The COVID-19 pandemic has put the spotlight on vaccine development in recent times, with the public showing a great amount of interest in the development and roll-out of COVID-19 vaccines. Vaccines have for a long time been pivotal in curbing the spread of infectious and often highly dangerous diseases, saving millions of lives each year. Behind the scenes, the stages involved in taking a vaccine to market are wide-ranging and complex, often spreading beyond the remit of one single company and involving numerous contractual arrangements between a number of different parties.
As is the case with other drug development, numerous stakeholders will contribute certain intellectual property (IP) that will feed into the development of a vaccine, ranging from patents, which typically protect the key components or active ingredients of the vaccine itself as well as know-how and confidential information, both of which are key for the production process. Parties seeking protection of these vital IP rights is a common theme throughout the contractual arrangements involved in the vaccine life cycle. The key stages of vaccine development and the relevant contractual arrangements are discussed below.
Research & development (R&D)
This is the initial stage of vaccine development and refers to a specific project targeted at developing a new vaccine. R&D commonly involves collaboration between two or more industry or higher education institutions that enter into research or collaboration agreements. Collaboration agreements will commonly cover the ownership and exploitation of any IP rights arising from the R&D, as well as confidentiality provisions in relation to technical information generated prior to and during the project.
Licensing
To aid vaccine development, parties will often enter into licensing arrangements, under which an inventor or proprietor (the licensor) grants a customer (the licensee) either exclusive, sole or non-exclusive rights to use its patents or know-how. These arrangements allow a party to commercially exploit its IP rights and tend to be complex arrangements containing multi-tiered payment structures and provisions governing the use of the licensed IP by both the licensee and third parties.
Manufacturing
The manufacturing stage of vaccine development is extensive. At the outset of the manufacturing pilot, batches of the product are made at a scale large enough for the relevant stability and quality testing to be carried out before larger-scale manufacturing takes place. As many companies do not have the ability or resources to manufacture vaccines at the scale required for commercial use in-house, third-party manufacturers are widely used.
Development and manufacturing agreements are used to govern the terms of these third-party arrangements. Such agreements set out in detail the vaccine manufacturing specifications and pricing, clarify which party shall be responsible for sourcing the raw materials required for manufacturing, and specify storage and delivery terms. Once wider-scale manufacturing has commenced following the clinical trial stage, some companies will also enter into arrangements with third parties for the storage and distribution of the product, the terms of which are usually governed by a separate distribution and warehousing agreement. At a time where supply chains around the world are under a great deal of pressure, the negotiation of these types of agreements is becoming an increasingly important aspect of the vaccine life cycle.
Clinical trials
The clinical trials stage is key to getting a vaccine to market safely and, as a result, is heavily regulated. Before commencing work on any clinical trial, the relevant parties should enter into a clinical trial agreement. As is the case throughout the vaccine life cycle, the protection of IP rights is of vital importance to pharmaceutical companies to safeguard the significant investment in their vaccine.
The vaccine developer will want to ensure it retains ownership of its pre-existing background IP as well as any foreground IP created during the clinical trial. Meanwhile, the institution running the clinical trial will often seek ownership rights in any foreground IP created and the right to use any know-how developed in future trials, meaning negotiations can be lengthy to strike a commercially balanced position that protects the interests of both parties.
Regulatory approval
The final stage before marketing a vaccine for use in the public is the regulatory approval stage. Following Brexit, the relevant body for granting approval in the United Kingdom is the Medicines and Healthcare products Regulatory Agency (MHRA). Often with the support of regulatory lawyers, a vaccine developer will submit an application to the MHRA which will then assess the safety, quality and effectiveness of the vaccine using the results from the clinical trials before, where deemed appropriate, granting approval.
Melissa Fisher