In pursuance to its investigation into India’s trade, investment and industrial policies, the U.S. International Trade Commission (USITC) is holding a public hearing on February 13, 2014. Professor Srividhya Ragavan (University of Oklahoma College of Law), Brook Baker (Northeastern University School of Law), and Sean Flynn (American University Washington College of Law) submitted a statement to the USITC on issues pertaining to India’s patent regime.
This is a welcome intervention and provides a nuanced understanding of Indian patent laws and implementation. It is also instrumental in clarifying and rectifying certain misunderstandings regarding the Indian patent regime as evidenced by the GIPC IP Index.
The main theme of the submission is that whatever may be the effect of India’s patent policies on the profits of multinationals, the regime and its implementation are in consonance with the TRIPS. On the key issues of the Novartis case and Compulsory Licensing, the submission emphatically drives home the point that both instances are not TRIPS violative.
As stated, the Novartis judgment is well reasoned, reasonable and TRIPs permissible: “In essence, the Supreme Court of India, in a well-reasoned decision, found that beta-crystalline form of imatinib mesylate, was revealed and claimed in a pre-TRIPS patent and thus was time barred from patentability in India unless it showed significantly enhanced efficacy. Unfortunately for Novartis, the Supreme Court of India found that Novartis offered no evidence of increased efficacy of the relevant compound whatsoever, and thus that the patent was unmeritorious under section 3(d).” Also, the frequent reasoning of 40 other countries granting a patent to Gleevec has also been rebutted strongly “The argument that several other countries agreed that Gleevec was patentable despite being a mere variation of an existing, previously patented chemical entity is inconsequential to India’s own patent determination.”
On compulsory licensing the submission stated that India has the most sophisticated compulsory licensing system, only one compulsory license has been granted so far and “as a mark of its careful scrutiny, the Indian patent office rejected an application to compulsorily license Dasatinib.”
To contextualize these and other issues, the submission briefly explains and traces the history of the Indian Patent Act and the 2005 amendment, noting that the Preamble, Article 7 and Article 8 of the TRIPS allow countries to adjust their intellectual property laws to meet local needs. In dealing with introduction of a product patent regime, the submission notes that India’s ‘worldwide’ prior art and novelty standard is much broader than that which prevailed in the US till 2011. On the inventive step aspect, it was highlighted the US’s weak nonobviousness standard has become a cause for concern and a cause for the deteriorating standards of granted patents. Related to the weak nonobviousness standard, secondary patents have become commonplace in the US, teaching a lesson to other countries to strengthen regimes that prevent evergreening : “The low standards of inventiveness in the US has been alleged Such strategic patenting became commonplace in the United States thanks to the steady lowering of standards, especially for determining nonobviousness, has in turn contributed to such strategic patenting, which is now subject of much scrutiny in the United States.
The struggles of the United States with a barrage of secondary patents on medicines have served as a lesson to other countries, including India.
In the United States such patents are easily issued although they can be invalidated by litigation. Rather than accepting the resource investment, cost, judicial time and the loss of access to the public inherent in the U.S. model for combating evergreening, India’s Section 3(d), enacted in the 2005 amendment.”
Other provisions of the Patent Act such as exhaustion of rights, the bolar provision, opposition mechanism, creation of the IPAB etc. have been explained and highlighted in the submission.
The USITC launched this investigation on a request jointly filed by Senate Committee on Finance and the House Committee on Ways and Means. The USITC is an independent, nonpartisan, factfinding federal agency and is due to deliver its report by November 30, 2014.
Meanwhile, the U.S. Chamber of Commerce, in a submission to the Office of U.S. Trade Representative (USTR), has requested that India be classified as a Priority Foreign Country (a designation given to the worst offenders when it comes to protecting intellectual property and which could result in trade sanctions)
This is very interesting as press in US only wants to give what suits their side of the coin. Supreme Court of India is very astute and knows what makes sense. Every country has interest of its people and if there is not new invention but regurgitation of what has been invented, it should not be given a free ride.
