PATIENT WAIT FOR PATENT

American bio-pharmaceutical major Gilead, which has entered into generic licensing deals with 10 Indian companies to distribute its HIV drug Viread, is hoping to get a patent in India soon.
“We have made considerable progress in implementing our access programme and licensed Indian pharmas to manufacture Viread which originally announced a pricing of $1 a day for the pill,” Gregg Alton, senior vice president and general counsel of Gilead Sciences said.
“After much discussion, Gilead now believes that a larger number of manufacturers will intensify competition and drive down prices even further,” said Alton whose team was in Delhi last week.
Now, Gilead’s application for a patent is pending before the Indian Patent office as it believes that it has a right to protect its intellectual property.
Indian pharma major Cipla has filed a pre-grant opposition against the patent application for Viread before the patents office.
But Alton said: “We believe that protecting the intellectual property of companies who engage in drug research and development is a critical part of the treatment access equation. Intellectual property protection, when used responsibly, encourages research and discovery of newer and more effective molecules.
“Gilead respects Cipla’s right to oppose the issuance of a patent for Viread or any drug. But more importantly, we reaffirm our desire to work with Cipla whether or not a patent is issued,” said Alton.
Gilead has signed generic licensing deals with 10 Indian companies to distribute Viread in India and 94 other resource-limited countries.
More than 5.1mn people are believed to be infected with HIV in India, the second highest incidence of the disease after South Africa.
According to Alton, Viread (tenofovir disoproxil fumarate) is on its way to becoming the frontrunner drug across Europe for HIV/Aids due to its low toxicity and resistance levels observed in patients.
The tablet-a-day dosage of the drug also helps in better regimen and compliance among the HIV/Aids patients taking it.
Alton also pointed out that he expected generic versions of Gilead’s anti-retrovirals to be available from several of its partners within the next few months.
Asked whether the drug would become unaffordable if Gilead was granted a patent for Viread in India, Alton allayed fears voiced by critics and non-governmental organisations.
“The company plans to use this patent responsibly and has made its intention clear in the act of issuing non-exclusive voluntary licenses to Indian companies,” he said.

Yoga, ayurveda being documented to stop patent misuse

Bitten by patent rows over basmati and turmeric, India doesn't want to be caught off guard again by the West, certainly not when it comes to its ancient healing systems of yoga, ayurveda, unani and siddha.

A task force appointed by the government for protecting traditional knowledge and intellectual property is fast completing the documentation of yoga postures and techniques as well as formulae in ayurveda, siddha and unani - all Indian traditional medicinal systems.

The aim is to stop foreign practitioners and individuals, including Indian expatriates, from claiming copyrights.

"Most of the misuse has been done by people of Indian origin living outside India and multinational companies. By the documentation, we hope we would be able to control it largely," V.K. Gupta, head of the task force, told IANS.

"We have identified 1,500 yoga postures and thousands of formulae in Indian medicinal systems from ancient books to document and make it available for the office that grants patents and copyrights to trademark it as our public property."

He said the documentation process - including texts, voice and visuals - would be completed by March 2007.

"Most of the documentation is done," Gupta said, adding that around 100 experts had been working on it for the last three years.

"We have referred to 54 ancient books to research on ayurveda, 35 for unani and 15 for siddha and have documented 50,000 formulae in ayurveda and 24,000 in unani," Gupta said.

He said the task force has created a database of 10 million pages.

Under a Rs. 100-million project, the health and family welfare ministry would be preserving all possible details of yoga postures in a multi-media digital library - Traditional Knowledge Digital Library (TKDL).

The data will be made available in five international languages, and 11 countries, including the US, Britain, Japan and China, would be able to access it.

The task force has found that at least 150 yoga postures that were developed and practised in India for ages - the system finds mention in Vedic scriptures - have been pirated in the US, Europe and in Japan.

It says yoga is a $30 billion industry in the West.

The task force says the US Patents Office has so far issued 134 patents on yoga accessories, 150 yoga-related copyrights and 2,315 yoga trademarks while Britain has approved at least 10 trademarks relating to yoga training aids.

