I-Mak Blog

Update India: Abbott Files a Divisional Application for its Heat Stable Ritonavir/Lopinavir Formulation

In our earlier post, we informed you that the hearing on our opposition against Abbott's patent application in India for heat stable ritonavir, ritonavir/lopinavir formulation (Application No. 339/MUMNP/2006) took place on 15 April 2009.

It has now come to our attention that on the day of the hearing, Abbott filed a divisional application to 339/MUMNP/2006. The new application number for the divided application is 726/MUMNP/2009 ('726) A and was published in the Official Journal of the Indian Patent Office on 22 May 2009. A copy of the publication can be downloaded here.

Section 16 of the Indian Patents Act permits an applicant at any time before grant to file a further application in respect of an invention disclosed in the first/parent application i.e 339/MUMNP/2006 ('339). As required under sections 16(2) and (3) of the Act, the newly divided application cannot include any matter that was not disclosed in any substance in the parent application. The Controller may also require an amendment that the newly divided application does not include a claim that has already been claimed in the parent application.

Typically, applicants will seek to divide an application in order to overcome an objection during examination that the claims of the complete specification relate to more than one invention. In this case, such an objection does not exist against '339. Indeed, at no point in the hearing did the Controller make such a request.

So what will the new divisional application cover?

We are still waiting to see the complete specification for '726. Interestingly, as highlighted in the publication notice, '726 consists of 27 pages and 37 claims. This is the same number of pages and claims as originally filed in '339. It would appear that Abbott has re-filed the original application and will wait to see if the patent office will request an amendment to the claims in '726 so that they do not claim the same matter in '339. Alternatively, Abbott could amend the claims so as not to overlap with '339.

However, given that Abbott already amended its claims during the prosecution of '339, but which still cover all relevant subject matter relating to the claimed invention disclosed in the specification, it is difficult to see what claims '726 will cover. This is especially so given that '339 is still pending the outcome of the pre-grant opposition hearing.

To add another twist to this case, Abbott has yet to file its final written submission following the hearing of '339, which was due at the beginning of May. It is possible that Abbott may simply abandon '339 in the face of the oppositions against it and start over again with '726 in the hope for a different examiner or simply that potential opponents may miss the new application. This scenario is not unheard of in patent practice, especially given that Abbott took the unusual step of filing '726 on the day of the hearing.

We'll have to wait to see what Abbott is attempting with the divisional application. What is apparent from this case is that section 16 essentially allows applicants to file what are akin to continuation applications of existing applications where the original application is facing difficulties.

It would seem this is a loophole within the Act that could lead to applicants abusing the patent system. Such permitted practice leads to uncertainty in the market place as it delays the outcome of whether a patent will be granted or not. Uncertainty and delay is a criticism that the originator industries have directed at the Indian Patent Office's backlog in examination and the pre-grant opposition system. Yet, in this case it is the applicant that creates uncertainty and delay. Indeed, the recent EC Competition Report on the Pharmaceutical Sector discusses how originator companies use divisional applications to foster uncertainty and keep generic competitors off the market as long as possible.

In the current situation, Abbott is littering the patent office with applications that are overlapping in claims and which warrant investigation of double-patenting. Aside from '339 and now '726, Abbott's application numbers 676/MUMNP/2007 and 6733/DELNP/2007 cover subject matter already claimed in '339 (and '726).

We trust that the Indian Patent Office will remain vigilant of such overlapping patent applications and how section 16 is used.

We'll be sure to keep you informed of any developments as they happen.


Brazil’s Attorney General Challenges Constitutionality of "Pipeline" Protection in Patent Law

The Brazilian Attorney General has filed a brief with the Supreme Court of Brazil regarding the unconstituitonal nature of the pipeline provision and the patents granted under it. Should the action succeed, pipeline patenting and patents on medicines granted under the provision could be cancelled, saving the Brazilian government millions of dollars.

