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Press Release, Aug 20, 2009
Coalition against Bayer Dangers (Germany)

Bayer beaten in Indian court over patent law

Bayer sued Indian Government to retain monopoly rights / International coalition demands protection of generic pharmaceuticals

In a major win for Indian companies, the Delhi High Court dismissed German drug major Bayer's attempt to stop the drug regulator from giving marketing approval to Indian company Cipla for the generic version of a patented cancer drug, Nexavar. A favourable decision for Bayer would have given legal mandate to global pharma majors' demand of not granting marketing approval to low-cost drug makers for patented drugs. The court not only dismissed Bayer's ambitions to monopolise the Indian market with its cancer drug, but also imposed a penalty on the drug maker in a judgment extremely scathing in tone.

Philipp Mimkes from the Coalition against Bayer Dangers, an international network that has been monitoring Bayer for 30 years: “We laud the decision of the Indian High Court. Countries like India must have the possibility to issue compulsory licenses to generic companies or to impose price controls in order to make available affordable drugs. Safeguarding public health must take precedence over patents and monopoles of drug companies. Abnormal profits cannot be allowed when it comes to medicines.”

The case started last November when Bayer sought to block the Drug Controller General of India from granting a license for Cipla's generic version of Nexavar and was granted an interim injunction. That was an exceptional move as never before was an attempt made to prohibit the Indian drug controller from reviewing applications for licences. International health groups called on Bayer to cancel the suit in order to protect affordable drug treatment. The organizations feared that the fate of generics in India would be threatened and that thousands of Indians would die without affordable pharmaceuticals.

Bayer indicated in its petition that Cipla's drug could be "spurious" as it did not hold a valid patent. The judge now found clear words against this view: “This court is constrained to observe that the present litigation was what may be characterized as a speculative foray; an attempt to “tweak” public policies through court mandated regimes. The petitioner, doubtless is possessed of vast resources and can engage in such pursuits. Yet, often, these attempts, even unsuccessful in the ultimate analysis, achieve short term goals of keeping out competitors, through interim orders. That short term objective has been achieved, and the petitioner has successfully stalled an independent examination of Cipla’s application. Even though the writ petition cannot succeed, it would be a travesty of justice if the court does not direct realization of realistic costs, in this case.”

Amit Sen Gupta from the Indian Peoples Health Movement: “The Bayer case has implications for drug access, not just for patients in India, but for poor people in large parts of the world. Bayer not only seeked to safeguard its own monopoly rights, the company also wanted to set a precedent that other corporations could benefit from. In essence it would mean that the entry of generic versions of life saving drugs would be delayed.”

There have been instances of generic versions of Indian companies being delayed, because regulatory approval for their drugs was delayed because of their patent status. Cipla joint managing director Amar Lulla: “This is a historic judgement where the MNC's back-door patenting has been threatened. This was a frivolous and perverse case, and an attempt to stifle generics." Said Anand Grover, counsel for the Indian Cancer Patients Aid Association (CPAA), "we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent. If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs."

more info on Nexavar patents and developing costs

more information:
· Health groups: Defend affordable drug treatment in India
· The judgement of the Delhi High Court: http://lobis.nic.in/dhc/SRB/judgement/18-08-2009/SRB18082009MATC78332008.pdf

Times of India, 19 August 2009

Indian High Court rejects Bayer's plea

In a major relief to generic companies and promoting consumers access to affordable medicines, the Delhi High Court on Tuesday rejected pharma MNC Bayer's petition, which had indirectly sought 'patent linkage' - linking regulatory approval of generic medicines with their patent status.

Simply put, patent linkages mean that no marketing approval is given for generic versions of medicines, which have been granted a patent in India. The Delhi HC rejected Bayer's writ petition seeking to prevent the drug controller from granting approval to Cipla's generic version of a patented cancer drug.

Last year, Bayer Corporation had filed a writ petition before the Delhi high court against the Indian government, the Drug Controller General of India (DGCI) and Cipla seeking an order that the DCGI should consider the patent status of its drug, Sorafenib Tosylate, before granting marketing approval to any generic pharma company, and refuse marketing approval to it.

Sorafenib Tosylate is used to treat kidney cancer and is sold by Bayer at Rs 2.85 lakh for 120 tablets, for a months dosage, while the generic version, Nexavar, is expected to be at least half the price. MNCs have been hammering developing countries and generic companies to bring in laws beyond TRIPS, and there have been instances of generic versions of companies like Cipla and Ranbaxy being delayed in the country, because regulatory approval for their drugs was delayed, while 'patent status' was linked to it. Cipla joint managing director Amar Lulla told TOI: "This is a historic judgement where the MNC's back-door patenting has been threatened. This was a frivolous and perverse case, and an attempt to stifle generics."

Said Anand Grover, counsel for Cancer Patients Aid Association (CPAA) and project director of Lawyers Collective In India, "we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent. If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs."

YK Sapru, chairperson CPAA said: "We are very glad that the Court has recognised the aspect of access to drugs and has rejected Bayer's attempt to introduce a policy change with adverse public health consequences through the court."

While holding that unpatented drugs are not spurious drugs, Justice Ravindra Bhat held that this petition was an attempt to tweak public policy.

August 19, 2009, Business Standard

Delhi High Court dismisses Bayer's plea for patent linkage

In a landmark judgment on Tuesday, the Delhi High Court dismissed Bayer Corporation's Writ Petition to sanction the patent linkage system in India through a court direction.

