India revokes Roche patent; questions high price of drug
12 years, 4 months ago

India revokes Roche patent; questions high price of drug

Firstpost  

The Intellectual Property Appellate Board cited a lack of evidence that the drug was any better than existing treatments and its high price as reasons for the decision. India dealt a fresh blow to the international pharmaceutical industry on Friday as its patents appeal board revoked a patent granted six years ago on Roche’s hepatitis C drug Pegasys. The decision follows another high-profile setback for the industry in March, when India granted the first ever compulsory licence to domestic drugmaker Natco to sell cheap copies of Bayer’s cancer drug Nexavar. Another case involving drug patents is currently in front of India’s the Supreme Court, with Novartis battling against an earlier decision refusing it a patent on cancer drug Glivec.

India Price Patent Drug Decision Sankalp Roche High Price Ipab Pegasys  price  roche  drug  board  patent  decision  ipab  high  revokes  drugs  india  protection  generic  questions

History of this topic

Availability Of Drug For Rare Diseases At Economical Prices Material Factor To Be Considered Before Restraining Via Interim Injunction: Delhi HC
5 days, 19 hours ago

Availability Of Drug For Rare Diseases At Economical Prices Material Factor To Be Considered Before Restraining Via Interim Injunction: Delhi HC

Live Law  

The Delhi High Court has observed that availability of a drug for treatment of rare diseases at economical and competitive prices is a material factor to be considered for grant of interim injunction in an intellectual property right lawsuit. “A drug which is the only one available for treatment in India, for a rare disease, its availability to the public …

Biosimilars and the need for a policy prescription
1 month, 1 week ago

Biosimilars and the need for a policy prescription

The Hindu  

To understand the class of drugs known as biosimilars, it is first necessary to understand the class of drugs described as biologics. There is plenty of empirical evidence demonstrating that increased competition in the case of small molecule drugs leads to significant price erosion, thereby improving accessibility and reducing costs to patients. Countries like India have an abundance of talent …

India’s patent policies: Lifeline for HIV/AIDS treatment worldwide
3 months, 4 weeks ago

India’s patent policies: Lifeline for HIV/AIDS treatment worldwide

Hindustan Times  

A major concern during the negotiations on the Trade-Related Aspects of Intellectual Property Rights Agreement, finalised in 1994, was how it would affect access to affordable medicines for diseases like HIV/AIDS since it contained provisions for a stronger and longer patent protection regime. World AIDS Day India has since 2000 emerged as the pharmacy of the developing world due to …

Thorny clause in ripening India-European Free Trade Association deal may hit generic drug industry
1 year, 1 month ago

Thorny clause in ripening India-European Free Trade Association deal may hit generic drug industry

The Hindu  

A clause in a draft free trade agreement text being negotiated between India and the European Free Trade Association — Switzerland, Iceland, Lichtenstein and Norway — could delay access to affordable, generic versions of patented drugs in India by a minimum of six years, according to documents viewed by The Hindu. A leaked draft of the Trade and Economic Partnership …

Navigating Legal Challenges In The Development Of The Pharmaceutical Sector In India
1 year, 2 months ago

Navigating Legal Challenges In The Development Of The Pharmaceutical Sector In India

ABP News  

New Delhi, January 25: India's pharmaceutical sector, a key contributor to the nation's economy, has encountered significant legal challenges influencing its growth trajectory. Balancing data exclusivity, protecting clinical trial data, and ensuring timely access to generic drugs is a delicate task crucial for fostering innovation and affordability in medicine. The pharmaceutical sector in India faces challenges beyond patents, including combating …

Johnson and Johnson Loses Key Tuberculosis Drug Patent in India
2 years ago

Johnson and Johnson Loses Key Tuberculosis Drug Patent in India

News 18  

India’s Patent Office rejected on Thursday US pharmaceutical giant Johnson and Johnson’s application to extend its patent on a key tuberculosis treatment, allowing local companies to make cheaper generic versions. India accounted for nearly 29 percent of 10.6 million tuberculosis cases worldwide, according to the World Health Organization’s 2022 Global TB report, a major public health problem as it struggles …

An obituary for the IP Appellate Board
3 years, 11 months ago

An obituary for the IP Appellate Board

The Hindu  

The demise of the Intellectual Property Appellate Board, India’s specialist tribunal for determining disputes relating to intellectual property rights, is symbolic of its tenuous life. Though the patents side of the IPAB existed in theory since 2002, the Central government notified its functioning only in April 2007 after a rebuke from the Madras High Court. After the notification, the High …

