Janssen Announces Intent Not to Enforce Patents for Darunavir in Resource-Limited Settings

       Janssen Announces Intent Not to Enforce Patents for Darunavir in
                          Resource-Limited Settings

  PR Newswire

  RARITAN, New Jersey, Nov. 29, 2012

- Policy Aims to Support a Sustainable Supply of Medically Acceptable Generic
Darunavir in Sub-Saharan Africa (SSA) and Least Developed Countries (LDCs)

RARITAN, New Jersey, Nov. 29, 2012 /PRNewswire/ -- The Janssen Pharmaceutical
Companies of Johnson & Johnson today announced their intention not to enforce
the patents they own and control on the antiretroviral (ARV) drug darunavir
provided the darunavir product is medically acceptable and is used only in
resource-limited settings.(1) This announcement is intended to assure generic
manufacturers that they may manufacture high quality darunavir product used in
SSA and the LDCs without a concern that Janssen will accuse these activities
of infringing its darunavir patents.

This new policy anticipates a greater future need to supply affordable generic
versions of darunavir (brand name PREZISTA®) for the treatment of people
living with HIV in the territory, and is consistent with the Company's focus
on access to medicines in those countries with the highest rates of HIV
infection and economic vulnerability.

"We are pleased to take this significant step toward bringing our innovations
to meaningfully impact the health of people living with HIV and enhance access
to our medicines for those in need," said Paul Stoffels, Scientific Officer
and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "As part of this
commitment, we believe that an effective access strategy includes responsible
intellectual property management and that intellectual property should not be
a barrier to ensuring a sustainable supply of medically acceptable darunavir
in the world's poorest countries."

Darunavir administered with ritonavir and in combination with other
antiretrovirals is currently indicated for highly treatment-experienced HIV
patients (third-line) in SSA and has been recommended by the World Health
Organization.(2) It is also included in several national HIV treatment
guidelines in SSA for use with highly treatment-experienced patients. Janssen
recognizes that, as more patients fail their initial treatment regimens due to
HIV drug resistance in SSA and LDCs, demand and uptake of darunavir will only

Under this policy Janssen will not enforce its darunavir patent rights,
provided the generic versions of darunavir produced or supplied by generic
manufacturers are quality, medically acceptable, and used only in the defined
territory. Manufacturers are still responsible for obtaining permissions from
other darunavir patent holders and health authorities where appropriate.

Janssen will continue to ensure the availability and appropriate use of
PREZISTA® in SSA and LDCs through its existing licensing agreement and

About Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, the Pharmaceutical Companies of Johnson & Johnson, we are
dedicated to addressing and solving some of the most important medical needs
of our time in oncology, immunology, neuroscience, infectious diseases and
vaccines. Driven by our commitment to patients, we develop innovative
products, services and healthcare solutions to help people throughout the
world. Janssen Research & Development, LLC is part of the Janssen
Pharmaceuticals Companies of Johnson & Johnson. Please visit
http://www.janssen.com/our-caring.html for more information.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen Research &
Development, LLC, any of the other Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited to,
general industry conditions and competition; economic factors, such as
interest rate and currency exchange rate fluctuations; technological advances,
new products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; challenges to
patents; changes in behavior and spending patterns or financial distress of
purchasers of healthcare products and services; changes to governmental laws
and regulations and domestic and foreign health care reforms; trends toward
health care cost containment; and increased scrutiny of the healthcare
industry by government agencies. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended January 1,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None
of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or future
events or developments).

(1) Resource-limited settings under this policy include all Least Developed
Countries ("LDCs") as defined by the United Nations (
http://www.unohrlls.org/en/ldc/25/ ) and the countries of sub-Saharan Africa
(SSA) which are not classified as LDCs. (2) World Health Organization.
Antiretroviral Therapy for HIV Infection in Adults and Adolescents:
Recommendations for a Public Health Approach, 2010 Revision.

Website: http://www.janssen.com
Contact: Seema Kumar, +908-405-1144; Daniel De Schryver, +32 14 60 3030
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