Abbott v.

Sandoz
From Wikipedia, the free encyclopedia
Abbott v. Sandoz was a US patent law case argued before the United States Court of Appeals for
the Federal Circuit that established a bright-line ruling regarding claims of patent infringement
relating to disagreements over so-called "product-by-process" claims. The case was decided on May
18, 2009.[1][2][3]

Contents
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1 Background
2 Case
3 Decision
4 Importance
5 References

Background[edit]
Abbott Labs had a patent on a specific drug called Omnicef used to combat ear infections. Lupin
Limited had a court rule that a generic form of Omnicef it produced did not infringe on Abbott's patent
since their process to make the drug was different. After the court had ruled in Lupin's favor, Abbott
appealed and the case was combined with several other legal suits against smaller pharmaceutical
companies, and thus was renamed Abbott v. Sandoz. The federal court affirmed the lower court's
decision.[1][2][3]

Case[edit]
For several years, the courts have disagreed on the product-by-process definition. Product-by-
process refers to the question of determining if a product is legally different from another if it is
created by a different process. Federal courts have offered contradictory resolutions on the subject.
The court determined that a patent may limit itself if it specifically defines the process of creation.[1][2][3]

Decision[edit]
Despite the legal discrepancies, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that
using a different process in this case did not infringe on Abbott's patent and ruled in Sandoz's favor,
along with ruling in favor of the other small pharmaceuticals companies. Since Abbott had not
patented all processes to create its drug, it could not protect from the processes being used by
others.[1][2][3]

Importance[edit]
This case further enforces the product-by-process definition, and holds that a patent does not protect
from infringement through a different process unless necessarily described. Patent-holders seeking
to cover their products entirely must find ways to protect every process to create the same item if
they want complete protection from infringement.[1][2][3]