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LML4801 Assignment 2 2025 - Due 24 April 2025

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LML4801 Assignment 2, First semester 2025 Due Date: 24 April 2025 Scenario Peter works for Pharmabayu Inc in South Africa, as a researcher testing various dosage regimes of known and new pharmaceutical compounds. While on holiday, he devises a new dosage regime for an existing pharmaceutical compound known to be used in cardiac arrythmia management medicine since 2004. Pharmabayu applies for a patent for which the patent claim for the patent (granted on 5 August 2023) reads as follows: ‘The use of the compound (maxorevo) for the manufacture of a medicament in an oral dosage form for the treatment of cardiac disorders for administration no more than once daily for at least seven consecutive days, where said compound has a plasma concentration half-life of 12 hours or less when orally administered to a human patient, wherein the cardiac disorder is arrhythmia, and wherein the oral dosage form is a rapid-release tablet.’ A rival pharmaceutical firm, R.D. Gen, decides to apply for the revocation of this patent to bring their own cardiac arrythmia medicine (which also makes use of maxorevo) to market. The maxorevo compound was first identified in March 2001. Question 1 Outline the potentially viable revocation grounds that R.D. Gen might rely on for this application and comment on the likelihood of success for each ground. Under section 61(1) of the Patents Act 57 of 1978: 1. R.D. Gen may consider applying for revocation of the patent which provides for several grounds on which a patent may be invalidated¹. One key ground, section

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LML4801
ASSIGNMENT 2
DUE DATE: 24 APRIL 2025

, LML4801
Assignment 2, First semester 2025
Due Date: 24 April 2025



Scenario
Peter works for Pharmabayu Inc in South Africa, as a researcher testing various
dosage regimes of known and new pharmaceutical compounds. While on holiday, he
devises a new dosage regime for an existing pharmaceutical compound known to be
used in cardiac arrythmia management medicine since 2004. Pharmabayu applies for
a patent for which the patent claim for the patent (granted on 5 August 2023) reads as
follows: ‘The use of the compound (maxorevo) for the manufacture of a medicament
in an oral dosage form for the treatment of cardiac disorders for administration no
more than once daily for at least seven consecutive days, where said compound has
a plasma concentration half-life of 12 hours or less when orally administered to a
human patient, wherein the cardiac disorder is arrhythmia, and wherein the oral
dosage form is a rapid-release tablet.’
A rival pharmaceutical firm, R.D. Gen, decides to apply for the revocation of this
patent to bring their own cardiac arrythmia medicine (which also makes use of
maxorevo) to market. The maxorevo compound was first identified in March 2001.




Question 1
Outline the potentially viable revocation grounds that R.D. Gen might rely on for
this application and comment on the likelihood of success for each ground.




Under section 61(1) of the Patents Act 57 of 1978:


1. R.D. Gen may consider applying for revocation of the patent which provides for
several grounds on which a patent may be invalidated¹. One key ground, section
61(1)(a), allows revocation if the patentee was not entitled to the grant.².This aligns

1 with the broader role of patents in South African law not only as tools for protecting
innovation but also for ensuring rightful ownership, particularly in employment contexts
(Outcome 1). In the present case, the invention was made by Peter, an employee of
Pharmabayu Inc., while he was on holiday in the Drakensberg Mountains. If it can be
shown that Peter developed the invention outside the course and scope of his

employment, and there was no assignment agreement transferring the rights to

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