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The higher the annual sales of a branded drug, the more intense its generic erosion at patent expiry. PDF Print E-mail
Pharma is facing not only a continued slow down in sales growth in the seven major markets (7MM), but the erosion of branded drugs
by generics following patent expiry is also increasing, driven by evolving payer initiatives to incentivize generic use.
However, the severity and speed of patients switching to generic versions of a drug is by no means equal across countries, therapy
areas and formulation type, which is important when managing and forecasting branded drug sales.
Tough competition, a focus on cost-containment and incentives for prescribing generic drugs make the US, UK and Germany
particularly prone to severe brand erosion immediately after patent expiry, and across all markets competition amongst generic players targeting high value drugs is also fierce - leading to a rapid decline in generic prices as more players enter the market.

Key findings and highlights

• Tough competition, a focus on cost-containment and incentives for prescribing generic drugs, make the US, UK and Germany prone
to severe brand erosion immediately after patent expiry. The US saw the strongest erosion for both oral and injectable drugs,
reflecting the high level of generic substitution in the US compared to other markets.
• Across all markets, the higher the annual sales of a branded drug, the more intense its generic erosion at patent expiry.
Competition among generic players targeting high value drugs is also fierce, leading to a rapid decline in generic prices as more
players enter the market.
• Overall, the most heavily eroded drugs by therapy area in the US were respiratory drugs, due to the large market size and low entry barriers for generics companies, while CNS drugs experienced the lowest levels of erosion
 
Prostate cancer patients recover after using new drug ipilimumab PDF Print E-mail
Prostate cancer patients recover after using new drug ipilimumab Sam Lister, Health Editor

Two men with advanced and inoperable prostate cancer have recovered after being treated with an experimental antibody drug.

The patients, who are now free of cancer, were taking part in the trial of a drug called ipilimumab that boosts the immune system. Before treatment at the Mayo Clinic in Rochester, Minnesota, each of them had aggressive tumours that had grown into abdominal areas.

Eugene Kwon, the trial leader, said: "The goal of the study was to see if we could modestly improve upon current treatments for advanced prostate cancer. The candidates for this study were people who didn't have a lot of other options. However, we were startled to see responses that far exceeded any of our expectations."

First, the patients received traditional hormone therapy to remove testosterone, which fuels prostate cancer. Researchers then introduced a single dose of ipilimumab. The drug boosts the immune system's response to the cancer.

When the surgeons made their incisions, they had a surprise. Dr Michael Blute, a Mayo clinic urologist, said: "The tumours had shrunk dramatically. I had never seen anything like this before. I had a hard time finding the cancer."

Dr Kwon said: "This is one of the holy grails of prostate cancer research. We've been looking for this for years."

John Neate, chief executive of The Prostate Cancer Charity, said: "If these early and small-scale results are replicated in larger trials, this represents a potentially very exciting development.
 
The rise of generics companies is an important factor in the rise of patent litigation PDF Print E-mail
Patent Litigation «
Muazzin Mehrban, July 2009

Innovation in the technology sector is constantly increasing, manifested by the fact that more patents are being issued than ever before. On the whole, this is a positive indicator for the sector's future, but consequently, patent related disputes have become more common. Indeed the US, a world-leader in technological innovation, has seen the number of patent litigation case filings grow steadily over the last 20 years. Furthermore, these disputes are perhaps more drawn-out than they need to be - the absence of a standardised dispute resolution system means that many companies have failed to adopt an effective litigation strategy. This will need to change in order to preserve innovation in the long term.

The spread of patent litigation and spiralling costs

Of course, the rise of patent litigation is not confined to the US, and emerging markets such as India are currently experiencing similar trends, especially in the pharmaceutical sector.


"The country is witnessing a number of litigations filed by multinationals, which are attempting to enforce their patents and stop the generics from selling copycat versions of their patented drug," says Calab Gabriel, a partner at K&S Partners. "We also see a number of Indian generic companies opposing the patents filed by multinational companies for new drugs and drugs undergoing clinical trials," he continues. Clearly, the rise of generics companies is an important factor in the rise of patent litigation in India, but it is only part of the story. In 2005, India introduced the product patent regime, which allows patents to be granted more quickly, and furthermore, allows patentees to exercise their rights more effectively. "These new provisions in the Patent law have given fresh impetus to the patent litigation scenario in India, which was almost dormant until recent years," explains Shanti Kumar, a partner at Lex Orbis. "There were five reported patent suits in 2004, compared with one in 2005, six in 2006, eight in 2007 and 22 in 2008. In the last year alone, nine patent infringement actions have been reported," he adds.

