Impact of Indian pharma laws on the essential improvement of the drug development

“Medicine is a science of uncertainty and an art of probability.”

– William Osler

It is a well-versed fact that a pharmaceutical company has to invest a lot of money in the R&D process for the invention of a new drug. This process takes a very long period, also being expensive, this R&D process has a high risk of failure. For compensation for this high investment risk, the pharmaceutical companies rely strongly on Patent protection Laws.  Moreover, the investment done in the R&D of failed drugs are also recoup by the high prices of the successful drugs.

It has been seen that understanding and modifying the polymorphism of an already existing drug creates a scope for the better functioning of that particular drug and plays a crucial role in drug development. The best exhibit of this phenomenon is the HIV drug Ritonavir. The original component used in this drug was less soluble, but the polymorphic form of this drug proved to be less bioavailable. Countries like America, Japan, and the EU Member states generally grant the patent to the pharmaceutical companies even the drug exhibits change in minimal qualities such as stability, solubility, hygroscopicity, etc.

 Talking about  India, according to section 3(d) of The Patents Act 1970, the polymorphs of a drug is considered to be the same compound unless there is proof that the polymers exhibit a difference regarding the efficiencies.

EVERGREENING

The maximum life of a patent is of 20 years from the date of filing of the patent. Due to very high competition, pharmaceutical companies generally patent their drug candidates early. Due to this, the development of that particular drug takes 10-12 years out of their 20 years of patent. It is not practically possible for any drug inventors to first conduct all the research regarding the drug and then filing a patient on it.

To tackle this situation, to extend the life of the patented drug, the pharma companies generally make some minor changes and modifications in the existing drug and then re-patent it for the next 20 years. It is a common practice followed even by big pharmaceutical companies, known as “Patent Evergreening.” The big pharma companies continue this practice to uphold the monopoly in the market and to sell their drugs at a high cost for a longer period, due to which these drugs are not readily available to the poor and needy people.

PRESENT SCENARIO IN INDIA

In India, according to section 3(d) of The Patents Act 1970, the polymorphs of a drug is considered to be the same compound unless there is proof that the polymers exhibit a difference regarding the efficiencies. But recent cases have shown that Indian Patent Office has turned down the patent application for the “improved invention” regarding drugs, stating that the alleged improved invention falls under the ambit of section 3(d) of the Patent Act. Whereas, when the pharma companies approach the court challenging the Patent Office’s decision, the court allowed the production and patenting of that “improved invention.” The main problem of this issue is the lack of a proper definition and difference between the “essential invention” and  “evergreening inventions.”

The case of Roche Ltd. & Anr. Vs Cipla Ltd., discusses the conflicting opinions of the   Patent Office and The Supreme Court regarding the concept of patenting the polymorph under section 3(d)  of the Patent Act. Erlotinib hydrochloride is a drug used in Tarceva therapy, which plays a vital role in curing non-small-cells cancer. This drug, including the therapy, was patented by Roche in India along with a second company. A company OSI applied for the Polymorphic B variant of Erlotinib, which the Patient Office rejected, stating that it is a polymer that is merely modified and falls under section 3(d). Clipa, after few years, announced the launch of a generic drug Erlocip after which Roche filed a complaint before the Delhi High court and claimed that the product of Clipa lacks inventive steps as required under section 2(1)(j) of the Patent Act. Clipa, on the other hand, stated that their drug consists of a different polymorphic structure than the patent drug. The patent drug consists of  2 polymorphic forms, A & B, whereas the drug made by Clipa consists of only a pure form of polymorph B. The court held that since the generic version of Clipa’s drug consists of Polymorph B, therefore it did not infringe the patient of Rocher’s drug.

In this case, when the OSI company applied for the patenting of  Polymorphic B variant of the  Erlotinib, then the Patient Office rejected that application stating that it is a merely modified drug and therefore comes under the ambit of section 3(d) of the Patent Act. But, when the Clipa company put the same contention in front of the High Court, the High court held that the Polymorphic B variant of that drug was completely different and didn’t come under the ambit of section 3(d) of the Patient Act.

It was in the case of Novartis and the Union of India in which The Supreme Court of India delivered a landmark judgment regarding the definition of “efficiency” in section 3(d) of the Patient Act. The company Novartis invented an anti-cancer drug, Imatinib mesylate, and marketed it in the USA under the name of Glivec. Furthermore, the company patented this compound in the USA and many more countries in the year 1990 but not in India since, at that time, India didn’t allow patents on drugs. Later in the year 1998, the company filed a patent application for their drug. The Patent Office rejected that patent, stating that the drug was a beta crystal form of Imatinib mesylate, which was already patent (US patent No 5 521 184). The matter reached the supreme court, in which the petitioners argue that the meaning of “efficiency” should not be narrowed down only to modifications that increase efficiency in treatments, but it should be widened and should include the modifications that can make the drugs easier and safer to use. The supreme court rejected the petitioner’s arguments and held that the efficiency would only include “therapeutic efficiency.”

Just like these, there are many more cases in which the court and the Patent Office share different views regarding section 3(d) of the Patent Act. Cases like these arose numerous questions like,

Regarding a drug, the Patent Office states that the “improved invention: is merely a modification, whereas the court allows that particular drug to be patient. How to stop these kinds of insufficiencies? Moreover, questions like do the Indian laws dispirits the essential improved inventions which are essential for drug development? Etc.

CONCLUSION

Several life-threatening diseases are present in India, and to cure that, there is a constantly increasing demand for life-saving drugs/medications. Innovation and the invention of such life-saving drugs are of the crucial need to be fulfilled in India urgently. In India. Section 3(d) is essential for removing the minor and insignificant inventions; the same should not be used against the critical and considerable inventions that can lead to life-saving drugs.

– By Abhinav Kumar, Vivekananda’s Institute of Professional Studies, GGSIPU