By
Donald Zuhn —

In
an online paper
published by the New England Journal of Medicine on Wednesday, a New York
patent attorney and two Harvard professors contend that follow-on biologics (FOB)
legislation being proposed in the House and Senate, which provides 12 years of
data exclusivity, would "upset[] the delicate balance between the
interests of consumers and those of innovators."  The paper was authored by Alfred
Engelberg, a New York patent attorney who represented the Generic
Pharmaceutical Industry Association and played a role in the passage of the
Hatch-Waxman Act in 1984; Dr. Aaron Kesselheim,
a patent attorney and Instructor in Medicine at the Harvard Medical School; and
Dr. Jerry Avorn, a Professor of
Medicine at the Harvard Medical School. 
The authors point to issues involving interchangeability and the impact
of the European biosimilars regulatory pathway on biologic sales (i.e.,
follow-on biologics, or biosimilars, have led to biologic price reductions of
between 25-30% as compared with innovator small molecule price reductions of up to 80%),
and contend that under an FOB regulatory scheme, "even after all patent
and exclusivity rights have expired and a biosimilar product is eventually
approved, innovator companies would maintain a substantial revenue stream in
the new system."  The authors
also argue that "[e]ven if the new legislation is adopted, manufacturers
of potential follow-on products would probably prefer to ignore the new pathway
and opt to file a standard BLA, which would not be subject to the 12-year delay,"
and therefore contend that "as currently fashioned, the biosimilar
legislation would have no value, because it would create a pathway that would
scarcely be used."

In
support of their argument, the authors cite the Federal Trade Commission (FTC)
report on follow-on biologics that was released in June (see "No One Seems Happy with Follow-on Biologics According to
the FTC"), admonising Congress for
"ignoring" the recommendations made in that report.  The authors also argue that:

[T]he
pharmaceutical industry's demand for a 12-year exclusivity period builds on one
of the glaring failures of the Waxman–Hatch Act.  The act allows innovator companies to delay competition from
generics for 30 months merely by asserting that their patents were infringed,
even if this claim is not borne out. 
Manufacturers of brand-name drugs have responded by seeking and
obtaining many patents of questionable validity, engaging in frequent and
costly patent litigation, and using litigated patents as vehicles for
settlements in which they pay the manufacturers of potentially competitive
generics to refrain from challenging their patents.  Congress is now considering additional legislation to
prevent these abuses, which allow questionable patents to extend exclusivity
improperly.  For biologic products,
innovators seek — and Congress seems willing to grant — an iron-clad 12-year
exclusivity period that would essentially eliminate the need to defend any patents.

The
paper suggests that the legislation currently being proposed in the House and Senate be
amended to "give the FDA the mandate to evaluate and approve biosimilar
drugs in a reasonable period, starting, as with small-molecule products, 5 years
after the approval of the original drug," and concludes that "[s]uch a
compromise would best balance the need for financial incentives with the need
for competition, promoting access and motivating important subsequent
innovation."

Patent Docs
thanks Kurt Karst of the FDA Law Blog for bringing this article to our
attention.