WHAT IS PHARMA PATENTING: A JUDICIAL APPROACH FROM {TAJ PHARMA INDIA} BRAND INFRINGEMENT

?Affluent societies are spending vast sums of money understandably on the search for new products and processes to alleviate suffering and to prolong life. In the process, drug manufactures have become a powerful industry. My idea of a better- ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death.? ? Mrs. Indira Gandhi , ( World Health Conf, 1982)

Patents work in a different way indifferent industries. In the electronic industry patents are often shared among competitors through pooling or cross licensing. This allocation is necessary because a given product often contains numerous patented technologies. However, in the pharmaceutical, and biotechnology industries the patent normally equals the product, and protects the widespread investment in research and clinical testing required before placing it on the market. Patent shield for chemical and pharmaceutical products is especially important compared to the other industries because the genuine manufacturing process is often easy to replicate and can be copied with a fraction of the investment of that required for the research and clinical testing.

The 112 pages judgment of the Supreme Court on the 1^st day of April, 2013 made everyone rethink, what should be the fitting standard to get patent protection through the patent granting system. There is a need to relook the whole Novartis judgment through the prism of judicial system and pharma companies existing all over the world, fervent to work for R&D in India. There is a need to rethink upon the ways to make balance among different views. So, for positive or negative assertion we need to analyze firstly, what exactly the patent & pharma patenting is all about. Secondly, Impact of patent justice system on pharma companies. Thirdly, what is the necessity of pharma patents and finally, understanding the judicial approach through new supreme court judgment and its future implications on society as well as pharma companies.

WHAT IS A PATENT?

A patent is a property right granted by the government to the inventor of a novel, non-obvious and useful invention. The holder of a patent has the right to exclude others from making, using, offering for sale, or selling his or her invention for a period of 20 years from the filing of the patent application. The term Patent has been defined under Section 2(m) of the Indian Patents Act of 1970.

The benefit of granting an inventor the exclusive property right of a patent for the limited period of 20 years is that he or she is given a powerful spur to create. The inventor is assured that investors will be given the incentive to commit the financial resources necessary to support the inventor?s research and to develop it to the point where it can be manufactured and made available to the market.

WHAT IS PHARMACEUTICAL PATENT?

Patent for an invention in pharmaceutical industry is called as pharmaceutical patent. In the pharmaceutical industry, the patent protection of drugs and medicines is accorded a meticulous importance, because drugs and medicines can easily be copied or imitated and because of the significant research and development spending and the high risks associated with the development of a new drug.

The pharmaceutical industry has asignificant characteristic that sets it spaced out from other industries that rely on patent protection. In many technology-based companies it is possible to keep inventions a secret till the moment they are marketed. This enables the inventors to holdup patent filings until the last likely moment and, therefore, to maximize the effect of the 20 year patent term which runs from filing of the patent application. The ethnicity of medical research, however, emphasizes very early revelation of inventions, more often than not long before a resulting product can be placed on the market. This is because scientists functioning in the meadow of human pathology have commitment to share their findings as soon as possible with their peers so that those peers will be able to advantage from the new knowledge in their own research. And, not like industries such as computers and software, the pharmaceutical industry is profoundly regulated by government agencies to assure the safety and efficacy of products which will be sold to consumers.

Effectual use of the patent system in the 20th Century gave rise to commercial enterprises that advanced the advancement of medical science beyond anything known in prior history. While public endowment or funding of the training of scientists and basic research immensely expanded the understanding of human pathology as the century progressed, it was the income incentive operating through pharmaceutical companies accountable to investor shareholders, which provided urgently needed new therapies to patients. By the decade of the 1980s patent reliant pharmaceutical companies developed more than 92% of all new drugs.

Given the considerable effects that patents can have on competition and, hence, prices of medicines, the criteria that are practical to examine and grant pharmaceutical patents are extremely relevant for public health policies, and not only a matter of concern for patent and industrial policy. Policy makers in the health region, as well as patent examiners should be conscious that decisions relating to the grant of a patent (which is generally presumed valid until proven to the contrary) can directly affect the health and lives of the people of the country where the patent is granted and enforced.

Patent protection is crucial to the inventive pharmaceutical industry. Innovative companies need the guaranteed period of market exclusivity afforded by patents in order to sustain drug prices, recoup research and development (R&D) expenditures and finance the development of new products.

Like other inventions, medicines are entitled to patent protection if they meet certain necessities. Unlike other products, however, medicines are required to go through a strict routine of tests and evaluations to determine their safety and efficacy before they can be sold commercially. The testing process is painstaking and lengthy, involving animal and clinical trials of each forthcoming new drug. Much of the testing takes place after a patent for a drug has been applied for and results in significant lag between the invention of the drug and its sale to the public. Meeting government-imposed authoritarian requirements consumes part of the period of patent protection, so that this is shorter for the pharmaceutical sector than for other industries.

pioneering companies have responded to this disadvantage by lobbying vigorously for measures to strengthen the patent system and for changes to the regulatory process that would decrease the time involved in obtaining marketing approval for a drug.

