Roll Call Authors Unite Against Current Follow Biologics Legislation

September 20, 2009
Patent Docs
By Donald Zuhn

Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed “alarm” regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway (“Don’t Kill Competition for High-Tech Drugs”).  That action included the recent passage by the House Committee on Energy and Commerce of a health care reform bill containing a licensure pathway for biosimilar biological products that would prevent the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed (see “House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period”), and prior approval by the Senate Health, Education, Labor and Pensions (HELP) Committee of an amendment providing a 12-year data exclusivity period for biologic drug makers (see “Senators Champion 12-Year Data Exclusivity in Senate”).

 James Love, the director of the public interest advocacy group Knowledge Ecology International, and James Glassman the former under secretary of State for public diplomacy and public affairs in the George W. Bush administration and editor of Roll Call from 1988-93, contend that passage of FOB provisions by the House Energy and Commerce and Senate HELP Committees would “make it difficult, if not impossible, for generic drugs to compete with biologics, even after patents have expired.”  The authors add that these provisions, if reconciled and passed into law, have “the potential to harm millions of sick people, in the United States and beyond.”

Mr. Love’s and Mr. Glassman’s assertions are based on a comparison of the predicted impact of the House and Senate provisions with that of the Hatch-Waxman Act, which they note provided “streamlined procedures [that] lowered the cost of entry by generic suppliers and created a highly competitive environment that has saved consumers billions of dollars.” According to the authors, the FOB regulatory pathway currently being proposed by Congress is “deeply flawed and will reduce, or even eliminate, potentially significant savings to consumers.”

Mr. Love and Mr. Glassman make it clear that the “flaw” in the process is the exclusivity period, which unlike the 5-year period for small molecule generics under Hatch-Waxman, at present stands at 12-years for biogenerics. They state that “[t]he original proposal for biogenerics would have retained most of the features of the 1984 Hatch-Waxman Act, including the five-year exclusion [i.e., exclusivity period].” However, their assertion is not entirely accurate, since one of the two House FOB bills introduced last spring (H.R. 1548) called for up to 14.5 years of exclusivity (see “Second Follow-on Biologics Bill Is Introduced in House”). It also disregards the White House’s call, in June, for an exclusivity period longer than 5 years (see “White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics”). Instead, the authors argue that “after an intense lobbying campaign by the manufacturers of biologics, new amendments to the Senate and House versions of the bill made it much more difficult for makers of generics to enter the market.” Again, this statement is somewhat disingenuous in that it ignores the fact that Rep. Anna Eshoo (D-CA), who helped introduce the 12-year amendment in the House Energy and Commerce Committee, also introduced H.R. 1548 last spring as well as a similar bill in the last Congress (see “New Follow-on Biologics Bill Introduced in the House”). Thus, Rep. Eshoo did not succumb to “an intense lobbying campaign” in introducing the amendment, but rather has been pushing for a double-digit exclusivity period since March of 2008. (In fact, in proposing a 12-year period, Rep. Eshoo actually backed off the longer period she had been seeking.)

Noting that “Members of Congress from both parties have claimed that long monopolies are needed to stimulate investments in research and development,” the authors declare their strong disagreement with this position. Although they acknowledge that developmental costs for new biologics are “undoubtedly expensive,” they contend that “this is just as true for products that the FDA classifies as ‘small-molecule,’ or conventional, drugs as it is for biologics.” Mr. Love and Mr. Glassman also argue that “innovation has prospered under the Hatch-Waxman regime.” Biologic manufacturers, however, would likely disagree with these assertions, and Amgen Inc. Vice President and Law & Intellectual Property Officer Stuart Watt did just that last March in a presentation at the Biotechnology Industry Organization (BIO) Intellectual Property Counsels’ Committee (IPCC) conference (see “Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation”).

Mr. Love and Mr. Glassman conclude their article by noting that while Article I, Section 8, Clause 8 of the Constitution confers upon Congress the power “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries,” the Founders “understood the need for balance in creating monopolies that were temporary” — i.e., which existed for limited times. The authors state that “[e]ndless monopolies, particularly those created by regulatory measures, must be avoided,” concluding that “a 12-year exclusion simply does not meet the test of logic.”