SIZE MATTERS
JUSTIFYING SIZEABLE REVERSE
PAYMENTS IN PATENT
DISPUTES
4th September 2016
EPIP 2016, Oxford
A4 - Improving Patent Systems
ANTITRUST VS PATENT
LAW
REVERSE PAYMENTS
POLICING PATENTS
THE LIMITS OF REASON
“[The Constitution’s art. I., § 8, cl. 8] Patent Clause itself reflects a balance
between the need to encourage innovation and the avoidance of
monopolies which stifle competition without any concomitant advance in
the ‘Progress of Science and useful Arts.’”
Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. (1989)
ANTITRUST VS PATENT LAW
ANTITRUST VS PATENT LAW
Patents are
barriers to entry
Patents are esssential
incentives
THE OSTENSIBLY IRRECONSIABLE TENSION
ANTITRUST VS PATENT LAW
Competition law and patents care about
dynamic markets
THE REALITY
ANTITRUST VS PATENT
LAW
REVERSE PAYMENTS
POLICING PATENTS
THE LIMITS OF REASON
REVERSE PAYMENTS
A patent
holder
THE DEAL
+ A claimed
infringement = A dispute
+ Consideration
to infringer
= A reverse
payment
i.e.
pay-to-delay
145 finalized patent settlements
29 were suspected for
potential pay-for-delay
2013
REVERSE PAYMENTS
Drug Price Competition and Patent Term Restoration Act i.e.
Hatch-Waxman Act of 1984
THE BATTLE GROUND: FIRST FILER ADVANTAGE
Abbreviated New Drug Application
certify that the patent in question is invalid or is not infringed by
the generic product and notify rights holder
180 day exclusivity
first filer gets 180 days marketing exclusivity, typically
worth millions
REVERSE PAYMENTS
ANTITRUST VS PATENT
LAW
REVERSE PAYMENTS
THE LIMITS OF REASON
POLICING PATENTS
Surely a formal agreement limiting
competition between two rivals is
unredeemable?
PRIMA FACIE
THE LIMITS OF REASON
ACTAVIS 2013
Settlements promote efficiency
THE LIMITS OF REASON
Exclusion can happen within the scope of the patent
Unusual form of settlement prone to cause harm
Not per se unlawful, but not immune from antitrust scrutiny
Courts to apply the rule of reason approach
ACTAVIS 2013
Unexplained size of payment can be a signal of collusion
THE LIMITS OF REASON
Unexplained size can be a signal of a weak patent
Has the brand conveyed to the generic a type of consideration
not available as a direct consequence of winning the lawsuit?
The size
Money
No-authorized-generic
The form
Procompetitive effects?
the typical litigation fees, inclusive of
translation and other services, range
from $2.65 million to $6 million with
generic manufacturer incurring costs of
$10 million during each litigation effort
on average
MEASURING UP
ANTITRUST VS PATENT
LAW
REVERSE PAYMENTS
THE LIMITS OF REASON
POLICING PATENTS
McDonald:
all patent settlements preclude a
judicial resolution by definition
THE MORAL WRONG
POLICING PATENTS
Reasoner:
Too great a willingness to find antitrust violations in
settlement arrangements would significantly inhibit
settlements of many types of cases at real cost to the
administration of justice, with little likelihood of any
countervailing benefit to the public interest
Does a competitor have the duty to go
forward with an invalidation suit?
OPEN QUESTIONS
POLICING PATENTS
Should reverse payments be
apportioned in accordance to estimated
probabilities of success in litigation?
How about a first filer?
Thank you
T. Alexander Puutio
alexander.puutio@gmail.com
,puutio@un.org
4th September 2016
EPIP 2016, Oxford
A4 - Improving Patent Systems

Size matters:Reverse payment settlements in patent disputes

  • 1.
    SIZE MATTERS JUSTIFYING SIZEABLEREVERSE PAYMENTS IN PATENT DISPUTES 4th September 2016 EPIP 2016, Oxford A4 - Improving Patent Systems
  • 2.
    ANTITRUST VS PATENT LAW REVERSEPAYMENTS POLICING PATENTS THE LIMITS OF REASON
  • 3.
    “[The Constitution’s art.I., § 8, cl. 8] Patent Clause itself reflects a balance between the need to encourage innovation and the avoidance of monopolies which stifle competition without any concomitant advance in the ‘Progress of Science and useful Arts.’” Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. (1989) ANTITRUST VS PATENT LAW
  • 4.
    ANTITRUST VS PATENTLAW Patents are barriers to entry Patents are esssential incentives THE OSTENSIBLY IRRECONSIABLE TENSION
  • 5.
    ANTITRUST VS PATENTLAW Competition law and patents care about dynamic markets THE REALITY
  • 6.
    ANTITRUST VS PATENT LAW REVERSEPAYMENTS POLICING PATENTS THE LIMITS OF REASON
  • 7.
    REVERSE PAYMENTS A patent holder THEDEAL + A claimed infringement = A dispute + Consideration to infringer = A reverse payment i.e. pay-to-delay
  • 8.
    145 finalized patentsettlements 29 were suspected for potential pay-for-delay 2013 REVERSE PAYMENTS
  • 9.
    Drug Price Competitionand Patent Term Restoration Act i.e. Hatch-Waxman Act of 1984 THE BATTLE GROUND: FIRST FILER ADVANTAGE Abbreviated New Drug Application certify that the patent in question is invalid or is not infringed by the generic product and notify rights holder 180 day exclusivity first filer gets 180 days marketing exclusivity, typically worth millions REVERSE PAYMENTS
  • 10.
    ANTITRUST VS PATENT LAW REVERSEPAYMENTS THE LIMITS OF REASON POLICING PATENTS
  • 11.
    Surely a formalagreement limiting competition between two rivals is unredeemable? PRIMA FACIE THE LIMITS OF REASON
  • 12.
    ACTAVIS 2013 Settlements promoteefficiency THE LIMITS OF REASON Exclusion can happen within the scope of the patent Unusual form of settlement prone to cause harm Not per se unlawful, but not immune from antitrust scrutiny Courts to apply the rule of reason approach
  • 13.
    ACTAVIS 2013 Unexplained sizeof payment can be a signal of collusion THE LIMITS OF REASON Unexplained size can be a signal of a weak patent Has the brand conveyed to the generic a type of consideration not available as a direct consequence of winning the lawsuit? The size Money No-authorized-generic The form Procompetitive effects?
  • 14.
    the typical litigationfees, inclusive of translation and other services, range from $2.65 million to $6 million with generic manufacturer incurring costs of $10 million during each litigation effort on average MEASURING UP
  • 15.
    ANTITRUST VS PATENT LAW REVERSEPAYMENTS THE LIMITS OF REASON POLICING PATENTS
  • 16.
    McDonald: all patent settlementspreclude a judicial resolution by definition THE MORAL WRONG POLICING PATENTS Reasoner: Too great a willingness to find antitrust violations in settlement arrangements would significantly inhibit settlements of many types of cases at real cost to the administration of justice, with little likelihood of any countervailing benefit to the public interest
  • 17.
    Does a competitorhave the duty to go forward with an invalidation suit? OPEN QUESTIONS POLICING PATENTS Should reverse payments be apportioned in accordance to estimated probabilities of success in litigation? How about a first filer?
  • 18.
    Thank you T. AlexanderPuutio alexander.puutio@gmail.com ,puutio@un.org 4th September 2016 EPIP 2016, Oxford A4 - Improving Patent Systems

Editor's Notes

  • #13 Solvay Androgel – Actavis claims para IV