IP, patents and commercial considerations in drug discovery

What is a tangible asset?

Land, buildings, plants and staff

What are intangible assets?

Ideas, inventions, trademarks, corporate image

What type of asset is intellectual property and why?

-              form of an intangible asset – includes confidential information, copyright, designs, patents and trademarks

What does copyright protect

Original work

What is a trademark and provide an example

An indication of a brand

o   Eg for Nexium:

§  Trademarks would be the device, the name ‘nexium’ and the logo

§  The patents would be on the compound, salts, polymorph, formulation, process and the method of treatment

§  The copyright would protect the layout of the packaging

What is a patent

-              protects a technical invention and can last for up to 20 years and is a national right

o   An agreement between a state and the inventors

o   In return of publication of the invention in full, the inventors have a legal right to exclude others from making, selling and using the invention

o   It is a right to exclude rather than a right to use

What are the product requirements of a patent?

Product must be new, useful, inventive and adequately described. This means that it needs to show that the product increases innovation

What would make a patent invalid?

• public disclosure because product would no longer be new

• Obvious adaptation on something is already known

What is a patent opportunity?

o   invention that solves a problem

What is prior art?

o   anything regarding the invention PRIOR to the filing date of the patent

What is a patent claim?

o   defines the technical scope of the monopoly, which can prevent/control others from using

What is a dominating patent?

§  patent someone else has filed includes the patent you may have filed

·      By falling within the dominating patent, you cannot sell or manufacture any of your own inventions

What is a selection invention?

Falling within someone else’s patent

What if 2 different companies occur such that one has a patent on commercialisation and one has. A patent on configuration?

·      normally leads to some form of agreement so both can profit from the situation

Describe the patent application process

-              Can take between 3-5 years to get a patent granted

-              Once something is invented, the application is places

-              Within 12 months, you decide which countries you want the patent to be active in

-              At 18 months, it becomes full prior art and is published

-              Then examination processes occur and eventually granted between 3-5 years

What can be patented?

-              Some pharmaceutical products can have their patents increased after a few years for up to 5 years to make up for delay during clinical trials etc

-              Intermediates

-              Salts/polymorphs/crystalline forms

-              Formulations

-              Processes

-              Devices and or packaging

-              New indications

-              Dosage regimens

-              Personalised healthcare/biomarkers

-              Combinations

What questions would you ask when developing a patent strategy?

-              What is the invention and essential features?

-              What features are known and how extensive is the prior art?

-              What is to be achieved by filing a patent application?

-              How broadly should the invention be claimed?

-              How much information needs to be disclosed?

-              When must this patent application be filed?

-              Where is the protection required?

-              The broadest claim should cover the workable space

o   So if a generic equivalent won’t work because without these excipients, the profile wont be the same at all