Under a draft "BioShield II" bill from Sens. Orrin Hatch (R-Utah) and Joe Lieberman (D-Conn.), the length of a "wild card" patent extension would be partially dependent on the availability of alternatives to the bioterrorism countermeasure.

A "wild card" patent extension would allow manufacturers of bioterrorism countermeasure agents to extend a patent on an unrelated product for up to two years based on determinations of the HHS Secretary.

The bill would provide the Secretary with five factors to consider when determining patent extension length, which would be at least six months but no longer than two years.

The Secretary should consider the nature of the bioterrorism threat and the importance of developing the countermeasure; the difficulty, risk and expense associated with development; whether review of safety and effectiveness of the product would require reports from clinical investigations; and the impact of the patent extension on consumers and healthcare providers.

The list is an expansion of factors included in the Senate leadership's biodefense bill (¹ 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).

S 3 lists three factors that HHS should consider in determining the length of the wild card extension: the nature of the threat, the difficulty of development and the impact of the extension on consumers.

The "wild card" provisions in the Hatch/Lieberman draft are also different from those in the biodefense bill that the pair introduced in the last session (³ S 666). That bill set the patent extension period at two years and allowed only small businesses ($750 mil. or less in paid-in capital) to earn patent extensions.

The draft BioShield II bill outlines a number of criteria a patent must meet to be eligible for the extension, including no previous extensions or restorations granted under authority of the bill and no association with any other patent extended for the same product.

These provisions would prevent manufacturers from extending the life of one specific drug for more than two years.

The Generic Pharmaceutical Association is opposed to the "wild card" provision, especially language in S 3 permitting unlimited patent extensions per product. (⁴ [A#00660410024], p. 32).

The group opposed the broad definition of countermeasure found in S 3 that is also included in some sections of the Hatch/Lieberman bill. S 3 refers to countermeasures as products for the diagnosis, treatment and prevention of bioterrorism agents.

"S 3 defines countermeasures so broadly that almost every drug in most people's medicine cabinets would qualify," GPhA said in a letter critiquing the bill.

"Commonly prescribed drugs that treat headaches, nausea and depression would be eligible for patent extensions with minimal testing performed by the brand manufacturer."

"The result of this legislation would be an additional two-year delay of generic competition for all major blockbuster drugs," the group said.

The draft legislation would also provide for an increased market exclusivity period for countermeasures. Under the bill, a new drug for such a purpose would be granted 10 years of market exclusivity, as opposed to the current five years.

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.

Sen. Richard Burr (R-N.C.), chair of the committee's newly formed Bioterrorism & Public Health Preparedness Subcommittee, is also likely to play a prominent role in crafting legislation. Burr is understood to be planning hearings on the issue, possibly beginning in June.

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

The Hatch/Lieberman draft, which is expected to be introduced in the next several weeks, is approximately twice as long as last session's S 666. Many of the intellectual property sections reappear with some modifications; the major additions focus on regulatory and financing provisions to encourage development of countermeasures.

The bill would grant FDA the authority to designate a countermeasure as a fast-track product and approve the product based solely on preclinical studies.

The bill would direct the Secretary to issue guidelines for the conduct of anti-microbial clinical trials, indicating the correct animal models and in vitro techniques, as well as valid microbiologic surrogate markers.

To assist FDA in evaluating antibiotics for the treatment of targeted pathogens, the legislation would authorize HHS to use $3 mil. to purchase microbiological data.

The draft legislation would create a number of new offices and positions within FDA and HHS.

A newly created Office of the Deputy Commissioner for Biological, Chemical, Nuclear, Radiological & Infectious Diseases would be added to FDA's Office of the Commissioner.

The Deputy Commissioner would direct resources and personnel of the Center for Biologics Evaluation & Research and the Center for Drug Evaluation & Research toward the evaluation of products related to bioterrorism threats.

There would also be the creation, within HHS, of the Office of Public Health Countermeasure Development, headed by an Assistant Secretary, and the creation of a Deputy Director of Medical Countermeasure Development.

An advisory committee chaired by the HHS Secretary and the Department of Defense Secretary would also be created to advise HHS, DoD and the Department of Homeland Security on the establishment of a biodefense, infectious disease, vaccine and research tool industry.

The committee would have the authority to gather relevant information from federal agencies and hold hearings.

The bill would also provide a significant degree of liability protection. Under the legislation, the U.S. government would be liable for claims arising out of the manufacture, distribution or administration of a covered countermeasure.

A number of tax incentives for countermeasure research and investment are also included.

The legislation would provide small businesses with a tax credit equal to 35% of the eligible countermeasure research expenses.

To be eligible for the credit for preclinical research, the firm would need to have a "research plan" filed with the FDA. Eligible expenses would not include any grants, contracts or outside funding by people or governments.

The 35% credit would also apply to countermeasure research expenses incurred at qualified nonprofit or academic institutions including universities, teaching hospitals, foundations and charitable research hospitals.

These expenses would also not include any funding by grant, contract, another person or any government entity.

In addition a taxpayer with an equity investment in a countermeasure research venture would be eligible for a tax credit - 9% of the investment in certain cases.

The bill also includes a "valley of death" section designed to create opportunities for small companies to fund the initial research and development of countermeasures.

Under the clause, HHS could reimburse a small business for costs related to improvement, increase or production of a countermeasure necessary for testing in humans or animals.

HHS could also award grants to small businesses and universities for preliminary screening of compounds and could provide security funding for such entities.

The bill also includes provisions designed to ensure the supply of flu vaccine by having HHS agree to purchase unused doses (see ⁵ Also see "Unused Flu Vaccine Would Be Purchased By HHS Under Draft “BioShield II”" - Pink Sheet, 4 April, 2005. ).

Patent Extension “Wild Card” In Hatch/Lieberman Bill Depends On Five Factors

More from Archive

More from Pink Sheet