These trends seen in India and the other emerging markets can generally be traced back to those seen in Western jurisdictions. As such, it can be useful for companies and counsel based in emerging markets to keep a close eye on patent-related trends in these jurisdictions. For example, in the US, there has been a rise in contingency fee litigation, one of the main drivers behind person injury and product liability suits. "Increasingly, corporations which traditionally pay their lawyers on hourly-fee basis have turned to contingency or partial contingency arrangement to enforce their patents, while flat fees and other alternative arrangements are also on the rise," explains James Li, a partner at Greenberg Traurig LLP. "This new trend will lead to more legitimate enforcement of patents, especially by small patent holders. It will also result in more frivolous patent lawsuits in the US." So clearly, the likelihood of litigation will continue to increase, and companies should start to rethink their patent strategies and to consider more ways to protect themselves from litigation risk, if they have not already.

But where litigation is already underway, both sides can take steps to smooth the process. In broad terms, both plaintiffs and defendants should allocate adequate resources to the process as early as possible. Indeed, simply understanding the facts of the claim being made can help defendants to avoid surprises, which could result in a faster, more satisfactory solution. However, experts warn that there will always be unpredictable factors such as time and cost to take into account. "Patent litigation costs vary wildly from case to case, and country to country," says Daryl Fairbairn, an associate at Clifford Chance. "The main factors are the value of the allegedly infringing product, the number of patents and claims, the complexity of the technology and the depth of discovery. Cases in the US typically take two years or longer to go to trial at a cost of more than $1m." However, he warns that the cost can be significantly higher where the stakes are high for both sides.

In other parts of the world, such as continental Europe, time and costs can be significantly less because discovery is restricted. The costs also tend to be somewhat lower in many emerging markets. "The average cost of patent litigation in India can range from $25,000 to $45,000, depending on the degree of contest by the opposite party and the engagement of senior counsel to argue the matter. For example, if the opposite party challenges the validity of the patent in reply to the suit filed, a significant amount of resources will have to be invested in defending the validity of the patent," explains Mr Kumar, adding that the need for expert witnesses tends to make patent litigation more expensive than other kinds of litigation. In addition, cases can take as long as four to five years to conclude. Mr Kumar further states, "Under the Intellectual Property Imported Goods Enforcement Rules of 2007, the import of a product infringing a patent may be stopped by customs authorities, if the right holder of the patent has pre-registered his rights with them and fulfilled all procedural formalities under the Rules." Recently, invoking the provisions of these Rules, customs officials have interdicted consignments of mobile phones alleged to be infringing on Indian patents.

Mitigating the threats

However, the situation is by no means beyond control. While there are clearly unpredictable elements, plenty can be done to make the process of patent litigation a little more certain. For example, building a defence patent portfolio, forming advice counsels and making key patent acquisitions before investment, can all help to mitigate patent-related risks. Patent litigation insurance is another option, but it is sparsely offered and very expensive. Furthermore, Mr Li warns that the mandatory patent insurance proposed by the EU could end up hurting innovation.

 
Total drug revenues in the sleep disorders market exceeded $7bn in 2008 PDF Print E-mail
World Sleep Disorders

Market Analysis 2009-2024

Sleep disorders affect hundreds of millions of people worldwide. It is a multi-billion dollar market for drug-based treatments with continuing potential for growth. This new report - World Sleep Disorders Market Analysis 2009-2024 - explains the commercial prospects for drugs to treat sleep disorders, an important, changing pharma market. The principal disorders are insomnia, narcolepsy, sleep apnea and restless leg syndrome, but there other potentially profitable market segments. Overall, sleep disorders are highly prevalent. Approximately 30% of the population worldwide suffer from sleep disorders analysis suggests. Capturing a segment of this market has enormous potential.

Total drug revenues in the sleep disorders market exceeded $7bn in 2008. Visiongain expects the market to expand during the forecast period 2009-2024 - but by how much? In this new study, you will discover market reach, both worldwide and in major national markets, with leading products and submarkets covered. Growth in the worldwide market will be driven by an increase in the use of insomnia-alleviating and wake-promoting drugs in particular. The treatment of insomnia and some other disorders will change during the forecast period - this report tells you how. An extensive pipeline with new treatment approaches - some close-to-market - will stimulate and increase profitablility in this market sector. A shift from traditional treatments to new drugs will improve treatment options, as well as broadening access to treatments, including use of generic substitutes. New drugs should provide more-attractive treatment options for patients and prescribers who have been deterred by the limitations of existing treatments.

