The document discusses the doctrine of equivalents, which allows a court to find patent infringement even if the infringing device or process does not literally fall within the scope of the patent claims, but is equivalent to the claimed invention. It provides an example of Astrazeneca v. Mayne, where Mayne attempted to work around Astrazeneca's anesthetic formulation patent by replacing the preservative EDTA with a similar preservative, DPTA. The court found infringement under the doctrine of equivalents because DPTA performs in substantially the same way as EDTA by sequestering metal ions to retard microbial growth.

1. DOCTRINE OF EQUIVALENTS
GITAM INSTITUTE OF PHARMACY
Pharmaceutical Validation
M. Pharmacy I-I
SUBMITTED BY
~ LIKITHA BOGA
PHARMACEUTICAL ANALYSIS

2. Definition:
The doctrine of equivalent is a legal rule in most of the
world’s patent systems that allow a court to hold a party liable for
patent infringement even though the infringing device or process
doesn’t fall within the literal scope of patent claim, but
nevertheless is equivalent to the claimed invention.

3. ASTRAZENECA V. MAYNE
 Mayne (infringer) attempted to work around
Astrazeneca’s anesthetic formulation patent.
 In attempting to formulate a generic composition
having a different preservative, Mayne replaced
EDTA by DPTA (Diethylenetriamine Penta
Acetate or pentetic acid) which is structural
derivative of EDTA.
 The district court, however, found that Mayne’s
product infringed both direct and under the
doctrine of equivalents.

4.  On appeal, the court revised the direct
infringement based on claimed construction, but
agreed that there was infringement under DOE.
 DTPA was well within the scope of equivalents
because DTPA performs in broadly the same way
as EDTA, noting that the way in which both
EDTA and DTPA perform as an antimicrobial
agent is by sequestering metal ions to retard
microbial growth.
ASTRAZENECA Cont….

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