| Legal Proceedings | NOTE 14 – LEGAL
PROCEEDINGS
On
July 15, 2013, the Company received a Paragraph IV Patent
Certification from Watson Laboratories, Inc.—Florida, known
as Actavis Laboratories FL, Inc. (“Watson”), advising
that Watson had filed an Abbreviated New Drug Application
(“ANDA”) with the FDA for a generic version of RAYOS,
containing up to 5 mg of prednisone. Watson has not advised the
Company as to the timing or status of the FDA’s review of its
filing. On August 26, 2013, the Company, together with
Jagotec, filed suit in the United States District Court for the
District of New Jersey against Watson, Actavis Pharma, Inc., Andrx
Corp., and Actavis, Inc. (collectively “WLF”) seeking
an injunction to prevent the approval of the ANDA. The lawsuit
alleges that WLF has infringed U.S. Patent Nos. 6,488,960,
6,677,326, 8,168,218, 8,309,124 and 8,394,407 by filing an ANDA
seeking approval from the FDA to market generic versions of RAYOS
containing 1 mg, 2 mg and 5 mg of prednisone prior to the
expiration of the patents. The subject patents are listed in the
FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book. The commencement of
the patent infringement lawsuit stays, or bars, FDA approval of
WLF’s ANDA for 30 months or until an earlier district court
decision that the subject patents are not infringed or are invalid.
The Company and Jagotec have granted WLF a covenant not to sue with
respect to US Patent Nos. 6,677,326 and 8,168,218, respectively,
and accordingly these patents have been dismissed from the lawsuit.
The court held a claim construction hearing on October 16,
2014, and issued its opinion and order on claim construction on
November 10, 2014, adopting our proposed construction of both
of the disputed claim terms. The court has set the pretrial
conference for September 10, 2015. The trial date will be set
following the pretrial conference.
On
November 13, 2014, the Company received a Paragraph IV Patent
Certification from Watson advising that Watson had filed an ANDA
with the FDA for a generic version of PENNSAID 2%. Watson has not
advised the Company as to the timing or status of the FDA’s
review of its filing. On December 23, 2014, the Company filed
suit in the United States District Court for the District of New
Jersey against Watson seeking an injunction to prevent the approval
of the ANDA. The lawsuit alleges that Watson has infringed U.S.
Patent Nos. 8,217,078, 8,252,838, 8,546,450, 8,563,613, 8,618,164,
and 8,871,809 by filing an ANDA seeking approval from the FDA to
market generic versions of PENNSAID 2% prior to the expiration of
the patents. The subject patents are listed in the FDA’s
Orange Book. The commencement of the patent infringement lawsuit
stays, or bars, FDA approval of Watson’s ANDA for 30 months
or until an earlier district court decision that the subject
patents are not infringed or are invalid. The court has not yet set
a trial date for the Watson action.
On
December 2, 2014, the Company received a Paragraph IV Patent
Certification against Orange Book listed U.S. Patent Nos.
8,217,078, 8,252,838, 8,546,450, 8,563,613, 8,618,164, and
8,741,956 from Paddock Laboratories, LLC (“Paddock”)
advising that Paddock had filed an ANDA with the FDA for a generic
version of PENNSAID 2%. On January 9, 2015, the Company
received from Paddock another Paragraph IV Patent Certification
against newly Orange Book listed U.S. Patent No. 8,871,809. On
January 13, 2015 and January 14, 2015, the Company filed
suits in the United States District Court for the District of New
Jersey and the United States District Court for the District of
Delaware, respectively, against Paddock seeking an injunction to
prevent the approval of the ANDA. The lawsuits alleged that Paddock
has infringed U.S. Patent Nos. 8,217,078, 8,252,838, 8,546,450,
8,563,613, 8,618,164, and 8,871,809 by filing an ANDA seeking
approval from the FDA to market generic versions of PENNSAID 2%
prior to the expiration of the patents.
On May 6,
2015, the Company entered into a settlement and license agreement
(the “Perrigo settlement agreement”) with Perrigo
Company plc and its subsidiary Paddock (collectively,
“Perrigo”), relating to the Company’s on-going
patent infringement litigation. The Perrigo settlement agreement
provides for a full settlement and release by both the Company and
Perrigo of all claims that were or could have been asserted in the
litigation and that arise out of the issues that were the subject
of the litigation or Perrigo’s generic version of PENNSAID
2%.
Under the
Perrigo settlement agreement, the Company granted Perrigo a
non-exclusive license to manufacture and commercialize
Perrigo’s generic version of PENNSAID 2% in the United States
after the license effective date (as defined below) and to take
steps necessary to develop inventory of, and prepare to
commercialize, Perrigo’s generic version of PENNSAID 2%
during certain limited periods prior to the license effective
date.
