Patents and Pharmaceuticals – the combination of these words often invokes visions of companies exploiting intellectual property for financial gain, sometimes at the expense of the general public. The maintenance of a monopoly versus having a duty to provide care is a fine balancing act when investing large amounts of time and money developing drugs to combat diseases, such as tuberculosis (TB).
TB is a debilitating disease, with an estimated 1.3 million people having died from the disease in 2022, according to the World Health Organization (WHO).[1] Yet, TB is preventable and curable with access to medication and adequate healthcare. More severe strains that are resistant to medication, known as multidrug-resistant tuberculosis (MDR-TB), pose a threat to society as treatment becomes more difficult and MDR-TB may spread throughout vulnerable populations.
The issues of patent rights and access to TB medicines was recently brought into the spotlight in South Africa. In September 2023, the Competition Commission of South Africa (“the Commission”) released a statement that it had initiated an investigation against Johnson & Johnson (Pty) Ltd and its subsidiary company Janssen Pharmaceutica (Pty) Ltd (collectively “J&J”).[2] The investigation was based on a reasonable suspicion that J&J may have engaged in exclusionary practices and excessive pricing in the provision of the drug Bedaquiline (trading as Sirturo®) which is used in the treatment of TB. Such suspected exclusionary practices would be in contravention of the Competition Act, which prohibits an abuse of dominance.[3] The basis of this investigation was a “secondary” patent held by J&J.
A patent is by its very nature exclusionary; however, such exclusion is firstly limited, and is secondly justified by the exchange of a full disclosure of an invention. In South Africa, this period of exclusion is limited to 20 years, which may not be extended. Essentially, in exchange for fully disclosing one’s invention to the public, a patentee may prevent others from exploiting its invention for the lifetime of the patent.
So-called “originator” pharmaceutical companies rely on patent protection to ensure that they can recoup their investments made in the research and development of novel pharmaceuticals. The full disclosure required for valid patent protection then enables generic pharmaceuticals to enter the market upon expiry of a patent, at a reduced price.
There is accordingly a balancing act between ensuring pharmaceutical companies can recover costs to allow for continued R&D versus access to medicines for the public. National patent laws are pivotal in this balancing act, providing for limited monopolies, based on valid patents which provide advancements in the relevant industries.
This issue may become a contentious one when originator companies seek to extend their monopolies by relying on “secondary” patents. Originator companies will initially rely on a first patent which may protect the compound of a pharmaceutical. Such a patent would be filed early in the drug development process, before the compound is publicly disclosed through clinical trials and the like. Secondary patents will be filed later – seeking to protect features such as dosage regimens or drug formulations. Depending on when such secondary patents are filed, and what the claims thereof are directed to, the inventiveness of these patents may be questionable.
In the case of J&J’s TB patents, an initial patent family was filed in July 2003, directed to compounds, particularly quinoline derivatives, and their uses in the treatment of the likes of TB. The corresponding South African compound patent therefore expired in July 2023. However, J&J had also filed several secondary patents, including at least one in South Africa, which was the subject of the Commission’s investigation. According to a further media statement of the Commission, this secondary patent would effectively prolong the lifespan of the Bedaquiline patent, and thereby restrict entry of generics, to 2027.[4] This extended monopoly allegedly enabled the “excessive prices” complained of by the Commission.
The Commission’s investigation into J&J’s conduct was halted in July 2024 as J&J agreed not to enforce the Bedaquiline secondary patent in 134 low- and middle-income countries, including South Africa. This will allow for the entry of generic Bedaquiline products in South Africa. Furthermore, J&J also renegotiated prices charged to the National Department of Health as the procurer of Bedaquiline in South Africa, resulting in a price reduction of approximately 40%. Ultimately, this represents a win for the South African TB patient population.
The recent TB drug controversy draws parallels to the Hazel Tau & others case against GlaxoSmithKline and Boehringer Ingelheim in 2002 [5] which “was triggered by excessive pricing of ARV’s”[6], and the Big Pharma versus Nelson Mandela [7] case. The optics of Big Pharma exploiting the sick appears to be a scene played out time and time again.
Despite pharmaceutical companies appearing to exploit the patenting system, it is important to ensure that inconsistencies in public discourse regarding patenting are addressed. Clarifying these inconsistencies are not intended to defend the patenting system for the benefit of patentee’s that seek to extend monopolies, but for the general population to understand how the patenting system is there to benefit society and to not be abused.
From a South African perspective, the following should be noted:
- South Africa has good and well-established patent laws:
It is not because these laws are “lacking” that companies manage to get secondary patents. For a South African patent to be valid and enforceable it must be, inter alia, novel and inventive. Accordingly, a secondary patent will not be enforceable unless it meets these requirements.
- South Africa does not have a provision for patent extension:
Once a patent has reached the end of its 20-year lifespan, there is not provision for extending this in South Africa. Other countries do allow for extensions under very specific conditions. Even if a secondary patent is granted after the 20-year life of a patent, the original patent does not receive any special protection and is open for use by other parties.
- South Africa does not examine patents:
The fact that the secondary patents are granted has got little or nothing to do with the fact that South Africa does not have substantive search and examination (SSE). These patents will likely have foreign counterparts that are rigorously examined and may still be granted. Trying to enforce clearly invalid patents in South Africa has resulted in egg on the patentees’ faces more often than not. Patentees are accordingly unable to “abuse” the South African system just because it is non-examining.
Secondary and subsequent patents in South Africa typically have claims that have stood up to scrutiny in other jurisdictions. Whilst the validity of those patents may still be questionable and could be revoked during litigation, South Africa does not receive more questionable patents because we do not examine.
- South Africa has a clear and workable procedure to attack and invalidate patents:
The law provides measures to revoke an invalid patent on multiple grounds, such as a lack of novelty or inventiveness.
- Not all secondary patents are bad:
It is important to keep in mind that not all patents, including secondary (or “evergreening” ones) are necessarily bad. There may be legitimate further inventions that warrant and deserve further patents. A secondary patent will only be enforceable if it provides a novel and inventive advancement over what was known at the time of filing the patent application.
The patenting system has proven to be an effective means of driving innovation and providing protection to individuals and companies who invest time and money into R&D. However, the lines between profit versus public good become blurred where the underlying inventions are questionable to begin with, or the patentees use them strategically to extend their monopolies in an unjustified way, or even potentially, to the detriment of those in need. As such, it is important to critically evaluate the validity of patents, particularly secondary patents, which have failed in examining jurisdictions.
[1] https://www.who.int/news-room/fact-sheets/detail/tuberculosis
[2] https://www.compcom.co.za/wp-content/uploads/2023/09/Media-Statement-Commission-investigates-Johnson-Johnson-15-September-2023.pdf
[3] Section 8(1)(a) and (c) of the Competition Act, 89 of 1998.
[4] https://www.compcom.co.za/wp-content/uploads/2024/07/TUBERCULOSIS-PATENT-COMPLAINT-AGAINST-JOHNSON-JOHNSON.pdf
[5] https://www.dailymaverick.co.za/article/2022-12-02-competition-law-and-healthcare-lessons-from-the-hazel-tau-case/
[6] https://unctad.org/ippcaselaw/sites/default/files/ippcaselaw/2020-12/Hazel Tau SA Competition Commission v. GSK BI et al 2002.pdf
[7] https://msfaccess.org/1998-big-pharma-versus-nelson-mandela
