Making the Intellectual Property case to New Democrats

by Caroline Joiner

Earlier today, the Global Intellectual Property Center held a Congressional briefing with the New Democrat Coalition to discuss the importance of IP as a job creator and solution to global challenges.  Among the panel participants was Michael Atieh, who serves as Executive Vice President and Chief Financial Officer of OSI Pharmaceuticals, a 500-employee biotechnology company based in Melville, NY.

Below is Mr. Atieh's perspective on the IP challenges facing OSI:

The story of OSI demonstrates the critical need of having strong intellectual property laws as a foundation on which to build an innovative enterprise committed to discovering, developing and commercializing novel pharmaceutical products for patients with cancer and diabetes/obesity. Our flagship product, Tarceva®, was the first drug discovered and developed by OSI, and is the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients.

In addition, OSI's diabetes and obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity.  By the end of this year, we will have four drugs in Phase I clinical trials – two targeted therapies for the treatment of cancer, one for diabetes and one for obesity.   Our research efforts are conducted by 300 scientists, PhDs and MD’s in New York, Colorado and Oxford, UK.

By all measures, OSI has become a top-tier biotechnology company that is both scientifically strong and financially successful.  However, that was not always the case and the story of our success is an integral part of the discussion today on intellectual property protection and innovation.

Twenty years ago, OSI became a public company by initially raising $16 million and listing on the NASDAQ.  Since 1987, OSI has raised approximately $1.6 billion in capital in order to fund our R&D efforts as we searched for our first breakthrough drug.  Our efforts were rewarded when Tarceva, a breakthrough treatment for lung and pancreatic cancers was discovered and then ultimately developed with our partners, Genentech and Roche.

Tarceva is now approved in 85 countries and had global sales of approximately $900 million in 2007.  Together with our partners, OSI has committed approximately $750 million to the global development program for Tarceva, and there are now over 250 studies investigating Tarceva uses around the world.  More importantly, Tarceva is having a major impact on global healthcare, with approximately 250,000 lung and pancreatic cancer patients treated, potentially adding 40,000 years of survival benefit.

It has been a long, difficult, but exciting journey as OSI has transformed itself into a top-tier biotech company.  Our success is especially significant when you consider that there are currently approximately 1,400 biotech companies around the world, with roughly 360 being public entities and only 50 or so that have achieved profitability. OSI’s success could have only happened with the help of investors willing to risk their capital in the hope that OSI scientists would discover a drug and that this breakthrough would be protected by strong intellectual property laws around the world.

However, there are disturbing developments occurring in the U.S. and other countries where both governments and the generic industry are employing aggressive tactics to challenge intellectual property.  As an example, in India, Tarceva was one of the first drugs granted a patent following India’s 2005 amendment of their patent laws to conform to the WTO’s agreement on trade-related aspects of intellectual property rights.  However, even with this patent protection, a major Indian generics manufacturer was recently given approval to launch a generic version of Tarceva.

We believe it is critical for the U.S. to play the leading role in ensuring that intellectual property is protected around the globe.  However, even here is the U.S., intellectual property is under attack. As Congress continues its work, I urge them to establish an environment where American innovation can flourish.  In doing so, our leaders will be helping US biotech companies that want to one day tell a story similar to OSI’s, where their breakthrough drug has alleviated disease and patient suffering.