Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem

As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.

Drug competition
Patent system is not being misused to unjustifiably delay drug competition, biopharma reps tell USPTO and FDA • Source: Shutterstock

As the US Patent and Trademark Office and Food and Drug Administration pursue initiatives to promote greater access to medicines, one factor is central to the debate: what constitutes an unjustifiable delay in the entry of generic drugs and biosimilars to the market?

Representatives of the biopharma industry countered claims that companies are misusing the patent system to delay competition

More from US FDA

More from Agency Leadership

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.