Larry Liu Professor Tal Lavian IEOR 190G Seminar-Patent (Burroughs-Wellcome) V.S.

Human Immunodeficiency Virus Just some Statistics… Has killed more than 25 million people since 1981 (start) 33.4 and 46 million people are currently living with HIV Type I is all over the world, easy to spread Type II is contained in South Africa Currently no vaccine or treatment….only drugs can slow it down…

AZT Antiretroviral Drug AZT works by inhibiting the reverse transcriptase that Virus produce HIV-1 Virus is neither dead or alive Virus “survive” by replicating its DNA/RNA by reverse transcription

How does AZT Work? Virus Reverse transcriptase incorporates AZT into the growing DNA chain in place of thymine. But because AZT has a 39 azido group instead of a 39 hydroxyl group, it can't make the phosphate bond with the next nucleotide. Thus terminating the synthesis of the DNA copy of the virus's RNA genome, blocking viral replication.

Research/Development History 1964: Discovered by Jerome Horowitz (Michigan Cancer Foundation) Claiming AZT is extremely toxic : GSK studied AZT’s effect on animal trials Claiming AZT is useless, and does not work on human 1985: National Cancer Institute (NCI) studied AZT again and found AZT actually stops virus from replicating…meaning it works!

Patent War! 1985: 12 days after NCI’s result…GSK filed for a British patent immediately following the science conference. Basically: The patent did not reveal or credit NCI and Duke University (part of research), so lots of people got angry……. And the war is on! although its scientist HAD NOT EXPERIMENTED with the virus!!!

Patent War Turned out…. 9 th February, 1988: The Court ruled in favor of GSK…it got its ownership of the patent and became the only company manufacturing AZT drug in the US (no competitors in the market) The war continued: 1991: Public Citizen sued GSK Reason one: GSK is using NCI’s result…1988 trial is unfair Reason two: AZT, the ONLY APPROVED HIV drug in US, is TOO EXPENSIVE!!! $2200/person/year!!! No one can afford it

…what’s going to happen? But again, the court ruled in favor of GSK… because of the incorrect approach to evaluate underlying validity of the patent Patent War So war continues… 2002: AIDS Healthcare Foundation sued GSK Facts are clear: GSK lied to the US Department of Commerce Patent & Trademark Office in 1986 in order to secure the patent on AZT…

There’s no winner or looser! Turns out the patent on AZT expired in 2005… This allowed other companies to produce generic AZT without paying royalties to GSK… Everybody’s quite happy: 1. GSK got away with patent infringement 2. Other Industries are happy with production rights and no royalty 3. Public is happy with low price

END! Questions?????