Drug makers can export patented medicines for approval: Delhi HC

Indian generic drug makers have the fundamental right to make, sell and export patented medicines for purposes of regulatory approval and clinical trials, the Delhi High Court ruled on Wednesday.

"The right of manufacturers/producers of medicines and of fine chemical producers, to make, construct and sell including by way of export, a patented invention, for the purposes prescribed in section 107A (of Patents Act) is a fundamental right protected by Article 19(1)(g) of the Constitution and the sale cannot be curtailed except by express law," Justice Rajiv Sahai Endlaw said.

The ruling came as the court allowed state-run pharma company Natco and generic drug maker Alembic Pharmaceuticals to export two patented medicines of German drug major Bayer's for clinical trials and regulatory approvals abroad as allowed under section 107A of the Patents Act. Natco and Alembic, however, were directed to undertake that during the life of the respective patent, they will not export the respective patented invention for purposes other than those specified in section 107A.

Section 107A of the Act explains what will not constitute infringement of a patent and includes selling of a patented invention for the purposes of development.

The drugs in question were Bayer's cancer drug Sorafenib marketed under the name of Nexavar, whose generic version Sorefenat was being exported by Natco, and the German company's blood thinning medicine Rivaroxaban, a generic version of which was being exported by Alembic.

The court disposed of Bayer's pleas against the two Indian companies, saying that sale by a non-patentee of a pharmaceutical product solely for the purposes prescribed in section 107A would "not be infringement and cannot be prevented".

The court noted that section 107A permitted sale of a patented product during the term of the patent but only for the purpose of obtaining regulatory approvals for making and marketing the patented product after the expiry of the patent.

Bayer, in its plea, had contented that once the patented invention is permitted to be sold by way of export for regulatory approvals, the court will no longer have the jurisdiction to ensure that the exports are used for that purpose only.

Rejecting the contention, the court said the Patents Act was concerned with protection of the rights of the patentees in India only and not outside India.

"Neither our legislature, nor this Court can impose any condition on the use of the goods exported once they reach the destination country," it said. AgenciesNew Delhi: Indian generic drug makers have the fundamental right to make, sell and export patented medicines for purposes of regulatory approval and clinical trials, the Delhi High Court ruled on Wednesday.

"The right of manufacturers/producers of medicines and of fine chemical producers, to make, construct and sell including by way of export, a patented invention, for the purposes prescribed in section 107A (of Patents Act) is a fundamental right protected by Article 19(1)(g) of the Constitution and the sale cannot be curtailed except by express law," Justice Rajiv Sahai Endlaw said.

The ruling came as the court allowed state-run pharma company Natco and generic drug maker Alembic Pharmaceuticals to export two patented medicines of German drug major Bayer's for clinical trials and regulatory approvals abroad as allowed under section 107A of the Patents Act. Natco and Alembic, however, were directed to undertake that during the life of the respective patent, they will not export the respective patented invention for purposes other than those specified in section 107A.

Section 107A of the Act explains what will not constitute infringement of a patent and includes selling of a patented invention for the purposes of development.

The drugs in question were Bayer's cancer drug Sorafenib marketed under the name of Nexavar, whose generic version Sorefenat was being exported by Natco, and the German company's blood thinning medicine Rivaroxaban, a generic version of which was being exported by Alembic.

The court disposed of Bayer's pleas against the two Indian companies, saying that sale by a non-patentee of a pharmaceutical product solely for the purposes prescribed in section 107A would "not be infringement and cannot be prevented".

The court noted that section 107A permitted sale of a patented product during the term of the patent but only for the purpose of obtaining regulatory approvals for making and marketing the patented product after the expiry of the patent.

Bayer, in its plea, had contented that once the patented invention is permitted to be sold by way of export for regulatory approvals, the court will no longer have the jurisdiction to ensure that the exports are used for that purpose only.

Rejecting the contention, the court said the Patents Act was concerned with protection of the rights of the patentees in India only and not outside India.

"Neither our legislature, nor this Court can impose any condition on the use of the goods exported once they reach the destination country," it said.