“Intellectual property, for the pharmaceutical industry, represents its most important asset”

Juan Pablo Malfavon, Legal Director LatAm at AstraZeneca, discusses intellectual property in the pharmaceutical industry and the use of innovative technological tools by the company’s legal department.

Posté le jeudi, mars 30 2023
“Intellectual property, for the pharmaceutical industry, represents its most important asset”

Juan Pablo Malfavon

What role do technology and innovation play in the legal sector of the business?

The legal areas of companies have the great challenge of carrying out the  role of a true business partners that add value, and therefore it is increasingly necessary to have technological tools that allow you to simplify and maximize resources and interactions with the different  areas, in order to devote as much time as possible to the strategic issues that have the biggest impact on the business.

Something that we must take advantage of in our areas is the technological impetus that the new generations are already bringing. Listening to their ideas can help us to see things from a different point of view and in some cases solve internal processes which can be improved or simplified with the use of the right technology.

One of the most important and time-consuming issues in the legal areas of companies is the process of drafting, reviewing and managing all types of contracts. In this regard, digital platforms that can be developed internally or externally are very important to simplify the time that is invested from the request, preparation, negotiation, signing and safekeeping of contracts. The issue of budgets in the legal areas will always be a challenge because they are not business areas, so if it is not possible to hire platforms from external suppliers, I recommend using internal technology areas for the development of such digital platforms.

Take, for example, the issue of the electronic application of a contract: if it does not come complete with the necessary information and documentation, you cannot start the preparation or review. This often avoids the need to send several emails with the information and documentation of the contract (the famous back and forth emails), consuming important time between both parties and on many occasions delaying the projects themselves.

Digital platforms in general can save you time in the administration and tracking of day-to-day work, time that’s better spent dedicated  to strategic business issues, which allows us to be involved in the most interesting and impactful matters as part of our role as in-house lawyers.

What do you see as the major differences in pharmaceutical industry pre and post pandemic?

During the Covid-19 pandemic the pharmaceutical industry, together with the scientific community, played a vital role in the development of vaccines to combat the virus in record time. According to information published by IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), prior to 2020 the fastest vaccine developed was the Ebola vaccine, which took approximately five years, while in the Covid-19 pandemic, from the moment the genetic sequence of the virus became available for the first time until the first emergency authorization was granted for the first vaccine, it took less than a year,  325 days, to be precise.

An Airfinity study estimated that AstraZeneca’s vaccine helped save more than six million lives, in the first year of availability alone, that is, in the period from December 8th 2020 to December 8th 2021, during which time it was distributed in Latin America on a non-profit basis.

The most important challenge for the pharmaceutical industry during the pandemic was the need to quickly and effectively adapt its business models to the reality of the day. For example, virtual visits with physicians, delivery of medical samples, continuous medical education, launching new products and indications digitally. Business strategies and various digital platforms had to be developed in a short period of time to allow for the promotion of our products and the contact we must have with the medical community, so that this critical service would not come to a standstill as many other activities had.

As we continue to deal with what seems to be the final phase of the pandemic, we must pause to consider the lessons learned. The first is to take advantage of the synergy and collaboration that has been generated in the different sectors, governments, businesses and society in general, to analyze what has worked for us and prepare the mechanisms that will allow us to better combat future health emergencies. One example is the goal of the “The 100 Days Mission” (which  would see governments work to ensure pandemic preparedness via the detection of diseases, early diagnosis of patients, as well as facilitating and expediting research and development of therapies and vaccines in a timeframe of no more than 100 days.

Finally, virtual connectivity has accelerated during this pandemic and on this point, the community of lawyers must commit ourselves to promote the creation or adaptation of regulations that generate the promotion of digital health, such as telemedicine, the system of digital prescriptions allowing pharmacies to make home deliveries, etc.

