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Wednesday, 3 April 2013

Public health and IP in India: Novartis loses Gleevec patent appeal at the Supreme Court


On Monday, the Supreme Court of India dismissed the appeal brought by Novartis against the Intellectual Property Appellate Board's decision which had rejected a patent application for the beta crystalline form of Imatinib Mesylate, a therapeutic drug for myeloid leukemia and other kinds of tumours (marketed as 'Glivec' in the EU or 'Gleevec' in the US). The Court found that the patent application did not satisfy the tests of invention and patentability laid out under Sections 2(1)(j), 2(1)(ja) and 3(d) of the 1970 Patents Act (as last amended by the 2005 Patents (Amendment) Act - consolidated version of the Patents Act here).

The Guardian provided an overview of the parties' reactions to the judgment. According to the newspaper, Novartis called the decision 'a setback for patients that will hinder medical progress for diseases without effective treatment options [and] discourage future innovation in India'. On the other hand, Médecins Sans Frontières noted that '[t]he Supreme Court's decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law'. The Cancer Patients Aid Association in India reacted in a similar way: 'We are very happy that the court has recognised the right of patients to access affordable medicines over profits for big pharmaceutical companies through patents. Our access to affordable treatment will not be possible if the medicines are patented. It is a huge victory for human rights'. But what did the court exactly say? Did it really make a clear choice in favour of affordable access to medicines, as opposed to stimulating and preserving the fruits of research and development? 

As many readers already guessed, the answer is more complex than yes or no. Most of the 97 pages of the Supreme Court's judgment are dedicated to reviewing the principles that govern the current IP regime in India, the changes that took place in the last decades, and the requisites of patentability that ensure a balance between the two conflicting objectives of protecting public health and safeguarding innovation. The Court openly recognized these issues at the beginning of its judgment:
The debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world”. The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India. 
To frame the debate and identify the applicable provisions of the Patents Act and their rationale, the Court embarked on a lengthy review of the changes that affected patent law in India in the last century. In particular, the Supreme Court focused on the development of the three provisions to be applied in the case, namely Sections 2(1)(j), 2(1)(ja) and 3(d) of the 1970 Patents Act, as amended by the 2005 Patents (Amendment) Act:
2(1)(j) - "invention" means a new product or process involving an inventive step and capable of industrial application.
2(1)(ja) - "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
3 - The following are not inventions within the meaning of this Act,
...
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Following the Supreme Court's articulated analysis, it is possible to distinguish the following key developments:

- 1911: Patents and Designs Act (PDA)
[It] had provisions both for product and process patents. It was, however, generally felt that the patent law had done little good to the people of the country. The way the Act was designed benefited foreigners far more than Indians. It did not help at all in the promotion of scientific research and industrialization in the country, and it curbed the innovativeness and inventiveness of Indians. 
- 1949: Committee for reform of the PDA
[The Committee recommended] that the Patent Act should contain a clear indication that food and medicine and surgical and curative devices were to be made available to the public at the cheapest price commensurate with giving reasonable compensation to the patentee.
Merpel and the IPKat - or Two Cats
Holding a Large Prawn
(c) Jamini Roy
- 1950/1952: the PDA was amended following the Committee’s recommendations. A compulsory license was introduced, in respect of food and medicines, insecticide, germicide or fungicide, and a process for producing substance or any invention relating to surgical or curative devices.

- 1957: Justice Ayyangar drafted a reform proposal, after discovering that the number of Indian patents was substantially lower than that of foreign patents. He proposed 'to define, with precision, those inventions which should be patentable and equally clearly identify certain inventions, the grant of patents to which would retard research, or industrial progress, or be detrimental to the national health or well-being, and to make those inventions non-patentable'. In relation to chemical and pharmaceuticals patents, he suggested to follow the German model, which allowed only process claims, to stimulate competition and to obtain the lowest possible costs for the public.

