Healthcare Technology Featured Article

November 21, 2012

A Strategic Win in Patent Wars Against Big Pharma



Big Pharma – 0, Hetero Labs – 1 … for now at least.

A generic Fixed Dose Combination (FDC) therapy will be available to HIV patients in developing countries, as well as lower-income patients in the developed world, according to analysts at GlobalData.

This news follows the FDA’s approval of drug manufacturer Hetero Labs’ FDC therapy, which involves a combination of efavirenz, lamivudine and tenofovir disoproxil fumarate, though the patents on efavirenz and  tenofovir disoproxil fumarate are still in force under the respective names of Sustiva (held by Bristol-Meyers Squibb) and Viread (by Gilead).

While patent restrictions preclude the FDC’s presence in the U.S. market, Hetero Labs can still market offshore through its partners; key among them is the President’s Emergency Plan for AIDS Relief (PEPFAR) – a commitment established by George W. Bush to allocate $15 billion in global HIV/AIDS efforts.

What makes the entrance of this drug unique is the way Hetero Labs approached HIV therapy. Rather than direct resources against the existing patent licenses, thus relying on governmental intervention, they developed a combination of individually-licensed drugs that altogether was not marketed as an FDC. 

This was an important step in Hetero’s acquisition of FDA approval, which is necessary for a PEFAR partnership.

In other words, rather than develop effective therapy that ‘happened to be’ an FDC, they sought an FDC that happened to be effective.

The other appeal of FDC’s pertains to the manner in which they are scrutinized by the FDC. Because the individual constituents already survived FDA clinical trials, the process for FDC approval is neither as lengthy nor arduous as that of other drugs. That cost-effective treatments for HIV/AIDS are in such dire need means that the FDA, by its own admission, will likely “fast-track” the application and approval process. 

One GlobalData analyst anticipates that Hetero’s approach, if adopted as a business model, could establish for the company a large share in the developing world’s pharmaceutical market. Though it’s hardly ideal, with alternative treatments being cost-prohibitive, and a vaccine – though promising – still years away, Hetero perhaps represents the best approach provide effective treatment to those regions of the world in the greatest need. It’s a win-win situation.




Edited by Braden Becker




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