PATENT WAR

Drug price negotiation may be way forward

Sidhartha TNN 

New Delhi: When the patent law was amended to provide for product patents, the big fear was aspike in the price of medicines, especially life-saving ones. 
    But eight years down the line, the government has managed to use provisions available to it under World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (Trips) to ensure that drug companies do not abuse the monopoly rights vested in them through patents. To begin with, Section 3(d) was inserted to ensure that minor changes were not passed off as invention. 
    “At the heart of every international agreement and national laws is consumer interest, especially when it comes to medicines and food. So, you can’t put patents on a machine and on a medicine at the same level,” a government official said. 
    But the law was still seen to be favouring multinationals with the monthly supply of some life-saving cancer drugs adding up to Rs 1 lakh or more. That prompted local manufacturers to resort to the use of a virtually unused provision in India — known as compulsory licensing, which allows the Patent Office to waive the patent rights in favour of a cheaper drug, provided a royalty is paid to the patent holder. 
    The compulsory licence (CL) for Nexavar, a renal cancer drug, seemed to open the floodgates for those seeking patent waiver. Health ministry has already moved a proposal for three cancer drugs — Trastuzumab, Ixabepilone and Dasatinib — citing “extreme urgency” and “public non-commercial use”, whose fate is yet to be decided. In the meantime, little-known BGR Pharma sought a CL for Dasatanib with the Patent Office. 
    The rush for CLs even prompted local players such as Cipla, known for its generic acumen, to start paring prices in the domestic market. 
    While all this was underway, there were instances of patents on some medicines being revoked. The Intellectual Property Appellate Board revoked Roche’s patent on hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments as also the high price. Schering Corporation and Novartis’s patents on two asthma medicines and Pfizer’s patent on cancer drug Sutent were also revoked. 
    Separately, the government has set up an inter-ministerial group to put in place norms on negotiated price for patented medicines, a practice followed in several developed countries such as the UK, Canada and Australia. “A CL is like a death sentence, which can’t be given in every case. A negotiated price system will be in the interest of foreign companies,” said a government official privy to the developments. SC verdict a blow to MNCs Big Pharma’s Ability To Sell Blockbuster Drugs May Be Hit Rupali Mukherjee TNN 
Mumbai: The Supreme Court’s decision on Monday came as a big relief to patients suffering from serious diseases like cancer, and is a huge positive for generic companies which manufacture affordable drugs. But at the same time, it deals a big blow to Novartis, and on MNCs’ ability to sell lucrative blockbuster medicines in the country. 
    The main beneficiaries of the Supreme Court ruling will be generic companies like Cipla, Natco Pharma and Sun Pharma which already market generic Glivec in India at a fraction of the cost of the Novartis product. The ruling cements the role of domestic companies as major suppliers of inexpensive generics not only to its Rs 70,000-crore domestic market, but also across the developing world, and further establishes India as a “the pharmacy of the world” (nearly 98% of anti-retrovirals are exported to developing countries from India). 
    Says Cipla chairman Dr Y K Hamied, “India can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world. This stops evergreening and all this is good for the patients in our country and for the generic industry in general. Competition also leads to reduction in prices and therefore this judgement is of benefit to everyone. Apart from cancer, Section 3(D) applies to all drugs. Hence this judgement will benefit all therapies, which again will be good for everyone.” 
    D G Shah, secretary general of the Indian Pharmaceutical Alliance, said, “The judgement serves to rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions.” 
    If Novartis had won the case, it would have impacted access of affordable medicines by extension of monopoly rights to new forms of known medicines, hence delaying and blocking affordable versions, for India and for millions across the world. 
    However, MNC industry body, Organisation of Pharmaceutical Producers of India, said the decision would only inhibit India’s own pharmaceutical industry from developing products for India, while doing little to improve accessibility of medicines for its population. “Sustainable solutions to India’s healthcare concerns should be found through programs that address the lack of healthcare financing,” it said. 
    Said Novartis India VC and MD Ranjit Shahani, “The current climate for intellectual property in India is uncertain, as so many pharmaceutical companies have experienced patent challenges. Besides, domestic companies need to first be a pharmacy to India rather than the world. This is a significant threat to medical advances since it seriously jeopardizes further investment in innovation.” 
    MNCs will turn cautious in making capital investments in the country, and may delay the launch of patented products. “Money flows only where it is welcome,” said a MNC executive. 
    Kewal Handa, who recently retired as MD of Pfizer India, said, “The Indian government needs to do introspection. Innovation will not flow to a place where there is no respect for patents. On the other hand, MNCs will also have to re-look at their strategies to build scale, and how to balance their portfolio more in terms of volume, rather than price.” 
    “What the ruling basically does is, provide a safe environment for generic companies to operate without the fear of injunctions, infringement suits, and the threat of secondary patents. The ruling will curb the practice of frivolous patents and évergreening, and provides a better interpretation of law for patent offices who have been lax by allowing secondary patents,” said Leena Menghaney, an IPR expert and coordinator of MSF, an international NGO.