Holding that unpatented (generic) drugs are not spurious drugs, Justice Ravindra Bhat held that this petition was an attempt to tweak public policy. While dismissing the petition, the Court also held that this is a vexatious and luxury litigation which should be discouraged and imposed cost of approximately Rs 6 lakh to be paid by Bayer Corporation to Respondents - Union of India and the Cipla Ltd.

Patent linkage is a system in which the Drug Controller refuses to grant or delay a marketing approval to a generic drug manufacturer to manufacture and sell a drug if the drug is already patented. Patent linkage is known to be against public health interests as it will delay the entry of cheap, generic medicines into the market and keep medicines out of reach of those who need them.

Hailing the High Court order, Y K Sapru, chairperson of Cancer Patients Aid Association (CPAA), who had intervened in the case filed by Bayer Corporation against the Drug Controller of General of India, said, "We are very glad that the Court has recognized the aspect of access to drugs and has rejected Bayer's attempt to introduce a policy change with adverse public health consequences through the court."

Bayer Corporation had filed a Writ Petition before the Delhi High Court against Union of India, the Drug Controller General of India and Cipla Ltd. seeking an order that the DCGI should consider the patent status of its drug, sorefenib tosylate, before granting a marketing approval to any generic pharmaceutical company and refuse marketing approval to any generic company. Sorefenib tosylate is used to treat kidney cancer and is sold by Bayer at Rs 2,85,000 for 120 tablets for a month dosage.

On November 7 last year, the Delhi High Court had granted an interim injunction to Bayer stopping the DCGI from granting marketing approval to the generic company (Cipla) until a final order is passed in this matter.

CPAA had filed an intervention application to be added as a party, which was allowed by the Delhi High Court. It was pointed out by CPAA that due to the stay in this case, the DCGI is not accepting the applications for marketing approval from any generic companies on any drug. The Court had then clarified that the stay would operate only with respect to the drug in question in the matter, i.e. sorefenib tosylate.

Anand Grover, counsel for CPAA and project director of Lawyers Collective HIV/AIDS Unit, said, "We welcome the High Court's judgment. In India, we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent. If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market. Such early entry is possible either through mechanisms such as compulsory licensing within the Patents Act itself, or where there is a bona fide belief that a patent has been wrongly granted This is especially important as we are now seeing an increase in the number of patents being granted to drugs, which we believe are being wrongly granted. Moreover, a patentee cannot use the DCGI, a government agency, to enforce its private rights. This was an attempt to introduce a TRIPS-plus requirement in India, which has been rejected."

CPAA had urged that the introduction of patent linkages in India would have adverse public health consequences. It had argued that despite the fact that the Legislature has kept the patent and regulatory systems separate, Bayer is attempting to link the two independent and separate systems and introduce a policy change through the Court.

Kiran Hukku, director, Cancer Patients Aid Association, New Delhi, said "With this rejection, we can hope to have early access to cheaper, generic medicines. This will benefit our patients."

Priyanka Golikeri / DNA, August 27, 2009

Even European Union doesn't link regulatory approval for generics to innovator patent

German healthcare giant Bayer is determined to introduce in India a system that can prevent early entry of low-cost generics despite the Delhi High Court quashing its plea to link regulatory approval to last week saying the company was trying to "tweak public policy."
"Bayer HealthCare is disappointed and disagrees with the court's decision and will consider its legal options in this regard," the company said after the judgment last week.
Under patent linkage, as sought by the company, the Drugs Controller General of India (DCGI) would not grant approval to a generic version of a drug if the innovator is patented in the country.
Ironically, even the European Union doesn't have such a system yet.
In fact, going by the European Generic Medicines Association, patent linkage is contrary to EU regulatory law and is one of the key entry barriers for generics.
Why then is the company seeking to introduce such a system in India?
"In the EU, generic companies usually do not launch a generic product while a patent is still valid. In most of the member states of the EU a preliminary injunction keeps patent infringers out of the market until a final decision on the validity of the patent concerned is achieved. Therefore, innovators are protected from the launch of spurious versions of innovative and patent-protected products while patents are still in force," Aloke Pradhan, vice-president, corporate communications, Bayer Group in India said in an email response.
The use of the word "spurious," despite Justice Ravindra Bhat holding in last week's judgment that unpatented (generic) drugs were not spurious, sure reflects the company's callousness, if not disregard for Indian law.
Alexandra Heumber, intellectual property (IP) policy advisor with humanitarian organisation Medecins Sans Frontieres, said, "Pharma companies are continuing their campaign against legitimate generics by portraying them as spurious drugs and confuse generics with counterfeit and spurious drugs."
Local IP experts feel the bid to link regulatory approval with patents gives away Bayer's desire for market monopoly by keeping out generics.
Currently, the patent and drug regulatory systems are two separate mechanisms in India.
According to Anuradha Salhotra, founding partner, IP law firm, Lall, Lahiri & Salhotra, there is no clause for patent linkage in India and the patent Act is a compete Act in itself. "The drugs controller should not be asked to look into the patent status of drugs."
Shamnad Basheer, professor in IP law, National University of Judicial Sciences, Kolkata, feels Bayer is pressing for patent linkage in India because the country does not have provisions for 'data exclusivity', which the European Union has.
Data exclusivity refers to a period of time during which the regulator cannot rely on an innovator's clinical trials data pertaining to novel drugs, in order to register a generic version of the drug. This is again said to delay entry of generics in the market, as generic companies would have to conduct the entire expanse of clinical trials, which are time consuming.
"EC has one of the longest data exclusivity provisions, so the generic cannot in any case get drug regulatory approval for about eight years or so after the innovator has introduced the drug," said Basheer.