By Perpetua Mwangi* and Chrispin Bosire*

“The World can be happy that scientific resources have been mobilized so quickly without capitulating to false IP claims…”[1]

-Brook Baker

Introduction

On 29^th March 2020, The Ministry of Health (“MoH”) indicated that the government had initiated plans to manufacture Protective Personal Equipment (“PPE”) materials locally for self-sustainability.[2]  This pronouncement intimated the possibility of enhancing local manufacturing capacity. The government’s intervention followed the interim guidance issued by World Health Organization (“WHO”) on the 27^th of February 2020 on the rational use of PPEs.

Disruptions in the global supply chain of PPE, particularly for medical masks and respirators; gowns and goggles calls for a local intervention. This is perhaps to guard against the potential outcome of an overrun of COVID 19 patients in Kenya, likely to overwhelm our medical systems.

Rivatex East Africa Limited and Kitui County Textile Center (“Kicotec”), among other local manufacturing companies, have been earmarked to start the manufacturing of PPEs for Kenyans.[3] Several aspects of local manufacturing affect Intellectual Property Rights inter alia Patents, Trademarks, Trade secrets, Utility Models and Industrial designs, which ought to be leveraged for strategic advantage in product development.

Patents create monopolies for rights holders thereby putting them in a strong position to set prices.[4] Such prices have made the required products costly hence inaccessible.[5] The monopoly contributes to the inaccessibility of medicines. Remission of royalties and removal of restrictions on generic competition, leads to affordable medicines through reduced prices, sometimes by 99%.[6]

Trademarks are source identifiers which influence consumer decisions.[7] A trade secret is confidential information that gives a company an economic advantage over its competitors and is often a product of internal research and development.[8] Utility models are patent-like as they protect innovations through a cheaper and easier to obtain and maintain process.[9] They have a shorter grant lag, less stringent than patent requirements and a shorter protection period as registration expires at the end of the tenth year after the date of filing and is not be renewable.[10]

Industrial designs are concerned with the appearance of a product as they protect the ornamental, or aesthetic aspect of a useful article that can be reproduced in large quantities.[11] They are particularly important as we continue to see articles such as face masks and other PPEs appealing to the eye and feel.

Patents and related IPRs rights continue to be at the center stage of the friction between private interests and profit motives of patent holders as against the public health concerns of governments, world over.[12]

Intellectual Property Law Concerns

The COVID 19 era solicits innovation and efficiency to generate quick solutions to consequent problems. The government is taking steps to ensure it is prepared to comply with its constitutional obligations, such as provision of highest attainable standards of health,[13] for COVID 19 patients. Towards this end, it has lobbied for private sector’s support and goodwill.

The reality that many of the much needed supplies may be protected by registered IPRs is a cause of concern.[14]  For countries subject to a patent regulation regime,[15] registration grants owners,[16] the exclusive legal right to make, use or sell an invention for a specified period, twenty years in Kenya.[17] Potentially, local manufacturers are likely to seek patent registration.

For a Patent to be granted, the invention must be novel, useful and inventive.[18] In the context of COVID 19 therefore, for the equipment to be afforded patent protection, the stated requirements must be met. The timeline from application to registration of a patent  may take up to five years or more.[19]

Patents obtained from regional and international bodies are also enforced in Kenya. This was the decision in Pfizer Inc vs Cosmos Limited,[20]  where Pfizer Inc successfully enforced its ARIPO patent against Cosmos, a local generic manufacturing company. The alleged infringing acts by Cosmos were manufacturing and formulating, using, offering for sale and selling and stocking Azithromycin Dihydrate without authorization. The tribunal affirmed that patents are territorial in nature, and that Section 58 of the IPA did not grant leeway for infringement of patent rights on the basis of non-registration in Kenya. The tribunal granted an injunction in favor of Pfizer.[21]

As time is of the essence due to the current crisis, it would be noble for companies to hold off any enforcement of their exclusive rights. IPRs holders could consider permitting the use of any of their technologies in the production of the vital supplies. Where necessary, the State could pursue compulsory licensing as in the IPA and TRIPS Agreement.

