Johnson and Johnson 2012 Annual Report Download - page 65

In May 2012, Medtronic Minimed, Inc., Medtronic Puerto Rico Operations Co. and MiniMed Distribution Corp. (collectively,
Medtronic Minimed) filed a patent infringement lawsuit against Animas Corporation in the United States District Court for
the Central District of California alleging that Animas’ OneTouch®Ping®Glucose Management System infringes nine of
their patents. Medtronic Minimed is seeking monetary damages and injunctive relief.
In June 2012, DePuy Orthopaedics, Inc. (DePuy) filed a declaratory judgment action against Orthopaedic Hospital (OH) in
the United States District Court for the Northern District of Indiana seeking a declaration of the parties’ rights and
obligations under a Patent Rights and License Agreement between the parties related to development of a polyethylene
material. OH has claimed that DePuy owes royalties on products made with anti-oxidant polyethylene. DePuy disputes that
it owes such royalties to OH and is thus seeking a declaration from the Court on disputed contractual provisions. After
DePuy filed the declaratory judgment action, OH filed a separate suit on the same subject matter in the United States
District Court for the Central District of California, and moved for consolidation with the California case.
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. In April 2012, the parties participated in an arbitration on the issue of JBI’s
defense that Abbott is equitably estopped from asserting the patents. In May 2012, the arbitrator rejected JBI’s defense.
The case has been reinstated in the District Court and fact discovery is ongoing.
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 Centocor, invalidating Abbott’s patent claims. Post-trial
briefing has been completed and the parties are awaiting a decision. 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 is scheduled for December 2013 in the Canadian Case. 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 these patents. In the event the subsidiaries are not successful in these actions, or the
statutory 30-month stays expire before the United States District Court rulings are obtained, the third-party companies
involved will have the ability, upon approval of the United States Food and Drug Administration (FDA), to introduce generic
versions of the products at issue, resulting in very substantial market share and revenue losses for those products.
CONCERTA®
A number of generic companies have filed ANDAs seeking approval to market generic versions of CONCERTA®.In
September 2011, a settlement agreement was entered into with Kremers-Urban, LLC and KUDCO Ireland, Ltd.
(collectively, KUDCO) pursuant to which KUDCO was granted a license under the patent-in-suit to market its generic
version of CONCERTA®starting on July 1, 2012, if and when KUDCO obtains FDA approval.
In November 2010, ALZA Corporation (ALZA) and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) (now Janssen
Pharmaceuticals, Inc. (JPI)) filed a patent infringement lawsuit in the United States District Court for the District of
Delaware against Impax Laboratories, Inc. (Impax), Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries
Ltd. (collectively, Teva) in response to Impax and Teva’s filing of a major amendment to its ANDA seeking approval to
market a generic version of CONCERTA®before the expiration of ALZA and JPI’s patent relating to CONCERTA®. Impax
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