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Financial Express : Anti-Indian generics policy stemmed from a global pharma report
A report prepared by the London-based International Policy Network (INP) could be greatly responsible for shaping the anti-Indian generics policy mindset that many of the African countries have either adopted in recent past or are in the process of adopting. This report, ‘Keeping it real: combating the spread of fake drugs in poor countries’, is learnt to be in wide circulation among the African countries and is being referred to. The governments of these countries conclude that India and China seem to be the largest producer of fake medicine.
It infers so on the basis of estimates derived from various secondary sources such as European Commission, The Associated Chambers of Commerce and media reports.
A 2004 survey of medicines on sale at a large bazaar in New Delhi found that only 7.5% were genuine. A report in a newspaper said that fakes are freely sold to exporters who sell them to unsuspecting health administrators in Sub-Saharan Africa, who receive some of the millions in aid money.
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A report prepared by the London-based International Policy Network (INP) could be greatly responsible for shaping the anti-Indian generics policy mindset that many of the African countries have either adopted in recent past or are in the process of adopting. This report, ‘Keeping it real: combating the spread of fake drugs in poor countries’, is learnt to be in wide circulation among the African countries and is being referred to. The governments of these countries conclude that India and China seem to be the largest producer of fake medicine.
It infers so on the basis of estimates derived from various secondary sources such as European Commission, The Associated Chambers of Commerce and media reports.
A 2004 survey of medicines on sale at a large bazaar in New Delhi found that only 7.5% were genuine. A report in a newspaper said that fakes are freely sold to exporters who sell them to unsuspecting health administrators in Sub-Saharan Africa, who receive some of the millions in aid money.
Lupin sends notice to Oscient over cholesterol generic
Indian pharma major Lupin has sent a legal notice to US-based Oscient Pharmaceuticals to inform them that they are seeking regulatory appr
oval for a generic version of Oscient’s cholesterol drug, Antara. Oscient received a notice to this effect on Wednesday, its official website said.
The notice stated that Lupin had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (USFDA) to launch a generic version of Antara in the market. The notice alleges that US Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for Antara, is invalid and will not be infringed by Lupin's manufacture, use or sale of the product. US Patent No 7,101,574 will be expired in 2020, the website stated.
Roche wins trademark case against Cipla in Bombay High Court
MUMBAI: Roche Ltd, the Indian arm of Swiss drugmaker F Hoffman La Roche Scientific, has won a trademark-infringement case against Cipla Ltd over its anti-infection drug brand-named Valcyte.
The Bombay High Court found Cipla’s brandname ‘Valcept’ —- for the generic version of the drug valganciclovir —- infringing upon Roche’s trademark rights.
The court has given Cipla three weeks to change the brand-name of its version.
Generic drugs are copycats versions of innovator drugs, and are sold far cheaper. Cipla’s Valcept is priced at Rs 245 per tablet against Roche Valcyte’s Rs 1,000.
New definition of fake drugs could save the day for local companies
The risk of India’s generic drugs being labelled counterfeit under the new definition proposed by WHO has receded, a government represe
ntative concerned with the issue said. This would ensure that India’s manufacturers continue to sell their drugs in foreign markets.
The WHO-funded International Medical Products Anti-Counterfeiting Taskforce (IMPACT) had proposed a new definition of counterfeit drugs as medical products with a “false representation about their identity, history or source”.
Ranbaxy buy may hit generic drugs supply
Ranbaxy has been aggressive in supplying generics, like anti-AIDS drugs, to developing countries, the company has participated in pre-grant oppositions in India (where a patent application is opposed before the Patent Office takes a decision) and it has been able to make similar versions of drugs like Tamiflu, used in the case of bird-flu, even as the patent situation was not clear.
This generic orientation could get influenced under the new owner and that would affect the supply of low-cost medicines to patients in India and other developing countries, the Centad representative said.
Corporate mergers and acquisitions in the pharma segment should not be viewed with the same lens as a regular corporate deal, as it could affect access to medicines, he added.
India bats for generics, seeks clarity on counterfeits
In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.
Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.
At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.
India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.
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In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.
Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.
At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.
India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.
Indian drug companies are largely producers of generic drugs or medicines that are chemically similar and are as efficacious as an innovative medicine. And India’s stance at the WHA brought cheer to the local industry, as they feared that the expanded counterfeit definition could be used as a non-tariff barrier against medicine exports from India.
Ranbaxy gets mixed verdict on Pfizer’s Lipitor in Australia
In a partial victory for Ranbaxy Laboratories in its patent litigation against Pfizer, an Australian court has ruled in favour of the Indian company in a case relating to Atorvastatin, the world’s largest selling cholesterol-lowering drug (marketed by Pfizer as Lipitor).
The court at the same time also ruled that a proposed Ranbaxy generic product under a different patent infringed Pfizer’s basic Lipitor patent.
The Federal court had ruled that one of Pfizer’s patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of Australian patent.
Mr Jay Deshmukh, Ranbaxy’s Senior Vice President-Global Intellectual Property, noted, “We are pleased with this decision as it stands, as it advances the entry of Ranbaxy’s generic atorvastatin in Australia to May 18, 2012.”
The ruling, the culmination of a lawsuit filed in 2005 by Ranbaxy, preserves Lipitor’s patent coverage in Australia through May 2012. Ranbaxy can appeal the decision.
Ranbaxy begins operations in Yemen
Pharma-major Ranbaxy Laboratories Ltd on Wednesday said it has commenced its operations in Yemen, strengthening its presence in the West Asian region.
Ranbaxy has tied up with Pharma Ltd (Natco) as business partners for its Yemen operations. Ranbaxy will focus on therapy areas such as anti-infectives, gastro-intestinal, cholesterol lowering and anti-allergic categories in Yemen.
WHO Counterfeit definition worries Pharmas
The domestic drug industry is concerned over ongoing World Health Organisation (WHO) negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers.
If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets.
Today, Indian firms have several brands that sound similar to those
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The domestic drug industry is concerned over ongoing World Health Organisation (WHO) negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
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</script>The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers.
If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets.
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Currently, this would at the most be treated as a trademark violation. However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit, the sources explained.
This attempt to widen the definition of counterfeit medicine is happening at a time when a deliberate attempt is being made to label India as a major source of counterfeit medicines.
Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major problem, the sources said.
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Financial Express : Patent Trials
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With drugs worth $60 billion going off patents in the US pharma market by 2011, Indian firms known for their expertise in copycat making are moving away from patent offices and aggressively taking the litigation route to get exclusive marketing rights in different parts of the world. Indian majors like Dr Reddy’s Labs, Sun Pharma, Glenmark and Ranbaxy have already entered into patent litigation with US-based MNCs to get the major chunk of the revenue from the sales of blockbuster drugs (having sales over $1 billion) in the US.
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The number of Paragraph IV abbreviated new drug applications (ANDA) submitted by Indian firms in the US has increased manifold in the last few years and what makes this more attractive is the chance for getting 180-day marketing exclusivity. “As part of building a large generics business through Glenmark Generics Limited (GGL), our Paragraph IV strategy would offer significant value,” says Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd.
According to the US FDA, a Paragraph IV certification begins a process in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts prior to the expiration of the patent. Paragraph III ANDAs can be submitted before the patent expiry, seeking marketing approval for the drug once the patent expires. Paragraph IV ANDA submission enables the applicant to prove that such patent is invalid or will not be infringed by the generic drug, for which approval is being sought.
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