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commit.
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
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.
Grounds for Patent Revocation: A Legal Assessment of the Pharmabayu Inc. Patent
This discussion explores the legal grounds for revocation of a recently granted patent to Pharmabayu
Inc., a pharmaceutical company operating in South Africa. The patent in question, granted on 5
August 2023, relates to a new dosage regime for an existing pharmaceutical compound, maxorevo,
which has been used in the treatment of cardiac arrhythmia since 2004. The patent claims the use of
maxorevo in an oral dosage form for treating cardiac disorders, particularly arrhythmia, with a
specified administration pattern—once daily for at least seven consecutive days—in a rapid-release
tablet, provided the compound has a plasma half-life of 12 hours or less. A competitor, R.D. Gen,
wishes to bring a competing product using maxorevo to market and is considering an application for
revocation of the patent.
Lack of Patentability: Section 61(1)(c) - Section 25 of the Patents Act
One of the most viable revocation grounds available to R.D. Gen is that the invention is not
patentable as defined under section 25 of the Patents Act 57 of 1978, which is made a ground for
revocation under section 61(1)(c). This section outlines the statutory requirements of novelty,
inventive step, and utility. R.D. Gen may argue that the claimed invention lacks both novelty and
inventive step, and as such, does not meet the criteria for a valid patent under South African law.
Please also note that the author of this document will not be responsible for any plagiarism you
commit.
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
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.
Grounds for Patent Revocation: A Legal Assessment of the Pharmabayu Inc. Patent
This discussion explores the legal grounds for revocation of a recently granted patent to Pharmabayu
Inc., a pharmaceutical company operating in South Africa. The patent in question, granted on 5
August 2023, relates to a new dosage regime for an existing pharmaceutical compound, maxorevo,
which has been used in the treatment of cardiac arrhythmia since 2004. The patent claims the use of
maxorevo in an oral dosage form for treating cardiac disorders, particularly arrhythmia, with a
specified administration pattern—once daily for at least seven consecutive days—in a rapid-release
tablet, provided the compound has a plasma half-life of 12 hours or less. A competitor, R.D. Gen,
wishes to bring a competing product using maxorevo to market and is considering an application for
revocation of the patent.
Lack of Patentability: Section 61(1)(c) - Section 25 of the Patents Act
One of the most viable revocation grounds available to R.D. Gen is that the invention is not
patentable as defined under section 25 of the Patents Act 57 of 1978, which is made a ground for
revocation under section 61(1)(c). This section outlines the statutory requirements of novelty,
inventive step, and utility. R.D. Gen may argue that the claimed invention lacks both novelty and
inventive step, and as such, does not meet the criteria for a valid patent under South African law.
