India: Court rejects Bayer's appeal for protections for its cancer drug against generic competitors

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Article
10 February 2010

Court rejects Bayer's appeal [India]

Author: Rupali Mukherjee, Times of India

In a relief to generic companies and promoting consumers' access to affordable treatment, the Delhi high court dismissed an appeal by...Bayer Corporation, which sought patent linkage — linking regulatory approval of generic medicines with their patent status... A division bench of Delhi high court on Tuesday dismissed Bayer's appeal against a judgment on an anti-cancer drug... Patent linkage is against public health interests as it will delay the entry of cheaper generic medicines into the market... Anand Grover, counsel for Cancer Patient
Aid Association (CPAA) told TOI: "The patent system and drug regulatory system are two separate and independent mechanisms...If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market..."

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Article
9 February 2010

Indian court gives boost to access to medicines - Bayer appeal rejected

Author: Médecins Sans Frontières (Doctors Without Borders)

In a welcome move for access to medicines, the Delhi High Court has rejected the appeal filed by...Bayer Corporation against an earlier court order which had rejected the implementation of a drug regulatory system which essentially linked registration of medicines to their patent status... “We are delighted with this decision – at the moment in India we are seeing a number of multinational pharmaceutical companies trying to use litigation to stifle generic competition,” said Dr. Tido von Schoen-Angerer of Médecins Sans Frontières’ Campaign for Access to Essential Medicines. “By rejecting Bayer’s attempts to introduce patent linkage, the Indian courts have ensured that public health safeguards like compulsory licensing can be used to open up generic production of life-saving medicines including antiretrovirals for millions in India and beyond..." [also refers to Novartis]

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Article
2 February 2010

[PDF] Bayer Corporation & Another vs. Union of India & Others

Author: High Court of Delhi

In the writ petition the appellants Bayer Corporation and Bayer Polychem (India) Ltd...sought directions inter alia to restrain the Drug Controller General of India (DCGI), respondent No. 2 herein, from granting a drug licence to Cipla Ltd...to manufacture, sell and distribute its drug “sorafenib tosylate”, prescribed for the treatment of advanced renal cell carcinoma...It would be stretching the language of Section 17B (b) DCA to an impermissible limit to hold that all generic versions of patented drugs, for which marketing approval is sought from the DCGI in terms of the DCA, should be considered to be "spurious‟ drugs...by accepting Bayer‟s contention that every generic drug would be a spurious drug, this court would be subjecting manufacturers of generic versions of patented drugs to prosecution under the DCA although the Patents Act does not provide for such a consequence. This is yet another reason why the attempt at bringing in patent linkage on the basis of the existing provisions of the Patents Act and the DCA cannot be countenanced...The appeal is accordingly dismissed.

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