Steps to apply for and protect a healthcare patent

Obtaining a healthcare patent is a crucial step in protecting inventions related to health. This protection spans a broad spectrum of products and processes, from medicines to medical devices and diagnostic techniques.

While the procedure for applying for a healthcare patent registration is identical to that of any other product, it involves legal specifics that we will explore later.

Healthcare patent: How is a medication patented?

In essence, patenting an invention in the healthcare sector means obtaining the exclusive right granted by the State to exploit that invention within its territory for a specified period of time. In Spain and the European Union, this period is typically 20 years from the date of application, with the possibility of extending it by 5 additional years for pharmaceutical and plant protection products. This right allows the patent holder to prevent others from manufacturing, selling, or using the invention without permission.

Medications, like any other product, must meet certain requirements to be patented, including novelty, inventive step, and industrial applicability. To initiate the patent application process, a detailed document describing how the medication is obtained, its characteristics, and its function must be drafted. This document must clearly define what is to be protected.

Once drafted, this document is submitted to the Spanish Patent and Trademark Office (OEPM) along with the required forms and payment of the established fees. From the date of application, the patent term (20 years) begins. However, for pharmaceutical and/or plant protection products, it’s possible to extend protection by an additional 5 years through the issuance of a Supplementary Protection Certificate (SPC).

Furthermore, international agreements allow extending patent protection to other countries, providing broader coverage and global protection. In our article Procedimiento de las patentes: cuestiones básicas, we detail this process.

If someone uses the protected invention without authorization from the patent holder, the latter has the right to initiate legal actions to enforce their exclusive rights. Additionally, the patent holder can grant exploitation licenses to third parties, typically in exchange for financial compensation.

Patent Management in Cases of Multi-Institutional Developments and International Protection

In the case of multi-institutional developments, it is common for patents to have multiple holders, each with a percentage of ownership based on their contribution to the invention’s development. In academic settings, such as universities, managing patents in collaboration with other institutions is common, as research often involves joint efforts among multiple stakeholders.

As suggested above, extending patent protection to multiple countries is possible thanks to international treaties that facilitate this process. Although each country has its own laws and requirements for patentability, there are similarities that allow the extension of a patent application to multiple jurisdictions, provided the holder meets certain criteria and has the necessary resources to do so.

Coordination between Healthcare Patent Application and Registration with the Medicines Agency

It is important to note that obtaining a healthcare patent does not automatically grant authorization to market the medication. For this, approval from the corresponding regulatory authority is required, which in Spain is the Spanish Agency of Medicines and Medical Devices (AEMPS). This involves meeting additional requirements related to the safety and efficacy of the product.

In the complex process of bringing a medication to market, coordination between the application for a healthcare patent and registration with the Medicines Agency is crucial yet often underestimated. Both processes are independent but interconnected, and their proper management can make the difference between success and failure in the commercialization of a pharmaceutical product.

The application for a healthcare patent is the first step in protecting an invention related to health, such as a medication. Obtaining a patent guarantees the holder the exclusive right to exploit the invention for a specified period of time.

It is essential to file the patent application once sufficient results are available to accurately describe the invention. Disclosing details about the invention before filing the patent application can negatively impact its novelty, which could hinder its approval. Therefore, maintaining confidentiality of research results until the patent application is filed is imperative.

The time it takes for healthcare patent protection and other categories to become effective varies according to each country’s regulations. Generally, patent applications provide some protection from the moment of publication, which typically occurs approximately 18 months after filing, offering provisional protection that becomes full once the patent is granted.

National Medicines Agency Authorization

Simultaneously, AEMPS authorization is granted after a thorough scientific evaluation of the quality, safety, and efficacy of the medication in question.

The evaluation by AEMPS is based on rigorous criteria that consider the benefits and risks of the medication for the diseases and situations for which it is intended. The agency conducts ongoing monitoring to oversee any developments regarding risks or new uses of the medication.

There are several authorization procedures for marketing medications in Spain. One of them is the national procedure, in which the applicant submits a comprehensive dossier including detailed information about the medication, its manufacture, and a risk management plan, among other aspects.

During the evaluation process, AEMPS thoroughly reviews all available data, including preclinical and clinical research results, as well as information on the manufacturing and quality controls of the medication. This evaluation may include analyses in official laboratories or inspections at the medication manufacturing facilities.

Once the evaluation concludes satisfactorily, AEMPS issues the authorization for marketing the medication, specifying conditions for its proper use such as dosage, precautions, and contraindications.

Once authorization is obtained, the healthcare patent takes on a more practical significance, ensuring control over the exploitation rights of the product.

Authorization Procedures in the European Union

Similarly, it is possible to apply for medication authorization in the European Union. For this purpose, there are three avenues:

  • Decentralized Procedure: In this procedure, the applicant submits their authorization application simultaneously in several EU countries. Coordinated, different agencies review the medication, with one acting as the coordinator or reference agency. Once the process is completed, all agencies issue a similar authorization valid for their respective territories. This approach allows for a comprehensive and coordinated assessment of the medication, ensuring access across multiple European markets.
  • Mutual Recognition Procedure: When a medication already has a Community marketing authorization, the holder can use the mutual recognition procedure to obtain authorization in other EU Member States. In this case, an application for recognition must be submitted to the relevant countries. Additionally, the holder must notify this action to both the reference Member State that granted the initial authorization and the European Medicines Agency (EMA). The assessment report of the medication is forwarded to the involved States, who recognize the initial authorization if appropriate. This option facilitates expanding access to the medication throughout the EU.
  • Centralized Procedure: The centralized procedure offers a single authorization valid for all EU Member States simultaneously. Responsibility lies with the European Medicines Agency (EMA), which coordinates scientific evaluations conducted by two designated Member States. A scientific committee, under the EMA, prepares opinions on the medication evaluation. Upon issuing a positive technical opinion, the European Commission grants marketing authorization for the entire EU. This procedure ensures a high level of harmonization and consistency in the evaluation of medications at the European level.

ISERN accompanies you throughout the entire healthcare patent application process

With over a hundred years of experience in the field of patent and trademark registration and protection, as well as intellectual and industrial property in Spain and Europe, ISERN takes pride in our established leadership. At ISERN Patentes y Marcas, we provide specialized legal advice and support throughout the entire process of applying for healthcare patents for your company.

Indeed, our team of highly qualified professionals is here to offer you the necessary support before, during, and after the patent application process. Once your healthcare patent is granted and marketing authorization is obtained, we remain vigilant against any unauthorized use by third parties, vigorously defending your rights. Contact us and visit any of our twelve locations in major cities across Spain!

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