To give some background to those unfamiliar with the pipeline provision in Brazil's patent law:

Under TRIPS, member states were required to accept patent applications from the date the Agreement came into force i.e. 1 January 1995. Developing countries were permitted an additional ten years, until 1 January 2005, within which to provide protection for pharmaceutical product patents. Brazil chose to start providing protection on pharmaceutical products from 1996.

More significantly, through Articles 230 and 231 of Law No. 9.279/96 (Industrial Property Act), Brazil introduced a 'TRIPS-plus' provision called pipeline protection. This provision guaranteed protection for patents on food and pharmaceutical products that were invented prior to the date the TRIPS Agreement came into force in 1995, provided such products were not already on the market anywhere and that there had not been any prior serious preparations to place the product on the market in Brazil. Therefore, patents on medicines which were filed in another country well before TRIPS came into force would be entitled to protection in Brazil.

To illustrate, a patent filed in the U.S. in 1990 and which was yet to be marketed as a product would be entitled to a patent in Brazil, even though technically such an invention would not be novel as it would be considered to be in the public domain before 1995 (the date TRIPS came about).

To date, 1,182 pipeline patents have been granted in Brazil. These include ritonavir, efavirenz and imatinib (Glivec).

The full press release by the Brazilian groups sponsoring the challenge is below:

GTPI/Rebrip blame pipeline patents for the exorbitant costs of drugs needed to combat the HIV/AIDS epidemic

Brazilian Attorney General Antonio Fernando Barros e Silva de Souza filed a brief with the Brazilian Supreme Court on April 24, 2009 challenging the constitutionality of articles 230 and 231 of the Intellectual Property Act of 1996 which deals with revalidation or “pipeline” patents. According the Public Attorney, a federal agency which represents the public interest, “knowledge which currently exists in the public domain is public property (…). This legislation indirectly promotes a de facto expropriation of public property in contradiction to the Brazilian Constitution.”

The pipeline makes it possible to retroactively patent already existing patented products in other countries. This has led to patent protection for foods, medicines and other products. A total of 1,182 patents have been filed through the pipeline, including those for major drugs used to treat such diseases as HIV/AIDS and leukemia.

The Attorney General’s response was driven in part by allegations made in a proposal co-filed in November 2007 by the Brazilian Network for the Integration of Peoples (Rebrib) and the National Federation of Pharmacists (FENAFAR). The allegations provided a detailed expert analysis in which economists underscored how the pipeline process drove up the cost of antiretroviral drugs purchased by the federal government to battle the AIDS epidemic between 2001 and 2007. According to the data, Brazil spent between US$420 million (WHO minimum price comparisons) and US$519 million (comparing with minimum prices used by Doctors without Borders-MSF) for the medications.

According to Cristina Pimenta, General Coordinator for the Brazilian Interdisciplinary AIDS Association (ABIA) which currently heads the Rebrip Intellectual Property Working Group (GTPI), “the pipeline process, instead of fomenting national development in the public interest, actually obstructs universal treatment access for people living with HIV/AIDS. It forces the government into constant negotiation with multinational companies to lower prices which are protected by the pipeline process even though more affordable generics are available on the international market.”

FENAFAR president Celia Chaves adds “this legislation hasn’t been good to anybody in Brazil – not for the domestic pharmaceutical industry nor for the population at-large. Everybody has been hurt by the pipeline process”. According to Eloisa Machado, legal counsel to organization Conectas Direitos Humanos, part of the intellectual property working group, “the constitutionality of this legislation must come into question at the Supreme Court’s hearings on health. Currently, the government is taking an incredible hit to guarantee access to these drugs for those in need because of the price gauging driven by the pipeline process. This constitutional challenge presents a wonderful opportunity for the Court to analyze the actual reasons as to why the government is paying such a high price for essential medications and to demystify the argument that such prices are justified to pay for the cost of innovation. Price gauging may just prove to be the fruit of unjustifiable monopolization.”

