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LML4801 Assignment 2 (DETAILED ANSWERS) Semester 1 2025 - DISTINCTION GUARANTEED

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LML4801 Assignment 2 (DETAILED ANSWERS) Semester 1 2025 - DISTINCTION GUARANTEED - DISTINCTION GUARANTEED - DISTINCTION GUARANTEED Answers, guidelines, workings and references ,.. 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.

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LML4801
Assignment 2 Semester 1 2025
Unique #:

Due Date: 24 April 2025

Detailed solutions, explanations, workings
and references.

+27 81 278 3372

, Under the South African Patents Act 57 of 1978, patents may be revoked on
various grounds, particularly if they fail to meet the substantive requirements of
novelty, inventive step (non-obviousness), or are otherwise excluded from
patentability.

1. Novelty (Section 25(5))
One of the primary grounds for revocation under section 61(1)(c) of the Patents
Act is that the invention claimed in the patent is not new. Novelty is assessed with
reference to the state of the art immediately prior to the priority date of the patent.
The compound maxorevo was identified as early as March 2001 and has been
used in cardiac arrhythmia management medicine since 2004.

In Cipla Agrimed (Pty) Ltd v Merck Sharp Dohme Group and Another 2014 BIP
27 (CP), the court initially held that mere disclosure of the invention was sufficient
to constitute anticipation. However, the SCA in Merck Sharp Dohme Group and
Another v Cipla Agrimed (Pty) Ltd 2015 BIP 101 (SCA) added that the disclosure
must be "enabling"—meaning that a person skilled in the art should be able to
perform the invention based on the prior disclosure.

In this scenario, if maxorevo and its use for treating arrhythmia were already
known in 2004, R.D. Gen must show that the specific dosage regime (once daily
for seven days using a rapid-release tablet for a compound with a 12-hour or less
half-life) was also disclosed in an enabling manner. If the prior art does not clearly
and sufficiently teach this particular dosage regime, then the invention may still be
novel.

Likelihood of Success: Moderate

Success depends on whether the precise dosage and method of treatment were
known or could be inferred from earlier disclosures. If not, the patent may
withstand this challenge.



2. Inventive Step (Section 25(10))
The Patents Act provides in s 25(10) that an invention is only patentable if it
involves an inventive step—meaning that it must not be obvious to a person
skilled in the art. The applicable test involves a multi-step process drawn from


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