- 1970: the Patents Act was approved. The Act recognized the distinction between invention and patentability and introduced Section 5, which expressly excluded the patentability of substances intended for use as food, medicine or drug. At the time, Section 2(1)(j) read as follows:
(j) "invention" means any new and useful
(i) art, process, method or manner of manufacture;
(ii) machine, apparatus or other article;
(iii) substance produced by manufacture,
and includes any new and useful improvement of any of them, and an alleged invention.
- 1995: the TRIPS Agreement entered into force. India was twice taken to the WTO panel, by the USA and the EC, for the lack of provisions guaranteeing patent protection to pharmaceutical and agricultural chemical products under Articles 27 and 70.8 (and exclusive marketing rights under Article 70.9) of the TRIPS Agreement. 

- 1999: the Patents (Amendment) Act amended Section 5 of the Patents Act, allowing claims "for patent of an invention for a substance itself intended for use or capable of being used, as medicine or drug".

- 2001: the Doha Declaration on the TRIPS Agreement and Public Health was drafted. It contained the following provision:
4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.
- 2002: a new Patents (Amendment) Act modified Section 2(1)(j), introducing its current formulation. Section 3, which provided for exclusions from patentability, was recast. Section 2(1)(ja) defined the inventive step:
(ja) "inventive step" means a feature that makes the invention not obvious to a person skilled in the art.
- 2004/2005: a Patents (Amendment) Ordinance eliminated Section 5 of the Patents Act. The Parliament was challenged with the task of providing the remaining changes to apply the TRIPS principles:
Parliament had an absolutely unenviable task on its hands. It was required to forge, within a very limited time, an Act that would be TRIPS compliant without, in any way, compromising on public health considerations ... India had learnt from experience the inverse relationship between product patents and the indigenous pharmaceutical industry, and its effects on the availability of essential drugs at affordable prices ... [T]he reintroduction of product patents in the Indian patent system through the TRIPS Agreement became a cause of alarm not only in this country but also for some international agencies.
In 2005, the Parliament accepted the changes proposed by the Government and passed a new Patents (Amendment) Act, which contained the current formulation of Sections 2(1)(ja) and 3(d).

The Supreme Court, after its analysis of the development of patent law in India, concluded that Section 3(d), introduced by the 2005 amendment, specifically concerns chemical substances and pharmaceutical products. The Section 'sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds'. The focal point of this provision appears to be the concept of 'efficacy', which sets the balance between the conflicting interests at stake, as the threshold of patentability. But what is 'efficacy'?
Efficacy means "the ability to produce a desired or intended result". Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be "therapeutic efficacy". 
According to the Court, the concept of 'therapeutic efficacy' is to be judged strictly and narrowly. From this perspective, 'efficacy' does not extend to the change of form of a substance, and the change of the chemical properties characteristics of that form. The Supreme Court also examined other possible definitions of 'therapeutic efficacy', which pointed to the evaluation of pharmacodynamics or referred to the distinct concepts of efficacy, affinity, potency and bioavailability.

Having established the theoretical background and the meaning of each of the applicable provisions, the Supreme Court applied its reasoning to the case before it [Merpel suggests that readers refer to the full judgment for a better understanding of the facts, since what follows is just a short recap]. Firstly, it turned its attention to the patent application filed by Novartis in 1998, which concerned the beta crystalline form of Imatinib Mesylate, a derivative of Nphenyl-2- pyrimidine-amine. The Court noted that the process of preparation of Imatinib (called formula I) and its therapeutic use had been previously disclosed by the Zimmermann US patent (granted in 1996), which expressly stated that the compounds of formula I included their respective salts. It found that, although a patent covering the beta crystalline form of Imatinib Mesylate had been granted in the US in 2005, the drug that contained the chemical compound, Gleevec, had been launched much earlier in the market, on the basis of the Zimmermann patent alone. Further, both in the Investigational New Drug Application (IND No. 55,666) and in the original New Drug Application (NDA No. 21-335) for Gleevec, filed respectively in 1996 and 2001 in the US, Novartis had declared that the active ingredient and the method of use were covered by the Zimmermann patent. Novartis had also made a Patent Term Extension Application for that patent, to compensate for the time taken in the regulatory review for Gleevec. 