Source:::: The Times of India, 02-04-2013, p.20,  
http://epaper.timesofindia.com/Default/Client.asp?Daily=TOIM&showST=true&login=default&pub=TOI&Enter=true&Skin=TOINEW&AW=1364887764359

SC rules for cheap cancer drug

Novartis Loses Battle To Block Indian Generics

Subodh Varma TIG (The Times of India, 02-04-2013, p.01)

    The Supreme Court on Monday rejected pharma giant Novartis AG’s plea to preserve its patent over a life-saving cancer drug, Glivec, drawing a huge sigh of relief from thousands of patients in India and in dozens of developing countries as the fear of an almost 15-fold escalation of drug costs 
receded. It is the biggest setback for multinational pharma companies, which have been denied patent protection for a series of life-saving drugs in recent years. 
    Invented in 1991, Glivec is a miracle cure for a type of blood cancer called chronic myeloid leukemia (CML). In this form of cancer, certain bone marrow cells go rogue and produce excessive white blood cells, causing mild fatigue and hip pain initially, but slipping into an out-of-control crisis of zooming platelet and white cell counts. It used to be fatal, but with Glivec, the survival rate is over 95%. Imanitib, the active component, is on the National Essential Drugs List in India. 
    India has an estimated 3 lakh CML patients, with 20,000 added every year. Glivec is sold by Novartis for about Rs 1.2 lakh per month. Indian manufacturers sell the same drug at a monthly cost of Rs 8,000. This was the reason why Novartis launched a seven-year-long legal battle to protect its patent on the drug. 
    Novartis, which made a net profit of $9.6 billion in 2012, criticized the judgment. Ranjit Shahani, VC & MD, Novartis India, said, “It is a setback for patients that will hinder medical progress for diseases without effective treatment options.” 
MNCs blast verdict, say it’ll hit innovation 
    The SC’s decision has come as a big blow to MNCs’ ability to sell lucrative medicines in the country. The main beneficiaries of the ruling will be companies like Cipla, Natco Pharma and Sun Pharma which already market generic Glivec at a fraction of the cost of the Novartis product. The ruling cements the role of domestic firms as major suppliers of inexpensive generics not only to the Rs 70,000-crore domestic market, but also across the developing world, and further establishes India as “the pharmacy of the world”. P 20 Key section of law applies to Glivec: SC 
    When the drug was first commercially sold in 2001, India was moving over from the old patent regime to a new one after signing the international trade and patent related agreements in 1995. The new patent law came into force in 2005. Novartis could not get apatent on Glivec as it dated from an earlier time when a different patent law prevailed. It tried but the patent tribunal rejected the claim in 2006. 
    After going through various appeals, Novartis ended up in the apex court pleading that a crucial section 3 (d) of the new patent law was not applicable to Glivec. This section says that just discovering a new form of a substance is not enough to grant a patent, if it does not enhance its “known efficacy”. 
    Novartis was arguing that a new “beta crystalline” form of Glivec is more effective and hence qualifies as a new invention, and hence should get patent protection. 
    The Supreme Court, in a 112-page analysis of all the claims and counter-arguments disagreed. It said that the beta crystalline form was nothing new. It has always existed in the original amorphous form. 
    The landmark judgement means that Indian firms like Natco and Cipla can continue making and selling Glivec, not only for India but to most third world countries. The SC judgment dims hopes for some other pharma giants fighting legal battles on patents. Pfizer’s cancer drug Sutent and Roche’s hepatitis C treatment Pegasys and Merck & Co’s asthma treatment aerosol suspension formulation lost their patented status in India last year, decisions the companies are fighting to have reversed. 
    Many pharma giants are concentrating their legal firepower on India because it is an $11-billion-a-year market growing at 13-14% annually. Equally important is that India has emerged as the ‘pharmacy of the world”, selling over $26 billion worth of cheap generic (non-patent) drugs to most of the poor and still developing countries. It is estimated that about 80% of the HIV patients in the developing world are surviving because of cheap Indian drugs.