Under-diagnosed and under-treated, sleep disorders present a significant market opportunity for existing and still-to-be-launched treatments. Currently, there is large untapped market potential in the sleep disorder market worldwide. Prescription drugs must compete with OTC products, natural remedies and other treatments, however. Under-treatment is widespread, with many sufferers not seeking medical guidance; that situation should gradually improve, increasing commercial opportunities. The full commercial potential of sleep disorder treatments has thus still to be achieved. The momentum in that sector will increase as companies further invest there, along with healthcare payers worldwide. This new report - Sleep Disorders Market Analysis 2009-2024 - is essential reading for anyone interested in the sleep disorders market. There, you will discover prospects for both existing competitors and potential market entrants from 2009 onwards.

Comprehensive analysis of the sleep disorders market area

Sleep Disorders Market Analysis 2009-2024 examines that market area critically, through a comprehensive review of information sources, both primary and secondary. This report provides detailed sales forecasts, discussions of pipeline developments and analysis of commercial drivers and restraints, including a SWOT analysis. There are many tables and figures included. The result is a comprehensive market- and industry-centred report with detailed analyses and informed opinion to benefit your work.

Why you should buy Sleep Disorders Market Analysis 2009-2024

 

There is great untapped potential in the sleep disorder market. Safety and efficacy concerns still limit the commercial potential of sleep disorder drugs, despite the vast potential treatment population - one of the largest in medicine. Some market leaders will soon reach patent expiry. What effects will generic competition have in the market? Will more-effective treatments emerge soon, with commercial gains for innovators? What effects will OTC switching have? This report covers those important questions and many others.


Table of Contents:

