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Patent Changes Pending

Originally Published MPMN April 2004

EDITOR'S PAGE

Patent Changes Pending

Wallace Coulter. Harry Coover. Robert Gallo and Luc Montagnier. John Gibbon.
 
Recognize these people? They may not be household names, but their inventions were critical in the development of modern healthcare. Coulter's Counter counts, measures, and evaluates particles suspended in a fluid. It made possible the complete blood-count diagnostic tool. Gibbon created the first heart-lung machine, which enabled the first successful open-heart surgery in 1953. Coover discovered cyanoacrylate adhesives, which allow for the quick closure of wounds. And Gallo and Montagnier both isolated HIV, determining that it was the cause of AIDS. 

To honor their achievements, these men will be inducted into the National Inventors Hall of Fame. In a ceremony on May 1, they will join the ranks of such highly regarded inventors as Thomas Edison, Alexander Graham Bell, and, of course, Roy J. Plunkett.
 
The inventions listed in the National Inventors Hall of Fame database span a wide range--from aspirin to plant hybrids to Velcro. Their inventors, however, all have one important thing in common. Their creations were protected by a patent.
 
In the medical device industry, especially, patents are critical. Holding a patent for a technology or product can be crucial for a start-up company to attract investors. It also provides a company with selling rights to the product or service and enables it to set standards and prices, and recoup R&D expenses. 

But according to the Medical Device Manufacturers Association (MDMA), the quality of patents granted by the U.S. Patent and Trademark Office (PTO) has declined. This has resulted in expensive litigation and uncertainty over legal rights in new products and services. And unless changes are enacted, the PTO predicts that the time a patent is pending will reach 45 months by 2008. 

That's why medical device companies should be concerned with the United States Patent and Trademark Fee Modernization Act of 2003 (HR 1561), which was passed in the U.S. House of Representatives on March 3, 2004. 

HR 1561 will change the way PTO runs by raising user fees and using the revenue to hire additional examiners to reduce backlogs and install new procedures. The bill would increase fees by 15 to 20%, but 100% of the money received would go to the agency. This would end a 12-year practice of diverting PTO user fees to unrelated government programs. Since 1992, more than $650 million in fees paid to the PTO have gone to such other programs. Independent and small-business inventors would still receive the traditional 50% discount on patent filing fees.

"In an industry comprising largely small, start-up companies that have not yet brought a product to market, patents are vital in attracting the necessary investment capital to sustain biological research," says Biotechnology Industry Organization president Carl B. Feldbaum. "Without quality intellectual property rights, many biotech companies would cease to exist."
 
"Passing HR 1561 will provide the necessary user fees to the PTO, so that it can continue to issue the strong, enforceable patents that underpin the biotech industry, which has already brought more than 180 new therapies to market," Feldbaum says.

The bill has been sent to the Senate, which referred it to the Committee on the Judiciary. 

If they approve it, medical device companies will certainly benefit.

And by the way, are you still wondering about Roy J. Plunkett? He invented Teflon.

Susan Wallace, Managing Editor

Copyright ©2004 Medical Product Manufacturing News

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