GERMANY – Bayer Healthcare and Amgen subsidiary Onyx Pharmaceuticals have agreed to drop their patent lawsuit against Dr. Reddy’s Laboratories over the proposed generic version of Nexavar.
According to a filing in Delaware federal court, the parties agreed to dismiss the case with prejudice, which means it cannot be brought again.
Nexavar is used to treat cancers of the liver, kidneys, and thyroid. According to a Bayer report, the drug earned the company more than US$700 million in global sales in fiscal year 2020.
According to an Amgen filing with the US Securities and Exchange Commission, Onyx received US$217 million in royalties from Bayer on drug sales last year.
In July, Bayer and Onyx sued Dr. Reddy’s, an Indian generic drugmaker, over its Abbreviated New Drug Application (ANDA) for U.S. Food and Drug Administration approval of the generic.
An ANDA asserts that the relevant drug patents are invalid or that the generic would not infringe, exposing the applicant to patent infringement claims from the patent owner.
Bayer and Onyx, which co-developed Nexavar asked the court to block Dr. Reddy’s from making and selling the generic and to order the effective date of any FDA approval to come after their patent expires.
In separate news, Pfizer, the world’s largest pharmaceutical company, has agreed to produce and distribute its experimental COVID anti-viral drug in dozens of low- and middle-income countries.
The agreement between the US company and the UN-backed international public health organization Medical Patent Pool (MPP) would allow manufacturers to manufacture and supply generic versions of the drug in 95 countries without fear of patent infringement.
The majority of the countries included in the agreement are in Africa and Asia, accounting for approximately 53% of the world’s population.
Moreover, Pfizer has asked US regulators to grant its pill emergency use authorization. Once a license is obtained, generic companies can begin preparations for the product, but they must wait for regulatory approval before they can supply it.
The drug has been shown to be most effective when used early in the course of an infection and in combination with an older antiviral known as ritonavir.
The company is considering several pricing options for low-income countries, with the goal of no barrier for them to have access.
Pfizer’s move comes after Merck, a US pharmaceutical company, signed a similar royalty-free agreement with the MPP last month to allow its antiviral drug, molnupiravir, to be manufactured and sold at a low cost in 105 developing countries. Merck’s medication was approved by UK regulators earlier this month.
Pfizer and Merck’s moves to share COVID-19 patents came amid international pressure on pharmaceutical companies to share and transfer technologies to allow the production of generic versions of their COVID-19 vaccines. Pfizer has so far refused to do so.
Critics have long argued that the unwillingness to share vaccine recipes has contributed to the stark disparity in vaccine distribution between rich and poor countries.