Drugs fight- a war waged between public health and patent right by T.Abhishek

Drugs fight- a war waged between public health and patent right

(with special reference to Novartis case)

INTRODUCTION

The history has repeatedly shown that innovation can strive without patents but in this present era it’s really important to be well aware about ones right and to get credit of work done by person. It is much more applicable in case of IP issues as in advanced technology what one invents; there are chances of securing the monopoly right/ownership by another person on the other part of world for inventing the same product. To secure right, one needs to be smart, quick and well aware to get credit of what one deserves. Such rights for intangible goods are granted by IP laws like copy-rights, trade-marks , patents

The pharma patents are not only centralized to drugs but it is related to hiking of price, and while talking about India it has widely affected the Indian generic drug regime. The multi-national Pharma companies have alleged the generic drugs companies for infringement of patents rights in large scale.

INDIA AND PATENTS

In the initial days India had a product patent domain which but in 1970 a new patent act was introduced which excluded pharmaceuticals and agrochemical products and hence turning out to be the leader of generic drugs in third world countries the primary provider of health care products, from a turnover of US $ 0.3 billion in the year 1980 to US $ 23 billion from the year 2009- 2010

India signed the TRIPS convention and became a signatory to it in the year1994 as consequence a new amendment was passed in 2005, Indian Patents Act 1970 provides two opposition proceedings, pre-opposing and post opposition^[1]. Section 25(1) talks about the pre-opposition, under this opposition can be made to avoid granting patent to substance which doesn’t qualify as patentable invention. Section 25 clause 2 provides opposition revoke or amends the patent claim which has already been granted. Section 3 and 4 are prohibition section, it describes what cannot be patented. Act provides for compulsory licensing by section 84 and 92A, to export drug.

 

Critical analysis of Pharma patents in pretext of India

A statistical representation of patents being filed Indian Patent Office during 1997-2010  (Drugs, Chemicals, Bio-technology)

During the term 1997-2010, figure 2 indicates patent application filings relating to drugs ranging from 9 to 22 percent based on year by year basis. The patent application filings are high during the transition period 1995-2005 wherein, India made a mailbox facility in accepting product patents as well. It is necessary to understand that several patent applications belong to chemical class and may also belong to pharmaceuticals. It is observed that patent applications relating to biotechnology are below 10 percent.^[2]

Trend in %  Patent Application Filings at IPO -Drugs, Chemicals, Biotechnology

Eminent Pharma manufacturers in India

India’s leading pharmaceutical companies are striving to compete not only in the domestic Indian market, but also in the global market for both generic drugs and original products. Sales for India’s largest 200 pharmaceutical companies grew from $7.9 billion in 2004 to $8.6 billion in 2005, or by 9 percent.21 By 2005, 9 of the top 10 Indian drug makers were Indian-owned firms accounting for more than 44 percent of total industry sales. India’s top five pharmaceutical companies, in terms of sales, are Ranbaxy Laboratories, Dr. Reddy’s Laboratories, Aurobindo Pharmaceutical, GSK-India, and Cipla . These companies manufacture a wide range of generic drugs (branded and non-branded), intermediates, and active pharmaceutical ingredients ^[3].

Novartis case

Novartis is a Swiss based company which and distributes medicine to whole world. They manufacture Imatinib Mesylate (Glievac), cancer drug. This drug used in treatment of Myeloid Leukemia (blood cancer). They filled an application in Chennai patent office for patent in year 1998. In 90s Indian IP laws were not that matured to grant product patent to pharmaceuticals. But in November 2003 patent office granted Exclusive market rights (EMR) for term of 5years. EMR is one of the obligations of TRIPS. In 2005, IP laws were reviewed and it was brought in decision that either EMR would be granted patent or rejected. In result of it Novartis’s claim face pre-opposing by five competitive pharmaceuticals companies and  from Cancer Patient Association on the basis of following 5 points^[4]:

1.    It is prior art as publication has been made in many countries;

2.    There is no inventive step, as process of making salt from free base of Imatinib mesylate is obvious to the person expert in that art;

3.    It should be rejected under Section 3(d) as patent doesn’t have therapeutic efficiency ;

4.    As Switzerland is not party of TRIPS , so it application is not eligible for 1 year;

5.    As Norvatis providing drug at Rs 1,20,000 per month, whereas same can be provided as generic drug at price Rs 8000 per month, which is more beneficial for public health.

