Protecting knowledge

Karo Bio is partly dependent on patents for its business. The company’s intellectual property rights are protected primarily through patents. Karo Bio makes great efforts to obtain adequate patent protection for among other things, new compounds, medical applications and various processes. Karo Bio divides patents and patent applications into three different categories; technology patents, compound s patents, and patents for clinical development.

Technologies
Patents that cover technologies are essential for the protection of the company’s knowledge base. Technology patents are mainly patents related to methods for identifying new potential pharmaceutical compounds. Technology patents provide a foundation for new projects and are usually followed by patents that cover chemical compounds or processes for their manufacturing. Karo Bio out-licenses certain of its technologies. Karo Bio has, in total, three patent families that cover different technologies.

Chemical compounds
Patent applications are filed for almost all new compounds that Karo Bio develops. Patents originating from these applications provide the company’s basic protection for new pharmaceutical products. Furthermore, patent applications covering the medical use of these compounds are also filed. In total, Karo Bio has 26 compound patent families.

Clinical development
In recent years, patent applications have been filed related to further development of existing compounds that enters clinical stages. Such further development involves for example pharmaceutical preparations, manufacturing processes and new crystalline forms. Karo Bio has in total seven patent families in clinical development.

Patents are by regulation applied for within regions where major generic companies and chemical industries are active, and in areas where competitors practice research activities. Competitors are monitored to secure that the patent is not object of patent infringement and that the company has a complete liberty of pursuing their operations. Karo Bio has a close collaboration with patent lawyers and legal advisors in Europe and the US and the operation is run by an internal patent expert. Literature and patent data bases are searched according to previously known information that could restrict Karo Bio’s possibility of earning a patent protection.

Patent strategy
Karo Bio has a geographically broad scope of protection of strategically important compound patents, which means that patents are applied for in the major pharmaceutical markets, such as Europe, USA and Japan, but also often in Australia, India, China, Canada, South Korea and Brazil.
As a rule, Karo Bio files for patents in regions where large generic companies and chemical manufacturers operate, as well as in areas in which its competitors conduct research. Competitors are monitored to ensure that patents are not infringed upon and that the company enjoys freedom to operate. Under the leadership of internal patent experts, Karo Bio works closely with patent attorneys and legal advisers in Europe and the United States. Karo Bio also searches patent databases and the literature for previous knowledge that might limit its ability to obtain patent protection.

Granted patent and patent applications
Currently, Karo Bio has obtained patents and patent applications that cover compounds in the following research projects: TR (11), ER (16) and GR (7). The figures reflect the number of compound patent families for each project. Karo Bio currently owns the rights for 36 patent families and based on these, there are around 150 individually granted patents around the world. Regarding the compound KB2115 (eprotirome, within TR) Karo Bio co-owns the majority of the patents and the patent applications together with Bristol-Myers Squibb. However, Karo Bio has an exclusive right to develop and sublicense the compound.