I-Mak News & Updates

New Look Website and Updates

Tahir Amin — Sat, 09 May 2009 17:29:14 +0000

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.

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

Tahir Amin — Tue, 12 May 2009 03:53:32 +0000

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 1.00.000.012584/2007-95.

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.

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

Tahir Amin — Sat, 23 May 2009 18:21:32 +0000

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.

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

Tahir Amin — Tue, 26 May 2009 18:11:07 +0000

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.

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

Tahir Amin — Sat, 30 May 2009 03:02:03 +0000

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.

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

Tahir Amin — Thu, 09 Jul 2009 21:01:05 +0000

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.

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

Tahir Amin — Mon, 13 Jul 2009 20:42:35 +0000

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).

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

Tahir Amin — Tue, 14 Jul 2009 19:34:56 +0000

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.

The Treatment Timebomb

Tahir Amin — Thu, 16 Jul 2009 19:46:09 +0000

Continuing the previous post on this topic, the report of the All-Party Parliamentary Group (APPG) on Aids called 'The Treatment Timebomb' was released yesterday. A copy can be downloaded here.

The key messages from the Report were highlighted in the Guardian article, but some other interesting highlights are:

The idea of creating a patent pool is to mimic the situation in India before the new product patent regime kicked in.
GSK in its written evidence to the APPG believes that HIV is not a neglected disease and to improve access they have given out extensive voluntary licenses (including the royalty free license to the South African company Aspen to produce abacavir, which was coincidently announced yesterday - see report here). As a result GSK does not see the need for patent pools on HIV medicines.
The Report also encourages the Gilead model of voluntary licensing of tenofovir to 11 Indian companies - but recognises that despite voluntary licenses being in place for several years there are still signiifcant research gaps.
Patents are an important incentive for R&D, but do not drive investment into HIV medicines specifically needed by developing countries. Indeed, patents can sometimes hinder such research.
WIPO should be held accountable for the new development agenda and asked to demonstrate examples of how it is supporting developing countries implement TRIPS flexibilities.
The UK government should use its influence within the EC to halt TRIPS plus trade agreements that are currently being negotiated, as well as pushing for a reviews of the EC custom regulations that have recently allowed originator companies to seize generic medicines in transit to countries where there are no patents in force on the product or under the guise of counterfeiting.
Most fixed-dose combinations (FDC) of ARVs come from the generic sector in response to market demand and not patent incentives.
Patents can create barriers to new FDC's given the cost and complexity with three different patent holders. Also, overly broad rights result in patent thickets.
Patent pools have the advantage of creating much larger fields of competition, coming close to a free market, whilst preserving benefits for originator markets.
Generic competition has been central in reducing the price of ARVs.
Any investment in anti-retroviral treatments should go hand in hand with investment in common serious co-infections or opportunistic infectons, such as turberculosis and hepatitis-C, which are usually responsible for most of the deaths of people living with HIV/Aids.
Where the generic purchase of 2nd-line ARVs is not possible because of patents, prices can be upto 17 times the price of first line drugs.
It took political activism almost a decade ago to make life saving medicines available to the poor. Political activism is needed once more to ensure the next generation of drugs is available to the world's poorest in the future.

A few comments/thoughts on some of the points above:

GSK's comments on voluntary licensing and the lauding of Gilead's licenses to Indian generics needs to be put in context.

I wrote a research piece for Oxfam in 2007 on the role of voluntary licenses, available here. One of the things I noticed during the research was that a number of the companies that took licenses never actually brought any product to market. Indeed, as of April 2008 (almost two years after the licenses were entered into), only 1 of the 11 licensees for tenofovir had a product on the market, with a possible two more companies that were almost ready to launch at that time. The fact that Gilead claimed to have given a royalty free technology transfer was misleading as many of the generic companies that had entered into the license told us that the technology transfer was nothing more than what was publicly available in the patent specification. To read an analysis of Gilead's example licence agreement, see here.

Therefore, for GSK to claim that voluntary licenses take care of the HIV market needs or that the Gilead model should be encouraged is a tad misleading without looking at the full picture. For voluntary licensing to work more transparency and regulation around such licenses needs to happen.

With respect to patent pools, while they offer a possible solution, a number of questions remain on how the system will work.

For example, one wonders whether companies will be willing to give the crown jewels in their ARV patent portfolios to the pool e.g. Abbott and ritonavir? Will companies pool patents for opportunistic infections like hepatitis-c as recommended in the Report? Who will ensure that the pooled patents are merited patents so as to prevent originator companies earning rent where there should be none? What will the patentability standard be? Will the patent pool system detract from developing countries using TRIPS flexibilities - such as implementing tougher standards of patentability? What will the royalty rates be? If royalty rates are too high that generic companies won't cooperate, we could end up in a blame game and stalemate.

In sum, there's nothing particularly new coming out of this report that those involved in the debate didn't already know or haven't been saying for the past 4-5 years. To say that political activism is needed once more to ensure the next generation of drugs is available to the worlds poor does a bit of a disservice to those that have continued to work on these issues for the past 5-10 years. If it takes a single government body this long to validate the ongoing problems with the patent system and access to medicines, one wonders how long it will take other governments. Still, it is good to see a developed country government body make inquiries and bring attention to the problems of access to ARVs and related illnesess.

On a separate but related note, for those of you who are not familiar with patent pools, the StopAIDSCampaign have launched this very useful animation explaining how they work:

India Rejects Gilead's Tenofovir Patent Applications

I-Mak — Tue, 01 Sep 2009 14:33:43 +0000

Breaking news: the Indian Patent Office has refused Gilead's applications for tenofovir disoproxil (2076/DEL/1997) and tenofovir disoproxil fumarate (896/DEL/2002).

More to follow shortly...