Download Pharma v. Pharma

Pharma v. Pharma or Pharma & Pharma:
The Legal Interface Between the Makers of
Original and Copied Versions of Medicines
Innovators, Generic Drug Makers,
Exclusivity Provisions, Antitrust Prohibitions,
New Biologics Regulatory Pathways: Policy
Alternatives for Navigating the Maze
AIPLA Antitrust, Biotechnology and
Chemical Practice Committees
© 2008 Dechert LLP
October 23, 2008
What is a “generic drug” and what makes
generic drug competition unique?
• What is a “generic drug” and how does it get to
market?
– ANDAs, bioequivalence, and substitutability.
• How does generic drug competition differ from
other types of competition?
– Pricing differences after generic launch.
– Market share changes.
– Residual value of trademarks & goodwill.
– Role of third-party payors in healthcare.
2
Will “follow-on biologics” (FOBs) differ from
“generic drugs,” if Congress authorizes them?
• Why might the FDA approval pathway for biologics
differ from the Hatch-Waxman (H-W) pathway for
drugs?
– Bioequivalence for drugs v. interchangeability for biologics.
– Data package needed for follow-on products.
– Would a standard less than interchangeability suffice?
• Should a law today account for new technology
developed in the future?
– Explicit statutory standards vs. FDA regulatory flexibility.
– What will change by 2020? 2030?
3
FDA approval of full NDAs and Abbreviated
NDAs (ANDAs): Non-patent “exclusivity”
• Key provisions that delay FDA approvals:
– Orphan drug: First NDA approval for an “orphan indication”
bars approval of the same drug for the indication for 7 years.
– Pediatric: All patent or non-patent exclusivity periods that
otherwise exist are extended for a further 6 months.
– ANDA moratorium: No ANDA can be filed during the 4-year
period after the NDA approval for an NCE drug.
– Linkage stay: If a patent challenge is made in an ANDA and a
lawsuit filed within 45 days, the ANDA approval is stayed for
up 30 months if needed to resolve infringement issues.
– First-filing generic: No other ANDA can be approved until 180
days after the first-filing generic company starts marketing.
4
Would H-W exclusivity, linkage provisions
provide the best model for FOBs?
• Has non-patent exclusivity for drugs under HatchWaxman worked well enough to be a model?
– Data package exclusivity: ANDA moratorium periods.
– Linkage exclusivity: 30-month litigation stays.
• What other options might Congress consider?
– Eliminate data & linkage exclusivity: depend only on patents.
– 14+ years of data exclusivity, tied to H-W patent term
restoration cap.
• Should non-patent exclusivity period under H-W for
small molecules be re-visited?
5
Should generic/FOB manufacturers have
registration exclusivity periods?
• How does generic/FOB exclusivity registration
differ from data package exclusivity?
– What policy goals should registration exclusivity
achieve?
– What problems does Hatch-Waxman 180-day
exclusivity create?
• How would elimination of market exclusivity
change generic business models?
– Would 14+ years of DPE change the equation?
6
What are “authorized generics”; why do they
exist; and what policy issues do they raise?
• What is an “authorized generic”?
– H-W loopholes; successful defense, failure-to-sue.
• What are the antitrust and policy issues with
authorized generics?
– Does generic exclusivity provide an incentive or
disincentive to challenge innovator patents?
– What if generic exclusivity were abolished?
– Is the FTC correct that an exclusive authorized
generic is an illegal “reverse payment”?
7
Should H-W patent settlements be treated
differently from other civil litigation resolution?
• Should some line be drawn between an
acceptable value to the generic company and
an anticompetitive “reverse payment”?
– OK, but only if anticompetitive effect operates within the
scope of the patent?
– OK, but only if “value” produces a pro-competitive effect in the
market affected by the settlement?
– OK, but only if payment doesn’t exceed reasonable litigation
costs?
– OK, but only if value to the generic company does not exceed
what the generic would have received on entry?
8
Should there be a prohibition on “side deals”?
• OK, if procompetitive in the relevant market
– Example: settlement of foreign patent dispute with early entry
• OK, but only at full value (no subsidy to the
generic)?
• Not OK: Illegal if it provides some value to the
generic and would not have been done “but
for” the settlement?
– See FTC Cephalon complaint
9