WASHINGTON – By providing international patent assistance to small biotechs, the U.S. government could indirectly increase funding for R&D.

That's the case the Biotechnology Industry Organization (BIO) laid out last week at a public hearing on international patent protection for small businesses.

The complexity of patent laws in other countries and biotech's need to protect intellectual property early on drains resources that could be better used for research, Novavax Inc.'s President and CEO Stanley Erck said in testimony submitted on behalf of BIO.

"Including translation costs, the aggregate expense of entering the national stage in Japan, Korea, Europe, Australia and the NAFTA countries can easily exceed $100,000," Erck said. Those costs can double if Brazil, China, India and Russia are added. Once prosecution of a patent begins, foreign attorney fees add another layer of cost.

"Many such costs must be incurred before a biotech company is able to decide whether to maintain or abandon [a patent] application," Erck said. "We have small member companies with 30 or 40 employees who are many years from the market, who must every year reserve for patent prosecution several hundred thousand of their sorely needed dollars."

Those companies would prefer to use that money to advance their science, he added.

BIO's solution is a government loan or grant program similar to those used in other countries to help small businesses defray patent costs both at home and abroad.

Since intellectual property assets "are at least as important as other, more tangible business assets, there is no reason to exempt patent rights from publicly funded small business assistance programs that are available for more tangible assets such as capital equipment, hiring or leasing space," Erck said.

"Extending the range of public assistance programs to patent rights for small businesses would help small biotechs spend money normally allocated to patent filing and prosecution elsewhere," he continued.

The public hearing was held in conjunction with a study the Patent and Trademark Office is conducting on international patent protection for small businesses. The study is required under the patent reform legislation enacted earlier this year. (See BioWorld Today, Sept. 9, 2011.)

FDA's Bioequivalence Rule Challenged

ViroPharma Inc.'s challenge to the FDA's new bioequivalency rule has picked up some support on its way to the U.S. Court of Appeals for the District of Columbia Circuit.

A lower court had dismissed the challenge, saying that ViroPharma didn't have standing because it hadn't been injured yet. In an amicus brief filed last week, the Washington Legal Foundation (WLF) said that those facing imminent injury as a result of FDA action should be able to challenge the action in court.

At the heart of ViroPharma Inc. v. Hamburg is a new rule that makes it easier for generic drugmakers to demonstrate bioequivalency to a brand drug. Originally, the FDA had required bioequivalence, in most instances, to be demonstrated through in vivo testing, but in a May 2008 policy statement, the agency said it had broad discretion to permit in vitro testing whenever it thought such testing was consistent with the public health.

Because in vitro testing is simpler and less expensive than in vivo testing, the change opened the door to swifter approval of generics. Soon after the FDA announced the new policy, 11 separate abbreviated new drug applications were filed for generic versions of ViroPharma's Vancocin (vancomycin) and approval of at least one of those is imminent, according to the WLF. (See BioWorld Today, Oct. 28, 2011.)

The WLF agreed with ViroPharma's claim that the bioequivalency policy effectively amended existing FDA regulations, adding that such amendments require the agency to go through a notice-and-comment process.

The FDA disagreed, saying the change was not an amendment but rather a permissible interpretation of an existing regulation.

"As the size of the administrative state grows, it is important that citizens continue to have a meaningful opportunity to participate in the operation of their government," WLF Chief Counsel Richard Samp said in a press release. The notice-and-comment process "ensures that agencies will be bound not only by congressional laws but also by their own internal rules," he added.

Public-Private Nanotech Partnership Launched

Wanted: Biopharma companies interested in joining a consortium to evaluate promising nanotechnology cancer platforms and facilitate their translation from academic research to clinical development.

Qualifications include having a successful track record of translating diagnostics and drug formulations to approved products and being engaged in developing nanotech-based products.

The consortium is part of the National Cancer Institute's (NCI) new public/private industry partnership to promote translational research and development opportunities of nanotech cancer solutions.

To be called TONIC (Translation of Nanotechnology in Cancer), the consortium will work in parallel with the NCI's Alliance for Nanotechnology in Cancer. It will be charged with setting a roadmap for the development of nanotech cancer products and creating a robust translational model for promising therapies and diagnostics.

Does the FDA's Bar Code Rule Work?

As part of its review of regulations that may be out of date, contradictory or excessively burdensome, the FDA is seeking comment on its 7-year-old bar code rule that requires certain drugs and biologics to have a linear bar code on the label so health care professionals can use scanners to ensure that the right drug is being given to the right patient at the right time.