To encourage and spur innovation, the Patents are granted and enforced by USA, UK and other advanced nations, while communist and socialist countries like Russia and India simply stole the innovation and patented information and made substandard carbon copies of the originator’s drug molecules. Thus, for the broad spectrum antibiotic CHLOROMYCETIN of Parke, Davis & Company in India, there were no less than one hundred cheap generic chloramphenicol products, made from bulk raw material by “mom and pop” companies mostly in Gujarat and Maharashtra, the cheap bulk drug sold by Italian drug thieves, Lepitit and Carlo Erba in Italy; AND THAT WAS HOW RANBAXY GREW INTO THE LEADING INDIAN DRUG COMPANY IN INDIA during the mid 70s, mainly due to Indian government patronage and favoritism to buy Ranbaxy’s SYNTHOMYCETIN instead of Parke-Davis CHLOROMYCETIN. Tellingly, when the Indian government developed its own antibiotic (whatever its name was!) at the Hindustan Antibiotics in Pimpri near Pune, no doctor in India wanted to use it and till today that government antibiotic is a mysterious dead drug! It is fitting that Ranbaxy should be going thru’ this regulatory mess in its US operations, notwithstanding its clever strategy pass on the buck and to unload its stinking regulatory burden on its new unsuspecting Japanese owner.
Dear Joseph Christie,
Don’t compare india and US on this. Each country is sovereign and so we are not bound to accept what US think is correct. We are a TRIPS compliant country and have just exploited the flexibilities already provided and agreed upon in TRIPS. In respect of RANBAXY, the US government did the same when it bailed out General motors and your supposedly in-collapsible banks during recession. Every country protects its industries.
Your anger has no basis. Also in this context, don’t forget you got independence in 1790 whereas we got it in 1947. So give the same time to reach your standards and we will tell you who is more capable to run MICROSOFT and PEPSI.
Sach, you make me laugh my head off with your silly absurdity, “and we will tell you who is more capable to run MICROSOFT and PEPSI.” FYI both of these CEOs are Americans as much as I am, though we were all born in a backward land called India. Learn not to connect disjointed facts and state your reasons coolly instead of letting your steam off unnecessarily. I have no earthly idea what the acronym TRIPS stands for.Incidentally, Ranbaxy IS NOT AN INDIAN COMPANY, but the Indian Division of a Japanese conglomerate. Good luck in your 200 year effort to catch up with China first.
Sach, you make me laugh my head off with your silly absurdity, “and we will tell you who is more capable to run MICROSOFT and PEPSI.” FYI both of these CEOs are Americans as much as I am, though we were all born in a land called India. Learn not to connect disjointed facts and state your reasons coolly instead of letting your steam off unnecessarily. I have no earthly idea what the acronym TRIPS stands for.Incidentally, Ranbaxy IS NOT AN INDIAN COMPANY, but the Indian Division of a Japanese conglomerate. Good luck in your 200 year effort to catch up with China first
If you have no idea what TRIPS stand for, then you have no idea of what you are talking about and therefore further discussion would be unfruitful. For your good knowledge, RANBAXY is an india incorporated company which was taken over by Japs. So you should go after the japs rather than spitting venom about India and its government. India is just exploiting the flexibilities of TRIPS provided therein and thus we are patronizing our companies legally in conformity with the international principles which have also been agreed upon by your esteemed folks.
I have no penchant nor proclivity to waste my time with a typical quibbler from the Land of Wasters. If you will only read our entire conversation, IT WAS YOU who started quibbling on trivialities. FYI, my nephew is with Ranbaxy as an R&D Scientist, currently in Japan. Don’t call a Japanese “Jap”, that is downright uncivil and an insult. Try it on a Japanese next and find out what happens ! According to Dictionary, “This term is a slur and should be avoided. It is used with disparaging intent and is perceived as highly insulting”. GOOD LUCK