CURRENT SOCIETAL CONCERNS
Elpidio V. Peria
6 April 2013
Last April 1, the Supreme Court of India issued its 112-page ruling on the case filed by drug multinational Novartis for a patent on Glivec, an anti-cancer (from the text of the ruling, a therapeutic drug for chronic myeloid leukemia and other tumours) drug whose patent application was denied by the Madras High Court back in 2007, in a patent application dating back from 1998.
The Indian Supreme Court decision denied the patent application of Novartis for such drug, ruling, among other things, that the said application fails to comply with sec. 3(d) of the Indian Patent Acts, 1970, which was amended back in 2005.
What does sec. 3(d) say of that law say? It reads:
“Section 3. What are not inventions.– 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.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
While the ruling also dealt with other relevant provisions of the Indian Patent Act, like what constitutes an invention, sec. 3(d) provides a criteria which can be used by patent authorities to exclude patent applications that are not distinctly innovative, and when applied to patent applications for drugs or medicines, will prevent the practice of big pharmaceutical companies to do “evergreening”, passing off minor modifications on an existing patented drug as a significant innovation, thus lengthening the monopoly on the same patented drug if another patent is granted on that minor modification.
This is true in the case of Glivec, which at the time the Indian Parliament was deliberating the amendments to the Indian Patent Act around 2004-2005 sold for something like Rs 1, 20,000 per month while its generic equivalent only sells for Rs 8,000 – 10,000.
Sec. 3(d) sets the bar higher such that patent applications of drug or medicines that purportedly presents itself as a mere discovery of a new form of a known substance is not immediately granted a patent unless it is shown that such new form demonstrates an enhancement of the known efficacy of the previous form of the known substance.
The new form involved in the Novartis case is the beta crystalline form of the drug compound Imatinib Mesylate. The Supreme Court decision resolved the question of whether the evidence presented by Novartis demonstrated an advance, or enhancement of its efficacy as such drug.
The Indian Supreme Court apparently did not issue a definitive ruling on what constitutes “enhanced efficacy” but it said that “in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’.” The Court then said that what “therapeutic efficacy” means must be construed strictly, and based on what has been submitted before it, it ruled 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”.
The Supreme Court then turned to the issue of increased bioavailability. It stated that “… just increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data.”
This elaborate citation of the major part of the ruling in the case is being presented here since that sec. 3(d) is relevant to the Philippines as we have copied such provision and transplanted it here, with some slight drafting modification, as secs. 5 and 6 of Republic Act 9502, or the “Universally Accessible Cheaper and Quality Medicines Act of 2008”.
Nonetheless, in spite of the mandate of the implementing rules and regulations of the Act that the Philippine Intellectual Property Office (IPO) will further elaborate the changes in the rules on patentability of drugs and medicines in the country through its Manual For Substantive Examination for Patent Applications, the Intellectual Property Office has not yet done so, in spite of the assertion of Bureau of Patents Director Epifanio Evasco in a workshop last November 2012 organized itself by the IPO that there is already a specific administrative order dealing with the changes wrought by RA 9502 on specific items regarding the patentability of drugs and medicines in the country.
This is being asserted since a repeated search of the IPO website today does not yield such mentioned Administrative Order, even the existing Manual for Substantive Examination in the website seems outdated since it does not mention even the Cheap Medicines Act or RA 9502.
Perhaps the Department of Health, through the Food and Drugs Administration (FDA), should prod the IPO to already issue such guidelines for patent examination, since the Indian Novartis ruling gives some suggestions on how the matter of “enhanced efficacy” can be determined, and the FDA would surely have some ideas how such concepts can be further elaborated, using the same principles applied in the Indian case.
Groups who are lobbying against the entry into negotiations of the Philippines into a free trade agreement, be it the EU (through the EU-RP FTA or EU-ASEAN FTA) or the US (through the Trans Pacific Partnership, even if the US so far has consistently rejected entreaties by Philippine trade officials to join the emerging regional trading arrangement) will now have a stronger basis to resist calls by Philippine trading partners for stronger patent rights for drug companies and a related call for a repeal of the beneficial IP Code amendments in the law– the Indian amendments to its patent law, is WTO-consistent, and is part of what is called “flexibilities” which takes into account a country’s developmental needs when formulating its intellectual property (IP) laws. The Philippines being a developing country will also have the same rights to such “flexibilities” in its IP laws.
Nonetheless, it is also not clear at this point whether the amendments to the IP Code brought about by Republic Act 9502 has really resulted in beneficial changes to, among other things, drug prices in the Philippines. There are groups like Consumers Action for Empowerment who assert the law is a failure. But that deserves a much-closer look by all concerned, including the various patient groups and stakeholders and key government agencies, considering that come June 6 this year, it will be five years since such law has been passed.