1 Executive Summary: Sleep Disorders Market Analysis 2009-2024

2 An Introduction to Sleep Disorders

2.1 Sleep Hygiene

2.2 Measuring Sleep

2.3 Circadian Rhythm

2.4 Sleep Disorders

2.4.1 Dyssomnias

2.4.2 Parasomnias

2.5 The Treatment of Sleep Disorders

2.5.1 Therapeutic Approaches

2.5.2 Medical Therapies

2.5.3 Alternative Therapies

2.5.4 OTC Products

2.6 Pharmacological Treatments

2.6.1 Specific Treatments

2.6.2 Off-Label Treatments

3 The Global Sleep Disorder Market Forecast

3.1 The World Market

3.1.1 Growth in the World Sleep Disorder Market to 2012

3.1.2 Growth in the World Sleep Disorder Market from 2013

3.2 The Global Sleep Disorder Market Geographical Breakdown

3.2.1 Sleep Disorder Market Forecast - US

3.2.2 Sleep Disorder Market Forecast - Japan

3.2.3 Sleep Disorder Market Forecast - European Markets

3.2.4 Sleep Disorder Market Forecast - Emerging Markets

4 Insomnia Market Analysis and Forecasts

4.1 The Total Insomnia Market Forecast

4.1.1 Increased Use and Access to Insomnia Treatments Will Drive Market Growth

4.1.2 Pipeline Treatments Will Revive the Insomnia Market

4.2 Ambien Forecast 2009-2024

4.2.1 How Will Generic Competition Impact Upon Ambien Sales?

4.2.2 Will Pipeline Products Make Ambien Treatment Obsolete?

4.3 Lunesta Forecast 2009-2024

4.3.1 Lunesta Will Experience Revenue Growth in the Early Forecast Years

4.3.2 Patent Expiry in 2012 - What Effects?

4.4 Lendormin Forecast 2009-2024

4.4.1 Lendormin Revenues Over the Forecast Period

4.5 Imovane Forecast 2009-2024

4.5.1 How Will Generics and Novel Compounds Affect Imovane Revenues?

4.6 Rozerem Forecast 2009-2024

4.6.1 Will Generic Eszopiclone Seriously Affect Rozerem Sales?

4.6.2 Generic Ramelteon and New Long-Term Treatment Options

4.7 Total Other Insomnia Drugs Market Forecast 2009-2024

4.7.1 Generic Zolpidem - What Effects on Market?

4.7.2 New Pipeline Agents and the Market Entry of More Generic Agents

4.7.3 Generic Ambien CR and Pipeline Products

4.8 Insomnia Market Summary

5 Restless Leg Syndrome Market Analysis and Forecasts

5.1 The Total RLS Market Forecast 2009-2024

5.2 Mirapex Forecast 2009-2024

5.2.1 Patent Expiries and Generic Competition

5.3 Requip Forecast 2009-2024

5.3.1 Competition from Generics and Pipeline Products

5.4 Total Other RLS Drugs Forecast 2009-2024

5.5 RLS Market Forecast Summary

6 Wake-Promoting Drugs Market Analysis and Forecasts

6.1 The Total Wake-Promoting Market Forecast 2009-2024

6.2 Provigil Forecast 2009-2024

6.2.1 How Will Sales of Provigil be Affected by Market Entry of Nuvigil?

6.2.2 Loss of Marketing Exclusivity from 2015

6.2.3 How Competition with Pipeline Agents Will Affect Growth to 2024

6.3 Nuvigil Forecast 2010-2024

6.3.1 Nuvigil Will Experience Consistent Growth from a Large Treatment Base

6.3.2 Growth of Nuvigil Will Slow Due to Entry of New Agents

6.4 Xyrem Forecast 2009-2024

6.4.1 Xyrem Will See Increased Revenues in the Early Forecast Years

6.4.2 New Agents Will Result in Negative Growth in the Later Forecast Years

6.5 Other Wake-Promoting Drugs: Forecast 2009-2024

7 Sleep Disorder Treatments: SWOT Analysis, 2009-2024

7.1 Market Drivers

7.2 Market Restraints

7.3 Current Treatments

7.4 The Large, Competitive Market

7.5 New Insomnia Drugs Will Drive Market Growth

7.6 High Sleep Disorder Prevalence and Unmet Market Needs

7.7 Public Opinion

7.8 Sleep Apnea Market Drivers and Restraints

8 The Sleep Disorder Treatment Pipeline

8.1 Insomnia Treatment Pipeline

8.1.1 Zolpimist (Novadel)

8.1.2 Edluar (Meda)

8.1.3 Silenor (Somaxon)

8.1.4 Indiplon (Neurocrine Biosciences)

8.1.5 Ciltyri (Sanofi-Aventis)

8.1.6 Intermezzo (Transcept)

8.1.7 Almorexant (GSK/Actelion)

8.1.8 Tasimelteon (Vanda)

8.1.9 Medodorm (Essential Nutrition)

8.1.10 Esmirtazapine (Schering-Plough)

8.1.11 Gabitril (Cephalon)

8.1.12 649868 (GSK)