Unattested will just a piece of paper: SC

New Delhi: The Supreme Court has said that a document bequeathing a property will remain just a piece of paper unless it is registered or attested by two witnesses to qualify it as a will. Upholding the finding arrived at by the Punjab and Haryana high court, the apex court said a document by Rao Gajraj Singh was neither a transfer of property as the same was not registered as required under the provisions of the Indian Registration Act, 1908 nor was it a will as it was not attested by two witnesses as it should have been done for a will. “Thus, the writing executed by Rao Gajraj Singh, in the eyes of law, was only a piece of paper, having no legal effect,” said a bench of justices RM Lodha and Anil Dave in their recent judgment upholding the decision of the high court. “Factually also, the said writing was not a will because it was not attested by two attesting witnesses as is required to be done for execution of a valid will. It is also a fact that the said writing had not been registered,” said that court. Gajraj Singh, who died March 29, 1981, had executed a document, which said that upon his death or the death of his wife, his property would be inherited by the survivor. His wife Sumitra Devi, who passed away June 6, 1989, executed a will June 1, 1989, bequeathing the property to one of her eight children Narinder Singh Rao. Terming the document executed by Rao Gajraj Singh a piece of paper, the court said that after his death, the suit would have to be equally divided amongst his widow and eight sons. — Agencies Source:::: DNA, 29-03-2013, p.09,  http://epaper.dnaindia.com/story.aspx?id=42261&boxid=15530&ed_date=2013-03-29&ed_code=820009&ed_page=9

She didn’t intend to kill daughter-in-law, so no life term: HC

DNA Correspondent

The Bombay high court has acquitted a woman of the charge of murdering her daughter-in-law, observing that she did not intend to kill her.  A division bench of Justice VK Tahilramani and Justice PD Kode reduced the charge and found the appellant, Mangala Thorat, guilty of “culpable homicide not amounting to murder. Her sentence has been brought down from life imprisonment to six years’ jail. Mangala has already served five years of her sentence. The judges have noted in their order that although there was no doubt that the appellant had set her daughter-in-law Neelam on fire, she had immediately doused the flames. “If the appellant had ever intended Neelam to die, she would not have immediately extinguished the fire in an effort to save her,” observed the bench. The judges noted: “Unfortunately, the situation slipped out of control and it went to a fatal extent.” Neelam married Mangala’s son Sunil on April 30, 2005, and the couple lived in suburban Ghatkopar with Sunil’s parents. On November 25, 2005, Neelam and Mangala had a heated argument over some money-related matter. Mangala poured kerosene on Neelam and set her on fire. Neelam died of her injuries four days later. In her dying declaration, she implicated her mother-in-law, father-in-law, brother-in-law and husband. The sessions court sentenced Mangala to life imprisonment. It acquitted the others. Mangala had challenged the conviction. Source:::: DNA, 29-03-2013, p.3, http://epaper.dnaindia.com/story.aspx?id=42261&boxid=15530&ed_date=2013-03-29&ed_code=820009&ed_page=9

AN EASIER UNION?

Indian marriage laws not as knotty as US’s

Have A Big Advantage Being Gender-Neutral

Dhananjay Mahapatra | TNN 

New Delhi: US law makers are proposing an amendment to the definition of marriage, which mandates the relationship to be between a man and woman, to bring it in line with judicial pronouncements legalizing same-sex marriages. 
    Will Indian Parliament need to amend the definition of marriage if our Supreme Court upholds a Delhi high court verdict decriminalizing same-sex relationships and if that ultimately leads to same-sex marriages? 
    Though marriage laws — the Hindu Marriage Act (HMA) and the Special Marriage Act (SMA) — were framed nearly 60 years ago, the framers had shown great vision by keeping it gender neutral and saving the ruling party of the headache to garner enough support in Parliament to pass an amendment to the definition of marriage. 
    Section 5 of HMA, which was enacted in 1955, says “a marriage may be solemnized between any two Hindus”. The SMA was enacted in 1954 to allow marriage between “any two persons” irrespective of the religion they professed. 
    The two phrases “any two Hindus” in HMA and “any two persons” in SMA, both of which do not refer to man and woman as in the US Constitution, would help the law getting applied to marriage between the same sex, if it materializes in the event of the Supreme Court agreeing with the view taken by the Delhi HC. 
    What Indian marriage laws were more worried about was the age and health of the “persons” getting married and to prevent any incestuous relationship. The only differentiation it prescribes is that the groom has to be 21 years and bride 18 years.
    Both marriage laws have fastened identical conditions on parties to a marriage: 

• No person has a spouse living at the time of the marriage (they have to be either single or divorced); 

•At the time of the marriage, neither party (a) is incapable of giving a valid consent to it in consequence of unsoundness of mind; or (b) though capable of giving a valid consent, has been suffering from mental disorder of such a kind or to such an extent as to be unfit for marriage and the procreation of children; or (c) has been subject to recurrent attacks of insanity; 

• The parties are not within the degrees of prohibited relationship (very near relatives) unless the custom or usage governing each of them permits a marriage between the two; 

• The parties are not sapindas of each other, unless the custom or usage governing each of them permits of a marriage between the two.

