Novartis loses landmark patent case on glivec

[Bang Galore]

Aids patients can smile after landmark Novartis case

The decision made on Monday by India's Supreme Court to reject pharmaceutical multinational Novartis' plea to preserve its patent on cancer drug Glivec is a game changer, especially for HIV treatment programmes around the world.

Glivec is used to treat chronic myeloid leukaemia _ a type of blood cancer _ and is a life-saver for sufferers of the disease. But the relevance of the ruling on similar applications of multinational companies seeking to preserve their patents on second- and third-generation anti-retroviral drugs (ARV) for HIV can't be ignored.

Many of these applications are based on the same legal issue of patent continuation even after its expiry by slightly tweaking the existing product or process to seek a fresh lease of life for an extended period, or "evergreening".

The drug companies use this method to continue enjoying the benefits of the original invention beyond the patented period. Smart firms can enjoy unrestricted patent rights for very long periods based on original research done several years before.

Fortunately, the Indian Patent Law tried to plug this loophole by adding Section 3(d) which seeks to prevent patenting new forms of a known drug unless it exhibits enhanced efficacy. The Indian Patent Office took the view in a number of such cases that mere improvement of process without enhanced "therapeutic efficacy" cannot satisfy the requirement of patent as a new drug.

This has generated a host of litigation by pharmaceutical companies with the Novartis case reaching the Supreme Court in 2009. It then took three years for the court to examine all aspects of the patent law, and resulted in this week's historic judgement.

The landmark ruling comes at a time when more than 8 million people around the world are getting antiretroviral (ARV) treatment for HIV, with a further 6-7 million needing treatment urgently. The cost of ARV drugs is a major determining factor for providing universal access to treatment to people living with HIV.

India today supplies almost 90% of generic ARV drugs for patients in a number of countries in Africa and Asia. The Supreme Court judgement in the Novartis case raises optimism about providing drugs on a continuous basis for the 8 million people who are on antiretroviral treatment today.

But one threat still remains. India _ like Thailand _ is expected soon to sign a comprehensive free trade agreement with the European Union. There is overall concern that this might contain TRIPS (trade-related aspects of intellectual property rights) and other provisions that might restrict the generic drug industry in India from manufacturing new drugs that will be out of patents in coming years.

The Indian government has assured that nothing will be agreed to that affects the future of the generic drug industry in India. However, it remains to be seen whether the optimism generated by the Supreme Court ruling will be matched by a strong government stand on protecting TRIPS flexibilities for public health purposes as envisaged in the Doha declaration.

The author is the Special Envoy of UN Secretary-General on HIV/AIDS for Asia Pacific. The views of the author are personal.
Aids patients can smile after landmark Novartis case | Bangkok Post: news

 

[Jade]

This is a very useful mention.

There are both positive and negative directions in the consideration of the impact of the patent regime on healthcare in south Asia. There is an informed and educated body of opinion that has more or less been informing the rest of us, less knowledgeable in these areas, that there is an unfortunate body of judicial pronouncement which endangers medical research, or at the lowest level, prevents us from getting the fruits of this research.

Medicine makers must get the fruits of their research. However, looking at their balance sheets, the matter has gone far beyond the right of individual scientists to get protection of their intellectual property. It now seems to some that we are looking at exploitation of the seriously ill and the diversion of money from poor people to very rich shareholders.

What you have is relevant, but I am not personally so knowledgeable about this very complex matter that I can make meaningful comment.

I see more positives than negatives. In the absence of credible healthcare system in poor countries such as India, people should be able to afford lifesaving drugs. Supreme Court verdict is beacon of light not only to Indians but also to other poor countries.

As regarding medical research, I don’t think this will largely affect R&D plans of large Pharma companies, as they have large protected and richer markets to market their new drugs. Off late Pharma companies are becoming greedier. This verdict will bring large Pharma companies to ground

 

[Bang Galore]

The Judgment In Novartis v. India: What The Supreme Court Of India Said

Intellectual Property Watch

By Frederick M. Abbott

As part of a series of amendments to the India Patents Act that took effect on January 1, 2005, the Parliament of India adopted Section 3(d). This statutory provision has been in force for more than seven years. A challenge brought by Novartis to the constitutionality of the provision and to its compatibility with the WTO TRIPS Agreement (World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights) was rejected by the High Court at Madras in 2007. That judgment was not appealed. On 1 April 2013, the Supreme Court of India rendered judgment [pdf] on an appeal by Novartis against rejection by the India Patent Office of a product patent application for a specific compound, the beta crystalline form of imatinib mesylate. Imatinib mesylate is used to treat chronic myeloid leukemia and is marketed by Novartis as “Glivec” or “Gleevec”. Affirming the rejection, the Supreme Court confirmed that the beta crystalline form of imatinib mesylate failed the test of Section 3(d). The Court clarified that efficacy as contemplated under Section 3(d) is therapeutic efficacy.

