Manufacturers who enter into biodefense contracts must notify the government within 180 days which patent would be covered by a potential "wild card" extension under the final version of "BioShield II" legislation from Sens. Orrin Hatch (R-Utah), Joe Lieberman (D-Conn.) and Sam Brownback (R-Kan.).

"Not later than 180 days after entering a contract with the Secretary of Health & Human Services...or with the Secretary of Homeland Security...for the procurement of a countermeasure" for which a patent extension is available "the entity that enters such contract shall notify such appropriate Secretary of the patent that would be extended if such entity" received a patent extension, the ^FDL-1 bill (S 975) states.

Under the legislation introduced April 28, if a company develops a product that is deemed to have biodefense utility, the HHS Secretary may grant it an exclusivity extension of six months to two years to use on another of the company's products (¹ Also see "Patent Extension “Wild Card” In Hatch/Lieberman Bill Depends On Five Factors" - Pink Sheet, 4 April, 2005., p. 27).

The 180-day clause, which was a late addition to the legislation, is designed to provide generic firms with advance notice of therapies under consideration for patent extension.

The Generic Pharmaceutical Association remains opposed to the wild card provision, especially the "overly broad definition" of a countermeasure and the ability of a manufacturer to apply the extension to "any product in a company's portfolio," the group said.

Provisions in the bill "would provide substantial and unnecessary windfalls to the brand pharmaceutical industry and impose a tremendous and needless burden on the nation's health care system," GPhA said in an April 29 letter.

The Pharmaceutical Care Management Association, the pharmacy benefit manager group, also raised some concern with the wild card extension.

"Based upon an initial review of the legislation, PCMA has serious concern that patent extension provisions contained in the proposal could have the unintended consequence of increasing prescription drug costs for consumers and purchasers throughout the entire health care system," the group said in a May 3 letter.

The bill is an extension of the Senate leadership's biodefense placeholder bill (^FDL-2 S 3) introduced by Sen. Judd Gregg (R-N.H.) Jan. 24 (² Also see "FDA “Rapid-Action” Team, Pre-Emption Included In GOP Bioterror Bill" - Pink Sheet, 31 January, 2005., p. 29).

Six Senate committees will process S 975: Health, Education, Labor & Pensions; Finance; Judiciary; Homeland Security & Government Affairs; Agriculture; and Banking, Lieberman's office said.

Senate Majority Leader Bill Frist (R-Tenn.) will "ensure that all of the committees take up their elements of the bill and report on them in a timely manner so that he can offer an 'amendment in the nature of a substitute' for S 3 on the floor," Lieberman's office said.

The final version of the Hatch/Lieberman bill also includes an ownership provision relating to patent extensions.

Under the legislation, a patent eligible for an extension is defined as "a patent that at the time the eligible entity entered into the contract to develop such countermeasure product, was owned by or licensed to that eligible entity."

The provision is designed to prevent patent extensions for firms which bought or merged with a countermeasure developer during the 180-day period.

Another bill on development of bioterror countermeasures is expected from Senate Health Committee Chairman Michael Enzi (R-Wyo.). Enzi appears interested in exploring the handling of wild card patents in developing a bill.

The various bills are intended to expand on the "BioShield" act signed into law by President Bush in 2004.

Sen. Richard Burr (R-N.C.), chair of the Health Committee's newly formed Bioterrorism & Public Health Preparedness Subcommittee, is likely to play a prominent role in crafting legislation.

Burr is understood to be planning hearings on the issue, possibly beginning in June.

Hatch/Lieberman “BioShield II” Sets 180-Day Window For “Wild Card” Patents

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