Swiss pharma giant, Novartis,Â faced another blow in India, when Chennai High Court rejected its writ petition challenging the validity of Indian Patent Laws.
Novartis had sought to declare Section 3 (d) of the Indian Patents Act as substituted by Patents (Amendment) Act (2005) as being “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality).”Â The section denies patent protectionÂ to the discovery of new form of known substance which does not result in enhancement of the known efficacy of that substance.
Novartis also rasied concerns over the discretion of patent authorities to define and determine the “enhancement of efficacy”. The Bench rejected the concerns by saying that the amended section cannot be invalidated solely on ground that there was a mere possibility of misuse of power.
Since Novartisâ€™s 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate and the crystalline forms of imatinib mesylate.Â The crystalline forms of imatinib mesylate claimed in the application in question does not differ significantly in properties with respect to efficacy. In fact, with respect to efficacy, the current specification of Novartis itself admits that wherever Î²-crystals are used the imatinib free base or other salts can be used. The various forms of imatinib mesylate can, therefore, very well be considered the â€œsame substanceâ€ under section 3(d) of the Patents Act.Â Â view of IP practitioner Swarup Kumar
Novartis unlikely to challenge High court ruling in Indian Supreme Court. Novartis faced first setbackÂ in January last year, when the Indian Patent Office rejected a patent application ofÂ its leukaemia drug Gleevec. It had filed appeal against the patent office decision to Intellectual Property Appellate Board and a writ petition in Chennai High Court.
Doctrine of Equivalents was set forth by US Supreme Court in 1950 to extent the protection of patent rights to a good patent holders beyond the literal meaning of the claims i.e. literal infringement. US Supreme Court also established Function-Way-Result test with the objective to ensure the fundamental fairness to it to all.
Reverse of the doctrine is also hold good, i.e. if the claim elements did not Function is the same Way to accomplish the same Result then there would not be actual infringement under the doctrine.
Till date, neither US Supreme Court nor Federal Circuit Courts of Appeal had reversed a finding of non-infringement based on reverse doctrine of equivalence.
read more from ipfrontlines authored by Jay Sandvos
Scotch Whisky Association of UK has won a legal action in Delhi High Court to refrain Indian whisky manufacturers to use word “Scot” or Scotch”.
The association filed suit against Indian producer “Golden Bottling Ltd” under the Geographical Indications of Goods (Registration and Protection) Act, 1999. India enacted it under WTO-TRIPS Agreement obligations.
GIs are IPRs attributed to the products of a particular place like Darjeeling Tea, Banarsi Saari, Champagne etc.
Posted in GI, India, TRIPS, WTO
India emerged as the country with 2nd best conditions for innovation, after the US. UKÂ ranked third and Japan at the fourth.
Japan has emerged as the world’s most innovative nation in terms of business practises, followed by Switzerland, US and Sweden. India has been ranked at 58th position, ahead of China’s 59th position in a ranking of 82 economies, based on their level of innovation during 2002-06. India fared marginally better on a study of innovation enablers (or the ability of a country to facilitate innovation), coming in at No. 50.
The Economic Intelligence Unit, The Economist, survyed 485 senior executives worldwide and analysed data collected between 2002 and 2006.Â
A forecast by the agency for 2007-2011 expects China to improve its rank by five positions, while India is expected to move up by two. Hence, India will give away its lead over China as an innovative country in the next five years.
The top four will maintain their positions, according to the forecast, while China will move up five places to 54th and Mexico will climb six places to 39th.
The Brazilian governmentâ€™s decision to override the patent rights of Merckâ€™s HIV/AIDS drug Stocrin (efavirenz) and buy reverse engineered generic versions of the drug at low cost has come as a boon for Indian pharmaceutical companies manufacturing generic versions of efavirenz such as Cipla, Ranbaxy, Aurobindo Pharma and Strides Arcolab.
On Friday, Brazilian President Luiz Inacio Lula da Silva announced invoking the compulsory licensing provision for pharmaceuticals under the World Trade Organisationâ€™s (WTO) agreement on intellectual property – the TRIPS (Trade-Related Aspects of Intellectual Property Rights) – to buy copycat versions of efavirenz from laboratories certified by the World Health Organisation.
With over 200,000 registered cases, Brazil has the most AIDS patients in Latin America. Of them, only 75,000 patients are currently treated with efavirenz.
Welcoming the Brazilian governmentâ€™s move, Amar Lulla, joint managing director of Cipla, said it was heartening to note that Brazil has invoked the compulsory licensing provision to treat its HIV/AIDS patients with affordable generic drugs.
