A patent portfolio is one of a company’s most important assets. Patents not only provide protection for the company’s products and can be used to prevent a competitor from entering the market place; they can also be used as a great business tool. A strong patent portfolio can demonstrate the wealth of technology that has been created by the company to potential investors and clients, which is often crucial to the company moving forward. This is of particular relevance in the pharmaceutical industry where the nature of the research and the need to meet regulatory requirements means that it can be some time before a concrete product can be brought to the market place. Accordingly, it is important to ensure that your patent portfolio is as strong as possible.
One of the toughest decisions with filing patent applications is choosing the right time to file the application. Below, we take you through the main areas you need to think about in deciding when to file your patent application, and highlight some of the common pitfalls.
Preventing Publication until IP Rights are in Place
The main hurdles for obtaining patent protection are that the subject matter of the invention is new (novel) and non-obvious over disclosures made before the filing date of the patent application. If companies do not put the correct procedures in place, it can often be their own disclosure(s) that destroys the novelty and/or obviousness of their invention. It is extremely important to monitor when and how any information is disclosed.
Any non-confidential disclosure will potentially be detrimental to a later filed patent application, and ideally should not be made before filing a patent application. Even a general disclosure of your product, without any specific details, can render your invention obvious. For example, indicating that you are carrying out research on a particular class of compounds for treating a specific disease is likely to render the same use of a specific compound of that class of compounds obvious. Therefore, care must be taken when any disclosures outside of the company are made; particularly any publications to promote the business.
It is essential that all disclosures are confidential before a patent application is filed. Anyone under a contract of employment is considered to be under an obligation to keep all information confidential. Therefore, all internal communications should be considered to be confidential.
If it is necessary to make disclosures to third parties for collaborative or other purposes, then it is essential that the company has already secured a patent application filing date or made the third parties sign a confidentiality agreement prior to disclosure of the invention. For example, a confidentiality clause should be included in all contractual agreements. Verbal confidentiality agreements should be avoided because they can be difficult to rely on at a later date.
When to File?
It is extremely important that a patent application is filed at the correct time. A careful balance must be made between the benefits associated with filing early to plant your flag in the ground, and ensuring that the application contains sufficient technical information and experimental data to support the invention.
Europe operates a first to file system, which means that a party with an earlier filing date has an advantage over a party with a later filing date. The need for an early filing date, particularly in areas where advancements are happening all the time such as in the pharmaceutical industry, often leads to companies filing patent applications as soon as possible to secure a filing date.
Patent offices around the world, and in particular the European Patent Office (EPO), are imposing increasingly stricter requirements on the need for successful patent applications to provide data demonstrating that the invention works. Therefore, there is a high risk that patent applications may be rejected if they do not contain sufficient data.
It is also important to ensure that there is sufficient data to support fairly broad claims. For example, if the patent application only contains experimental data to show a small subset of a class of drugs can achieve a desired effect, it may only be possible to obtain protection for that specific subset rather than all of the drugs in the class.
Other business requirements may also come into play when deciding the correct time for filing a patent application. It may be that certain collaborators will only enter into agreements once the patent application has been filed. Also, it may be necessary to make certain disclosures or publications about the invention in order to advance the company. If these business requirements lead to patent applications being filed before substantial experimental data can be produced, it is recommended that as much technical data as possible is included and supplemented with technical explanations as to why the invention will work across its scope. If possible, further applications should be filed within the priority year containing more experimental data.
If possible, it is recommended to delay filing the application until there is sufficient data to demonstrate the effectiveness of the invention.
Be Careful What You Disclose During the Priority Year
Once you have filed your initial application, you have a year from its filing date to file further applications (such as foreign applications), claiming priority from your initial application or subsequent applications in the same year. This year is known as the “priority year”. The later application is considered to have the filing date of the earlier application for any common subject matter.
This means that disclosures of the invention by the applicant, or any relevant disclosures by third parties, during the priority year will not invalidate your later application, even though they occur before the actual filing date of your later application.
It is possible to include additional information in the later application, such as modifications, alternatives or additional advances. However, any additional information in the later application takes the actual filing date of the later application. This means that publications between the filing of the earlier application and that of the later application may be relevant to the additional information.
Who Owns What?
It is important to resolve, as soon as possible in the patenting process, who owns the invention. To avoid complications, this should be determined before filing the application.
Generally, inventions made by employees resulting from their work for a company are owned by the company. It is recommended that this is stated in each employee’s employment contract. In contrast, consultants are usually considered to own the rights in their contribution to the invention, unless there is a contract to the contrary. Therefore, it is essential that an agreement is in place before the work is carried that states who owns the rights in the invention. If it is determined that the invention is a joint collaboration, it is also prudent to include clauses relating to who will be responsible for obtaining IP rights and paying the associated costs.
Therefore, it is essential that ownership of an invention is clearly established and documented before any patent application is filed. This will prevent any subsequent challenge to the applicant’s entitlement to file, which could lead to invalidity of the patent.
Drafting Patent Specifications
Once you have determined that you are in a position to file a patent application, it will be necessary to have a patent specification prepared. It is strongly advised that you consult a qualified patent attorney to draft the application, who has experience in meeting the relevant requirements. It is crucial to sit down early with your patent attorney and be certain that you pass on all the relevant information concerning the invention. A good patent attorney will ask the right questions to ensure that they gain the relevant information. However, the process will run more smoothly, and more cost-effectively, if you collate all of the technical information and experimental data before the meeting.