8.1.13 EVT 201 (Evotec)

8.1.14 PD 200390 (Pfizer)

8.1.15 TIK 301 (Tikvah Therapeutics)

8.1.16 HY 10275 (Hypnion)

8.1.17 LY 2624803 (Eli Lilly)

8.1.18 Pruvanserin (Eli Lilly)

8.1.19 MK 4305 (Merck & Co)

8.1.20 TGARO1H (Fabre Kramer)

8.1.21 ITI 007 (Intra-Cellular Therapies)

8.1.22 Staccato Zaleplon (Alexza)

8.1.23 SKP 1041 (Somnus)

8.1.24 Pimavanserin (Acadia)

8.1.25 NBI 75043 (Neurocrine Biosciences)

8.1.26 Adipiplon (Neurogen)

8.1.27 Summary of Promising Late-Stage Insomnia Pipeline Products

8.2 Wake-Promoting Sleep Disorder Treatment Pipeline

8.2.1 Nuvigil (Cephalon)

8.2.2 Tiprolisant (Bioprojet)

8.2.3 CX 717 (Cortex)

8.2.4 VSF 173 (Vanda)

8.2.5 APD 916 (Arena)

8.2.6 COL 204 (CoLucid)

8.2.7 Concluding Thoughts on the Wake-Promoting Pipeline

8.3 Restless Legs Syndrome Treatment Pipeline

8.3.1 NEUPRO (UCB Pharma)

8.3.2 NENAD (Axxonis Pharma AG)

8.3.3 Solzira (Xenoport)

8.3.4 Aplindore (Neurogen)

8.3.5 JZP 7 (Jazz Pharmaceuticals)

8.3.6 Istradefylline (Kyowa Hakko Kirin)

8.3.7 Safinamide (Merck Serono)

8.3.8 Nitisinone (Synosia Therapeutics)

8.3.9 Concluding Notes on the RLS Pipeline

8.4 Sleep Apnea Pharmaceutical Treatment Pipeline

8.4.1 BGC20 0166 (BTG and Collegium)

8.4.2 AVE 0657 (Sanofi-Aventis)

8.4.3 CX 1739 (Cortex)

8.4.4 Gall 200 (Galleon)

8.4.5 Factors Affecting Sleep Apnea Pharmaceutical Market Potential

9 An Expert's Opinion - Dr. Remy Luthringer

9.1 Unmet Needs in the Treatment of Sleep Disorders

9.2 The Future of the Wake-Promoting Market

9.3 The Insomnia Market

9.4 Long-Term and Off-Label Use of Insomnia Treatments

9.5 The Sleep Disorder Pipeline

9.6 The Evolution of Sleep Disorder Treatments

9.7 Growth in the Sleep Disorder Market


Companies Mentioned

Acadia

Actavis

Actelion

Alexza

Apotex

Arena

Astellas

Axxonis Pharma AG

Barr

Bayer

Bioprojet

Boehringer Ingelheim

BTG

Cephalon

Collegium

CoLucid

Cortex

Daiichi Sankyo

Eisai

Eli Lilly

Essential Nutrition

Evotec

Fabre Kramer

Forenap Pharma

Galleon

GlaxoSmithKline

Hypnion

Intra-Cellular Therapies

Italfarmaco

Jazz Pharmaceuticals

Kyowa Hakko Kirin

Meda

Merck & Co

Merck Serono

Mylan

Neurocrine Biosciences

Neurogen

Novadel

Orexo

Pfizer

Pharmascience

Ranbaxy

Sanofi-Aventis

Schering-Plough

Sepracor

SkyePharma

Somaxon

Somnus

Strada

Synosia Therapeutics

Takeda

Teva

Tikvah Therapeutics

Transcept

UCB Pharma

Valeant

Vanda

Watson

Wyeth

Xenoport

 
 
A new drug for genetic breast cancer could help thousands of women with hereditary forms of the disease PDF Print E-mail
From The TimesJune 1, 2009

New drug olaparib offers hope to women with genetic breast cancer

A new drug for genetic breast cancer could help thousands of women with hereditary forms of the disease, the first tests on patients suggest.

A study involving 54 women with advanced genetic breast cancer found that the drug olaparib could stop the growth of tumours, and shrink them in more than 40 per cent of cases.

In one case, a woman's tumour disappeared completely after treatment with the drug, according to results to be presented at a science conference today.

About 5 per cent of the 46,000 cases of breast cancer in Britain each year are caused by defects on the BRCA-1 and BRCA-2 genes, which put women at much higher risk of developing aggressive cancers of the breast or ovaries.

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Many women who test positive for the mutations have their breasts removed as a precaution, as they have an 80 per cent risk of developing breast cancer in their lifetime.

Olaparib, made by AstraZeneca , is the first of a new class of drugs specifically designed to treat BRCA-related cancers to be tested on patients. If further tests are successful, they could be used at an early stage to treat or prevent disease occurring within affected families, scientists say.

Pharmaceutical companies are also due to present targeted therapies for cancers of the lung, stomach and ovaries this week at the American Society of Clinical Oncology conference in Orlando, Florida, the world's largest gathering of cancer scientists.

Andrew Tutt, director of the Breakthrough Breast Cancer Research Unit at King's College London, who led the trial, said that the results for olaparib were "very promising".

"We are hopeful that olaparib could provide a targeted treatment for women with BRCA-related breast cancer," he said. "Some women also develop breast cancer before they know they are carrying the gene, or see it recur if they have been diagnosed previously."

Charlotte Sword, 40, has had breast cancer diagnosed twice, because of the potentially deadly mutation to the BRCA-1 gene which runs in her family. Her younger sister Audrey has suffered it three times. Both women have had double mastectomies and their ovaries removed.

"Breast cancer has left a horrific mark on our family due to a mutation being passed down the paternal line", Mrs Sword said yesterday. "I have three nieces who could benefit from this treatment, and could be spared the dreadful illness and side-effects of treatment that my sister and I had to go through."

Olaparib works by blocking a protein that makes cancer cells which have a BRCA fault unable to repair their own DNNA. This causes the cancer cell to die and means that the tumour should either stop growing or get smaller.

