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On July 30, 2012, the Federal Circuit issued a decision in
Caraco Pharmaceuticals, Ltd. v. Novo Nordisk on remand
from the Supreme Court. As summarized in an earlier client alert
(click
here for the previous alert), the Supreme Court held in April
2012 that a generic pharmaceutical company may pursue a
counterclaim against a brand pharmaceutical company to force a
correction of a use code listed with the FDA regarding
method-of-use patents. On remand, the Federal Circuit held that
even if a court orders the brand company to correct a use code, the
brand company must be allowed to come up with its own revised use
code. According to the Federal Circuit, a court cannot dictate the
precise terms of the use code to be submitted by the brand company,
but may only provide general guidance regarding the proper scope of
the use code.
This article is intended to provide information of general
interest to the public and is not intended to offer legal advice
about specific situations or problems. Brinks Hofer Gilson &
Lione does not intend to create an attorney-client relationship by
offering this information and review of the information shall not
be deemed to create such a relationship. You should consult a
lawyer if you have a legal matter requiring attention. For further
information, please contact a Brinks Hofer Gilson & Lione
lawyer.
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Whether you are an employer that provides health insurance for your employees, a business in the growing healthcare industry, a hospital, or other medical provider—or you provide services to any of those entities—you need to know about changes to the privacy and security rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
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Marilyn Tavenner received bipartisan support from members of the Senate Committee on Finance in her confirmation hearing to lead the Centers for Medicare and Medicaid Services (CMS) though a full Senate vote is being held up, the president released his FY 2014 budget proposal with health care reform and specified reimbursement reductions to providers and manufacturers totaling $400 billion over 10 years sprinkled throughout it, and Department of Health and Human Services (HHS) Secretary Sebelius
The Office of Inspector General for the Department of Health and Human Services has recently issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs.
On Tuesday, the North Carolina legislature has enacted into law, pending the governor's signature, a prohibition on the use of most favored nations clauses in contracts between commercial health insurers and providers.