Evaluating this evidence, the Court found that Imatinib Mesylate was a known substance from the Zimmermann patent, whose pharmacological properties were described in the patent itself and in published medical studies. Accordingly, it held that the chemical compound did not qualify as an 'invention', within the meaning of Section 2(1)(j) and 2(1)(ja) of the Patents Act. Assessing the beta crystal form of Imatinib Mesylate, instead, the Court provisionally accepted the novelty of its formulation, but submitted it to the test of patentability prescribed by Section 3(d). Keeping in mind the notion of 'efficacy' as previously identified, the Supreme Court noted that Novartis itself, in the patent application, had stated that the therapeutic qualities of the beta crystalline form of Imatinib Mesylate were the same as those possessed by Imatinib in free base. The Court clarified that chemical properties such as solubity, thermodynamic stability and hygroscopicity may yield effects on the processability and storability of the substance, but bear no significance in relation to its 'therapeutical efficacy'.

En passant, the Court also analysed the US case In re Hogan, where it was held that a patent application disclosing a method of making the crystalline form of a polymer was entitled 'to a claim for the method of making a solid polymer, because the only known method for making a solid polymer at the time was the applicants’ method of making the crystalline form'. Implicit in the controversial US judgment was the idea that a patentee may 'claim a genus that includes unknown species that may be discovered in the future, if the specification describes and enables all the species that are known at the time of filing the patent application'. The Supreme Court rejected the parties' arguments aimed at applying Hogan to the case, but took the occasion to identify the path for the future developments of Indian patent law, in a different direction:
[W]e would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.
This Kat thinks that the judgment deserves an in depth analysis, before evaluating its significance and possible effects. However, the Supreme Court's reasoning does not appear to be hostile, a priori, to the development and recognition of IP rights in the pharmaceutical sector. Rather, it merely sets a threshold for patentability which may be higher than in other countries, but not unreasonable per se. As is the case for any IP right which crosses the boundaries of fundamental human rights, including those related to health and genetic resources, the task of setting the right balance is going to keep lawyers and legislators busy for a predictably long time. Obviously, it remains open to discussion if indirect economical considerations should be allowed to alter the balance [Merpel suspects that the Supreme Court is not indifferent to similar arguments - see, for example, the Court's thoughts on the development of the pharmaceutical industry in India...].

On a last note, the IPKat wanted to highlight the Supreme Court's words on the role of lawyers in the Novartis case. Somehow, he thinks that they may serve as an inspiration for all of us:
Before putting down the records of this case, we would like to express our deep appreciation for the way the hearing of the case took place before the Court. Every counsel presented the issues under consideration from a different angle and every counsel who addressed the Court had something important and valuable to contribute to the debate. It was also acknowledged that the illuminating addresses of the counsel were the result of the hard work and painstaking research by the respective teams of young advocates working for each senior advocate. The presence of those bright young ladies and gentlemen in the court room added vibrancy to the proceedings and was a source of constant delight to us.

9 comments:

Anonymous said...

Novartis is responding quite vehemently to this judgement: http://www.novartis.com/newsroom/product-related-info-center/glivec.shtml. But the public opinion in India is highly satisfied with the Supreme Court's decision (http://www.thehindu.com/news/national/landmark-verdict-gives-big-boost-to-cancer-patients/article4569056.ece).

Rahul said...

Supreme Court has basically struck down the argument of "affordability of pharmaceutical drug to be considered while granting a patent". The judgment heavily focussed on section 3d and other relevant sections under which Glivec was claimed as "not an invention". This is one laudable judgment to keep the lazy armchair champagne swilling healthcare activists of India from hijacking the debate of patentability of pharmaceutical products to the issue of "affordability". While Supreme Court rightly kept healthcare activists' romanticism at bay, it also tackled Novartis' attempt to patent frivolous "inventions".

As usual, Novartis and the healthcare activists, in their respective press releases, are harping more on affordability, accessibility etc. while completely forgetting that Supreme Court did not even consider the claims made by activists under section 3b and Novartis is also projecting a wrong image of the judgment making it appear like a judgment driven by public health benefits even though the patent was rejected purely on technical grounds of prior disclosure in a patent.

