Ginger R. Dreger

Dreger's world spans the globe and it takes constant monitoring to stay ahead of the rapidly shifting patent landscape.

Among her clients, she represents Genentech Inc. - both domestically and abroad -with the prosecution of patent portfolios that are critical for the protection of key oncology products. Dreger also represents the company in proceedings throughout the world, defending its patents against challenges by third parties, including generic companies.

Her work takes her before the European Patent Office and other venues, such as Australia, India, Israel, as well as in South Africa and China.

Throughout her travels, Dreger said that she never loses sight of the big picture.

"In the years to come, a large number of biopharmaceutical products are about to lose patent protection," she said.

This, she added, opens the way for biosimilars - biologic drugs that are similar, but not identical, to previously approved drugs that can be marketed after the expiration of the innovator company's patents covering the drugs.

"Regulators have been grappling with developing guidelines for the approval of biosimilar drugs," Dreger said. "Relevant legislation and how the laws are being implemented are still in a stage of development," she said.

Developers of biosimilar drugs, Dreger said, often don't wait until the expiration of patents covering biologic drugs.

"Innovator companies and IP attorneys are facing significant challenges in defending such patents worldwide," she said.

There also are significant policy issues associated with the emergence of biosimilars, Dreger said, noting that in some countries, biosimilars are being "met with sympathy."

"The argument with their going to market is that drug prices will fall," Dreger said. "On the other hand, if innovators are not able to enforce their patents, there won't be any incentive or money to invest in the development of new drugs."

The issue, she added, is how countries can find a balance between these two considerations.

"It gives us an opportunity to learn a lot and be in the forefront of really tacking issues that are being raised," she said.

- PAT BRODERICK

<!-- Ginger R. Dreger -->