LEGAL APPROACH:

Section 3(d), as introduced in April 2005 into the Indian patent Act, 1970, represents a unique prerequisite to be fulfilled for patentability of definite types of pharmaceutical inventions. According to Section 3(d), in order for a new form of a known substance to be patentable, it must show an improved efficacy with respect to the known efficacy of the substance concerned. It states that? ?

?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 new use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant?.

Section 3 of Indian Patent Act,1970 defines what is not patentable. Section 3(d) gives out that the mere discovery of a new form of an old drug does not make it an invention.

Since enforcement of patent protection law in India the whole matter before the Indian courts have been about the battle of public good versus market monopoly.

The Supreme Court?s ruling of April 1, 2013 rejecting patent application from Novartis, the world?s second-largest drug manufacturer, for the leukemia drug Glivec was an epic finale to a tortuous seven year-old legal battle that pitted Novartis against the Indian government, the country?s leading generic drug makers and the Cancer Patients Aid Association. It ruled that Novartis? new drug represents only a ?minor tweak to an existing drug? whose patent has expired, hollowing critics? complaints that the manufacturer was attempting to exploit a loophole to squeeze more money out of the medicine. The practice of making minor changes to drugs to extend their patents known in the industry as ?evergreening? was effectively outlawed in 2005 by Indian lawmakers, and this decision solidified that ruling.

Novartis patented anti-cancer drug Imatineb (also sold as Gleevec and Glivec), in the US in 1993. The Indian Supreme Court affirmed Novartis? new drug, rather old drug with a new name, was not novel and useful enough to merit a separate, new patent in India. Apparently this is a game pharmaceutical companies routinely play, to get new patents on old products to continue profiteering at the expense of consumers all over the globe.

The ruling will definitely save a lot of lives athwart the developing world. The verdict doesn?t signify no patents will be granted in India, but the abusive practice of seeking many patents for one drug will be cramped. Nowadays, Print and electronic media are publishing several opinions on the pros and cons of the judgment highlighting the issues related to cancer patient?s benefit and issues related to impact on pharma companies investing huge amount of money currently in India. The verdict is seen as a bluster to Western pharmaceutical companies seeking to protect their economic interests. Experts say it could bolster pharmaceutical companies in other countries hoping to produce generic versions of name-brand medications. That could stand for wider availability of the less expensive drugs throughout the developing world.

In recent months, the Indian judges have revoked the patent on several drugs giants Pfizer and Roche, as the cancer drug Tarceva, which is ?copied? from the Indian Cipla, in fact discouraging their monopoly. The remarkable story of Nexavar, an expensive drug against kidney cancer and liver produced by Bayer. A few months ago, the Court of Appeal in India has given the green light for production by the Indian generic Natco Pharma, although the drug was still beneath patent. A decision on the grounds that the drug ?was not accessible to the majority of patients.? In fact, the Indian judges have mandated Bayer to grant the license to produce the drug in exchange for 6 percent of royalties. Bayer did not appreciate the judgment and has already been used.

BOTH SIDES OF THE COIN:

The decision will have a positive impact on drug affordability, accessibility and availability of this drug in India for cancer (myeloid leukemia) patents, as Glivec (imatinib) outlay more than Rs.10 lacks for monthly treatment compared to Rs.10,000 for our generic imatinib tablets.

On the other side of the coin, the decision will have a negative impact on research and innovation in India, a country which ?refuses to protect the patent for Glivec, although the drug is recognized worldwide and protected in almost forty states,? says Novartis said in a statement.

CONCLUSION& SUGGESTION:

Thus, Looking deeply into the issues relating patenting of drugs and judicial approach and concern for large number of cancer patients in India, the judgment will set a constructive precedent. However, The monopoly granted by patents to the Drug companies should not be exercised without responsibility. Last but not the least, thanks to Indian Patent Act, 1970 which since 1970 permitted India to produce generic versions of drugs still under patent abroad, the Indian pharmaceutical industry has become, with that of Brazil, the largest producer of generic drugs. This has led to major benefits especially for the poorest countries in the world, where the cost of some therapies have been literally shattered. It would advantage especially Taj Pharmaceuticals, a leading Indian generic manufacturer among others like Dr. Reddy?s lab, Celon Labs, Natco Pharma, Cipla, Glenmark Pharmaceuticals and Ranbaxy.

The most workable solution to the problem which at the same time allows for TRIPs compliance would be granting of dual licenses. This would indicate that the patent would be partly product patent and after a reasonable time being given to the inventor to make a reasonably large profit it would be converted to a process patent whereby the patented drug can be manufactured by competing manufacturers using an alternative process. This would unravel the problem of excessive hike in prices and would render the drugs more accessible to the millions suffering. Collaboration with the MNC?s on various fronts such as research and development, manufacturing and marketing will assist Indian Pharma companies make profitable breakthroughs.

Source: Lawz Bureau

Tags: Trademark Protection, Brand name protection, Business Disruption, Health Care Industry, Indian Pharma companies, Taj Pharmaceuticals, judgment, pharmaceutical companies, Patent, Glivec, imatinib, FDA, Drug regulator, Patent and Trademark

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Taj Life Sciences was established in 2008 under Taj Pharma Group to avail quality affordable generic medicines in India and abroad. Taj Life Sciences focuses on innovative therapeutics with convenient application.

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