THE United States was on the verge of making a controversial amendment to the US patent law in June this year that would have modelled it on India's Patent Law which prohibits the patenting of new forms, new uses and new methods of administration of new medicines unless the patent applicant can show "a statistically significant increase in efficacy". The bill - which would have "turned the US into India", according to American critics - was withdrawn at the last minute, but a similar measure may reappear in the future because many Americans are appalled at the prohibitive cost of prescription drugs.
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Introduced by Senator Lindsey Graham, the amendment blamed a plethora of new patents that resulted in jacking up drug prices. While the amendment rightly aimed to address worries in the US over escalating drug prices which many people find unaffordable, it caused deep anxiety among the big pharmaceutical companies, known as Big Pharma, because they believe the amendment would have delivered a massive blow to medical innovation in the US. Critics in the US find that the language in the Graham amendment was worryingly similar to the Indian patent law.
They argue that the Graham amendment would turn the United States into India where the patent-granting rules are too restrictive. The Indian Patent Act requires a pharmaceutical invention developed from a known substance to demonstrate substantially high levels of therapeutic efficacy in order to be eligible for a patent. This is where the controversial element comes in: Big Pharma believes that the Indian rules are inconsistent with India's international obligations. India has been under US scrutiny because it has only allowed "process patents" in the three-decade period from , which meant that even a patented product could be manufactured by anybody other than the patent-holder if they used a different method to produce it.
But, India asserted its autonomy in a landmark judgment in April , when India's Supreme Court dismissed Swiss drugmaker Novartis AG's attempt to win patent protection for its cancer drug Glivec. The judgment set a benchmark precedent for intellectual property cases in India where many patented drugs are unaffordable for most of the country's 1. The beneficiaries of the judgment were the Indian firms Cipla Ltd and Natco Pharma Ltd, which sell generic forms of Glivec in India at around one-tenth of the price of the branded drug. The Indian court's decision was based on whether Glivec was a "new product" under the terms of the law.
The drug failed the "novelty test" because the court adhered to an Indian patent office ruling in January that the drug was not substantially different from one for which patents had already been granted in the US and Europe. The Indian Parliament had inserted a new provision, known as Section 3 d , in the Patents Act to prevent "evergreening", which describes a practice by companies to slightly tweak an existing process or product to seek a new patent after the original protection expires, enabling them to extend their monopoly rights.
Yet, the critics argue that the Indian law is ambiguous in its Section 3 d because it demands an "enhanced efficacy" or effectiveness, efficiency or usefulness for known drugs, in addition to the requirements of demonstrating standard novelty, inventiveness, and industrial applicability. American critics argue that the Graham amendment had proposed similar provisions, despite its condemnation in the US.
Prior to the Graham amendment, in late April, the United States Trade Representative put India on a "priority watch list", for "serious intellectual property rights deficiencies". Indian patent laws help keep prices of medicines low and allow Indian generic-drugs makers to profit, the USTR argues. From the Indian perspective, India has already acceded to some US demands and it need not make any more compromises as it would hurt the interests of the Indian people and their right to cheap life-saving drugs. Home Discussions Workshop Market Broadcasts.
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Add to Cart. Bundle info. Add to Account. About This Content Grab your free samples and your company credit card because it's time to schmooze - Big Pharma style! Oversee clinical trials and fudge the results! Run disease awareness campaigns to convince the public that they're sick, and that you've got the drug to cure them. And many more! With manual price setting Will you: Undercut your opponents prices to force them out of the market? Attain a monopoly and charge an extortionate price for a life-saving cure?
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And watch out, your competitors have access to them too! System Requirements Windows.