Delhi HC allows Alembic, Natco to export Bayer drug for specific purposes

The Delhi high court on Monday has allowed Alembic Pharmaceuticals and Natco Pharma to export cancer drug (sorafenib) and a blood thinner (rivaroxabin) for development, clinical trials and regulatory clearances.

A divison bench of Justice S. Ravindra Bhat and Justice Sanjeev Sachdeva has agreed with the majority of the findings of the single bench comprising of Justice Rajiv Sahai Endlaw.

“Sale, use, construction of patented products (by individuals and entities that do not hold patents) in terms of Section 107A of the Act for purposes both within the country and abroad is authorized and legal provided the seller ensures that the end use and purpose of sale/export is reasonably related to research and development of information in compliance with regulations or laws of India (or the importing country), for its submission in accordance with such laws. The impugned judgment of the learned single judge and the findings recorded on this aspect are accordingly affirmed. A dispute about the sale, i.e. whether it is legitimately related to the reasonable end use or purpose of research etc. for submission of information is properly the subject matter of a civil suit in which the full range of reliefs available in law can be granted having regard to the circumstances and the evidence led,” the order reads.

The Delhi high court on March 8, 2017 had allowed generic drug manufacturers to export patented drugs for the purposes of development, clinical trials and regulatory clearances as reported by Mint on March 8, 2017. The ruling came on two pleas filed by manufacturer Bayer Corp. Ltd, which had moved against Natco Pharma Ltd and Alembic Pharmaceuticals Ltd for a cancer drug and a blood thinner, respectively. Justice Rajiv Sahai Endlaw had allowed Natco Pharma and Alembic to export the active pharmaceutical ingredient (API) Sorafenib and Rivaroxaban for development purposes and regulatory clearances.

The two generic drug makers had furnished undertakings that exports of patented drugs will not be for purposes other than those in Section 107A. Section 107A of the Patents Act explains what will not constitute infringement of a patent, and includes selling of a patented invention for the purposes of development. The court had said that sale under Section 107A, even if for profit, cannot be prevented. Bayer had then moved the division bench of the Delhi high court and had got an interim stay on exports for some time.