Under the
Perrigo settlement agreement, the license effective date is
January 10, 2029; however, Perrigo may be able to enter the
market earlier in certain circumstances. Such events relate to the
resolution of any other third party PENNSAID 2% patent litigation,
the entry of other third party generic versions of PENNSAID 2% or
certain substantial reductions in the Company’s PENNSAID 2%
shipments over specified periods of time.
Under the
Perrigo settlement agreement, the Company also agreed not to sue or
assert any claim against Perrigo for infringement of any patent or
patent application owned or controlled by the Company during the
term of the Perrigo settlement agreement based on the manufacture,
use, sale, offer for sale, or importation of Perrigo’s
generic version of PENNSAID 2% in the United States.
In certain
circumstances following the entry of other third party generic
versions of PENNSAID 2%, the Company may be required to supply
Perrigo PENNSAID 2% as its authorized distributor of generic
PENNSAID 2%, with the Company receiving specified percentages of
any net sales by Perrigo. The Company also agreed that if it enters
into any similar agreements with other parties with respect to
generic versions of PENNSAID 2%, the Company will amend the Perrigo
settlement agreement to provide Perrigo with terms that are no less
favorable than those provided to the other parties.
Currently,
patent litigation is pending in the United States District Court
for the District of New Jersey against four generic companies
intending to market VIMOVO before the expiration of patents listed
in the Orange Book. These cases are in the United States District
Court for the District of New Jersey and have been consolidated for
discovery purposes. They are collectively known as the VIMOVO
cases, and involve the following sets of defendants:
(i) Dr. Reddy’s Laboratories Inc. and
Dr. Reddy’s Laboratories Ltd. (collectively, “Dr.
Reddy’s”); (ii) Lupin Limited and Lupin
Pharmaceuticals Inc. (collectively, Lupin); (iii) Mylan
Pharmaceuticals Inc., Mylan Laboratories Limited, and Mylan Inc.
(collectively, “Mylan”); and (iv) Watson
Laboratories, Inc.—Florida, known as Actavis Laboratories FL,
Inc. and Actavis Pharma, Inc. (collectively,
“Actavis”). Patent litigation in the United States
District Court for the District of New Jersey against a fifth
generic company, Anchen Pharmaceuticals Inc.
(“Anchen”), was dismissed on June 9, 2014 after
Anchen recertified under Paragraph III. The Company understands
that Dr. Reddy’s has entered into a settlement with
AstraZeneca with respect to patent rights directed to Nexium for
the commercialization of VIMOVO, and that according to the
settlement agreement, Dr. Reddy’s is now able to
commercialize VIMOVO under AstraZeneca’s Nexium patent
rights. The settlement agreement, however, has no effect on the
Pozen VIMOVO patents, which are still the subject of patent
litigations. As part of the Company’s acquisition of the U.S.
rights to VIMOVO, the Company has taken over and is responsible for
the patent litigations that include the Pozen patents licensed to
the Company under the Pozen license agreement.
The VIMOVO
cases were filed on April 21, 2011, July 25,
2011, October 28, 2011, January 4,
2013, May 10, 2013, June 28,
2013, October 23, 2013 and May 13, 2015 and
collectively include allegations of infringement of U.S. Patent
Nos. 6,926,907, 8,557,285, 8,852,636, and 8,858,996. On
June 18, 2015, the Company amended the complaints to add a
charge of infringement of U.S. Patent No. 8,865,190. The
Company understands the cases arise from Paragraph IV Notice
Letters providing notice of the filing of ANDAs with the FDA
seeking regulatory approval to market generic versions of VIMOVO
before the expiration of the patents-in-suit. The Company
understands the Dr. Reddy’s notice letters were dated
March 11, 2011, November 20, 2012 and April 20,
2015; the Lupin notice letters were dated June 10, 2011 and
March 12, 2014; the Mylan notice letters were dated
May 16, 2013 and February 9, 2015; the Actavis notice
letters were dated March 29, 2013 and November 5, 2013;
and the Anchen notice letter was dated September 16, 2011. The
court has issued a claims construction order and has set a pretrial
schedule but has not yet set a trial date.
On
February 24, 2015, Dr. Reddy’s Laboratories, Inc.
filed a Petition for Inter Partes Review (“IPR”) of
U.S. Patent No. 8,557,285, one of the patents in litigation in
the above referenced VIMOVO cases. The Patent Trial and Appeal
Board has not yet issued a decision with regard to whether or not
the IPR will be instituted.
On May 21,
2015, the Coalition for Affordable Drugs VII LLC filed a Petition
for IPR of U.S. Patent No. 6,926,907, one of the patents in
litigation in the above referenced VIMOVO cases. The Patent Trial
and Appeal Board has not yet issued a decision with regard to
whether or not the IPR will be instituted.
On June 5,
2015, the Coalition for Affordable Drugs VII LLC filed another
Petition for IPR of U.S. Patent No. 8,858,996, one of the
patents in litigation in the above referenced VIMOVO cases. The
Patent Trial and Appeal Board has not yet issued a decision with
regard to whether or not the IPR will be instituted.
On or about
December 19, 2014, the Company filed a Notice of Opposition to
a European patent, EP 2611457, to Roberto Testi, et al., covering
compositions and methods for treating FA with interferon gamma,
e.g., ACTIMMUNE. In the European Union, the grant of a patent may
be opposed by one or more private parties.
On
February 2, 2015, the Company received a Paragraph IV Patent
Certification against Orange Book listed U.S. Patent Nos.
8,217,078, 8,252,838, 8,546,450, 8,563,613, 8,618,164, 8,741,956,
and 8,871,809 from Taro Pharmaceuticals USA, Inc. and Taro
Pharmaceutical Industries, Ltd. (collectively, “Taro”)
advising that Taro had filed an ANDA with the FDA for a generic
version of PENNSAID 2%. Taro has not advised the Company as to the
timing or status of the FDA’s review of its filing. On
March 13, 2015, the Company filed suit in the United States
District Court for the District of New Jersey against Taro seeking
an injunction to prevent the approval of the ANDA. The lawsuit
alleges that Taro has infringed U.S. Patent Nos. 8,217,078,
8,252,838, 8,546,450, 8,563,613, 8,618,164, and 8,871,809 by filing
an ANDA seeking approval from the FDA to market generic versions of
PENNSAID 2% prior to the expiration of the patents. The subject
patents are listed in the FDA’s Orange Book. The commencement
of the patent infringement lawsuit stays, or bars, FDA approval of
Taro’s ANDA for 30 months or until an earlier district court
decision that the subject patents are not infringed or are invalid.
The court has not yet set a trial date for the Taro
action.
On
March 18, 2015, the Company received a Paragraph IV Patent
Certification against Orange Book listed U.S. Patent Nos.
8,217,078, 8,252,838, 8,546,450, 8,563,613, 8,618,164, 8,741,956,
and 8,871,809 from Lupin Limited advising that Lupin Limited had
filed an ANDA with the FDA for generic version of PENNSAID 2%.
Lupin Limited has not advised the Company as to the timing or
status of the FDA’s review of its filing. On April 30,
2015, the Company filed suit in the United States District Court
for the District of New Jersey against Lupin, seeking an injunction
to prevent the approval of the ANDA. The lawsuit alleges that Lupin
has infringed U.S. Patent Nos. 8,217,078, 8,252,838, 8,546,450,
8,563,613, 8,618,164, and 8,871,809 by filing an ANDA seeking
approval from the FDA to market generic versions of PENNSAID 2%
prior to the expiration of the patents. The subject patents are
listed in the FDA’s Orange Book. The commencement of the
patent infringement lawsuit stays, or bars, FDA approval of
Lupin’s ANDA for 30 months or until an earlier district court
decision that the subject patents are not infringed or are invalid.
The court has not yet set a trial date for the Lupin
action.
The Company
received from IGI Laboratories, Inc. (“IGI”) a
Paragraph IV Patent Certification dated March 24, 2015 against
Orange Book listed U.S. Patent Nos. 8,217,078, 8,252,838,
8,546,450, 8,563,613, 8,618,164, 8,741,956, and 8,871,809 advising
that IGI had filed an ANDA with the FDA for a generic version of
PENNSAID 2%. IGI has not advised the Company as to the timing or
status of the FDA’s review of its filing. On May 21,
2015, the Company filed suit in the United States District Court
for the District of New Jersey against IGI seeking an injunction to
prevent the approval of the ANDA. The lawsuit alleges that IGI has
infringed U.S. Patent Nos. 8,217,078, 8,252,838, 8,546,450,
8,563,613, 8,618,164, and 8,871,809 by filing an ANDA seeking
approval from the FDA to market generic versions of PENNSAID 2%
prior to the expiration of the patents. The subject patents are
listed in the FDA’s Orange Book. The commencement of the
patent infringement lawsuit stays, or bars, FDA approval of
IGI’s ANDA for 30 months or until an earlier district court
decision that the subject patents are not infringed or are invalid.
The court has not yet set a trial date for the IGI
action.
The Company
received from Amneal Pharmaceuticals LLC (“Amneal”) a
Paragraph IV Patent Certification dated April 2, 2015 against
Orange Book listed U.S. Patent Nos. 8,217,078, 8,252,838,
8,546,450, 8,563,613, 8,618,164, 8,741,956, and 8,871,809 advising
that Amneal had filed an ANDA with the FDA for a generic version of
PENNSAID 2%. Amneal has not advised the Company as to the timing or
status of the FDA’s review of its filing. On May 15,
2015, the Company filed suit in the United States District Court
for the District of New Jersey against Amneal seeking an injunction
to prevent the approval of the ANDA. The lawsuit alleges that
Amneal has infringed U.S. Patent Nos. 8,217,078, 8,252,838,
8,546,450, 8,563,613, 8,618,164, and 8,871,809 by filing an ANDA
seeking approval from the FDA to market generic versions of
PENNSAID 2% prior to the expiration of the patents. The subject
patents are listed in the FDA’s Orange Book. The commencement
of the patent infringement lawsuit stays, or bars, FDA approval of
Amneal’s ANDA for 30 months or until an earlier district
court decision that the subject patents are not infringed or are
invalid. The court has not yet set a trial date for the Amneal
action.
On
March 17, 2014, Hyperion received notice from Par
Pharmaceutical, Inc. that it had filed an ANDA with the FDA seeking
approval for a generic version of the Company’s product
RAVICTI. The ANDA contained a Paragraph IV Patent Certification
alleging that two of the patents covering RAVICTI, U.S. Patent
No. 8,404,215, titled “Methods of therapeutic monitoring
of nitrogen scavenging drugs,” which expires in March 2032,
and U.S. Patent No. 8,642,012, titled “Methods of
treatment using ammonia scavenging drugs,” which expires in
September 2030, are invalid and/or will not be infringed by
Par’s manufacture, use or sale of the product for which the
ANDA was submitted. Par Pharmaceutical, Inc. did not challenge the
validity, enforceability, or infringement of the Company’s
primary composition of matter patent for RAVICTI, U.S. Patent
No. 5,968,979 titled “Triglycerides and ethyl esters of
phenylalkanoic acid and phenylalkenoic acid useful in treatment of
various disorders,” which would have expired on
February 7, 2015, but as to which Hyperion was granted an
interim term of extension until February 7, 2016. Hyperion
filed suit against Par Pharmaceutical, Inc. on April 23, 2014
and the Company has taken over and is responsible for this patent
litigation.
On
April 29, 2015, Par filed petitions for IPR of the ’215
patent and the ’012 patent. The Patent Trial and Appeal Board
has not yet issued a decision with regard to whether or not the
IPRs will be instituted.
On August 3,
2015, the Company filed a lawsuit in the Superior Court of the
State of California, County of Santa Clara, naming as defendants
Depomed and the members of its board of directors (the
“Depomed Board”), Vicente J. Anido, Jr., Karen A.
Dawes, Louis J. Lavigne, Jr., Samuel R. Saks, James A. Schoeneck,
Peter D. Staple and David B. Zenoff. The lawsuit alleges that the
adoption by the Depomed Board of the Rights Agreement dated as of
July 12, 2015 between Depomed and Continental Stock Transfer &
Trust Company, as Rights Agent (the “Depomed Rights
Agreement”), and Sections 2(b), 2(c), 2(d), and 5(d) of
Depomed’s Amended and Restated Bylaws, effective July 12,
2015 (the “Depomed Bylaws”), violates the General
Corporation Law of the California Corporations Code, constitutes
ultra vires acts and breaches the fiduciary duties of the members
of the Depomed Board. The lawsuit seeks, among other things, an
order (i) declaring that the Depomed Rights Agreement and Sections
2(b), 2(c), and 2(d) of the Depomed Bylaws are invalid under
California law, (ii) declaring that the members of the Depomed
Board breached their fiduciary duties by enacting the Depomed
Rights Agreement and Sections 2(b), 2(c), 2(d), and 5(d) of the
Depomed Bylaws, (iii) enjoining the members of the Depomed Board
from relying on, implementing, applying or enforcing either the
Depomed Rights Agreement or Sections 2(b), 2(c), 2(d), or 5(d) of
the Depomed Bylaws, (iv) enjoining the members of the Depomed Board
from taking any improper action designed to impede, or which has
the effect of impeding, the Company’s proposal to acquire
Depomed in an all-stock transaction or the Company’s efforts
to acquire control of Depomed and (v) compelling the members of the
Depomed Board to redeem the Depomed Rights Agreement or to render
it inapplicable to the Company.
Also on August
3, 2015, Depomed filed a complaint against the Company in the
Superior Court of the State of California, County of Santa Clara,
alleging that, in connection with the Company’s bid to
acquire Depomed, the Company used confidential and proprietary
information related to Depomed’s product NUCYNTA ® |
