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HINDU EDITORIAL ANALYSIS:27th DEC'17 https://unacademy.com/user/abhishek6077 Editorial analysis- Nov & October News Analysis- November & October . Crash course on Polity, Modern, Ancient & Medieval History Ncert Class VI History Summary Delhi Sultanate Essay writing
How India rejects bad patents In 2005, India made some remarkable amendments to the Indian Patents Act of 1970, to keep medicines affordable in the country. Since then we have faced a significant blowback not just from the global pharmaceutical industry but also from developed world including from the U.S. and the European Union. At the heart of the matter are the strong standards for patents which India introduced to promote genuine innovation across all fields of technology, in perfect compliance with the World Trade Organisation (WTO) norms. In contrast, developed countries have weaker standards as a result of incessant lobbying by corporate behemoths. Twelve years later, we now know what it means: India rejects bad patents in far greater number than developed countries The background The findings of a new study by us which examined all 1,723 pharmaceutical applications rejected by the Indian Patent Office (IPO) between 2009 and 2016 have been an eye-opener
Section 3(d) of the Indian Patents Act, a provision introduced to restrict the patenting of new forms of known pharmaceutical substances, became the subject of international attention after its use in rejecting a patent application by Novartis for the anti-cancer drug, Gleevec. We found that exceptions to patentability in Section 3 of the Act, which includes Section 3(d), were responsible for 65% of all rejected pharmaceutical patent applications. Over its short lifetime, Section 3(d) has survived a challenge to its constitutionality before the Madras High Court, and Novartis's fight against the rejection of its patent that went to the Supreme Court. Both courts ruled decisively to uphold the legality of Section 3(d) The United States Trade Representative has also repeatedly rebuked India for this provision in its Special 301 Report, despite its perfect compliance with WTO norms. While the world's attention is still fixed on this legal experiment that the Indian Parliament introduced into law, there has been a dearth of information onh We found that it filters the bad from the good, with the lowest possible administrative and financial burden.
Rejected using Section 3(d) An astonishing 45% of all rejected pharmaceutical patent applications cited Section 3(d) as a reason for rejection: the applications were identified as mere variants of known compounds that lacked a demonstrable increase in therapeutic value. Between 1995 and 2005, prior to our new law, India provided a temporary measure to receive patent applications for pharmaceutical products at the IPO, called the mailbox system. Though introduced in 2005, the use of Section 3(d) gradually increased from 2009 when mailbox applications were examined The spike coincides with the Supreme Court's ruling in the Novartis case, in April 2013. It would appear that this judgment provided legal certainty to Indian patent law in general, and Section 3(d) in particular, enabling the IPO to weed out trivial innovations. At the patent office In the last decade, we found that the IPO rejected about 95% of all pharmaceutical patent applications on its own. Only 5% were through the intervention of a third party, such as a pre-grant opponent.
Our basic patentability criteria, that the invention should be new, involve an inventive step (also known as non-obviousness), and should be capable of industrial application, were the most frequently used grounds for rejection, followed by the exceptions to patentability grounds in Section 3. Section 3(d) invaluably equips the IPO with a yardstick to evaluate applications that are merely trivial innovations over existing technology. In cases where the invention is a variant of a known substance, the criterion for patentability is proof of a necessary improvement in its performance for its designated use, i.e., increased efficacy. In the context of pharmaceuticals, as was the case involving Novartis, this translates to evidence of an improvement in therapeutic efficacy. In other words, trivial innovation must result in a far better product in order to qualify for patent protection. Within the arcane world of patent law, an argument against provisions such as Section 3(d) is that it is no more than an extension of one of the basic requirements of patentability: non-obviousness Certainly, for an application to be deemed non-obvious, it has to establish a technical advance over what was known before.
But non-obviousness standards are more effectively applied in invalidity proceedings before a court of law than by officials at the IPO. The advantage that a provision such as Section 3(d) provides is the ability to question an application at the IPO itself without having to go through expensive and time-consuming litigation. The high cost of litigation poses significant barriers. Cases are often settled before reaching a conclusion, in pay-for-delay settlements negotiated by patent owners, where generic manufacturers are essentially paid to stay off the market. Patent litigation is expensive, but it is the patient who eventually pays a higher price by being subject to exorbitant medicine prices, driven by the unmerited exclusivity that bad patents create. As a check Without Section 3(d), the Indian public would have to bear the burden of invalidating a bad patent through litigation. India is certainly not alone in facing two connected challenges: constrained government budgets and urgent public health needs. As Section 3(d) has been efficient in separating the bad patents from the good in India, it would be a wise move for other developing countries, grappling with similar challenges, to incorporate similar provisions in their law
After the sanctions The fresh round of economic sanctions imposed unanimously by the UN Security Council on North Korea is a predictable response to mounting international frustration over the nuclear stand-off. The measures come days after the U.S., echoing suspicions in other countries, charged the North Korean government with the world-wide 'WannaCry' cyberattacks in May. The sanctions include an 89% curb on refined petroleum imports into North Korea, stringent inspections of ships transferring fuel to the country, and the expulsion of thousands of North Koreans in other countries (who send home crucial hard currency) within two years. Despite the crippling nature of the curbs, there is some good news on this imbroglio. As on previous occasions, Beijing and Moscow were able to impress upon the Security Council the potentially destabilising and hence counterproductive impact of extreme measures. This is significant given the intercontinental ballistic missile that Pyongyang launched in November.
It was described by U.S. Defence Secretary Jim Mattis as technically more sophisticated than anything witnessed previously, and the North Korean regime's claim that it could deliver nuclear warheads anywhere in North America has been viewed with concern. However, even as China and Russia approved the latest measures, they continued to state their preference for diplomatic engagement. It remains to be seen how much more pressure Beijing can exert upon Pyongyang. The stated aim of the sanctions regime has been to force North Korea to halt its nuclear programme and start disarmament negotiations. In September, North Korea detonated its sixth underground nuclear device, which it claimed was a hydrogen bomb. That assertion remains unverified, but experts believe the explosion was many times more powerful than previous detonations. The development has served as a reminder to the U.S. that the scope for military options may be increasingly narrowing. Against this backdrop, a revival of stalled peace negotiations between the P-5 nations and North Korea may be the only realistic alternative on the horizon.
The successful conclusion of the 2015 civilian nuclear agreement between the P-5 plus Germany and Iran affords a constructive template to move ahead with North Korea. Certainly, U.S. President Donald Trump has delivered a scathing blow to the Iran deal, even as he stopped short of scrapping it. Iran's continued compliance with the inspections of the International Atomic Energy Agency may not mean much to Mr. Trump, given his overall distrust of multilateral institutions. But that is no reason why other big powers should not pursue the diplomatic effort with redoubled energy. Countries that backed the recently adopted UN nuclear weapons abolition pact should likewise lobby Pyongyang.
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