SUPREME COURT CARACO V.
NOVO NORDISK DECISION
The United
States Supreme Court ruled on April 17, 2012, in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk, A/S, (Case
No. 10-844), that a generic manufacturer may counterclaim against the name
brand to force correction of an Orange Book “use code” that inaccurately describes the
brand’s patent as covering a particular method of using a drug.
The FDA
requires the New Drug Application (“NDA”) holder to list the patents that it
believes cover the reference drug product in what is commonly referred to as
the “Orange Book”. The NDA holder must
also include a “use code,” which is a brief description of the scope of the
patents that are listed. The FDA uses
this information, when evaluating an Abbreviated New Drug Application
(“ANDA”) submitted by a generic drug manufacturer, to determine whether the
ANDA would infringe the NDA’s listed patents or may be approved.
In the
present case, the FDA approved three “uses” of the active ingredient
(repaglinide) to treat diabetes, namely, use of the active ingredient alone,
in combination with metformin, or in combination with another drug. The Novo
Nordisk Orange Book listed patent covers only the use of the active
ingredient with metformin – but Novo Nordisk changed the use code to cover
all three “uses.” Thus, Caraco’s ANDA,
which was directed to using the active ingredient alone, fell within the
scope of the use code, permitting the NDA holder to sue Caraco under the
Hatch-Waxman statutory scheme.
Caraco
brought a counterclaim seeking to require Novo Nordisk to amend its use code
to reflect the active ingredient and metformin, which would permit FDA to approve its ANDA. The lower court granted Caraco’s request,
but the Federal Circuit reversed.
The Supreme
Court sided with Caraco, reversing the Federal Circuit and concluding that a
counterclaim may be filed whenever the Orange Book listed patent does not
claim a method of use for which the ANDA applicant seeks to market the
generic drug.
NEWS
· BIOSIMILAR UPDATE FROM FDA: FDA held a public hearing
on May 11, 2012 regarding the Draft Guidance documents related to the development
of biosimilar products. There were
multiple presenters. The topics
discussed included: (i) requiring clinical trials; (ii) determining what
constitutes a “protein” on a case-by-case
basis; (iii) naming strategies for biosimilars; (iv) trade secret
protections; (v) 12 year market exclusivity; and (vi) using non-US reference comparator products
in biosimilar applications. An archive
of the webcast may be found at the FDA website at http://www.fda.gov/Drugs/NewsEvents/ucm265628.htm.
· Baxter International is collaborating with
Chatham Therapeutics to develop a hemophilia B gene therapy treatment. Baxter paid $25 million to advance the
program through early clinical trials, with additional money to be paid in
view of development/commercial milestones.
· GSK continues its efforts to take over Human Genome Sciences Inc. HGS rejected a $2.6 billion hostile
takeover bid by GSK May 17, 2012. GSK
extended its unsolicited tender offer of $13 per share of HGS to June 29,
2012.
· Amylin has rejected a $3.5 billion buyout offer from Bristol-Myers. It remains to be seen whether Bristol-Myers
will try to increase its offer or whether AstraZeneca, Sanofi, Merck and
Takeda will try to bid for Amylin. |
