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Patenting and clinical trials go hand in hand

Back when he was doing his degree thesis at the German Cancer Research Centre in Heidelberg, the immunologist Prof. Peter Öhlschläger, who now works at the University of Constance, laid down the basic principles for developing an artificial gene for the treatment of cervical cancer. Prof. Öhlschläger is currently in the process of filing a patent for DNA vaccines for HPV. In the following interview, the scientist says that the greatest challenges are still ahead of him.

Prof. Peter Öhlschläger is an immunologist at the University of Constance © private

Prof. Öhlschläger, can you please tell me a little bit about your invention and the project you are currently working on?

In Prof. Dr. Lutz Gissmann's laboratory at the German Cancer Research Centre in Heidelberg, we have developed an artificial gene that we hope to use for the adjuvant treatment of cervical cancer. Every year, approximately 500,000 women worldwide are diagnosed with cervical cancer and in Germany alone, 2000 women die of this tumour every year. Since conventional therapies (especially surgical interventions, but also radio- and chemotherapy) are largely ineffective, we came up with the idea of mobilising the body's own immune system against the cancer cells using a vaccination. Cervical cancer is caused by a persistent infection with certain human papillomaviruses (HPV). The gene that we have developed is based on the E7 oncogene of the human papillomavirus type 16. The artificial gene, which we are using for the immunotherapy of cervical cancer, has already led to an impressive antitumour activity in the animal model.

What is it that makes your research result an invention?

The invention relates to the composition of the artificial gene. We have generated a gene which is very immunogenic, but in contrast to the E7 wild-type gene, no longer has transforming properties. The gene is synthesised using PCR involving long overlapping primers. This work is being done by the company GENEART, which is based in Regensburg.

When did you decide that the findings should be protected by a patent, and what was the major reason for this decision?

This was not a random decision, but rather a decision that developed little by little. Prof. Lutz Gissmann was the major driver of the idea when it became clear in animal experiments that the new gene revealed an immunogenic potential.

What would the industrial application of your intervention look like?

One potential commercial application might be a pharmaceutical company buying or licensing the patent in order to commercialise the gene as a therapeutic vaccine. We are currently in contact with industrial companies and are discussing potential cooperations.

Following the patenting of the artificial HPV gene developed by Peter Öhlschläger, there are plans to commercialise the gene as a therapeutic vaccine. © private

How could the gene be used for developing a therapy? How many years do you think this will take?

In this project, the patent application and the preparation of the clinical trial are happening simultaneously. We are currently preparing a phase I study. If all three phases of clinical testing turn out positive, the vaccine might well be available in a few years' time. The vaccine will then be used to treat women diagnosed with cervical cancer, or ideally in the early stages of this cancer. The vaccine will activate the patient's immune system against the cervical cells affected by the cancer and be used in combination with the aforementioned conventional therapies. But I estimate that the development of the vaccine will take another five to ten years.

Do you have plans to obtain a worldwide patent for the vaccine?

We have plans to file a PCT application with the European Patent Office. This will not lead to an international patent, but rather a kind of option for subsequent national registrations. When it comes to dealing with the expensive nationalisation of the vaccine, we will definitely need industrial partners. The patent will initially be valid for one year, and we will use this time to actively approach companies and get them interested in the project.

What are the biggest obstacles you've experienced so far with the patent application process?

None of the steps were easy; there was nobody in our team who really had a great deal of experience in the details. This of course led to one or two mistakes, but we have learned from this and will be better prepared for future patent applications. But I am sure that the biggest challenge is still ahead of us - the search for suitable industrial partners.

Will you outsource this difficult task or will you and your team of researchers try to find industrial partners yourselves?

We have decided that it will be me who contacts companies. If the companies are interested I will give a talk to present our invention.

Do you have previous experience with the patenting of inventions?

No, we did not have any prior experience. The patent application for the artificial HPV gene was our first contact with the patenting process. Currently, we are working on a patent application in connection with our prostate cancer project. The procedures are nearly identical, meaning that we are gaining valuable experience from both projects.

Did you receive professional support for finding the necessary information before you actually filed the patent? Or did you do this on your own?

The search for information regarding the patents was done professionally by a patent attorney. The process took several weeks.

What kind of professional support do you receive in the patent registration process?

We receive support through the Department of Technology Transfer at the German Cancer Research Centre.

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