Intellectual Property and Patent Strategy

What are tangible company assets listed in the presentation?

Land, Buildings, Plant, Staff"

What are intangible company assets listed in the presentation?

Ideas/Know-how, Inventions/Patents, Trade Marks, Corporate Image"

What types of intellectual property are mentioned?

Copyright, Patents, Trade Marks"

What aspects can patents protect in pharmaceuticals?

Compound, Salts, Polymorph, Formulation, Process, Method of treatment"

What can design rights protect in pharmaceuticals?

Packaging"

What can copyright protect in pharmaceuticals?

Layout of packaging"

What is a patent?

A legal right to exclude others from making, selling, or using a technical invention, lasting up to 20 years, granted by a state in return for full publication of the invention."

Is a patent a right to use or a right to exclude?

A right to exclude, not a right to use."

What are the patentability criteria?

Novelty, Inventive step, Industrial applicability"

What does novelty require in patent applications?

No public disclosure by any means prior to the date of application."

What is the 'first to file' principle in patent novelty?

The first person to file a patent application for an invention is considered the inventor, regardless of who invented it first."

What is an inventive step?

An invention that is not an obvious adaptation of what is already known, judged from the perspective of a person skilled in the art."

How can you identify a patentable invention?

A problem solved is often a patent opportunity; consider what is already known, if a technical problem was solved, and if there are surprising or unexpected results."

What is the golden rule for identifying patentable inventions?

A problem solved is often a patent opportunity."

What should you avoid when considering a patentable invention?

Do not talk yourselves out of a patentable invention."

What are the components of a patent specification?

Claims, Description, Drawings (if applicable)"

What is the role of patent claims?

Define the scope of subject matter you can prevent or control others from using."

What is the purpose of the patent description?

Supports the claims by providing detailed information about the invention."

What is the timeline for the patent application process?

Priority Application (0 months), Foreign Filing (12 months), Publication (18 months), International Search (19 months), Examination (24 months), Grant (30/31 months)"

What can be patented in pharmaceuticals besides chemical compounds?

Formulations, Processes, Methods of treatment, Packaging designs, Delivery systems"

What is the case study about in the presentation?

Developing a long-acting (LA) injectable depot for a new small molecule."

What were the challenges in the injectable depot case study?

Sub-optimal physicochemical properties, sub-nanomolar aqueous solubility, high lipophilicity, excipient compatibility issues, high dose requirement, lack of predictive PK/PD models, need for >1 month release duration."

What approaches failed in the injectable depot case study?

Manipulation of physical and chemical form, simple solution and suspension formulations, alternative routes of delivery."

What was the successful solution in the injectable depot case study?

A specific ratio of components (Form C: API 5.6% w/v, other components q.s.) achieving efficacy, release duration, acceptable safety, and manufacturability."

What questions should be considered when developing a patent strategy?

What is the invention and its critical parts? What features are known and how extensive is the prior art? How broadly should the invention be claimed? How much information should be disclosed? When must the application be filed? Where is protection needed?"

What are indicators supporting an inventive step?

Teaching away by those skilled in the art, unexpected results, failed attempts to solve the problem, unrecognized problem, long-felt but unsolved need, commercial success."

What are the recommended 'Do's' for patent strategy?

Regularly review work for new opportunities, seek advice on third-party patents, recognize that a problem solved is a patent opportunity, ask if in doubt."

What are the recommended 'Don'ts' for patent strategy?

Do not publish or present externally before considering patent opportunities, do not express written opinions about patentability or infringement, such as 'We haven't made an invention yet,' 'It was obvious,' or 'It was a mere replacement.'"