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21 Health Law. 1 (2008-2009)

handle is hein.journals/healaw21 and id is 1 raw text is: 





A Patent Law Primer for
Health Law Practitioners .......... 1

CMS Finalizes Major Stark
Changes - New Physician-Self
Referral Rules in the 2009
IPPS Final Rulemaking Will
Require Restructuring of
Many Common Healthcare
Arrangements ..................... 14

The Role of PSQIA Privilege
in Medical Error Reduction ..... 24

Medicare's Medical Necessity
Criteria: A Mystery in the
Making ..............................  30

What Are Never Events, and
Why Do They Matter? ...... 34

Volume 21, Number 1
October 2008


David B. Gornish, Esq.
Caesar, Rivise, Bernstein,
Cohen & Pokotilow, Ltd.
Philadelphia, PA

    Advancements in medical technology
have changed the way medicine is prac-
ticed. Modern medical technology has
saved countless lives and improved quality
of life for patients in ways that were not
conceivable decades ago. Many advance-
ments in medical technology were
conceived and developed by physicians.
Although inventing is not usually a part
of a physician's job description (unless,
perhaps, the physician is involved in
research), the practice of medicine is fertile
ground for creative problem solving, which
often results in improved methods and
products for diagnosing disease and/or
treating patients. Thus, many physicians
have become inventors in the course of
practicing medicine. Hospitals that employ
these inventive physicians often protect
this valuable intellectual property (IP),
usually with patents
    The trend of hospitals acting as
patent-generating institutions is growing.
Hospitals are recognizing that physicians
make excellent inventors and that patent
protection can provide a source of
revenue. Consequently, a growing number

of hospitals have issued clear and compre-
hensive policies regarding IP conceived
and developed by hospital-affiliated physi-
cians. Some hospitals have internal IP or
technology transfer offices that are focused
exclusively on strategic protection and use
of IP developed by hospital employees or
otherwise acquired by the hospital.2
    Accordingly, health lawyers who regu-
larly counsel physicians and hospitals are
likely to confront IP issues, including
patent-related issues, during their careers.
This article is a primer on patent law for
the health lawyer. It introduces health
lawyers to the practice of patent law by
addressing patent law fundamentals as well
as some particular patent-related issues
germane to physicians and hospitals.

What is a Patent?
    A patent is a temporary grant3 by the
United States government giving its
owner the legal right to stop others from
making, using, selling, offering to sell, or
importing an invention.
    All industrialized nations have their
own patent systems. A nation's patents are
enforceable only within its own territorial
jurisdiction. For example, a United States
patent can only be asserted against individ-
uals or companies that engage in infringing
activities in the United States and its terri-
tories. For this reason, inventors may wish
                    continued on page 3

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