[LIVE NOW] Webinar On "Revisiting The Access To Medicine Debate In The COVID-19 Era"-
4 years ago

[LIVE NOW] Webinar On "Revisiting The Access To Medicine Debate In The COVID-19 Era"-

Live Law  

The Society for Democratic Rights, New Delhi in partnership with the Georgetown University Law Center, the O'Neill Institute for National and Global Health Law, and Institute for Technology Law and Policy at Georgetown Law invites you to a Comparative Law discussion on the topic "Revisiting the Access to Medicine Debate in the COVID-19 Era". How has India's patent law enabled …

Groups ask India to rescind Gilead’s COVID-19 drug patent
4 years, 10 months ago

Groups ask India to rescind Gilead’s COVID-19 drug patent

Al Jazeera  

Indian drug patents are important because generic forms of critical drugs are manufactured in this country. To expand its access, Gilead said this week that it had signed nonexclusive licensing pacts with five generic drugmakers based in India and Pakistan, allowing them to make and sell remdesivir for 127 countries. The letter by Third World Network, a Malaysia-based non-profit group, …

USTR’s move to keep India on IP watch list could hit covid-drug access
4 years, 11 months ago

USTR’s move to keep India on IP watch list could hit covid-drug access

Live Mint  

The US Trade Representative's move to keep India on the priority watch list for patenting norms can be used to block access for affordable drugs against covid-19, said health activists. The USTR late Wednesday released its Special 301 Report, in which it continued to place India on the 'Priority Watch List' for lack of sufficient improvement to its intellectual property …

No Infringement Action Maintainable In Respect Of An Unregistered Or Revoked Patent : Delhi HC [Read Judgment]
5 years, 7 months ago

No Infringement Action Maintainable In Respect Of An Unregistered Or Revoked Patent : Delhi HC [Read Judgment]

Live Law  

The Delhi High Court has rejected the claim of Novartis seeking injunction against Natco Pharma from manufacturing a cancer drug. In the present case, Novartis AG had filed a petition seeking permanent injunction, damages, rendition of accounts and delivery up in respect of its granted patent, Indian Patent No. The Respondent, Natco Pharma Ltd, on the other hand had submitted …

Patent restricts easy access to vital drugs
6 years, 2 months ago

Patent restricts easy access to vital drugs

Deccan Chronicle  

Hyderabad: The Centre’s move to remove patents on new drugs will come as a huge relief to patients but some vital drugs are still under a 20-year-patent rule, forcing patients to pay through their nose for these medicines. But with the removal of patent, there is hope that these drugs will be easily available,” said the national president of Doctor …

Innovate in India: The country cannot afford to wait any longer for a robust intellectual property rights regime
6 years, 10 months ago

Innovate in India: The country cannot afford to wait any longer for a robust intellectual property rights regime

Firstpost  

India’s patent productivity is quite low compared to that of Japan, US, South Korea, and China. It is time for us to progress from manufacturing to innovation and an important requirement is a robust intellectual property rights system, India has improved its ranking in the U.S. Chamber’s international IP Index, to 44 out of 50 countries this year, which represents …

How India rejects bad patents
7 years, 3 months ago

How India rejects bad patents

The Hindu  

In 2005, India made some remarkable amendments to the Indian Patents Act of 1970, to keep medicines affordable in the country. Section 3 of the Indian Patents Act, a provision introduced to restrict the patenting of new forms of known pharmaceutical substances, became the subject of international attention after its use in rejecting a patent application by Novartis for the …

Patent Battle Over Breast Cancer Drug: Roche Withdraws Its SLP Against Delhi High Court’s Approval To Biosimilars
7 years, 7 months ago

Patent Battle Over Breast Cancer Drug: Roche Withdraws Its SLP Against Delhi High Court’s Approval To Biosimilars

Live Law  

Swiss Pharma major, Roche has withdrawn its Special Leave Petition filed in the Supreme Court against the Delhi High Court’s March 3 decision, rejecting its challenge to the grant of approval to drug companies, Biocon and Mylan, to use product data for Trastuzumab, a generic biosimilar for cancer.The Supreme Court bench of Justices R.K.Agrawal and Abhay Manohar Sapre, noted in …

Patent Battle Over Breast Cancer Drug: Roche Withdraws Its SLP Against Delhi High Court’s Approval To Biosimilars
7 years, 7 months ago

Patent Battle Over Breast Cancer Drug: Roche Withdraws Its SLP Against Delhi High Court’s Approval To Biosimilars

Live Law  

Swiss Pharma major, Roche has withdrawn its Special Leave Petition filed in the Supreme Court against the Delhi High Court’s March 3 decision, rejecting its challenge to the grant of approval to drug companies, Biocon and Mylan, to use product data for Trastuzumab, a generic biosimilar for cancer.The Supreme Court bench of Justices R.K.Agrawal and Abhay Manohar Sapre, noted in …

Patent Battle Over Lung Cancer Drug: SC Disposes Of Cipla’s Appeal Against Roche As Withdrawn
7 years, 9 months ago

Patent Battle Over Lung Cancer Drug: SC Disposes Of Cipla’s Appeal Against Roche As Withdrawn

Live Law  

The Supreme Court’s Vacation Bench of Justices R.K.Agrawal and Sanjay Kishan Kaul, on Friday, June 16, allowed the withdrawal of the Special Leave Petitions against the Delhi High Court’s November 27, 2015 judgment holding that Cipla had infringed Roche’s patent over the lung cancer drug, erlotinib hydrochloride.The bench allowed the withdrawal on the ground that the matter has. The Supreme …

Petition filed in Delhi HC challenging patent granted to Gilead for costly Hepatitis-C drug
8 years, 10 months ago

Petition filed in Delhi HC challenging patent granted to Gilead for costly Hepatitis-C drug

Live Law  

A Writ Petition has been filed before the Delhi High Court, challenging the grant of patent to costly Hepatitis-C drug, Sovaldi. The patent, granted by Deputy Controller Dr. Rajesh Dixit, is being viewed as a complete U-turn by the Patent Office, which had rejected Gilead’s application for Sovaldi last January. Dr. Dixit however noted in the ruling that the Gilead …

Petition filed in Delhi HC challenging patent granted to Gilead for costly Hepatitis-C drug
8 years, 10 months ago

Petition filed in Delhi HC challenging patent granted to Gilead for costly Hepatitis-C drug

Live Law  

A Writ Petition has been filed before the Delhi High Court, challenging the grant of patent to costly Hepatitis-C drug, Sovaldi. The patent, granted by Deputy Controller Dr. Rajesh Dixit, is being viewed as a complete U-turn by the Patent Office, which had rejected Gilead’s application for Sovaldi last January. Dr. Dixit however noted in the ruling that the Gilead …

Gilead gets patent for Hepatitis C drug Solvadi
8 years, 10 months ago

Gilead gets patent for Hepatitis C drug Solvadi

The Hindu  

In direct contradiction to its earlier order, the Controller General of Patents, Designs and Trademark granted American pharmaceutical company Gilead Sciences the patent for the blockbuster Hepatitis C drug Sofosbuvir in India. On Monday, however, the patent office dismissed all pre-grant oppositions and stated that it found, “claimed compounds are novel, inventive and patentable under Patents Act.” The decision is …

Patent pressures
9 years, 10 months ago

Patent pressures

The Hindu  

In its 2015 Special 301 Report on Intellectual Property Rights, the office of the United States Trade Representative has retained India in its “Priority Watch List”, noting however that bilateral engagement between the two countries on IPR concerns had increased over the past year. The progressive Act has been invoked in several judgments recently in relation to pharmaceutical patents — …

Gilead’s India patent snag may spur more low-cost Sovaldi copies
10 years, 2 months ago

Gilead’s India patent snag may spur more low-cost Sovaldi copies

Live Mint  

Mumbai: The Indian patent office’s rejection of a key patent for Gilead Sciences Inc.’s Hepatitis C treatment Sovaldi may pave the way for more low-cost copies in the country, potentially aiding local companies including Natco Pharma Ltd. The New Delhi patent office this week rejected the main patent claim for Sovaldi on grounds that it “lacks novelty” and lacks an …

Patented medicine and affordability
10 years, 3 months ago

Patented medicine and affordability

The Hindu  

India’s ongoing efforts at safeguarding its intellectual property rights have been facing challenges from different directions. In turn, there are serious implications for India’s public health programme, especially in providing affordable drugs without in any way compromising on the treaty obligations with other countries. Almost coinciding with the last national elections, the U.S. Trade Representative placed India on a ‘priority …

Defending India’s patent law
10 years, 10 months ago

Defending India’s patent law

The Hindu  

India and its intellectual property laws have been the subject of sharp criticism recently. “The TRIPS agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. India’s laws and experiences could provide a useful example for low-income and …

