Patent protection for microorganisms

Disclosure of the invention is a requirement for a patent application. A person skilled in the art should be able to perform the invention without undue burden based on the description of the invention in the application. In general, the requirements of disclosure are met by a written description that enables the person skilled in the art to perform a claimed method or to obtain a claimed product. Where a microorganism is involved, a written description may be sufficient to perform a claimed method or to obtain a claimed (biological) product.

For example, when a method uses a microorganism that is publicly available, the person skilled in the art can perform the invention based on the written description and by obtaining the microorganism from a public source. Likewise, when a microorganism is claimed as a product and can be obtained and reproduced by general means known in the art from a microorganism that is publicly available, there can be sufficiency of disclosure. In contrast, when a microorganism is claimed as a product or used in a method and such microorganism cannot be obtained and reproduced, for example when the biological product is the result of a chance event such as a classical mutagenesis, a written description is not sufficient and the microorganism should be made available to the public.

Depositing

Since depositing the microorganism in every country where one wants to obtain a patent would be cumbersome, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (the Budapest Treaty) provides the possibility to deposit microorganisms with an International Depositary Authority (IDA). Such a deposit is recognised by all contracting states to the Budapest Treaty, as well as several regional patent offices such as the European Patent Office (EPO), the Eurasian Patent Organization (EAPO) and the African Regional Intellectual Property Organization (ARIPO). Some countries, such as Venezuela, are not signatories to the Budapest Treaty and local arrangements have to be made. The Budapest Treaty has established a uniform system of deposit, recognition and furnishing of samples. The deposits are retained for at least 30 years and a deposit cannot be withdrawn or cancelled even when the patent application has been withdrawn, abandoned or refused.

"The Budapest Treaty does not contain substantial patent law and the IDAs are bound only by the articles and rules of the Budapest Treaty; one cannot expect the IDAs to be familiar with the patent laws of all contracting states."

It should be noted that such a deposit only receives a deposit date from the IDA when the deposit has been demonstrated to be viable. In the case of non-viability, a new deposit has to be made and, if proven viable, the new deposit date becomes the effective date of the deposit. If this effective date is after the priority date, there could be an irreparable issue on enablement/sufficiency of disclosure in most jurisdictions. The US is an exception as the deposit must have been made before the patent is ultimately granted.

The Budapest Treaty does not contain substantial patent law and the IDAs are bound only by the articles and rules of the Budapest Treaty; one cannot expect the IDAs to be familiar with the patent laws of all contracting states. Accordingly, the national or regional patent offices decide what the requirements are for, for example, the obligation to make a deposit or the furnishing of samples to third parties. This can lead to a lack of clarity for applicants. Besides that it has, among other things, led to a difference in assessment of whether a request by a third party to obtain a sample is legitimate or not; in one jurisdiction such a request may be legitimate, in another jurisdiction it may not be.

As an example, the new IP law in New Zealand, which came into force on September 13, 2014, dictates that when inventions relate to a microorganism, a deposit receipt must be filed with the New Zealand Patent Office within three months of the date of the deposit. Although apparently unintended, it means that for any microorganism in a patent application, a deposit would have to made and the deposit receipt be furnished shortly after the priority date, whereas in other jurisdictions citing it in the Patent Cooperation Treaty publication suffices.

Furnishing of samples to third parties

Of course, the whole idea behind patenting is to protect one’s invention. One does not want the microorganism to end up with a competitor without proper patent protection or, when the patent is not granted yet, a limitation to the use of the microorganism. In some jurisdictions, like the EU, there is the expert solution (Rule 32 EPC) that dictates that the applicant may inform the EPO that until the publication of the mention of the grant of a European patent, a sample of a deposited microorganism may only be issued to an expert. In addition, the material may be used only for experimental purposes and may not be transferred to third parties.

This would be satisfactory when only seeking patent protection in jurisdictions where such a limitation exists. However, not all jurisdictions have such limitations. Furthermore, in some jurisdictions it is possible for a person who is not even a resident of that country to obtain a sample of a deposited microorganism based on a patent application in such jurisdictions. This provides an opportunity for a villainous competitor to “forum shop” a jurisdiction where one can easily obtain a sample without any limitation; not a big deal when the patent application is finally granted in all jurisdictions, but quite unpleasant when in some jurisdictions the patent application does not proceed to grant.

Thus, depositing microorganisms may be quite useful and even inevitable for patent purposes, but your precious material ending up with parties you would rather not have it may be a nasty consequence. Accordingly, before the priority date, when making the deposit one should already be thinking beyond the international phase and checking the national requirements on depositing and the furnishing of samples.

The requirements of national patent offices for, for example, the obligation of making a deposit and the furnishing of samples to third parties can be found at: http://www.wipo.int/treaties/en/registration/budapest/guide/index.html.

Peter ten Haaft is an associate partner and Dutch and European patent attorney at NLO. He can be contacted at: tenhaaft@nlo.nl