IP, Patents and Commercial

What are tangible company assets?

Land, buildings, plant, and staff."

What are intangible company assets?

Ideas/know-how, inventions/patents, trademarks, and corporate image."

What is intellectual property (IP)?

Creations of the mind, such as inventions, designs, trademarks, and copyrights."

What types of IP protection exist for pharmaceuticals?

Patents, design rights, trademarks, and copyrights."

What can patents protect in pharmaceuticals?

Compounds, salts, polymorphs, formulations, processes, and methods of treatment."

What can design rights protect in pharmaceuticals?

Packaging designs."

What can trademarks protect in pharmaceuticals?

Device names, product names (e.g., Nexium), and logos."

What can copyrights protect in pharmaceuticals?

Layout of packaging."

What is a patent?

A legal right to exclude others from making, selling, or using a technical invention for up to 20 years."

What is the purpose of a patent?

To stimulate innovation by granting exclusivity in exchange for full public disclosure."

Is a patent a right to use an invention?

No, it is a right to exclude others, not a right to use."

What are the three main patentability criteria?

Novelty, inventive step, and industrial applicability."

What does novelty mean in patent law?

The invention must not have been publicly disclosed before the patent application date."

What counts as public disclosure for novelty?

Publications, lectures, or use/sale of the product."

What is the 'first to file' principle?

The first person to file a patent application gets priority, regardless of who invented first."

What is an inventive step?

The invention must not be an obvious adaptation of what is already known."

Who judges whether an invention has an inventive step?

A person skilled in the art, assessing if the advance solves a technical problem."

What is a key indicator of an inventive step?

Solving a technical problem, especially with unexpected results."

What is industrial applicability in patent law?

The invention must be capable of being made or used in some kind of industry."

What are the two main parts of a patent specification?

Claims and description."

What do patent claims define?

The scope of the monopoly, controlling what others can be prevented from using."

What does the patent description do?

Supports the claims by providing technical details of the invention."

Why might a granted patent not be usable?

It may infringe on a dominant patent or fall within the scope of another invention."

What is a selection invention?

A patentable improvement within the scope of a known genus, like a specific compound."

What is the timeline for a patent application's publication?

18 months after the priority application."

When does a patent application become prior art?

Upon publication, it becomes full prior art."

What can be patented in pharmaceuticals besides chemical compounds?

Intermediates, salts, polymorphs, formulations, processes, devices, packaging, new indications, dosage regimens, biomarkers, and combinations."

What was the target of the injectable depot case study?

To develop a long-acting injectable depot for a new small molecule."

What were the challenges in the injectable depot case study?

Sub-optimal physicochemical properties, low solubility, high lipophilicity, excipient issues, high dose needs, and lack of predictive models."

What was achieved in the injectable depot case study?

A formulation with efficacy, over one-month release, acceptable safety, and manufacturability."

What are key questions in developing a patent strategy?

What is the invention, what is known, how broad to claim, how much to disclose, when to file, and where to protect?"

What is prior art in patent strategy?

All publicly available information relevant to the invention before the filing date."

How can bioequivalent claim scope be protected?

By generating experimental support for specific formulation ratios."

What is 'teaching away' as an indicator of inventive step?

When prior art suggests the invention would not work or is undesirable."

What is an unexpected result in patenting?

A surprising outcome that supports the invention's non-obviousness."

What is a long-felt but unsolved need?

A persistent industry problem solved by the invention, supporting inventive step."

What is commercial success in patenting?

Market success of the invention, indicating its non-obvious value."

What is a key 'do' for patent awareness?

Regularly review work for new patent opportunities."

What is another key 'do' for patent awareness?

Seek advice on third-party patents."

What is the golden rule for patent opportunities?

A problem solved is often a patent opportunity."

What is a key 'don't' for patent awareness?

Do not publish or present externally before considering patent opportunities."

What should you avoid expressing about patentability?

Written opinions like 'we haven't made an invention' or 'it was obvious.'"

Why should hindsight bias be avoided in patenting?

Many inventions seem obvious after the fact but were not beforehand."

What is an example of AI in healthcare patenting?

AI tools for detecting skin cancer or analyzing echocardiograms."

What is an example of AI in process chemistry patenting?

AI tools that provide instructions for multi-step chemical reactions."