Business Development

Intellectual Property

WHAT IS A PATENT?

A patent is a legal title which protects an invention for a limited period of time. In particular, it provides a 20 years protection against unauthorized use or copying of the invention in the countries for which it has been granted, and increases the likelihood of commercially exploiting your invention.

Patentability requirements

  • Novelty: the invention cannot be patented if it is already known to the public
  • Inventiveness: the invention cannot be obvious
  • Industrial applicability: the invention must be susceptible of industrial application, i.e. an invention which can be made or used in any kind of industry

Types of Inventions

  • Product (proteins, antigens, biomarkers, small molecules, etc.)
  • Process (method for isolating/enriching a cell population, methods for obtaining cells/proteins/antibodies, etc.)
  • New Medical Use (new uses of existing drugs, molecules, etc.)

There are certain things that are deemed to be un-patentable:

  • A discovery, scientific theory or mathematical method
  • A literary, dramatic, musical or artistic work or any aesthetic work whatsoever
  • A scheme, rule or method for performing a mental act, playing a game or doing a business, or a program for a computer (software)
  • The presentation of information
  • Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application, therefore are not patentable, as such. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods

Aims of the prior art search

  • Patentability evaluation of an invention
  • Find out what already exists and build on it (it helps you formulate your patent application more precisely and avoids negative search reports issued by the examining divisions)
  • Get access to -hard to get information- from commercial suppliers
  • Keep track of who’s doing what (keep an eye on your business competitors, or even locate potential partners)
  • Evaluate if your project is innovative, before even starting it
  • References for grant proposals, paper publications, etc.
  • Freedom to operate analysis to avoid infringing other parties’ patent rights

LICENSING

As soon as a patent is filed BD will proactively search potential licensees of the technology. Inventors’ suggestions of and connections with companies to be approached are extremely valuable. If the company shows interest in the technology, then a Confidentiality Agreement needs to be signed to protect all confidential information to be disclosed in the technology evaluation process. The negotiation of a license requires flexibility and clear vision of the market opportunities as well as the capacity to find creative solutions to accommodate the needs of licensees and licensor. License agreements regulate long-term relationships, need to be closely monitored (due diligence milestones and financial reports) and might need to be amended/re-negotiated over the license lifespan.

A license is a legal agreement by which the owner of the intellectual property grants the licensee the right to use and to eventually commercialize, after further development, the invention. The agreement defines also the commercial value of the licensed material, foreseeing upfront payments, milestone payments and royalties on the net sales of the licensed product. OBT plays an important role in assessing the value of a product and in the negotiation process aiming at safeguarding San Raffaele research and the development of a product of use and value to the community.

MATERIAL AND ANIMAL TRANSFERS

Material Transfer Agreements and Animal Transfer agreements need to be signed whenever there is a transfer of technology or biological material or animal models.

MTAs are contracts which rule the transfer of material that is not commercially available from the owner or licensor towards an external institution whether profit or non-profit for research purposes only.

The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. The main issues defined in a MTA are: confidentiality, delay in publication, use of material in sponsored research projects, definition of material, loss of control of intellectual property, conflicts with existing agreements.

Every time a scientist working at San Raffaele Scientific Institute needs to transfer material to another institution profit or non-profit or to obtain material from third parties a MTA agreement needs to be signed before any material is transferred.

Note: for processing the necessary documents please contact locatelli.simona@hsr.it