This judgment has attracted worldwide press coverage. It has received severe criticism from a number of originator pharmaceutical companies, including Novartis, and from the US Chamber of Commerce, to the effect the judgment of the Indian Supreme Court has dealt a harsh blow against the future of innovation, particularly in India. It is somewhat difficult to know why this decision interpreting Section 3(d) should come as a major surprise to anyone. Perhaps more important, it is difficult to understand what it is about the Supreme Court judgment that might so offend the sensibility of patent lawyers or government policymakers. The judgment is well-crafted, with close attention to the facts presented, and appears to take a balanced view of the matters brought before the Court. What did the Supreme Court of India say?

The case involves a substantial number of fairly complex technical issues, including some fairly complex legal issues. Without intending an injustice to that complexity, the main points made by the Court are these:

1. The express terms of the Patents Act as amended in 2005 reflect the considered judgment and will of the Indian Parliament as found in the legislative record. Section 3(d) was proposed by the Government with the stated purpose of addressing concerns raised by members of Parliament that the introduction of pharmaceutical product patent protection would substantially inhibit the availability of medicines for the population of India and developing countries more generally. Parliament sought to limit practices that might result in the grant of patents for insubstantial technological contributions. Parliament adopted in the Section 3(d) amendment, including the explanation, a requirement that patents for new forms of known substances should only be granted on the showing of a significant enhancement in known efficacy.

2. International legal rules accepted by India, in particular the WTO TRIPS Agreement, provide sufficient leeway or flexibility in the adoption of patenting standards to allow the approach adopted by the Indian Parliament.

3. The facts of this case involve certain transitional arrangements between the former pre-2005 Indian patent system which did not allow patents for pharmaceutical products, and the post-2005 regime under which such patents are permitted. For patent applications filed (with priority date) before 1 January 1995, a patent could not be secured in India for a pharmaceutical product. From 1995 to 2005, pharmaceutical product patent applications could be filed and held in a “mailbox”. A patent could be granted and become effective after 1 January 2005, based on a “mailbox application”.

4. In 1992, Novartis filed an initial patent application in the United States covering the drug “imatinib”, which patent application also covered pharmaceutically acceptable salts. It was subsequently granted a patent. Novartis applied for and received US Food and Drug Administration (FDA) approval for the marketing of a salt form of that drug called “imatinib mesylate”. The drug was placed on the market in that form in 2001.

5. In 1997, Novartis filed a patent application for a specific variation of the imatinib mesylate salt, the “beta crystalline” form. An examiner in the United States rejected this patent application, but the examiner was overruled by a Patent Office appeal board because the new crystalline form of the mesylate salt of imatinib involved a sufficient “manipulative step” under US patent law. The patent was granted for the United States.

6. In 1998, Novartis filed an application in India for this beta crystalline form. The application did not disclose any improvement in efficacy. However, when India adopted section 3(d) in 2005, Novartis undertook some studies to meet the statutory requirement to show enhanced efficacy.

7. The first issue before the Supreme Court was whether the mesylate salt form of imatinib had been disclosed, and was therefore publicly known, prior to 1997. On the basis of the documents, the Supreme Court found that it was. The mesylate salt was the form in which the drug was marketed. To satisfy the requirement of “enhanced efficacy” in section 3(d), comparison of the beta crystalline form had to be made with the already known mesylate salt. In light of this, the Indian Supreme Court found the efficacy studies reported by Novartis very odd. Novartis alleged that the beta crystalline form showed a 30% increase in “bioavailability” (based on tests in rats). But this 30% increase in bioavailability was not in comparison to the known and previously marketed mesylate salt form of the drug, which would ordinarily be soluble, but rather in comparison to the “free base” form of the imatinib drug that was not marketed because it was not soluble. So, Novartis did not compare its “new” form of salt to its “old” marketed form of salt, but rather to what it knew would be a much less bioavailable form. There was no evidence in the record as to how the new salt compared to the old salt even in terms of bioavailability.