Compulsory Licensing within TRIPS Agreement

The framework for compulsory licensing,[22] empowers a State to acquire a patented invention, as a matter of public interest, like in times of COVID 19 Pandemic. IPA provides for compulsory licensing under section 80.  Compulsory licensing may be utilized to address public health situations including high prices of medicines; anti-competitive practices; failure to locally work the patents; and failure by pharmaceutical patent holders to sufficiently supply the market with needed medicines.[23]

Compulsory licensing is restrictive and intrusive to rights holders. This is premised on Article 31 of the TRIPS Agreement which provides the minimum conditions for compulsory licenses. The conditions include equitable remuneration of the patent owner,[24]  the acquisition must be for strictly non-commercial use and for the benefit of the public. These conditions should be utilized in the current circumstances, should need arise, to enhance the local manufacturing capacity.

Article 31 TRIPS provides for: consideration of each case of compulsory licensing on its individual merits; express authorization from a patent owner on reasonable commercial terms; and limiting the scope and duration considering the purpose for the grant. The Article also makes available compulsory licenses once granted for everyone to exploit, considering commercial interest of patent owners. TRIPS also grants leeway to challenge the legality of compulsory licenses.

Section 74 of the IPA provides that a compulsory license shall not be granted unless the request for a commercial license is unsuccessful. This requirement is waived and the owner notified as soon as is reasonably practicable where there is a national emergency.[25] These procedural requirements perhaps make compulsory licensing unattractive.

In the alternative, we suggest the need to adopt a cooperative and consultative approach.  Some registered patent holders of these supplies have consented to use of their patented inventions by other companies,[26] in the manufacture of medical supplies, including PPEs and ventilators.[27]

For instance, the drug manufacturer AbbVie, has made a bold and unprecedented move by suspending  enforcement of its patent rights all over the world, on the formulations of its HIV drug – Kaletra.  The drug is currently on evaluation as a possible treatment for COVID-19 in a number of clinical trials. The waiver is broad enough such that countries can import from generic companies and further it may be domestically manufactured.

With such initiatives as AbbVie’s, manufacturing can kick off without the threat of infringement of any IPRs. In light of potential suits bordering patent infringement, perhaps there is need to obtain permissions or licenses from some of the patent holders, if at all some products are subject to patent. However, in the absence of such concessions within the context of COVID 19, compulsory licensing becomes an important and urgent policy mechanism.

In 2004, the IPA well within the provisions of the TRIPS Agreement was invoked. This empowered the Government to co-opt the domestic pharmaceutical company, Cosmos, to obtain two voluntary licenses for ARVs, which led to reasonably affordable ARVs.[28]

Compulsory licensing may therefore be utilized to ensure compliant manufacturing of the much-needed supplies in the current COVID 19 pandemic.

Flexing Pharmaceutical Product Patent Rights

Regarding medicinal drugs and related pharmaceutical products, the monopolistic nature of patents enhances inaccessibility of drugs, as patent owners reserve the discretion to set roof top prices and control supplies.[29] To counter this, there should be a balance between granting IPRs to incentivize inventors and ensuring access to affordable drugs.

As held in Patricia Asero Ochieng & 2 Others v Attorney General,[30] any actions thatthreaten to violate the rights to life;[31] human dignity;[32] and the highest attainable standard of health,[33] must be curtailed in light of constitutional safeguards. Patent inherently have the effect of limiting these rights, considering that they protect private proprietary interests. They should therefore be scrutinized to ensure a balance as against public rights.

Where there is evidence that such restriction seeks to limit access to essentials of health, it must be lifted. In reality, for the constitutional guarantee to affordable healthcare[34] to be met, there is great need to encourage innovation in the pharmaceutical industry. There should be a range of affordable pharmaceutical products from generic to originally patented products.[35]

Manufacturing Standards

While taking into consideration IPRs concerns, it is essential to insist on quality of medical supplies. Allistair Booth of Pinsent Masons posits that the need to streamline regulatory compliance will be critical but must be finely balanced with the need to ensure that appropriate standards are met.[36] In our opinion, the justification for this concern perhaps stems from the fact that original patent holders of most of these products employ minimum standards that shadow products should meet. The intention is to guarantee user safety and the overwhelming need to comply with international manufacturing standards. To maintain manufacturing standards, principal manufacturers continue to share intellectual property specifications and manufacturing protocols for use by other manufacturers.[37]

Conclusion

The exceptional circumstances surrounding the novel COVID 19 call for rapid response from local manufacturers and practice of public empathy. However, the law on IPRs, as is, precludes any unfair use leading to infringement. Creative inventors have the natural rights to their inventions, including benefitting from them and precluding unauthorized use. As Kenya looks to utilize its local manufacturing capacity, there is need to cover the intellectual property concerns.