Anonymous said...

If the Beta form is not beneficial to the patients, why do the generic manufacturers wish to sell it rather than the old, non-beta form?

Anonymous said...

@Anonymous. An affidavit cited by the Supreme Court stated that:
"a) The beta crystal form has substantially more beneficial flow properties and
thus results in better processability than the alpha crystal form.
(b)The beta-crystal form of the methanesulfonic acid addition salt is the thermodynamically more stable form at room temperature. Greater stability is thus to be expected.
(c) The beta-crystal form is less hygroscopic than the alpha-crystal form of the methanesulfonic acid addition salt of a compound of formula I.
(d) The lower hygroscopicity is a further advantage for processing and storing the acid addition salt in the beta-crystal form."
As the author noted, the Court said that these properties may increase the drug's processability and storability, but have nothing to do with its therapeutical efficacy. See Paragraph 187:
"187. In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy."

Anonymous said...

Section 3(d) is in breach of TRIPs. This section provides that certain inventions are not 'inventions'. This is not an assessment of patentability based on the facts.

India's drug firms contribute nothing to the advancement of healthcare.

India is one of the worst examples of a divided society and the wealthy couldn't care less about the health of the poor.

The Supreme Court judges clearly only had the interests of India's generic drug makers at heart when they made their decision.

The answer to the question of anon, re why don't generics make the non-patented form: They don't because they don't have the knowledge, experience or intellect to do anything other than direct copying and their desire is only to make a fast buck.

Ever wondered why you suddenly get phone calls about compensation for car accidents shortly after reporting a claim to to an insurance company with a call centre in India? I have.

Ever wondered how your email accounts are hacked shortly after allowing a service provider in India access your computer? I have.

India is an untrustworthy place to do business. IP firms tout for business quoting their high levels of confidentiality, such as 92%! Only 8% of clients' information is leaked every year. Way to go IN!

Rahul said...

To Anon @21:19

I agree with all your points barring this
"the Supreme Court judges clearly only had the interests of India's generic drug makers at heart when they made their decision." In this particular case, SC totally relied on prior art reference.

On a different yet similar line, India, since independence, is being governed by the stupid philosophy and romanticism of "Socialism" the more apt term would be "Nehruvian Socialism" which is actually sick form of socialism which combines "selfish" (pun intended on "socialist" leaders) political aspirations with populist policies for immediate political benefits. That system has crept into the minds of average Indian. They cannot think beyond socialism. For them, everything ought to be free or cheap, otherwise it is against "morality" or "public order". I am an India, so I know it.

Most of the court orders are not driven by law,rather by this idea. All laws in India are not interpreted in the spirit of legal excellence but in a backdrop of socialism. Even though I disagree with your statement that this case was driven by interests of Indian generic manufacturers, I won't be surprised if it comes out to be true.

Anonymous said...

Would everyone please calm down.

The media coverage that has followed this Supreme Court decision, and dare I say the comments on this blog, have shone a light on many a prejudice.

This was a simple case about Art 3 (d). If you look at what the end result was, then there is not a great deal of difference between what the Indian Supreme Court has come up with and the position that we have in Europe with decisions such as T 0777/08.

Rahul said...

"India's strong stance on minor drug innovations could reverberate in national parliaments and courthouses of the developed world as Australia, the EU and Canada get ready to discuss and ban patent protection for frivolous improvements" http://timesofindia.indiatimes.com/india/eu-australia-canada-may-follow-indias-patent-law/articleshow/19376054.cms

Other nations will also tighten their laws and have clauses like section 3(d) of Indian patent act.

Anonymous said...

My comments are highly critical of Indian practices, but they are not based on prejudice.

I personally do not see India as a socialist state. Far from it. It's class system is probably (purely speculatory) what gave it such close ties to Olde England. Maybe not so olde.

"..a simple case about Art 3 (d)"?

Yes, but that should not diminish its relevance. The result may not differ to the likes of T0777/08, but it is the process of obtaining that result that is of sole importance.

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