Source::: The Times of India, 28-03-2013, p.17.

GNLU to have museum of legal history of India

Ahmedabad: Do you know about the contribution made by Manu Smriti or Narada Smriti in developing our modern legal structure? Or, what is the role of House of Lords and House of Commons of England and Law Commission of India in our law setup?

If you don’t, Gujarat National Law University (GNLU) would give you all the answers. The varsity has initiated the process to set up ‘Indian Legal History Museum’ within its premises in Gandhinagar which will hold knowledge of 2,500 years of legal history of India. It is reportedly the first such initiative in India. 

According to the plan drawn by the institute, visuals in the pictographic, sigillographic and paleographic mode will acquaint one with the Indian legal history. Not only anecdotes from history, but contribution of people who shaped law and order will also be recorded. 

Bimal Patel, director of the premier law institute, said that only a basic plan has been drawn for the first legal history museum. He added that more information would be made available as the project reaches the implementation stage. Repeated attempts to reach the director for further information failed.

As per the plan, the museum, where a collection of history of ‘dharma’ will also be preserved, will narrate the evolution of law and order system in India, development of judicial institutions in ancient, medieval and modern time as well as the codification of civil and criminal law. 

Officials at the varsity claim that the museum will be unique in its approach in dealing with the history of development of precedents set in India. It will elaborate on the roles of Dharmashastras, Smritis, Sutras and Neetis. “It will also explain about Muslim Law Codes like Fiqu-i-Firoz Shahi and Fatwa-i-Alamgiri along with the Reports of Constituent Assembly debates and case studies,” states a note prepared by the varsity about the plan.

The museum will have a law gallery, quotations on justice and various such installations to understand Indian Law through the principal of dharma and Indian legal manuscripts apart from Smritis like Manu Smriti, Narada Smriti, Yagnavalkya Smriti as well as different shastras like Dharmashastra and Arthshastra to mention a few.

Source::::  http://daily.bhaskar.com/

Press Information Bureau 
Government of India
Ministry of Human Resource Development

18-March-2013 18:44 IST

Copyright Rules 2013

The Copyright Rules, 2013 has been notified by the Copyright Division, Department of Higher Education, Ministry of Human Resource Development on 14th March, 2013. The amendments to the existing provisions of the Copyright Act, 1957 and introduction of new provisions under the Copyright(Amendment) Act, 2012, which came into the force on 21st June, 2012, necessitated amendments to the Copyright Rules, 1958. The draft Rules were posted on the website of the Copyright Office on 28th August, 2012 seeking comments of all stakeholders and experts giving a deadline of 20th September, 2012. The Ministry also held a meeting with various stakeholders and copyright experts on 8th October, 2012 to seek their suggestions on the draft rules.

The Copyright Rules, 2013 provide new rules for statutory licence for cover versions and broadcasting of literary and musical works and sound recording; compulsory licences for works withheld from public, unpublished and published works, for benefit of disabled; registration of Copyright Societies and Performer’s Right Societies; storage of transient or incidental copies of woks; making or adapting the work by organisations working for the benefit of persons with disabilities; importation of infringing copies and technological protection measures.

The fee for registration of copyright for various works and fee for licences to be issued by register of Copyrights under the directions/orders of the Copyright Board have been increased under the Copyright Rules, 2013. The minimum fee has been increased for registration from Rs. 50/- per work to Rs. 500/- per work and the maximum fee has been increased from Rs. 600/- per work to Rs. 5,000/-. The fee for licences has been increased from Rs. 200/- to Rs. 2000/- per work and the maximum fee has been increased from Rs. 400/- to Rs. 40,000/-. The new fee structure provided under Second Schedule of the Rules is applicable from the date of coming into force of the Copyright Rules, 2013 that is 14th March, 2013. A copy of the same has been made available on the website of the Copyright Office (copyright.gov.in).

R N M

Source | www.pib.nic.in

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