DNP+ Press Release: Increasing IP barriers impact on generic medicines ‘Made in India’

Increasing IP barriers will have severe impact on generic medicines ‘Made in India’

Indian Prime Minister Must Resist Big Pharma Pressure to Trade Away

New Delhi, 29 April 2015: At a conference titled  ‘IP as Frontline Tool for
Make in India’, organised by the Federation of Indian Chambers of Commerce
and industry (FICCI) to mark World IP Week, the Delhi Network of Positive
People and the International Treatment Preparedness Coalition held a protest
before Mr. Amitabh Kant (Secretary DIPP), Mr. Rajeev Agarwal (Patent
Controller General) and Mr. N.K. Sabarwal (Convenor, IP Thank Tank),
highlighting the negative impact of IP barriers on generic medicines ‘Made
in India’.

lion picThe protest comes as Prime Minister Modi has expressed an intent to
potentially change the country’s pro-public-health laws that support the
production of affordable generic medicines ‘made in India,’ upon which
millions of people in India and beyond rely to stay alive.

In 2001 the cost to treat someone with HIV fell by over 96 percent – from
10,439 dollars to 360 dollars – per person per year due to generic
competition from India.  Since then, India’s role in ensuring global access
to life-saving medicines is considered vital, including HIV, TB, cancer and
hepatitis. India is often referred to as the ‘pharmacy of the developing
world’ because of its critical role in providing affordable generic
medicines for use in India and across the world.

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Posted in access to medicines, Generic drug, Indian Patent Law, Intellectual Property, IPR policy, Make in India Campaign | Leave a comment

Letter from DNP+ to PM Modi on the adverse impact of IP on Affordable Generic Medicines ‘Made in India’

Dear Mrs. Sitharaman, Mr. Kant, Mr. Kher, Mr. Aggarwal,

India’s role in ensuring global access to life-saving medicines is vital. India is often referred to as the ‘pharmacy of the developing world’ because of its critical role in providing affordable generic medicines for use in India and across the world. Read DNP+ Statement here

The Department of Industrial Policy & Promotion (DIPP) has recently launched the ‘Make in India’ Campaign, which has the potential to further promote and encourage the manufacture and supply of affordable generic medicines from India, but could also backfire if stronger intellectual property (IP) provisions are introduced as part of the effort.

As patients who rely on a life-long supply of quality generic medicines to stay alive, we are intimately aware that IP barriers undermine the availability of low-cost, life-saving medicines ‘made in India’ and the future of the generic industry in India altogether.

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Posted in Generic drug, Indian Patent Law, Make in India Campaign, patent, TRIPS, TRIPS plus | Leave a comment

Data exclusivity back on the table for India

Source : Spicy IP, March 27, 2015

D.G. Shah, Secretary General of the Indian Pharmaceutical Alliance sends us news that will be of interest to many of our readers. He says,

“… Government plans to introduce a Pesticides (Amendment) Bill in the Parliament during the current session. The Bill has a provision that not only makes India’s Intellectual Property (IP) regime TRIPS Plus but would also eliminate competition and create legal monopoly for agro-chemicals and pesticides making them unaffordable to small farmers. The Bill proposes to introduce Data Exclusivity for a period of five years. As you may be aware, MNCs and their local agents have been demanding this TRIPS Plus provision in India’s IP regime for both agro-chemicals and pharmaceuticals…” (See full Note here) Continue reading

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12 cancer drugs may come under price control

Source : Indian Express, May 5, 2015

As per the pharmaceutical pricing policy passed in 2012, any brand of drugs included in NLEM cannot cost more than the weighted average of all brands of that particular medicine that have a market share of at least one per cent.

In a move that could bring relief to thousands of cancer patients, the pharmaceutical pricing authority has recommended the inclusion of 12 drugs used to treat a range of life-threatening conditions, from leukaemia to breast cancer, in the National List of Essential Medicines (NLEM). Continue reading

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Mixed signals not a good sign for IPR

Source : Business Today, April 29, 2015

On April 23, while speaking at a three-day Global Exhibition of Services in New Delhi, Prime Minister Narendra Modi made a statement that intrigued many in the Indian pharmaceutical industry.

Though he spoke in Hindi, what he said was to the effect that “India must also work on intellectual property rights guidelines to match global standards.” So the obvious question is, what are these global standards?

Even experts are not sure. “India already complies with the World Trade Organization’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). So is being TRIPS-compliant not good enough?” asks Shamnad Basheer, a member of the first panel set up by the government on Intellectual Property law last year and a former professor of IP law at the West Bengal National University of Juridical Sciences.

He feels there is clearly no consistency and transparency regarding what the government is planning to do on the IPR front. This has spread a false notion that India is not globally compliant on intellectual property issues, despite being TRIPS-compliant. Plus, the fact that the government has not put out its new IPR policy, which was supposed to be out early this year, only adds to the confusion. Result: there is now a fresh guessing game in industry circles on what the government actually plans to do on the IPR front.

