-grant opposition system has not been effectively incorporated into the patent system, with less than 200 oppositions having been filed since 2005, as against 50,000 new applications;
  • Upgrading the quality of staff at the patent office by offering improved remuneration/packages to prevent job migration.
  • That the Government not agree to a system of data exclusivity
  • There be a cap on the royalty rate payable to patent holders in the case of compulsory licences.
  • Instead of granting interim injunctions, an interim royalty mechanism be put in place so that the patent holder is remunerated and access to medcinines is not prevented until the final trial. 
  • Clearer guidelines on what consitutes a national emergency or circumstances of extreme emergency.
  • It is in the interest of the country to have a patent law which has correlation with a human angle and is pro-generic.

The Committtee should be at least applauded for looking into how to improve the current patent and trade mark system and taking into consideration public health needs. It remains to be seen whether any of the recommendations in the report will be acted upon. Inevitably, there is likely to be lobbying from both sides of the debate on some of the more controversial parts of the Report.


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

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.



Divisional or Continuation Application? Abbott Re-Files the Same Application.

Updating our earlier post, we have now obtained a copy of Abbott's 'divisional' application. A copy of 726/MUMNP/2009 ('726) can be downloaded here.

As predicted, the disclosure and claims of the '726 application are identical to Abbott's first application, 339/MUMNP/2006 ('339).

At this moment in time, we have an unusual situation where Abbott has two pending applications for the same product - the first of which has been opposed and has had a hearing to decide whether it is patentable. With a decision due shortly on the first application, we wait to see whether Abbott will abandon its '339 application before a decision is issued and then attempt to start afresh with '726. Or, will Abbott amend the claims of '726 to be different to '339 - which we believe will be difficult to do given that they have already covered all relevant subject matter of the claimed invention in the first application.

If Abbott does abandon its first application, it creates a situation where section 16 is open to abuse by applicants. Rather than being a provision entitling applicants to divide out an application, it will be a provision used for filing endless continuation applications until a patent is granted - a problem which the U.S patent system faces and has unsuccessfully tried to address. This problem is compounded in India given that electronic access to complete specifications of published patents is still unavailable. It could also make the pre-grant opposition system less effective and resource intensive if opponents have to be continuously vigilant and re-file oppositions over and over again. The Indian Patent Office would be well advised to avoid this from happening.

We will be watching these developments closely and post updates as they happen.