The importance of data exclusivity in ensuring that developers of biologics receive a reasonable return on investment in the face of competition from follow-on products is stressed by the National Venture Capital Association in comments submitted to the House Energy and Commerce Health Subcommittee.

Data exclusivity and patents are "complementary forms of intellectual property protection," NVCA explains in its response to a panel questionnaire on biosimilars issues (see ¹ Also see "Most Biosimilars Would Need Clinical Trials, ASCO Tells House Panel" - Pink Sheet, 9 June, 2008.).

Patents generally are received prior to the most expensive part of drug development and may expire shortly after a product's approval, NVCA says. If a biosimilar manufacturer has access to the brand product's clinical data, the biosimilar product could come onto the market shortly after the brand product, before the patent holder can achieve a return on investment, the group points out.

Without data exclusivity, "there would be little incentive to invest in developing and marketing new product candidates with few remaining years of patent protection or with uncertain forms of protection."

Data protection also keeps generic firms from using the brand product's supporting data while evading the patent, NVCA says.

Since follow-on biologics would be required to be "similar" but not "identical" to the innovator product, the group notes, it would be possible for a generic manufacturer "to develop a product that is similar enough for approval purposes, but at the same time cleverly designed to avoid infringing the innovator's patents."

Data exclusivity protects the innovator's proprietary data, NVCA says. It does not prevent competition; the generic firm is free to collect its own data.

A sufficient return on investment is necessary to reward venture capital firms for risky investments in biologics, NVCA warns. "FOB legislation without a minimum of 14 years of data exclusivity will adversely affect this risk/reward equation and drive VCs away from funding development of biotechnology."

The European Union provides 11 years of data exclusivity. However, NVCA points out, U.S. per capita biotech R&D expenditures are 574 percent higher than those in Europe. "The European time period of 11 years will not suffice in the U.S. market."

NVCA also suggests that following approval of new indications, innovator biologics should receive an additional period of data exclusivity, and that second-generation and modified products be given the full period of data exclusivity, once approved.

Who Should Disclose What To Whom?

The concept of broad data exclusivity protection should not be used for biologics, Consumers Union contends. Research on drug safety and effectiveness serves "a public health interest that, in our view, supersedes" proprietary rights, the group says. "All studies and clinical trials on innovator biologics should be registered and publicly released."

While not opposed to limited exclusivity on production and manufacturing methods, Consumers Union says this should be tied to the full and expedited disclosure to FOB developers of all data and information on such methods.

To assure a predictable period of full market exclusivity, the group calls for a "hard-and-fast fixed patent-plus-exclusivity period" for innovator biologics. It also urges strict penalties for patent violations.

The Association of American Universities says the five-year data exclusivity period provided by Hatch-Waxman will encourage patent challenges for biologics, just as it has for small molecule generics. The group favors the 12-year period in Senate legislation and the House bill introduced by Reps. Anna Eshoo, D-Calif., and Joe Barton, R-Texas, because such a lengthy term "will reduce the extent of patent litigation and its attendant cost and diversion of resources."

The universities also urge that biosimilars legislation provide fair notice and opportunity for third-party patent holders to participate in the patent identification and enforcement process, and that inventors "be given confidential access to technical information about the proposed biosimilar product and its method of production" in order to determine whether a patent is being infringed.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Biogeneric Exclusivity Debate: At Least 14 Years Or “Hard And Fast” Combo?

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