8. The Supreme Court interpreted the meaning of “efficacy” in Section 3(d). It said that the new form of a drug must demonstrate an improvement in its therapeutic effect or curative property as compared to the old form in order to secure a patent. Novartis offered evidence that the beta crystalline form differed regarding certain properties relating to production and storage (e.g., heat stability). The Court held that these properties may be important from storage point of view, but would not be relevant to showing “enhanced therapeutic efficacy”.

9. As previously noted, Novartis also presented evidence regarding increased “bioavailability”. The Court observed that “bioavailability” measures the level at which the drug is made available in the human body. The level of bioavailability may or may not have an influence on the therapeutic or curative effect of the drug. In this case, the Court held that such effect was not demonstrated.

10. The Court discussed at some length the meaning of therapeutic efficacy in respect to pharmaceutical products, and observed that there are different possible meanings. The definition may be limited only to action resulting in a curative effect, or it might be more broadly extended to cover improved safety or reduced toxicity. The Court decided to leave open what is the appropriate definition of enhanced (therapeutic) efficacy – the narrower or broader interpretation – because it did not need to reach that question in this case. Novartis had provided no evidence that the beta crystalline form of imatinib improved the therapeutic effect of the drug. There was nothing to measure. The Court did not say that a change in bioavailability may never result in enhanced efficacy. It said that the patent applicant needed to demonstrate that there was a resulting enhancement in efficacy.

11. At the very end of the decision, in requiring Novartis to pay the costs of the challengers, the Court said that it appeared that Novartis was in fact marketing an older form of the drug and not the beta crystalline version, and that it appeared that Novartis may have been trying to use a patent in India to cover a drug that it was not actually selling. It suggested that this showed Novartis “in rather poor light”.

The Supreme Court affirmed that India has adopted a standard of pharmaceutical patenting that is stricter than that followed by the US or the EU. For India, a patent applicant must not only show that a new form of known compound is different than an old form, but that the modification will result in an improvement in the treatment of the patient. There is in fact nothing new about such a standard. This was the approach followed by the US Patent Office up until a case decided by the Court of Appeals for the Federal Circuit, In re Brana, in 1995. Today, the Patent Office and Federal Circuit will approve patents for very minor modifications, supporting the practice known as “evergreening”. This is a very expensive proposition for US consumers because it allows the manufacturers to market and sell higher-priced patent-protected versions of their popular drugs.

The Federal Circuit rationalizes this practice, saying that allowing patenting without demonstration of significant therapeutic effect encourages the development of new compounds, therefore encouraging innovation. But, this is just a theory about the best time along a continuum for granting a patent. It may well be that granting patents after researchers have demonstrated that drugs will accomplish something significant in terms of curative effect will encourage researchers to concentrate on achieving desirable end results, rather than winning marketing games. The race will not be won by the first person who creates a new compound, but the first person who creates a new compound and shows that it is therapeutically significant.

The Indian Parliament, supported by the Supreme Court, has decided that Indian consumers should only pay for expensive patented products when those products represent a genuine advance over older versions. It is important to note what the Supreme Court did not say. It did not say that a new form of known compound may never be patented. It did not say that improving the bioavailability characteristics of the drug may never result in enhanced efficacy. It left open the question whether enhanced efficacy refers narrowly to curative effect, or more broadly to improved safety profile and reduced toxicity.

From a patent law standpoint, it is rather difficult to discern what about the Supreme Court’s decision strikes the US Chamber of Commerce, Pfizer or Novartis as some great threat to innovation or the long-term welfare of patients. It may put a damper on the profits of Pfizer or Novartis as they are less able to extend the life of patents by minor modifications that result in patients and public health systems paying more for drugs. But, one should be very careful of confusing the interests of the shareholders of Pfizer and Novartis with the interest of patients in the United States, Europe, India or Kenya. One might also be skeptical of claims from the industry that it will withdraw from the Indian market. Where there are profits to be made, the industry will be participating.



Frederick Abbott is Edward Ball Eminent Scholar Professor of International Law at Florida State University College of Law. He has served as expert consultant for numerous international and regional organizations, governments and nongovernmental organizations, mainly in the fields of intellectual property, public health, trade, and sustainable development. Professor Abbott regularly serves as panelist for the WIPO Arbitration and Mediation Center. He serves as Rapporteur for the Committee on International Trade Law of the International Law Association and is on the editorial board of the Journal of International Economic Law (Oxford). Professor Abbott is widely published in the fields of international intellectual property rights law, international economic law, public health and international law.

The Judgment In Novartis v. India: What The Supreme Court Of India Said | Intellectual Property Watch