The application was initially rejected after hearing pre-oppossion of above mentioned parties. Novartis approached the Madras high court, the appeal was transferred to Intellectual Property Tribunal Board. IPTA rejected the appeal of Novartis.Novartis opposed the Judgment of Madras High Court and filled an appeal in Supreme Court^[5]:

1.    Challenging the decision of High court and IPTA

2.    Challenging the constitutionality of section 3(d), stating that it is not with compliance with TRIPS.

Supreme Court rejected patent application of Novartis on “Glivec” as Novartis failed to prove the therapeutic efficiency. Court held that Section 3(d) is not in violation of Article 14 of constitution and same is in compliance of TRIPS.

Social Desirability in Pharmaceutical Patents and Public welfare

“This is the patent age of new inventions for killing bodies, and for saving souls. All propagated with the best intentions.” Lord Byron

Patents are profitable for monopolists, but that much we knew already. But the important thing is to be kept in mind is the purpose of the patent system which is to benefit society through innovation. It makes no sense to grant patent monopolies in medicines for the kind of innovation produced until it is mainly driven by the purpose to benefit the society.

Whatever one feels about patents and the “property rights” of monopolists, it is hard to fathom the defense of existing patents when millions of lives are at stake. Whatever religious altar one worships at, whether it be a more traditional religion, the religion of capitalism, or that of monopoly, there can be no excuse for allowing either the idea or reality of private property to interfere with the business of saving one’s fellow man. If compensation for the taking of medical and pharmaceutical patents need be paid, so be it. But we can only hope that along with the great mass murderers of the 20th Century – the Stalins and the Hitlers – there is a special place in hell reserved for those who stood by and refused to act while those around them died.^[6]

During the golden days of Indian Generics – India (as per the Patent Act of 1970) did not recognize patents as considered vital to human life, hence made pharmaceutical patents non-applicable in India, thereby allowing the Indian companies to manufacture generic medicines without obtaining grant of license from the originators till the process used was different from the original manufactures. Indian Pharma companies  got expertise in reverse engineering which boosted these companies and hence stood out as an eminent competitor in the world market and supply drugs at an affordable price in the international market. These generics were made available in Africa as well as South America. The availability of these generics at an affordable prize no doubt had a great effect on curtailing the spread of the HIV epidemic, cancer drugs.^[7] So in cases of epidemics and life threatening situations availability of a drug is solely humanitarian and it should be implemented as such. Whatever the loss incurred by the company might be, it cannot be worse than the loss of lives due to unaffordability of the life saving drugs. It is time to turn around and protect the person for whom the drugs are actually manufactured rather than the profits (which seems to be the only direction companies are heading in).^[8]

Conclusion

There is a an urge for strong patent laws in India since the companies cannot attract the huge cost incurred in manufacturing the products and investment done in research but these laws are actually in contradiction with concept of public welfare and health concern, since with the patents laws becoming stringent the production of the generic drugs would be decreased and the citizens of the third world countries cannot avail it. Public rights prevail over the private rights especially when it comes to life of a person.

Studies shows that stringent patent laws liberate the MNCs to increase their monopolistic magnitude in the market. The huge debate which is going around the world about the Supreme Court decision, and the patent laws in India Pharmaceuticals would be reluctant to invest in India as negative environment given by the Supreme Court in Judgment of Novartis Case. But when we read the Section 3(d) it gives crystal clear mean of “efficiency” as therapeutic efficiency”, which Novartis has failed to provide it. The most important element of patent that it should be innovative and should be in public domain or should not be part of prior art. But unfortunate to the part of Novartis’s contention, it was known and Supreme Court found that if a person who is an expert in that art would know the process of making salt from free base of Imatinib mesylate. Norvatis contention regarding Section 3(d) of the Act that this section would be applicable for comparison between claims invention of the “same substances” and “same efficiency”. The Supreme Court struck down the contention stating that Zimmerman Patent of 1993 has already identified the similar substance for treatment of tumor.

The researcher stands in favor of the opinion justice has been done to the five year battle of medicine for lives of several patients. As said by the Prof. Brook K Baker of Health Global Access Project that to get patent in medicine, medicine or said company has to meet the Lawful standards of what is inventive and patentable.^[9]  As market experts have observed that pharmaceutical companies have not imported that quantity of medicines of the medicines as they promised in the patent application. As the motive of the Act is to maintain a balance between granting patent to promote the inventions and to protect the public interest by securing their right to health by providing accessibility of the medicine. The Supreme Court has safeguarded the objective of the Act as the price established by Norvatis would have promoted the invention but was out of reach of common person.

Life of a common man stands out when compared to patenting rights.

Submitted by:
T.ABHISHEK
B.A LL.B (HONS)
YEAR 3^RD
D.S.N.L.U VISHAKHAPATNAM

I.S.S.N No 2321 6417

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