â€œThe compulsory licensing provision of the TRIPS help countries to protect the rights of its citizens. We welcome the Brazilian move,â€ he said.
Lulla confirmed that the Brazilian government was negotiating with Cipla for the supply of these medicines.
The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market.
The bill brought by Senator Patrick Leahy, (D-Vt.), and supported by Senators Herb Kohl (D-Wisc.), Chuck Grassley (R-Iowa), Russ Feingold (D-Wisc.), and Charles Schumer (D-NY).
The bill aims to end the trend of anti-competitive agreements between brand name pharmaceutical companies and generic companies to delay entry of affordable generics into the market.
Today, the law can’t stop the original patent holder from launching an “authorized generic” through a subsidiary or a third party. Sales of an authorized generic during the exclusivity period can cut the generic maker’s profits by 59 percent, according to research by Merrill Lynch analyst Greg Gilbert.
On the other hand Branded drug companies are lobbying with Bush administration to impose a new fees for the drug application filed by generic drug companies
This is the question .. going to be decided by US SC in july 2007, while hearing Microsoft Corp. v. AT&T Corp., 05-1056 case.
In a long-running case between Microsoft and AT&T, AT&T had been able to secure favorable judgments from lower federal courts.
In this case, Microsoft has accepted the infringement of an AT&T patent in US but disputed the infringement of the patent in overseas markets.
The patent is related to technology that converts speech into computer code, so the speech can be transmitted electronically. It accused Microsoft Corp. of infringing the patent by including similar capabilities in its Windows software.
AT&T has cited the provision of US patent law, which restricts the export or infringed products from country. It says by incorporating the infringed technology in windows and selling it overseas Microsoft has violated the said provision and hence liable for the damages.
Microsoft, has pleaded that it is exporting only the “master copy” of the software and said feature has been added by computerÂ manufacturers in the foreign markets.
AT&TÂ protested the idea of “master version” of the software and argued that Microsoft has collected the royalty on the infringing software sold in the overseas markets, hence it is liable for the damages for the infringement inÂ overseas markets.
US Supreme Court is expected to deliver its judgment on the issues in july 2007.
The secret to successful use of technology in a corporate setting
By Ernest Svenson on Legal Tech
It’s sad how much money is wasted on technology. If you need transportation and you buy a car then you aren’t wasting money. But if the car doesn’t run properly so that you don’t use it then you have a problem. Corporations buy lots of technology. Amazingly, most of that money is wasted because they don’t know how to use technology properly.
What’s the secret to using technology well in a corporate world? I don’t really care, because I gave up on the corporate world. But, if I ever went back to that world, then it would have to be a company that understands this principle.
Duncan BucknellÂ talks about theÂ â€˜6Tâ€™ framework for analysing IP issues.Â This article uses the same framework to show you how to simply structure an IP due diligence.Â
Just to remind you, here are the 6 Tâ€™s:
1 Â- Type of IP
2 – Time (until expiry)
3 – Territories (in which IP is held/registered)
4 – Terminated (ie the status of the IP)
5 – Technical Scope of the monopoly
6 – True monopoly? (validity)
An Indian Law firm Lex Orbis analyzies the trend in patent application in India.
The revival of the Indian economy and globalization of markets have thrown open new opportunities in the field of foreign investments and a strong patent regime is a key driver for foreign investment in India, particularly when other competing countries in South East Asia, including China offer better investment climate. As technological innovation is facilitated by healthy IPR protection, the onus is on the policy for correct balance between industrial development goals and protection of national interest.
The number of patent filing rate in India had tremendously grown in recent years and it has been growing 30% annually since 2002-03. The accession to PTC and the amendment of the Patent Act and Rules are the contributory factors. But the Indian Patent office infrastructure is still undergoing a change. The IT infrastructure is improving and the government realizing the advantages is planning a 1,300 crore-modernization plan. Currently India is ranked 12th in the world in patent filing. It has been reported that the numbers of applications have increased 400 percent over the past 15 years. Nearly 800 companies submitted international applications to the WIPO in 2004, which is more than a double of what has been filed in 2000. An increased patent filing was witnessed in the year 2005-2006 due to the changes brought about in the Patent Act where the product patent was introduced for the first time in pharmaceutical sector.
Currently, the patent office expects the growth to be maintained at 30% this year also. Delhi office has recorded the largest number of application around the country and majority of the application continues to be from foreign countries and is from the chemicals and pharmaceutical segment, which account for half of the applications filed followed by Information Technology and Electronics.