JULY 2013
Legal Focus
95 Protecting Pharmaceutical Patents
Patents are an important and valuable aspect of Intellectual Property, especially in fast paced and ever-evolving industries such as the Pharmaceutical sector. To find out how Pharmaceutical companies can most effectively protect their patents, we speak to Rodrigo Calderón, a Senior Associate for the Mexican IP Firm, Uhthoff, Gómez Vega & Uhthoff S.C.
What are the common challenges faced by your clients when trying to protect pharmaceutical patents?
Up until a few years back, innovator companies faced few challenges when their IP was well protected. Now, the current economic and political situation, the more aggressive approach of generic manufacturers, as well as the recent changes in the Mexican IP legal framework, most of which relate directly to this particular industry, due to strong pressure from the local generic companies, have made the Mexican pharmaceutical situation more competitive. Patent litigation in the biotech and pharmaceutical industry has grown considerably in the past few years and new developments such as patent-marketing authorization linkage, data exclusivity, use patents, biosimilars, etc… have provided a different and far more complex playing field.
The two challenges that I would consider to be currently the more interesting and under debate in Mexico are: 1) Patent – Marketing Authorization linkage, i.e. the Mexican Medicament Patent Gazette or Mexican “Orange Book” and 2) the correct interpretation and enforcement of “Swiss-type use” and new “compound-for-use” (New European use) claims.
How has/can your firm assist the client when such challenges arise?
We have recently created a Biotech and Pharma Special- ized Team within our Firm that offers our biotech and pharmaceutical industry clients with customized IP services and specialized know-how for gearing up in the new highly competitive environment.
Our Biotech and Pharma Specialized Team is comprised, not only by top of the line lawyers, but also by high level scientists and technical specialists in the field; all working together in providing our clients with broad-scoped and integral IP counseling ranging from the insights and best practices in filing and prosecuting biotech and pharmaceutical patents and trademarks, to the necessary legal and technical skills of patent and trademark litigation.
The team has been designed to provide the highly specialized assistance that biotech and pharmaceutical research companies now need to reach and maintain a leading position in the Mexican market.
Recent reports show that the number of patents filed by major pharmaceutical companies has dropped dramatically in recent years. Why do you think this is?
I think that this phenomenon is probably not due to one sole factor but is rather multifactorial. From the recent and current economic situation, both in developing countries and also in developed countries that used to have strong economies and which now are going or have gone
through a monetary crisis. This precarious situation makes it, of course, harder and harder for pharmaceutical companies to invest in research and development and in the subsequent patent protection thereof.
A lack of proper enforcement of patent rights in many countries leads to pharmaceutical companies being discouraged in seeking patent protection when such protection will ultimately not be an asset in gaining position in the market, but rather a time and money consuming legal process, and will ultimately not promote more innovation.
Finally, the new orientation of pharmaceutical technology is turning more into developing new biotechnology products rather than chemical synthesis ones; developing new biomolecules and related products is a far more complex and time-consuming process than chemical- synthesis molecules mainly due to the intricacies of larger and more complex structures and the difficulties and variables involved in working with living organisms, this heightened level of complexity may result in less usable innovation and slower advances which, in turn, result in fewer patents.
What are the most effective strategies for pharmaceutical patent applications in your country?
Right now, I would say that the most effective form of patent protection in Mexico for pharmaceuticals is getting a patent listed in the Mexican Medicament Patent Gazette or the so-called Mexican “Orange Book”, this publication lists all patents granted and valid that cover or claim allopathic medicaments, whether the active compound or the formulation of the final drug. This publication is intended to inform the Mexican Regulatory Authority (COFEPRIS) of what products are patent- protected so that COFEPRIS abstains from issuing Marketing Authorizations to potentially infringing third party products.
In terms of prosecution of patent applications, the Mexican Patent Office is normally following foreign criteria regarding patent-examination and allowable subject matter issues, mostly those coming from the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO). In light of this, obtaining strong patent protection in Europe and/or the U.S. and then mirroring the claims in the Mexican case will generally result in expedite and strong patent protection in Mexico also.
Please tell me about the most recent substantial legislative change that has affected your work.
Although no major recent changes have occurred in Mexican patent legislation since 1994 when the current Mexican Law of Industrial Property was enacted, the most recent change in patent law was introduced in 2010 and
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it was related to an intent to put into action a pre-grant patent opposition proceeding.
This intent was, in fact, promoted by the generic pharmaceutical companies in an effort to stop or delay patent prosecution for certain cases which would result against their interests.
After much debate in congress, the final amendment to the law resulted in a fairly mild proceeding which should not affect patent prosecution in general. In brief, the amendment introduced new Article 52Bis which now permits any third party to submit observations and documents against a pending patent application within 6 months of publication. The third party may submit such observations and documents solely for the purposes of proving lack of novelty, inventive step of the subject matter or to make the Patent Office aware of the existence of subject matter in the patent application that is statutorily banned from patenting or not considered as an invention under Mexican Patent Law. These observations and documents will be included into the patent application file and should be reviewed by the patent examiner when the patent application goes into examination, the patent examiner will then determine if the submitted observations and documents are, in fact, relevant to the issue at hand and, if so, he will employ them as part of the normal examination, in other words, he may issue an objection against the patent application on the grounds stated above and the applicant may respond, amend and/or argue back. The Article clearly states that the determination from the examiner will be final and, if a patent is allowed, the third party may not contend the decision on the allowance, of course, a patent cancellation action will still be an available option after grant for that or any other third party provided that they comply with the requisites for such action. LM
Contact:
Uhthoff, Gómez Vega & Uhthoff S.C. Hamburgo no. 260, Col. Juárez, 06600, México, d.F. México
Phone: +52 55 55 33 50 60 Fax: +52 55 52 08 83 87 Email:
mailbox@uhthoff.com.mx Web:
www.uhthoff.com.mx
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