The sponsors of the proposal applaud the Attorney General’s constitutional challenge, and believe that it will unite those interested in the valiant fight for universal access to treatment.

The constitutional challenge was received by the Hon. Carmen Lucia Antunes Rocha, Supreme Court justice on April 27 who will evaluate possible suspension of the articles in question. The organizations expect that urgent action will be taken due to the dire effect of this legislation on the public health and access to treatment.

You can read the brief in its entirely (in Portuguese) Ação Direta de Inconstitucionalidade nº 4234 and of the position paper backing this action Representação nº

Pipeline patent examples:

Efavirenz, a medication whose compulsory license was recently issued, is protected by a patent obtained through the pipeline process. It did not meet the criteria for novelty when the patent was originally filed in Brazil which information about its invention had already been published outside Brazil five years prior. The active ingredient could have been manufactured in Brazil as it was in India.

Other basic medications used in the aresenal to fight the HIV/AIDS epidemic have also been protected by the pipeline, including lopinavir/ritonavir, abacavir, nelfinavir and amprenavir and thus withdrawn from the public domain. Cancer drugs such as Imatinib, sold commercially by the brand name Glivec®, have also come under protection by the pipeline. The drug is used to treat people living with chronic myeloid leukemia, which affects bone marrow, at a monthly cost of nearly US$4 thousand per patient.



New Look Website and Updates

Apologies to those of you who have been trying to access our website these past two weeks. As you can see we have had a bit of a makeover - we hope you like the new look.

We've moved some things around so that navigation is easier. For example, "Our Cases" lists all our patent opposition related work to date. Under "Resources" and "Pharmaceutical Patent Decisions", we will be providing copies of pharmaceutical patent case law from around the world, in particular from the developing world. For starters, we have made available all the Indian patent office and court decisions we are aware of. We'd like to thank those people who have already shared copies of decisions with us.

Another addition to the site is our "Testimonials" page. Over the last three years, we have been extremely fortunate to have the support and friendship of several people working in the field of IP and access to medicines. Without all of you, I-MAK would not have grown to what it is today. Some of our well-wishers have shared their thoughts about the work that we do which you can read here. If you would like to comment on our work, do contact us with your thoughts. Please know how appreciative we are of all those of you who supported us on this journey!

On the work front, a lot has been happening while we have been away. The H1N1 ("swine flu") scare came on the heels of the Indian patent office refusing Gilead its patent on oseltamivir (Tamiflu). The Indian patent office has also released a number of other decisions relating to pre-grant oppositions.

We have also been extremely busy with our opposition against Abbott's patent application in India and Europe for its heat stable ritonavir/lopinavir formulation (also known as Aluvia/Kaletra). You can read all the documents here. The hearing took place on 15 April 2009. If the Mumbai patent office follows the new circular to issue a decision within one month of the hearing, we can expect a decision by the end of the month. We'll be sure to keep you posted.


World Aids Day - Access to Life

Breaking from the usual type of post, today is World Aids day. The Guardian newspaper has run some powerful images from the famous Magnum Photos agency capturing people living with HIV/AIDS around the world.  As an avid photographer, the images capture perfectly the sombre reality many HIV/AIDS patients face and help put into context why we do what we do.


European Commission's Competition Department Releases Preliminary Report on the Pharmaceutical Sector

The competition department of the European Commission (EC) has released a preliminary report on the pharmaceutical sector in Europe. The report goes into some detail about the patent life cycle strategies used by companies to prevent entry of generic medicines.  In one example, the report points to the filing of up to 1,300 patents EU-wide in relation to a single medicine and uses the term 'patent clusters', a phrase usually reserved for software patenting practises.Indeed, from the initial data we have gathered to date on some key ARVs, the practice of creating patent clusters appears to be prevalent.

The information highlighted in this report will certainly add fuel to the fire about some of the egregious patenting techniques of pharmaceutical companies.  A copy of the report can be dowloaded here or you can visit the EC Competition DG's website here for further details.

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