Because the drug works in a targeted way, it kills cancer cells while leaving healthy cells alone in a way that chemotherapy does not, which could help to reduce the punishing side-effects of cancer treatment.

In the study carried out at hospitals in Britain, Europe, the US and Australia, 27 patients took 100mg oral doses of olaparib while another 27 took 400mg doses. More than 40 per cent of tumours in the higher dose group reduced significantly in size, while all tumours were prevented from progressing for an average of six months.

The Times reported this year that the London community of Ashkenazi Jews is being offered screening for BRCA genes that raise risks of breast, ovarian and prostate cancers. Ashkenazi have a high incidence of BRCA-related breast cancer.

The NHS currently offers BRCA testing, but only for women whose relatives have had cancer because of the mutations. But up to 50 per cent of people with the faulty genes do not have a family history of the diseases, largely because the gene can be carried by men.

Dr Tutt said that orlaparib may also have potential as an early-stage or preventative treatment. He added: "It is important to remember this drug is at a very early stage of development." Herbie Newell, Cancer Research UK scientist at the Northern Research Institute, Newcastle University, said he was "extremely encouraged" by the study's results.

He said: "Olaparib is one of a family of targeted therapies currently in clinical trials and Cancer Research UK expect that this new class of anti-cancer treatments will make a significant impact in the fight against cancer."

In the family

8% Proportion of cases of breast cancer in women thought to be triggered by genetic factors, although many of the exact causes remain a mystery

2,000 Number of breast cancer cases a year (5 per cent of the total) known to be caused by changes in either the BRCA-1 or BRCA-2 genes that were the first to be associated with a much higher risk of developing breast cancer

1 in 800 Proportion of women in whom a faulty BRCA-1 gene is present. One in 500 carries a faulty copy of the BRCA-2 gene

50-80% Chances of a woman with these genes of getting breast cancer in their lifetime, up to seven times higher than those who do not carry the mutations. They also have a 60 per cent increased risk of ovarian cancer

Sources: Cancer Research UK; Times database

 
 
Pharma firms continue to face patent violation charges in Europe PDF Print E-mail

Pharma firms continue to face patent violation charges in Europe
8 Jun 2009, 0122 hrs IST, Rupali Mukherjee, TNN

NEW DELHI: Even after India raised concerns with EU, troubles of generic companies which export drugs to developing countries through Europe are far from over as seizures by Dutch customs still continue.

In yet another case, a shipment of popular antibiotic, Amoxicillin was seized in Frankfurt recently. The drugs manufactured by domestic company Medopharm were shipped to Republic of Vanuatu, an island nation in the Pacific Ocean, through Frankfurt.

In this recent case, customs authorities seized a shipment of 3,047,000 pills (quantity equivalent to 76,000 courses of treatment) of Amoxicillin (250 mg) worth 25,000 euros, for almost a month before releasing it. Sources said that the consignment was detained on grounds of suspected trademark infringement.

Experts pointed out that there was no valid reason for detaining these medicines especially since the name ‘Amoxicillin' is an international non-proprietary name. This seizure is the latest in a long list of cases that demonstrate that EU regulations are actively hampering access to medicines to developing countries. In 2008, there were 16 similar cases of seizures of medicines shipped from India in the Netherlands. (Other recent seizures include those of medicines from Dr Reddy's and Ind-Swift.)

When this particular shipment came into Germany, customs noted that the medicines packed are of the same type as the drugs that GlaxoSmithKline in UK has copyrights for, according to an industry source. German customs authorities then informed the company, and gave them a sample of drugs for inspection. The consignment was later cleared and sent to the final destination.

These seizures have been driven by an EU regulation on border measures that has empowered customs officials to interfere in legitimate trade of generic medicines, a statement from Health Action Network says.

DG Shah, secretary general of Indian Pharmaceutical Alliance says "The EU member states continue to abuse Regulation 1383 of 2003 to create barriers and harass legitimate trade in generics. It is time that the government steps in and takes effective steps to protect India's exports of pharmaceuticals". Customs is incompetent to interpret IPRs and should not be entrusted to enforce the same, he added.

The issue has been raised by India at the TRIPS (Trade-related aspects of Intellectual Property Rights) council meeting in February, and thereafter when the Dutch trade minister was on a visit here. Experts pointed out that earlier international public health and consumer groups have raised the issue with World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru.

According to manufacturers, all products were ‘‘legitimate generics'' and did not violate any patent rights in the exporting or the importing countries.


 
 
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