Bikram Chowdhury, a Los Angelus-based multi-millionaire yoga guru, has popularised "hot yoga" - he reportedly developed 26 postures and two breathing exercises performed in a certain sequence in 105 degree heat - and claimed copyrights over it.

Chowdhury even sent legal notices to studios that practised this form of yoga, but later sought a secret agreement with them before the case went for trial in San Francisco.

In the past decade, a number of "specialists" have also mushroomed in ayurveda, siddha and unani systems who have made a fortune out of it.

Little wonder then that the Indian government's move has pleased many.

"This is a very good move. We should protect the heritage our saints have developed and preserved for the good of human kind," said Nivedita Joshi, daughter of former cabinet minister Murli Manohar Joshi and a yoga instructor.

Joshi, who was all praise for the decision, said: "It could have been done only by the government. No individual could have done it as it's a heavily expensive thing."

"No Indian would appreciate anybody patenting yoga postures as their own. Why should we let one particular person make money of some thing, which has been ours from time immemorial?" Joshi told IANS.

K.M. Gopakumar, a lawyer who is researching patent laws, said: "Once documented and published, it will be in the public domain. The so-called lifestyle gurus cannot claim copyright and allege infringement by others who practise it," said

"The documentation is a mechanism of protecting it from misappropriation also."

India learnt its lessons from past controversies - when a US company was granted a patent on the wound-healing properties of turmeric. Another US firm was granted a basmati patent. India challenged both successfully.

Einstein-Patent Examiner

Albert Einstein was born in 1879, and at 21, graduated in mathematics and physics from the Swiss Polytechnic Institute in Zurich. From age 23 to 30, Einstein worked as an examiner at the Swiss Patent Office in Bern. The primary job of Einstein, and of all patent examiners, is to understand and deal with definitions of inventions and discoveries. Once defined, an invention can be evaluated as to whether it is new or appropriate for patenting. Einstein honed his analytical skills in dealing with numerous invention definitions proposed by the patent applicants with whom he was dealing.

At the age of 26, while still employed as a patent examiner, Einstein made three of his greatest contributions to scientific knowledge. The year 1905 was an epoch-making one in the history of physical science, because Einstein contributed three papers to Annalen der Physik (Annals of Physics), a German scientific periodical. Each of them became the basis of a new branch of physics. In one of the papers, Einstein suggested that light could be thought of as a stream of tiny particles, in addition to being thought of as waves. This helped explain the photoelectric effect where light caused release of electrons from materials. In a second paper, titled "The Electrodynamics of Moving Bodies," Einstein presented the special theory of relativity, which allowed for time to be different for different observers. The third major paper concerned Brownian motion, an irregular motion of microscopic particles suspended in a liquid or gas. It confirmed the atomic theory of matter. It was not until Einstein was 30 years old that he held any academic position.

History of Indian Patent System

The first provision in the nature of patent rights in India, which was at that time under the British rule, was enacted in 1856. Under this Act, the monopolies were styled " exclusive privileges ". This Act was repealed in toto in 1857 as it was introduced without the prior sanction of the Queen. Soon after that in 1859 another Act free from the defects of 1857 was passed. In 1872 the provision of the Act of 1859 were further added by the provision of " The Patents and Designs Protection Act ", which solely related to designs. The Act of 1872 was further supplemented in 1883. In 1888 Act V of 1888 superseded all the Acts of 1859, 1872 and 1883. This was further revised and replaced by the Indian Patents and Designs Act, 1911. This was amended from time to time in 1920, 1930, and 1945.

After independence it was felt that the Indian Patents and Designs Act, 1911 was not fulfilling its objective. As such, a committee under the Chairmanship of Dr. Bakshi Tek Chand, a retired Judge of Lahore High Court was appointed in 1949 with a view to ensure that the Patent system was more conducive to national interest and to suggest modifications and alterations to the existing Act suitable for making the country self-reliant in technology. Based on the interim report the Act was modified, regarding working of the inventions in 1952, and in 1953 the Controller was authorized to grant licenses on foods, medicines etc. A bill based on the recommendations of this Committee was introduced in the Parliament in 1953, but it lapsed due to dissolution of the Lok Sabha.

