AstraZeneca seeks hearing with patent controller regarding Lee Pharma's CL application

Delhi High Court had earlier issued an order granting permanent injunction in favour of AstraZeneca

Pharma major AstraZeneca AB has filed a petition with the Controller of Patents requesting an in-person hearing before the Patent Office conclude the prima facie view in the Compulsory Licensing (CL) Application filed by Hyderabad-based Lee Pharma for diabetes mellitus drug Saxagliptin.

According to sources close to the development, the Controller of Patents has given a hearing to Lee Pharma this week related to its CL application for Saxagliptin, sold by AstraZeneca as Onglyza as a standalone drug and Kombiglyze as a combination with Metformin.

AstraZeneca, in its petition to the Controller of Patents seeking intervention, dated November 6, 2015, alleged that Lee Pharma has made a statement in the Delhi High Court that its CL application for Patent Number 206543 has been rejected by the Controller of Patent and by stating this, it has waived off or given up its right to seek a CL.

According to an order of a Single Judge in Delhi High court, in October 8, 2015, the counsel appeared for Lee Pharma stated that the application for CL has been rejected by the Controller of Patents and the company have no intention to launch the products. Justice Manmohan Singh, recording the statement, issued an order granting permanent injunction in favour of AstraZeneca and against Lee Pharma from using, making, selling, distributing, offering for sale and dealing in any product that infringes the subject matter of the patent.

In August, this year, Rajiv Aggarwal, the then Controller of Patents, concluded in a notice that a prima facie case has not been made out for the making of an order under Section 84 of the Act, for issuance of CL. The Official also said that Lee Pharma can request for a hearing within a month, failing which the application shall be refused. Following this, Lee Pharma requested for a hearing.

Afzal Hasan of Hasan and Singh, counsel appearing for Lee Pharma, said that the company has not submitted in the Delhi High Court that its application was rejected by the Patent Office. The company is in the process of filing a review petition against the order.

"The CL Application before the controller is still alive and pending before the Controller of Patent," he said. AstraZeneca's petition seeking intervention in the Patent Office procedures at this stage is not maintainable under the provisions of CL. The patent owner can present its case only after the application is accepted by the Controller of Patents, as per the provisions, he added.

AstraZeneca in its petition seeking intervention, said, "The petitioner believes that a hearing and/or a final decision on the prima facie case on the application for compulsory license filed by the Respondent (Lee Pharma) in relation to the Patent granted to the Petitioner (AstraZeneca) is currently pending before the Learned Controller".

It added that the Controller has the right to hear the petitioner in exercise of its discretionary powers and requested the Controller to take a departure from normal practice and procedure in the interest of natural justice.

Lee Pharma filed the compulsory license application to produce AstraZeneca's product, registered under Indian Patent No 206543 on June 29, 2015, alleging that the multinational company was not able to meet the demand for Saxagliptin. It was following this, AstraZeneca filed the suit against Lee Pharma in the Delhi High Court.

The patent for the drug was granted to Bristol-Myers Squibb in April 2007 and was transferred to AstraZeneca AB.