In
This Issue:
· Acorda Therapeutics v. Mylan Pharma: ANDA Filers Beware
· FTC Files Complaint Against Endo, Other Drugmakers for Blocking Consumer
Access to Generics
· Ferring Pharms, Inc. v. Burwell
· Amgen Seeks to Compel Sandoz to Participate in “Patent Dance”
Contact Us:
Walter
Schlapkohl, Ph.D., Esq.
wschlapkohl@gbpatent.com
703-716-1191 (phone)
703-716-1180 (fax) |
Acorda Therapeutics v. Mylan Pharma: ANDA Filers Beware
On March 18, 2016, the Federal Circuit affirmed a district
court’s decision that the filing of an abbreviated new drug application (ANDA)
for a generic drug with FDA opens the door to personal jurisdiction in any
state where the generic drug will be marketed if approved.
The Federal Circuit’s ruling involved two actions on
appeal from the District of Delaware against generic drug manufacturer Mylan
Pharmaceuticals, Inc., one by brand-name drug manufacturers Acorda
Therapeutics Inc. and Alkermes Pharma Ireland Ltd., and the other by
AstraZeneca AB.
Acorda, Alkermes, and AstraZeneca had sued for patent
infringement under 35 U.S.C. § 271(e)(2). Mylan had moved to dismiss the cases on the ground that the State of
Delaware – and therefore the federal district court in Delaware – could not exercise
personal jurisdiction over Mylan in these cases under the Due Process Clause
of the Fourteenth Amendment.
The Due Process Clause standards permit a state to
exercise specific personal jurisdiction over a defendant when the defendant
has certain “minimum contacts” with the state such that the maintenance of
the suit does not offend “traditional notions of fair play and substantial
justice.”
Although Mylan is incorporated in West Virginia and has its
principal place of business there, Mylan sent notices to AstraZeneca’s
subsidiary in Delaware. Mylan also
appointed an agent to accept service in Delaware. Of particular importance to the case, Mylan
intends to direct sales of its drugs into Delaware upon approval.
In view of the above, the Federal Circuit affirmed the
lower court’s rulings that Mylan had sufficient contacts related to the
subject matter of these cases such that Delaware could exercise specific
personal jurisdiction over Mylan.
The implications of the decision are consequential. It now appears that the filing of an ANDA may
essentially opens the door to suit filers in any state in the Union where a
generic drug company intends to market an FDA-approved drug.
FTC Files Complaint Against Endo, Other Drugmakers for
Blocking Consumer Access to Generics
Endo Pharmaceuticals
Inc. and several other drug manufacturers were sued by antitrust regulators
on March 30, 2016, in a complaint filed by the Federal Trade Commission (FTC)
in the U.S. District Court for the Eastern District of Pennsylvania.
The complaint
alleges that Endo; Endo International PLC; Teikoku Pharma USA, Inc.; Teikoku
Seiyaku Co., Ltd.; Watson Laboratories, Inc.; Allergan PLC; and Impax
Laboratories, Inc. were parties to anticompetitive reverse-payment agreements
orchestrated by Endo, and that these agreements violated antitrust law by
blocking access to generics of two brand-name drugs: Opana ER and Lidoderm.
In a statement
issued on March 31, 2016, the FTC asserted that the “enforcement action is
the first FTC case challenging an agreement not to market an authorized
generic – often called a ‘no-AG commitment’ – as a form of reverse
payment.” In the statement, FTC
Chairwoman Edith Ramirez also states that such pay-for-delay settlements harm
consumers twice – “first by delaying the entry of the generic drugs and then
by preventing additional generic competition in the market following generic
entry.”
Ferring Pharms., Inc.
v. Burwell
In a memorandum opinion issued March 15, 2016, the U.S.
District Court for the District of Columbia granted FDA summary judgement on
its interpretation of “drug” to mean “drug product” (rather than “drug
substance”) under the five-year exclusivity provisions for new chemical
entities of the Federal Food, Drug, and Cosmetic Act (FDCA).
Ferring Phaarmaceuticals, Inc. manufactures PREPOPIK, a
combination drug product that contains three substances: sodium picosulfate,
magnesium oxide, and anhydrous citric acid. The drug is intended for use in cleansing the colon in preparation for
colonoscopy. Ferring sought five-year
marketing exclusivity because one of the substances, sodium picosulfate, had
never been approved by FDA in a new drug application. FDA determined that PREPOPIK was not
entitled to five-year marketing exclusivity because two of the active
ingredients had previously been approved for market.
In response, Ferring filed a Petition for Reconsideration
and a separate Citizen Petition with FDA, which resulted in FDA’s change in
position on the matter as to prospective applicants, but not Ferring.
By statute, a five-year period of marketing exclusivity
may be obtained “for a drug, no
active ingredient (including any ester or salt of the active ingredient) of
which has been approved in any other application,” 21 U.S.C. §355(j)(5)(F)(ii)
(emphasis added).
Among other things, Ferring challenged FDA’s (old) interpretation
of the five-year exclusivity provisions as contrary to the plain language of
the FDCA or an unreasonable interpretation of statutory ambiguity.
However, the court found nothing in the statute compelling
a particular definition for “drug” as set forth in the five-year exclusivity
provisions. Further to this, the court
found that FDA’s (old) interpretation of the term “drug” as referring to a
“drug product” was reasonable.
However, Ferring also argued that FDA’s refusal to apply
its new interpretation of “drug” as referring to a “drug substance”
retroactive to it was arbitrary and capricious. On this point, the court directed the parties
to file renewed motions for summary judgement that more fully address the
retroactivity issue. Thus, Ferring’s
ultimate fate with regard to PREPONIK remains to be determined.
Amgen Seeks to Compel Sandoz to Participate in Biosimilars
“Patent Dance”
In a complaint
filed on March 4, 2016, (New Jersey Civil Action No. 16-cv-01276), Amgen
seeks a declaration that Sandoz has failed to participate in the patent
information exchange provisions, also known as the “patent dance” under the
Biologics Price Competition and Innovation Act (“BPCIA”). Amgen also seeks an order to compel Sandoz to
participate. The Amgen complaint
raises two issues of interest to biosimilar stakeholders. First, the complaint seeks to address the
question of whether a biosimilar applicant must participate in the “patent
dance” after providing the reference product sponsor with its application and
manufacturing information (as well as its contentions regarding invalidity,
unenforceability, and non-infringement). Second, Amgen raises the issue of whether a biosimilar applicant’s
decision not to participate requires the reference product sponsor to file a
suit for patent infringement earlier than it otherwise would have under the
BPCIA, i.e., prior to the negotiation and exchange of patent lists that are
part of the “patent dance.” |
