The last time the debate on ‘Data Exclusivity’ surfaced was when the Department of Chemicals and Petrochemicals (DCPC) under Ministry of Chemicals and Fertilizers, Government of India came out with a Report on Steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement. Protection of Clinical Test-Data has touched a raw nerve again with the ex parte ad interim order from the Delhi High Court (IA No. 15772/2008 (u/O39 R 1 and 2 CPC in CS (OS) No. 2680/2008). The Court apart from restraining the defendant from dealing directly or indirectly in any product infringing the plaintiff’s patent directed the plaintiff to make a representation to the Drug Controller general of India making out a case for the drug for which approval had been sought by the defendant being in breach/violation of the patent of the plaintiff. The plaintiff had also sought an ex parte relief of restraining the defendant from pursuing their application before the Drug Controller General of India.

A news report, linked to the above mentioned ex parte ad interim order, tells that the government may not give in to MNC pressure on data exclusivity as a parliamentary standing committee on commerce endorses the current practice of approving generic versions of drugs from the stable of MNCs without insisting on Indian generic manufacturer to repeat the clinical research once done by pioneer drug makers. In India, the drug regulator approves drugs, if the second applicant can show it is chemically equivalent to the pioneer drug.

The parliamentary panel has advised the government not to fall prey to “certain vested interests” of MNCs which may prevent domestic companies from getting marketing approvals for generic medicines at lower prices.

The news report further dwelling on the issue of data exclusivity conveys that generic drug makers view data exclusivity as an extension of monopoly, beyond patent, and any attempt to introduce it should be opposed. But MNCs are of the view that India should provide an effective period of exclusivity for clinical dossiers that are independent of patent protection. A prominent voice in this domain has to say that - “Data exclusivity is required apart from patent (as these are different rights). If India does not allow this, then why would research-based pharma companies invest time and money in developing new molecules”?

Echoing the same sentiments is the Bayer’s case against the government. Bayer has taken the Union government and the Drug Controller to court, linking regulatory approval of generic medicines with their patent status. A patent linkage would mean that no marketing approval is given for generic versions of medicines, which have been granted a patent in India.

The ground of Bayer's petition is the entertainment of Cipla’s application by the Drug Controller for the grant of marketing rights to the generic version of its anti-cancer drug, ‘Nexavar’, for which it has obtained a patent in India. Bayer is of the view that a marketing approval for the generic version of its patented drug would affect its patent rights on the drug. Bayer had earlier requested the drug controller to reject Cipla's application, as well as grant a hearing to the company before taking any decision on the matter.

According to the news report, the case has a huge impact on accessibility of medicine and generic production in general as it may encourage patent holders to approach courts to prevent or delay marketing approval of affordable versions of patented drugs.