Mexico: The Challenge Of Protecting Polymorphs In Mexico

Last Updated: 12 December 2018
Article by Mariana González and Lino Almazán
Most Read Contributor in Mexico, December 2018

Polymorphism refers to the ability of a compound to exhibit more than one crystalline form. Each polymorph exhibits different physical properties such as density, solubility, melting point, and stability under storage or use conditions, among others. Solid state characterization techniques provide electromagnetic spectra with particular data for a polymorph through which it can be distinguished from others.

In the pharmaceutical field, polymorphs are important because of advantageous properties such as better solubility, compressibility, and/or bioavailability; however, they may also exhibit undesired side-effects as in the case of deformities in children by maternal intake of a crystalline form of thalidomide during pregnancy.

A drug may show to be effective only through a determined polymorph. Therefore, the selection of polymorphs is typical in healthcare-related patents because of the regulatory barriers to market entry for products in this industry and the advantages of polymorphs as pharmaceutical active ingredients.

However, protection of crystalline forms is sometimes a real challenge in Mexico.

The Mexican Industrial Property Law (MIPL) establishes the following:

"Article 19: Will not be considered inventions for the purposes of this Law:


VIII. The juxtaposition of known inventions or mixtures of known products, variations in their use, form, dimensions or materials, unless actually it is about a combination or a merger so that they cannot function separately, or that the qualities or characteristic functions thereof are modified to obtain an industrial result or use not obvious to a person skilled in the art."

It seems that article 19, section VIII obliges the applicant to a burden of proof, particularly when the compound is already disclosed in the prior art, since the crystallography is being construed as a routine experimentation. Thus, some examiners of the Mexican Institute of Industrial Property (IMPI) take a strict position in terms of the inventive step requirement, as sometimes they consider that the production of a polymorph is achieved through routine experimentation, and an inventive step is not involved, so it becomes difficult to convince Mexican examiners about the inventiveness of patent applications regarding crystals which contain characterization tests as the only experimental evidence.

Moreover, Mexican examiners have adopted common criteria in considering a crystalline form as a product without involving an inventive step if the application does not contain experimental data other than characterization techniques. So, examiners require proof which demonstrates the advantageous technical effect provided by such crystalline form over the amorphous form known, particularly when the compound in amorphous or another crystalline form is already known in the art.

However, it is important to consider that until now, there is no an infallible method for predicting that a specific compound is going to have polymorphs and the technical features of the same. From a thermodynamic point of view of polymorphism, the thermodynamic stability and the time it takes for a transformation to equilibrium should be considered. The pharmacokinetics of this transformation will finally establish the type and stability of the polymorphs.

The existence and identity of polymorphs is not predictable, and even if it were possible to predict that a compound might be susceptible to having polymorphs and what their structures might be, generally a person skilled in the art could not deduce how to produce a specific polymorph (eg, crystallization conditions) or predict its properties.

Frequently the crystallization of new polymorphs requires between hundreds and thousands of experiments that analyse the effects of various parameters such as temperature, solvents and mixtures thereof, mixing time, cooling rate, agitation rate and concentrations, as well as methods and processes for the precipitation, cooling, evaporation, and thermal cycles.

In this way, the number of crystallization conditions is so great that if it were possible to predict the most stable crystalline form, a person skilled in the art would not have defined a series of specific experiments or variables on which it could be based for its production.

The rationale above has been successfully used to overcome objections made by Mexican examiners when inventive step is questioned based on the idea that polymorphs are obtained by routine experimentation and when there are enough experiments described on the application showing how different parameters of the specific crystallization procedure were defined, for example, by trial and error.

Nevertheless, in order to face the challenge of protecting polymorphs in Mexico with the highest chances of success and to demonstrate without a doubt the inventiveness of polymorphs, it is recommended that applicants include further evidence duly supported by examples and comparative examples in addition to solid state characterization techniques.

This evidence should be specially focused on demonstrating an advantage and/or unexpected effect of said polymorph when compared with the amorphous form of the compound or already known crystalline form.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Mariana González
Lino Almazán
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions