Johnson and Johnson 2013 Annual Report Download - page 67

District Court for the Central District of California alleging that Animas’ OneTouch®Ping®Glucose Management System
and the IR 1250, IR 2020 and IR 2000 insulin pumps infringe nine of their patents. Medtronic MiniMed is seeking
monetary damages and injunctive relief.
In March 2013, Medinol Ltd. (Medinol) filed a patent infringement lawsuit against Cordis Corporation (Cordis) and
Johnson & Johnson in the United States District Court for the Southern District of New York alleging that all of Cordis’s
sales of the CYPHER®and CYPHER SELECT®Stents made in the United States since 2005 willfully infringed four of
Medinol’s patents directed to the geometry of articulated stents. Medinol is seeking damages and attorney’s fees.
Pharmaceutical
In May 2009, Abbott Biotechnology Ltd. (Abbott) filed a patent infringement lawsuit against Centocor, Inc. (Centocor)
(now Janssen Biotech, Inc. (JBI)) in the United States District Court for the District of Massachusetts alleging that
SIMPONI®infringes Abbott’s U.S. Patent Nos. 7,223,394 and 7,541,031 (the Salfeld patents). Abbott is seeking
monetary damages and injunctive relief. Oral argument on summary judgment motions was held in December 2013. The
parties are awaiting a decision.
In August 2009, Abbott GmbH & Co. (Abbott GmbH) and Abbott Bioresearch Center filed a patent infringement lawsuit
against Centocor (now JBI) in the United States District Court for the District of Massachusetts alleging that STELARA®
infringes two United States patents assigned to Abbott GmbH. JBI filed a complaint in the United States District Court for
the District of Columbia for a declaratory judgment of non-infringement and invalidity of the Abbott GmbH patents, as well
as a Complaint for Review of a Patent Interference Decision that granted priority of invention on one of the two asserted
patents to Abbott GmbH. The cases have been transferred from the District of Columbia to the District of Massachusetts.
Trial was held in September 2012 with a jury verdict in favor of JBI, invalidating Abbott’s patent claims. In March 2013, the
Court denied Abbott’s post-trial motions challenging the outcome and granted JBI’s motion on the appeal of the
interference decision. Abbott filed its notice of appeal in April 2013. Oral argument is scheduled for March 2014 in the
Court of Appeals for the Federal Circuit. Also in August 2009, Abbott GmbH and Abbott Laboratories Limited brought a
patent infringement lawsuit in The Federal Court of Canada alleging that STELARA®infringes Abbott GmbH’s Canadian
patent. A trial was held in December 2013 in the Canadian Case. In January 2014, the Court ruled in favor of Abbott,
finding that the asserted claims were valid and infringed by STELARA®. Janssen will appeal that decision. The Company
believes Janssen has strong arguments supporting its appeal. In addition to the U.S. and Canadian litigations, in August
2012, Abbott filed patent infringement lawsuits in the Netherlands, Switzerland and Germany. In each of the above cases,
Abbott is seeking monetary damages and injunctive relief.
LITIGATION AGAINST FILERS OF ABBREVIATED NEW DRUG APPLICATIONS (ANDAs)
The following summarizes lawsuits pending against generic companies that filed Abbreviated New Drug Applications
(ANDAs) seeking to market generic forms of products sold by various subsidiaries of Johnson & Johnson prior to expiration
of the applicable patents covering those products. These ANDAs typically include allegations of non-infringement,
invalidity and unenforceability of the applicable patents. In the event the subsidiaries are not successful in these actions, or
the statutory 30-month stays of the ANDAs expire before the United States District Court rulings are obtained, the third-
party companies involved will have the ability, upon approval of the FDA, to introduce generic versions of the products at
issue, resulting in very substantial market share and revenue losses for those products.
ORTHO TRI-CYCLEN®LO
A number of generic companies filed ANDAs seeking approval to market generic versions of ORTHO TRI-CYCLEN®LO.
Janssen Pharmaceuticals, Inc. (JPI) filed patent infringement lawsuits against these generic companies seeking an Order
enjoining them from marketing their generic versions of ORTHO TRI-CYCLEN®LO prior to the expiration of JPI’s patent
relating to ORTHO TRI-CYCLEN®LO (the OTCLO patent). In 2012, JPI entered into settlement agreements with certain of
these generic companies. The two remaining cases were concluded in the fiscal first quarter of 2013, as described below.
In January 2010, Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) (now JPI) filed a patent infringement lawsuit against
Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin) in the United States District Court for the District of
New Jersey in response to Lupin’s ANDA seeking approval to market a generic version of ORTHO TRI-CYCLEN®LO
prior to the expiration of the OTCLO patent. Lupin filed a counterclaim alleging invalidity of the patent. In September 2012,
the Court issued a decision in favor of JPI upholding the validity of the patent and ordering that the effective date of the
approval of Lupin’s ANDA (which had previously been approved) be not earlier than the expiration of the OTCLO patent.
Lupin appealed the decision and in March 2013, JPI and Lupin entered into a settlement agreement pursuant to which
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