The biggest take home is that the current pandemic presents an opportunity for Kenya to exploit the manufacturing capacity of local manufacturers; an opportunity for Kenyan innovators to showcase their innovativeness in response.  Kenya could leverage the crisis to manufacture for exportation to neighboring countries that may lack manufacturing capacity. COVID 19 is bitter sweet opportunity that Kenya should not waste!

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*Perpetua Mwangi is a partner at Simba and Simba Advocates

*Chrispin Bosire is a lawyer at Simba and Simba Advocates

[1] Brook Baker, (April 3, 2020), “Expect a Wave of Pro-IP Proposals from Industry in the Wake of the COVID-19,” available at <https://healthgap.org/expect-a-wavw-of-pro-ip-proposals-from-industry-in-the-wake-of-the-covid-19/> last accessed on 5^th April 2020.

[2] Ministry of Health daily address of 29^th March 2020, available at <www.moh.go.ke> last accessed on 31^st March 2020.

[3] ibid.

[4] Moni Wekesa and Ben Sihanya, (2009) “Intellectual Property Rights in Kenya,” Konrad Adenauer Stiftung, SportsLink Limited, available at https://www.kas.de/c/document_library/get_file?uuid=5e532191-8a73-ded8-1922-2fcd04d8f66e&groupId=252038 at Page 21.

[5] ibid.

[6] ‘India says “no” to policy that would block access to affordable medicines’ MSF Access Campaign 22 June 2011, available at <http://www.msfaccess.org/about-us/media-room/press-releases/india-says-no-policy-would-block-access-affordable-medicines> last accessed on 8^th April 2020.

[7] Trade Marks Act Cap 506, Section 2.

[8] TRIPS Agreement 1995, Article 39.

[9] Industrial Property Act (IPA) Section 2.

[10] IPA Section 82.

[11] IPA Section 84; See also <https://www.wipo.int/sme/en/ip_business/industrial_designs/index.htm> last accessed on 4th April, 2020.

[12] ICTSD-UNCTAD at p.15.

[13] Constitution of Kenya 2010, Article 43 (1) (a).

[14] In Germany, new emergency legislation passed by the country’s parliament impacts on patents in the life sciences sphere; competent authorities to allow themselves or third parties to make use of patented inventions for public interest purposes.

[15] TRIPS Agreement 1995, Article 27.

[16] TRIPS Agreement 1995, Article 33.

[17] IPA 2011.

[18] Ibid n1.

[19] Ibid n17.

[20] Pfizer Inc vs Cosmos Limited Industrial Property Tribunal Case No. 49 of 2006.

[21] At paragraph 19 of the ruling.

[22] IPA 2011, Section 58.

[23] TRIPS Agreement 1995, Article 31(g).

[24] Article 31(h) of the TRIPS Agreement 1995.

[25] IPA, Section 74.

[26] Dorothy R. Auth (2020) ‘Patent Rights in the COVID-19Pandemic: How will Industries and Governments Respond?’ Available at <https://www.google.com/amp/s/www.natlawreview.com/article/covid-19-update-patent-rights-covid-19-pandemic-how-will-industries-and-governments%famp> last accessed on 8^th April 2020.

[27] A ventilator is a medical artificial intelligent (AI) equipment with the capability of delivering the breathing function on behalf of the patient with respiratory illness.

[28] Moni Wekesa and Ben Sihanya, (2009) “Intellectual Property Rights in Kenya,” Konrad Adenauer Stiftung, SportsLink Limited.

[29] Patricia Asero Ochieng & 2 Others v Attorney General, [2012] eKLR.

[30] [2012] eKLR.

[31] Constitution of Kenya 2010, Article 26 (1).

[32] ibid Article 28.

[33] ibid Article 43 (1).

[34] Constitution of Kenya 2010, Article 43(1).

[35] LR Helfer ‘Towards a human rights framework for intellectual property’ (2007) 40 U.C. Davis Law Review 973.

[36] Pinsent Masons, “Corona Virus: Manufacturing Change in the Fight against Covid-19,” available at <https://www.pinsentmasons.com/out-law/analysis/coronavirus-manufacturing-change-covid-19> last accessed on 5^th April 2020.

[37] The UK government has published a specification for a ventilator system and invited parties to help.