Is depositing better than sequencing?

Another focus of yesterday’s workshop on IP Protection of Biological Inventions organized by VIPS/ACBIS and the University of Basle was the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. “The International Microorganism Deposit System” provides a practical solution when pursuing patents involving biological material in some 80 countries through the recognition of one international recognized deposit with an international depositary authority (IDA; there are currently 45 IDAs and like Indiana Jones when choosing the grail, you should choose wisely).

Deposits of biological material have gone out of fashion with the advent of reliable DNA sequencing like phone books have with the advent of the internet. Why go through the costly and time consuming process of depositing your strain when you can specify the invention by reference to the strain’s DNA sequence?

Well, as Jürgen Meier (Vossius & Partner) highlighted, the key is the reliability of DNA sequencing. DNA sequencing is done by humans, and humans make errors. Errors in a claimed DNA sequence can lead to the premature death of a patent (Article 83 EPC, anybody) and according to Jürgen Meier have in fact killed a number of valuable patents. He referred, by way of example, to EP 0 759 993 of Bayer Biosciences GmbH, where all the claimed DNA sequences were wrong and the patent was saved by the deposit of the microorganism with an IDA under the Budapest Treaty. Depositions, in other words, provide for a safe way of ensuring enablement, and unlike phone books, enjoy a revival.

When depositing biological material, make sure to observe the formalities (use the forms) and keep in mind that the deposit should occur before the priority date of the application. You can only be sure that your deposit is valid once the IDA confirms the viability and non-contamination of the material. Viability testing can take surprisingly long when time is tight.

During discussion, the concern was raised that depositing a plasmid capable of expressing a gene in a suitable host may give competitors a head start over the mere disclosure of the DNA sequence. It was pointed out that while the deposited clone is capable of expressing, e.g., the claimed antibody, it generally differs in yield etc from the clone used in actual production.