The follow-on biologics bill recently unveiled by Rep. Henry Waxman (D-Calif.) and Sen. Chuck Schumer (D-N.Y.) would create an "unfavorable" intellectual property environment for innovators, Wyeth Senior Regulatory Attorney Cecilia Burke suggests.

Burke outlined her initial take on the bill during an Oct. 19 presentation at a National Association of Chain Drug Stores conference on biopharmaceuticals in Philadelphia. She pointed to the absence of provisions for a stay of approval during patent litigation and the bill's silence on data exclusivity as areas that have drawn her attention.

The legislation (HR 6257/S 4016) would create an approval process for follow-on biologics that differs fundamentally from the current system for approving generic versions of small molecule drugs (¹ Also see "Biogenerics Bill Differs From ANDA System In Exclusivity, Patent Listing" - Pink Sheet, 9 October, 2006., p. 5). It would define two categories of follow-ons: "interchangeable" and "comparable."

Most stakeholders, on both the brand and generic sides, view the bill as a starting point for discussion, and many are just beginning to take stock of the measure's provisions and their implications.

Rep. Waxman met with some member companies of the Pharmaceutical Research & Manufacturers of America while drafting the "Access to Life-Saving Medicine Act" and plans to meet with brand representatives soon to discuss the proposal further.

Unlike the Hatch-Waxman generic drug statute, "which had a 30-month stay of any kind of approval if there was patent litigation, there is no equivalent stay in this legislation," Burke commented.

The bill proposes a new patent listing and notification procedure whereby applicants for follow-on biologics would obtain a list of patents related to the reference product from the brand company.

The bill's procedures are intended to avoid perceived abuses seen with the patent listing system for drugs, including the listing of irrelevant patents that allowed for multiple 30-month stays. Waxman's aides indicated the bill also seeks to avoid stumbling blocks that arose in the attempts to correct the problem of multiple stays.

The Medicare Modernization Act generally limits innovators to a single 30-month stay. FDA has seen a drop in the number of disputes over "Orange Book" listings and the number of patents listed since that provision took effect (² [A#00670440013], p. 21).

But courts have stifled a second reform contained in MMA that allows companies to file declaratory judgment actions in order to gain patent certainty or trigger another firm's exclusivity (³ Also see "Generic Exclusivity Forfeiture Provision Hits Snag In Courts; FTC Wants Fix" - Pink Sheet, 25 September, 2006., p. 15). Since MMA, brand companies have failed to file timely infringement actions unless a 30-month stay exists and, as a result, generic launches have been delayed due to the fear of treble damages, Waxman's office said.

The follow-on biologics bill aims to avoid such problems by allowing generic companies to choose which patents must be litigated for launch of a follow-on.

The proposed system also would add disincentives for innovators failing to file timely infringement suits. Patents would not be enforceable if they are not on the innovator's list provided to a follow-on applicant. Further, if a patent owner fails to file an infringement action within 45 days of receiving notice from the applicant, potential remedies are limited to a "reasonable royalty."

Wyeth's Burke pointed to the bill's silence on data exclusivity as a shortcoming. The generic drug statute "allowed some years of data exclusivity for new chemical entities in order to give an incentive for research and development," she said. "This act doesn't have any kind of parallel data exclusivity provision for innovators."

Such exclusivity was most likely excluded because it conflicts with the goal of moving follow-on products to market as quickly as possible.

Under the bill's exclusivity provisions for interchangeable products, a second follow-on product can receive approval if the sponsor demonstrates interchangeability but concedes to a comparable designation. Waxman's office explained that exclusivity for first approved applicants was "kept small" because exclusivity does not allocate costs proportionately, with the largest burden borne by the uninsured.

Waxman believes that the bill's tax incentives for interchangeability studies are a fairer method than exclusivity for subsidizing such research.

- John Rancourt

Follow-On Biologics Bill IP Provisions Are “Unfavorable” – Wyeth Attorney

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