Some Latin American countries such as Argentina, Mexico, Chile and Peru also achieved important advances by allowing online judicial and administrative processes,  during the pandemic, to ensure continuity in the provision of judicial services, or in the case of Colombia, with virtual means that allowed family conciliation and arbitration centers to continue to provide services.

The most important challenge within each of the functions in pharmaceutical companies, including legal, is to seek to have the best possible scenario for innovation

What are the biggest challenges for the pharmaceutical industry in Mexico?

The most important challenge within each of the functions in pharmaceutical companies, including legal, is to seek to have the best possible scenario for innovation. The role of in-house counsel in the pharmaceutical industry is critical to generate the regulatory framework and administrative systems that allow the fulfillment of this objective. For example, promoting industry-wide initiatives to foster intellectual property protection systems, thereby strengthening the ecosystem conducive to promoting innovation, discovery, development and access to new treatments and cures.

Evidence shows that the rate at which developing countries grow depends substantially on the transfer of technology from developed nations, and intellectual property protection in developing countries plays a critical role in determining whether such transfers take place. Robust intellectual property systems in countries help foster innovation, research and development, helping prevent and cure increasingly complex diseases and improve patients’ quality of life.

Another example is encouraging the creation of adequate regulatory frameworks that help with the implementation of protocols and clinical studies in the countries in question, which reduce the impact of certain diseases that affect so many of populations in the region. On many occasions, the decision to carry out clinical studies in a country depends on the regulatory facilities offered. Unfortunately, in this regard, this type of investment often finds its way to other continents, due to the complexity of the regulations and the time involved in the development of clinical studies.

What are the keys to adequate intellectual property rights management in this industry?

Let’s remember that intellectual property is not only an engine of growth for economies globally, for the pharmaceutical industry it represents its most important asset.

A report published by NDP Analytics notes that "... countries with a high level of patent registration (those that register more patents) tend to experience higher rates of economic growth and this growth accelerates over time as patenting activities increase...", so it is essential in Latin America to continue promoting systems that guarantee the protection of intellectual property. Especially taking into account that patents are considered the most effective tool to reward and encourage innovation, including all the benefits mentioned above for patients and for countries' economies.

Some recommendations for the management of intellectual property rights are as follows: 1) make sure you have properly identified all intellectual property assets that are subject to protection (patents, trademarks, works, industrial secrets, etc.); 2) protect them before the relevant authorities; 3) generate strategies that guarantee the protection of the benefits granted in the market; 4) create internal procedures and policies that guarantee their management and internal protection; 5) it is also important to train your personnel to understand the importance of these assets and avoid their misuse; among others.

Within transnational pharmaceutical companies, it is common for patents and trademarks to be centralized and managed globally by the corresponding IP areas. For example, the process of registration, follow-up and administration of patents is handled globally by the patent attorneys of the IP area of the companies, who coordinate directly with law firms in each country.

The local legal areas intervene on some occasions during the process in market-related issues, such as the granting of exploitation licenses when required by regulatory authorities or to assess the potential infringement of illegal generic patents, among others.

How does management of outside counsel work, and what matters do they typically get referred?

When handling legal matters it’s important to know which matters should be handled in-house and which can be handled by outside counsel.

For example, routine day-to-day matters can be handled in-house, but  cases such related to intellectual property, civil, commercial or administrative litigation are best handled by an expert law firm.

For matters where the support of an external lawyer is required, it is important to know how to identify the best fit for a specific case. Sometimes it is important to select a Tier 1 firm, sometimes a specialized boutique firm and sometimes an independent lawyer. Everything will depend on the nature of the matter at hand and which law firm or lawyer can best provide the results you need.

Once the firm has been selected, a fee proposal should be requested. There are several alternatives (hourly rate, flat fee, capped fee, fixed fee, etc.), the important thing will be to see which is the best and most convenient depending on the nature of the matter, to establish an adequate remuneration for the services provided, thinking of both parties with a view to establishing a long-term relationship.