48 Food & Drug L.J. 571 (1993)
Supplementary Protection Certificates in the European Economic Community

handle is hein.journals/foodlj48 and id is 619 raw text is: Supplementary Protection Certificates in the European
Economic Community
EDWARD H. MAZER, ESQ.*
I. INTRODUCTION
On July 2, 1992, the European Parliament enacted supplementary pro-
tection certificate (SPG) legislation' which became effective on January 2,
1993 in the European Economic Community (EEC).2 The SPC legisla-
tion extends market exclusivity rather than patent term. This will be
achieved by denial of marketing approval to generic competitors during
the allotted term of market exclusivity.
The SPC legislation is noteworthy because it represents the culmination
of several years' work to reconcile the interests of the EEC member states
and the pharmaceutical industry. In the EEC, national governments fre-
quently pay a significant percentage of the cost of the pharmaceuticals
used by their citizens. Therefore, some countries, such as Germany, which
sought to keep expenditures down were strongly opposed to any SPC leg-
islation. Other countries, including Italy and France, felt that in view of
the large development costs and lengthy regulatory review times, the pat-
ent life remaining after market approval did not permit adequate returns
for the research-based pharmaceutical companies.
II.  PHARMACEUTICAL INDUSTRY RESPONSE
The European pharmaceutical industry was able to wage an effective
campaign to gain extended protection for pharmaceuticals. They noted
that the United States and Japan already had passed patent term exten-
sion legislation,' and showed that the effective patent life after marketing
approval was getting shorter in Europe. European-based pharmaceutical
companies, while very successful, were losing their competitive edge to
U.S. and Japanese competitors based on several criteria, including: total
sales, percent of total pharmaceutical industry employment, percent of to-
* Mr. Mazer is the Group Patent Counsel for Schering Plough Corporation, Madison, New
Jersey. A previous version of this article was presented at The Food and Drug Law Institute's semi-
nar Regulation of Human Medicinal Products in the European Community, Arlington, Va. (June
10, 1992).
1. 1992 O.J. (L182) 1-5.
2. The EEC is a confederation of 12 countries: Belgium, Denmark, France, Germany, Greece,
Holland, Ireland, Italy, Luxembourg, Portugal, Spain, and the United Kingdom.
3. See Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat.
1585 (1984); Law No. 27 of 1987, reprinted in OFFICIAL GAZETTE, May 25, 1987, at 2. These
statutes became effective January 1, 1988.

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