In 1957, Govt. of India further appointed Justice N. Rajagopala Ayyangar to examine and review the Patent law in India who submitted his report in September 1959 recommending the retention of Patent System despite its shortcomings. The Patent Bill, 1965 based mainly on his recommendations and incorporating a few changes, in particular relating to Patents for food, drug, medicines, was introduced in the lower house of Parliament on 21st September, 1965. The bill was passed by the Parliament and the Patents Act 1970 came into force on 20th April 1972 along with Patent Rules 1972. This law was suited to changed political situation and economic needs for providing impetus to technological development by promoting inventive activities in the country.

The Patents Act, 1970 is a landmark in the industrial development of India. The basic philosophy of the Act is that patents are granted to encourage inventions and to secure that these inventions are worked on a commercial scale without undue delay; and patents are granted not merely to enable patentee to enjoy a monopoly for the importation of the patented article into the country. The said philosophy is being implemented through compulsory licensing, registration of only process patents for food, medicine or drug, pesticides and substances produced by chemical processes which, apart from chemical substances normally understood, also include items such as alloys, optical glass, semi-conductors, inter metallic compounds etc. It may, however, be noted that products vital for our economy such as agriculture & horticulture products, atomic energy inventions and all living things are not patentable. Thus, the Patents Act 1970 was expected to provide a reasonable balance between adequate and effective protection of patents on the one hand and the technology development, public interest and specific needs of the country on the other hand.

Uruguay round of GATT negotiations paved the way for WTO. Therefore India was put under the contractual obligation to amend its patents act in compliance with the provisions of TRIPS. India had to meet the first set of requirements on 1-1-1995. This was to give a pipeline protection till the country starts giving product patent. It came to force on 26th March 1999 retrospective from 1-1-1995. It lays down the provisions for filing of application for product patent in the field of drugs or medicines with effect from 01.01.1995 and grant of Exclusive Marketing Rights on those products.

India amended its Patents Act again in 2002 to meet with the second set of obligations (Term of Patent etc.), which had to be effected from 1-1-2000. This amendment, which provides for 20 years term for the patent, Reversal of burden of proof etc. came into force on 20th May, 2003. The Third Amendment of the Patents Act 1970, by way of the Patents (Amendment) Ordinance 2004 came into force on 1st January, 2005 incorporating the provisions for granting product patent in all fields of Technology including chemicals, food, drugs & agrochemicals and this Ordinance is replaced by the Patents (Amendment) Act 2005 which is in force now having effect from 1-1-2005 .

Under the Patents Act, the Government of India is empowered to make rules for implementing the Act and regulating the Patent Administration. Accordingly, the Government brought into force Patents Rules, 1972 w.e.f. 20.4.1972. These Rules were amended on 2.6.99 and replaced by the Patents Rules 2003 w.e.f. 20.5.2003 and further it is amended by the Patents (Amendment) Rules 2005, which is in force now; this includes provisions relating to time-lines with a view to introducing flexibility and reducing processing time gradually for patent applications, and simplifying and rationalizing procedure for grant of the patent.

There are four Schedules to the Patents (Amendment) Rules 2005; the First Schedule prescribes the fees to be paid; the Second Schedule specifies the list of forms and the texts of various forms required in connection with various activities under the Patents Act are set out in this schedule. These forms are to be used wherever required and if needed, they can be modified with the consent of the Controller. The Third Schedule prescribes form of Patent to be issued on Grant of the Patent. The Fourth Schedule prescribes costs to be awarded in various proceedings before the Controller under the Act.

Patent Scenario in India

The Patenting system in India is becoming more advanced and hardly a day passes by without mention of Patents in the news. Recently the Indian Patent Office celebrated its 150th year of existence.In Chennai,the Office organised a grand celebration from 25-26 April,2007, inviting school and college students to participate in essay competitions,paper presentations and was overwhelmed by the response. It is a misconception that the system of intellectual property rights is only for humongous multinational companies and their sophisticated patent attorneys. But the anniversary celebrations are an indication that in India people from ordinary walk of life are becoming more interested in patenting.