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Biotech Offers Great Opportunities for Mexican Pharmaceuticals

By Jan Hogewoning | Thu, 05/14/2020 - 13:37

Q: What differentiates Research Pro from other consultancy firms that offers similar services?

A: Many consultancies dedicated to the area of patents have teams of 10 to 15 lawyers and one pharmaceutical specialist. In our case, it is the other way around. Our team is composed of a majority of specialists in the development of pharmaceuticals. Our analysis is fundamentally technical, meaning we provide solutions that are centered around the composition and manufacturing of pharmaceuticals that address questions in the area of intellectual property.

Q: What is the benefit of a technical analysis for these issues?

A: We provide clients with guidance on how to develop their own product without breaching existing patents. If you study the technical aspects of a patent you can find openings that allow for a new innovative product with certain modifications. This allows a client to develop a medication before the original patent expires and everyone else enters with their own generic. When a patent expires and generics are introduced, the medicine loses a lot of market value. Therefore, providing a client an earlier alternative is of great strategic value. Apart from this service, we also help clients to defend their patents. One of the first cases we had was helping Pfizer defend Viagra against Cialis. Since then, we have also undertaken technical defenses for Bayer, AstraZeneca and others.

Q: What is the step by step processes of your technical analyses?

A: We prefer to work with a client from the beginning. The client will tell us what product it intends to develop. We analyze existing patents. There are almost always multiple patents that need to be studied. The process takes place in phases. The first phase is to determine feasibility. We ask ourselves: Is it possible or not? Some patents regard the principal active ingredient, others concern secondary aspects, such as other ingredients or manufacturing methods. We access information about medication from different sources, including laboratory work and information contained in the Drug Master File (DMF) and authorities such as COFEPRIS. If we see a point where the DMF is not clear, we inform the client. They can then conduct trials with a product that has a variation in certain properties. Many pharmaceutical products have a polyform; however, these come in different structures – some patented, others not. There are times when the excipient, lubricant or oxidant content is protected. We create a map that provides an overview of how you can produce the medication without breaching the patent. For our research, we have alliances with third parties and universities, particularly UNAM. Research Pro also has its own laboratory, which is normally used for studies of food products. However, this team can also study the percentage of certain ingredients in a medication.

Q: How does intellectual property differ in the area of biotechnology products?

A: The analysis is practically the same, but biotechnology products tend to have far more patents. As a result, there are no generic biotechnical products in the Mexican market. The patents simply tend to be so excessive. It is important to point out that even though countries have signed the Paris Convention for the Protection of Industrial Property, countries have varying policies with respect to patents. This leads to some countries not respecting some patents, or choosing to respect them but with different limits of ingredients. In Europe, the levels of anti-oxidant content may be protected at 1-2 percent, whereas in the US, the level can be between 1-5 percent. To get around this, manufacturers add a greater percentage of anti-oxidant or they add a second oxidant to make it different altogether.

Q: How is the current political situation impacting the pharmaceutical industry?

A: The political situation in Mexico today is complicated by the changes that are constantly occurring, generally forcing to the industrialists to seek strategies that allow better access to medicines at a lower price, while respecting pharmaceutical patents. Therefore, in addition to seeking new markets such as Latin America, companies must be much more efficient in their pharmaceutical development efforts and seeking new business models. We hope that the government generates fair and efficient schemes for health regulation and the purchase of medicines.

Q: What steps should the government take?

Generally speaking, I think there should be a greater dialogue to discuss these developments. I also think the agenda should focus on stimulating national production. We need to train a greater number of people in the area of biotechnology, which has great potential in this country. There are only two major companies in the world that develop these products. With one, we are signing an agreement that would allow Mexican partners to develop new products with them. The benefit of biotechnology is that these patents are going to endure, whereas in the area of conventional pharmaceuticals, many patents are expiring. There needs to be technical basis for Mexican laboratories to compete in developing their own innovative products. This coincides with a need for solid technical consultancy. Before you develop a product, you need to know which market you are developing it for, and for which country as well.

 

 

Research Pro is a consultancy focused on intellectual property in the area of pharmaceuticals, biology, agricultural goods, and food products. It aims to provide technical solutions for pharmaceutical companies to defend patents or develop innovative protects without breaching existing patents

Jan Hogewoning Jan Hogewoning Journalist and Industry Analyst