January 1, 1970 (Vol. , No. )

Ann-Sofie Sternas Karolinska Development

Protect your inventions with these tips.

1. What can be patented?

An invention is a technical solution to a technical problem. In order to be patentable your invention must be novel, nonobvious, and have a utility. If you in your research for example discover the mechanism of action for a compound that you are doing research on, the actual mechanism of action is not patentable since mechanisms are considered mere discoveries and hence not patentable. If the compound however is novel and has certain advantages over closely related prior art compounds, that compound may be patentable.

Conclusion: Discovering a new mechanism of action for a known compound will not provide anything new and patentable for that compound.

Don’t let patent confusion get you down—just let this expert advice guide you. [© Aamon – Fotolia.com]

2. File your patent application before publishing

If you plan to publish anything around your science, such as chemical structures that you are working on, or scientific results from your work, make sure that you have filed a patent application prior to submitting your manuscript or making any other public disclosure.

3. Prior art disclosures

Any prior disclosure regardless of such disclosure being in writing, orally or informally, will count as prior art and may be a bar to patentability. Make sure that you file your patent application before disclosing your invention.

4. Do not speculate in the patent specification

A patent is completely different from a scientific publication. The patent disclosure should therefore be focused on facts and what you have done in terms of working examples to make credible that your invention works. Do not speculate about mechanisms, theories, and future possibilities in relation to your claimed invention; if your compound or product protected by the patent makes it to the market, every statement in your patent will be scrutinized in litigation, and any statement in the patent proven not true may invalidate your entire patent.

Conclusion: “Less is more”!

5. Consistency between your patent and post-filing scientific publications

Make sure that any scientific publications that you make after having filed your patent application are consistent with your patent disclosure.

6. Scientific data supporting your claimed invention

Your claimed invention needs to be supported by scientific data. If you claim novel compounds, it is advisable to provide, for example, potency data for all specific compounds included in the patent application, since patent authorities around the world are strict on the inclusion of data already in the patent application as filed. It is also advisable to make a statement in the specification that the compounds of the invention have a potency within a certain numerical range.

If your invention is directed to a new medical use of a known compound, you can prove your invention on the basis of in vitro data or animal data—clinical data is not required if unavailable.

If your invention concerns, for example, a combination of two drugs, the type of data required is monotherapy data for each compound (drug) and data resulting from combining the two compounds (drug).

7. Overly broad claims will not save your day

The broader patent claims, the more scientific supporting data will be required for patentability. A balance between what you have made and broadening the scope of your patent claims is important, also bearing in mind not shooting yourself in the foot for your future new and improved inventions of importance.

8. Keep track of your documents and publications

Under the U.S. patent law and in some other jurisdictions, persons who are associated with the preparation and prosecution of a U.S. patent application (such as inventors and attorneys) have a duty to inform the patent examiner of any information they know is important (“material”) to patentability (Information Disclosure requirement, IDS). If an inventor misses out on informing the U.S. Patent Office (USPTO) of, for example, a publication made prior to the filing date of a patent application, that may be regarded as withholding important information from the USPTO and could invalidate the patent. Hence, make sure to tell your patent attorney of all the prior art of which you are aware, and particularly your own publications.

9. Freedom-to-operate

Even if you have a patent protecting your product it does not necessarily mean that you are free to put that product on the market, since there may be earlier third-party patents under which your product may fall. Hence, make sure that the product that you intend to market is subjected to a noninfringement evaluation prior to making large investments for a product to be launched.

Ann-Sofie Sternas is vp, IPR at Karolinska Development.

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