Friction over drug patents
11 years ago

Friction over drug patents

The Hindu  

Differences over intellectual property rights have emerged as a strong undercurrent in India’s economic relations with the U.S. The attempt by the influential pharmaceutical lobby to stymie India’s efforts to ensure the supply of medicines at affordable rates without violating existing treaty commitments, requires a principled response from New Delhi. At the core of the issue is what Columbia University …

Natco wins Indian patent dispute case
11 years ago

Natco wins Indian patent dispute case

The Hindu  

Natco Pharmaceuticals, the Hyderabad-based drug manufacturer, has won a patent case against Teva Pharmaceuticals of Israel. The New Delhi High Court, on February 28, dismissed Teva’s suit seeking an injunction over the marketing of a generic version of multiple sclerosis drug, copaxone in the U.S. The decision could allow Natco to launch generic version of Teva’s Copaxone in the U.S., …

India patent regime not about access to medicine: US body
11 years, 1 month ago

India patent regime not about access to medicine: US body

The Hindu  

With U.S Trade Representative Michael Froman set to announce a trade enforcement action tied to India, the highly influential U.S Chamber of Commerce has lashed out at India’s recent pattern of pharma patent denials, pointing out that the country’s actions “are not about access to medicine.” In the case of Swiss drug-maker Novartis, whose cancer drug’s patent protections were dismissed …

World Cancer Day: Debate on affordable drugs must focus on life or death for millions
11 years, 1 month ago

World Cancer Day: Debate on affordable drugs must focus on life or death for millions

Firstpost  

On World Cancer Day, here is arithmetic to show that big pharma’s justification for high prices of life-saving drugs is not the complete truth. Speaking at an industry forum a few days ago, Mr Dekker characterised India’s compulsory license to Bayer’s “blockbuster” cancer drug Nexavar as “essentially theft”, and added, “We did not develop this medicine for Indians. Two provisions …

Patent challenge
11 years, 5 months ago

Patent challenge

The Hindu  

IT has been more than a year since the first compulsory licence was granted to an Indian company manufacturing generic drugs to produce a patented drug. Anand Grover, senior advocate and director of Lawyers’ Collective, said: “There has been a barrage of patent infringement suits against generic drug companies since 2009.” The most recent challenge to Natco’s compulsory licence that …

Patent lies and convenient truths
11 years, 6 months ago

Patent lies and convenient truths

The Hindu  

Even as the campaign by U.S. drug majors to paint India as a haven for intellectual property pirates intensifies, the government has swung into action to stem the false propaganda. It is difficult to take issue with Ms Rao’s piece, not least because she makes fair and reasonable points; but then again, the qualifier is “reasonable.” In pertinent part, she …

Why Novartis case will help innovation
11 years, 11 months ago

Why Novartis case will help innovation

The Hindu  

On April 1, 2013, the Supreme Court upheld the Intellectual Property Appellate Board’s decision to deny patent protection to Novartis’s application covering a beta crystalline form of imatinib —the medicine Novartis brands as Glivec, and which is very effective against the form of cancer known as chronic myeloid leukaemia. Thirdly, the Supreme Court judgment effectively recast Indian patent law as …

Patent justice
11 years, 11 months ago

Patent justice

The Hindu  

The rejection of the Novartis petition challenging one of the most progressive tenets of the Indian Patents Act, as amended in 2005 by the Supreme Court, is a landmark verdict for the public health community and the generic drugs industry, in particular, and for global health. Under the amended Indian Patents Act, Section 3 allows drug companies to obtain product …

U.S. industry reviews Supreme Court decision on Novartis
11 years, 11 months ago

U.S. industry reviews Supreme Court decision on Novartis

The Hindu  

The US industry on Wednesday said it is reviewing the order of the Supreme Court early this week that denied patent on Glivec, a cancer medication produced by Swiss drug maker Novartis, as Corporate America expressed dismay at the court verdict. “We are aware of the Supreme Court decision and are reviewing the Court’s order,” the U.S. Trade Representative spokesperson …

A just order
11 years, 11 months ago

A just order

The Hindu  

The Supreme Court order rejecting a plea to grant patent protection for Glivec, a cancer-fighting drug from Novartis, is a landmark. That pharmaceutical companies employ high pricing to limit the number of beneficiaries of “blockbuster” patented molecules and even older “evergreened” medicines is an irony, because making additional copies of a drug is not expensive. The court order should prompt …

Novartis judgement will hit investments in medicine: US commerce body
11 years, 11 months ago