One leading industry representative saw in the PM’s statement “a clear signal to bureaucracy not to resist TRIPs Plus measures such as Patent Linkage, Data Exclusivity, Dilution of Section 3(d) and Declaration of No-use of compulsory license.”

These have all been pain points for the global pharma industry. Global pharma (read: some of the US drugmakers) have three major problems with India’s patent law-Section 3(d) and Section 84 of the Indian Patents Act, and absence of a period of exclusive marketing rights when a new drug gets regulatory approval.
Under Section 3(d), new forms of existing medicines can’t be patented unless they improve therapeutic efficacy. It was under this provision that India rejected a patent for Glivec, a cancer drug.

Section 84 allows issuing a compulsory licence to meet the reasonable requirements of the public at a reasonably affordable price. A compulsory licence can also be granted under Section 92 of the Act in case of a national emergency. Natco Pharma got a compulsory licence, the first ever in India, for generic Nexavar under Section 84. Multinational drug-makers say Section 84 narrows the criteria for patentability and undermines incentives for innovation.

In fact, the situation has not changed from January this year when concerns were raised on this matter just after US President Barack Obama’s visit to India.

Posted in Indian Patent Law, Make in India Campaign, Sec 3 (d), TRIPS, US pressure on India | Leave a comment

How Marketing Exclusivity Led to Higher Drug Costs and Questionable Benefits

Source- Wall Street Journal Pharmalot, 6 May, 2015

Six years ago, the FDA approved a drug called Colcrys to treat acute gout attacks and familial Mediterranean fever, an inherited inflammatory disorder. The move came as part of an agency initiative to regulate dozens of medicines that had never been formally approved, but were on the market when the FDA received authority to oversee the drug approval process.

In this instance, Colcrys was the brand name given colchicine, which was sold for decades by several companies and cost 9 cents a pill. URL Pharma won FDA approval – and seven years of marketing exclusivity – by running a small study that gauged the effectiveness of different dosages. URL sued other colchicine makers and, by early 2011, marketing exclusivity took hold. And Colcrys cost $5 a pill.

Now, a new study says the approval was not worth the effort, at least for patients. Harvard Medical School researchers examined nearly 217,000 enrollees in an insurance database who were diagnosed with gout or FMF before and after marketing exclusivity kicked in. Here is what they found: Continue reading

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India again on US IPR priority watch list; Govt disappointed, but not worried

Source : The Hindu, 1 May, 2015

India is disappointed at being featured yet again in the US Priority Watch List of weak IPR countries. But it is not worried.

A senior Commerce & Industry Ministry official told BusinessLine that the country’s IPR legislations are well in line with the requirements underlined in the World Trade Organization’s TRIPS Agreement.

The US has once again placed India on the ‘Priority Watch List’ of countries with an unfavourable Intellectual Property Rights (IPR) regime.

Nudging India to tighten its IPR rules, the Special 301 report for 2015, released by the United States Trade Representative (USTR) on Thursday, expressed hope that the new channels of engagement created in the past year with India will bring about “substantive and measurable improvements” in India’s IPR regime for the benefit of a broad range of innovative and creative industries. Continue reading

Posted in Indian Patent Law, Intellectual Property, TRIPS, TRIPS plus, US pressure on India, USTR 301 report | Leave a comment

In Search of ‘Just’ Prices: Questioning the High Cost of New Cancer Drugs – A Conversation With Hagop M. Kantarjian, MD

Source : The ASCO Post, 25 April, 2015

As the oncology community begins the slow and often difficult-to-define transition from volume to value in the delivery of cancer care, the relationship between the price and value of certain high-priced cancer drugs is getting more scrutiny. We generally correlate the efficacy of a new drug and its price by complicated cost-efficacy ratios or quality-adjusted life-years. To shed light on this important issue, The ASCO Post recently spoke with nationally regarded leukemia expert Hagop M. ­Kantarjian, MD, Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston. Continue reading

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India remains on USTR priority watch list

Source : Express Pharma, 4 May, 2015

But no OCR this year … as yet

India remains on the US Trade Representative’s Priority Watch list of its annual Special 301 review. Unlike last year, the USTR is not announcing an Out of Cycle Review (OCR) at this time, but the Report mentions that it will monitor progress over the coming months, and will be prepared to take further action, if necessary.

Other countries on the 2015 Priority Watch List are Algeria, Argentina, Chile, China, Ecuador, Indonesia, Kuwait, Pakistan, Russia, Thailand, Ukraine and Venezuela.

Drawing attention to the increased bilateral engagement in 2015 between the US and India on IPR concerns, following the 2014 OCR, the Report states that while India will remain on the Priority Watch List in 2015, there is expectation that the new channels for engagement created in the past year will bring about substantive and measurable improvements in India’s IPR regime for the benefit of a broad range of innovative and creative industries. The Report reiterates the US’ offer to work with India to achieve these goals. Continue reading

Posted in Indian Patent Law, Intellectual Property, Out of Cycle Review (OCR), TRIPS, TRIPS plus, US pressure on India, USTR 301 report | Leave a comment