PTO Not Qualified To Judge FDA Review of "Pipeline" Products - Barr

Proposed legislation to reform the drug patent term restoration process could undercut FDA's "scientific judgements" by transferring undue authority to the Patent and Trademark Office, Sen. Leahy (D-Vt.) said during the Senate Judiciary committee's Aug. 4 hearing, "Pipeline Drugs: Proposed Remedies for Relief in S 1172."

The Drug Patent Term Restoration Review Procedure Act of 1999 (S 1172), introduced in May by Sen. Torricelli (D-N.J.), "proposes to create a new step in the patent review process by allowing the PTO to question and potentially undercut scientific judgements made by the FDA and its advisory committees," Leahy said.

The bill would establish an independent review process within PTO to consider the possibility of patent term restoration for seven pipeline drugs that were under FDA review when Waxman/Hatch was enacted and remained under review for five or more years: Claritin, Relafen, Penetrex, Nimotop, Eulexin, Dermatop and Cardiogen-82 (¹ (Also see "Patent Review Method Should Consider Public Interest Factors - Torricelli" - Pink Sheet, 5 Jul, 1999.)).

In testimony before the committee, Barr Labs Chairman Bruce Downey questioned PTO's qualifications for judging FDA review actions.

S 1172 "would place the technical decisions of the FDA under scrutiny of a separate agency ill-qualified to address them," Downey argued. "At no time during the entire consideration of the legislation has there been a credible demonstration that [PTO] has sufficient knowledge and understanding of the FDA and its processes or pharmaceutical policy to justify this delegation of authority."

The pipeline drugs at issue were granted a two-year patent extension under Waxman/Hatch, instead of the five years granted to drugs approved after 1984. Torricelli's bill creates a process by which the drug manufacturers could be granted an additional three years of patent life.

The Senate legislation is a companion piece to the "Patent Fairness Act" (HR 1598) introduced in the House on May 27 by Reps. Bryant (R-Tenn.) and McDermott (D-Wash.).

Claritin and Eulexin maker Schering-Plough has assumed a lead role in supporting the bill. The firm has attempted to enact patent restoration for Claritin through other mechanisms: the Omnibus Patent Act of 1997, the 1998 Omnibus Appropriations Bill and the 1997 appropriations bill conference process.

Testifying on behalf of the bill, Schering CEO Richard Kogan characterized PTO as "an informed decision maker with expertise on patent matters" and noted that under the proposed legislation, "FDA is given a significant consultative role and PTO has access to all relevant documents and information." He added that PTO "is not put in the position of second-guessing FDA's scientific judgements."

Covington & Burling attorney Peter Barton Hutt also testified in support of the bill, contending that "FDA could not be impartial" with regard to the assessment of regulatory delays inherent in the patent restoration process, as the agency itself could potentially be at fault for a delay.

Hutt went on to take issue with a proposed alternative that would refer patent restoration requests for the seven products to the Federal Court of Claims for resolution (² (Also see "Claims Court Role In Pipeline Patents Urged; Amgen Wants Bolar Limited" - Pink Sheet, 14 Jun, 1999.)). Labeling the approach "unproductive," Hutt noted that the backlog of cases in the courts would likely prevent the patent cases from being heard before the patent terms expired.

Critics of S 1172 cited a recently released study from the Pharmaceutical Research in Management and Economics Institute which found a three-year Claritin patent extension would cost consumers $5.31 bil. between 2002 and 2007. Over the same time period, the bill would cost taxpayers $2.5 bil., and cost Medicare $1.34 bil. "That's nothing to sneeze at," Sen. Leahy commented.

PRIME study author Stephen Schondelmeyer estimates the total cost to consumers from an exclusivity extension for all "pipeline" drugs at $11.1 bil.

The PRIME report includes DayPro as an additional "pipeline" product, though the product has not generally been grouped with the seven other potentially affected pipeline products because its patent expires Aug. 8, making the product ineligible to reap benefits from the legislation.

Schering emphasized that the bill does not guarantee extension, but merely provides the company with the opportunity to present its case (³ (Also see "Broad Waxman/Hatch Reform Could Encompass "Pipeline" Patent Extensions" - Pink Sheet, 9 Aug, 1999.)).