Novartis judgement will hit investments in medicine: US commerce body

Firstpost  

Supreme Court of India’s decision to deny patent to Swiss firm Novartis for its cancer drug Glivec will negatively impact the ability of companies to invest in medical and technological advancements, the US Chamber of Commerce said. Washington: Supreme Court of India’s decision to deny patent to Swiss firm Novartis for its cancer drug Glivec will negatively impact the ability …

Novartis patent case: Section 3(d) of Indian Patent Act explained
11 years, 11 months ago

Novartis patent case: Section 3(d) of Indian Patent Act explained

Firstpost  

This section states that inventions that are a mere “discovery” of a “new form” of a “known substance” and do not result in increased efficacy of that substance are not patentable. In its verdict, the Supreme Court said that the drug showed no new innovation or invention and therefore did not satisfy the criteria under section 3 of the Indian …

Landmark verdict, say pharma bodies
11 years, 11 months ago

Landmark verdict, say pharma bodies

The Hindu  

The Indian pharmaceutical industry and health aid agencies have welcomed the judgment of the Supreme Court which has upheld the refusal by the Patent Office to grant multi-national pharma giant Novartis a patent for the beta-polymorphic form of imatinib mesylate sold as Glivec and used in the treatment of cancer. “This is a landmark judgment that will serve to set …

Boost for cheaper drugs: SC rejects Novartis patent on Glivec
11 years, 11 months ago

Boost for cheaper drugs: SC rejects Novartis patent on Glivec

Firstpost  

A decision in the seven-year legal battle is keenly awaited by the two most interested parties- big pharma companies and health aid groups - with both sides saying the outcome will set a precedent with far-reaching consequences for the future availability of the drugs. New Delhi: In a landmark judgement, India’s Supreme Court today rejected a patent plea by Swiss …

India’s patent protection regime to be key issue in talks with US
12 years, 10 months ago

India’s patent protection regime to be key issue in talks with US

Live Mint  

New Delhi: India’s patent protection regime will be a key issue in next month’s strategic dialogue with the US, against the backdrop of a landmark ruling by the Indian patent office allowing Natco Pharma Ltd to make and sell a copy of German drug maker Bayer AG’s patented cancer treatment Nexavar. It added, “the United States will closely monitor developments …

Patent to plunder
12 years, 10 months ago

Patent to plunder

The Hindu  

India's efforts to produce and supply life-saving drugs at affordable prices face challenges from multinational companies trying to evergreen their patents. Simultaneously, Novartis filed two writ petitions in the Madras High Court, one challenging the decision of the patent office and the other challenging Section 3 of the Patents Act. In March 2012, the Indian patent office issued a compulsory …

The current patent system is deeply flawed'
12 years, 10 months ago

The current patent system is deeply flawed'

The Hindu  

Interview with Shamnad Basheer, Intellectual Property Law Professor at NUJS. Excerpts: In your written submission to the Supreme Court in the Novartis case, you have supported the Madras High Court's and the Intellectual Property Appellate Board's interpretation of Section 3 of the Indian Patents Act. Illustratively, the Explanation to Section 3 clearly states that all pharmaceutical derivatives would be considered …

India rejects patent claims on two HIV/AIDS drugs
15 years, 6 months ago

India rejects patent claims on two HIV/AIDS drugs

The Hindu  

The Indian Patent Office has rejected applications from two U.S. pharmaceutical companies on grounds of "evergreening", raising hopes of a further lowering of prices of two life-saving drugs used by HIV/AIDS patients in the country. India's rejection of the patent applications is a big step in ensuring that patients in India and in other poor/developing countries will continue to have …

A Showdown Over India's Generic Drugs
17 years, 11 months ago

A Showdown Over India's Generic Drugs

Wired  

Indian pharmaceutical companies have traditionally provided the developing world with generic versions of patented drugs. Last year, under pressure from western countries and pharmaceutical companies, India agreed to restrict the number of drugs that could be legally copied. However, India drew the line at extending patent protection to minor modifications of existing drugs, a technique routinely used to get a …

Patent trouble
18 years, 1 month ago

Patent trouble

The Hindu  

The Madras High Court is set to resume hearing arguments in the case on Novartis' patent application for its cancer drug Gleevec. The petitions plead against the rejection by the Chennai Patent Office last year of a patent application for Novartis' anti-cancer drug Gleevec and submit that Section 3 of the Indian patents Act, Patents Act, 1970, which provided one …

Discover Related