TERMIS PAP: Session 4 — IP Strategy in Tissue Engineering and Regenerative Medicine

Summary written by Dr. Richard Balint, University of Manchester

The fourth webinar in the 2016/2017 TERMIS PAP series was given by Ms MacKenna Roberts, a legal consultant at Life Sciences IP, UK.

Intellectual property (IP) is a fundamental part of business that has to be thought about from the beginning! Amongst others, it is key for securing investment, provides a competitive advantage, increases shareholder value, and can provide a source for revenue and tax incentives.

Map IP onto your product pipeline and do not forget to revisit IP strategy when your business plan changes. The ownership/licensing of IP must be done in a secure way involving legal professionals!

Types of IP:

· Patents — inventions, technical solutions

· Trademarks — branding, logos, images, words

· Copyright — literature, art, music, but also coding and sequencing

· Designs — aesthetic appearance

· Know-How — practical knowledge or expertise; highly valuable form of IP

· Data — much under considered type of IP

Amongst others the legal framework has been set out in:

Patents: Patents Act, 1977; the European Patent Convention 1973; and the Biotechnology Directive №98/44.

Supplementary protection certificates: EU Regulations No 1768/92 and 1610/96

Trademarks: Trade Marks Act 1994 and EU Regulation №207/2009 and No 2015/2424

Copyright: Copyright Designs and Patent Act 1988

Patents

A patent provides the patent owner with exclusive rights for a fixed-term to make, use and sell an invention in exchange for publicly disclosing the invention.

Only certain types of subject matter are patentable. Furthermore, patent protection is not invulnerable. Even following it having been granted, it can be challenged and found invalid. If your patent was found invalid, you may be financially liable!

Examples of patentable IP. What can be patented depends on the jurisdiction!

Patents normally run for 20 years. This can be extended up to an additional five years through a Patent Term Extension (US) or a Supplementary Protection Certificate (EU). These are intended to compensate for delays due to lengthiness of regulatory approval.

Lapsed patents may be revived for 12 months in the EU and up to 2 years in the US. Be careful: if your competitor revives a lapsed patent it owns, you may end up suddenly infringing on that patent.

One in three patent applications have already been patented!

It is essential to correctly name the inventors on the patent.

Costs of patenting:

· UK: £5,000–10,000

· EU: £10,000–20,000

· US: £15,000–25,000

To protect your IP in 5 countries over 5 years could cost you £90,000! There are also annual/periodic renewal fees that increase with time. Therefore, it is important to budget for IP protection costs in your business plan.

The timeline for protecting your IP through a patent.

Five minimum requirements for patents:

1. Subject matter: the invention must fall into a patentable class of things. Not all inventions are patentable. Which ones are can differ by country.

2. Novel: The invention must not already be known by others/must not have been disclosed to others.

3. Non-obviousness: The invention must involve an inventive step

4. The invention must be “useful” (US requirement) or capable of industrial application (EU requirement)

5. Enabled: The inventor must disclose enough information to allow a person skilled in the art to practice the invention without undue experimentation

Alternative IP assets

Patenting does not always fit tissue engineering and regenerative medicine (TERM) IP! Some alternative methods may be more appropriate:

Trade secrets — Valuable IP protected through confidentiality. Offers a weaker protection than patent, but has no expiration date.

Know-how — A very important aspect of IP in TERM is “know-how”, a valuable piece of practical knowledge, skill or expertise. For example, a practical procedure to improve the quality of an engineered tissue construct that nobody else knows about. Know-how should be recorded in a paper trail, evidencing it. You can have a patent and confidential know-how at the same time relating to the same invention.

Copyright — Copyright is an exclusive right given to print, publish, perform, etc. a certain literary, artistic or musical material for a fixed number of years. If your copyright is important for your actives as a company, make sure you are aware who owns it: Unless there is an agreement to the contrary, copyright is owned by the person who created the work!

Patentability vs. Infringement

Can I patent my invention? — Patentability

Patentability depends on what “prior art” has been invented/disclosed as to whether your invention is novel and non-obvious. Public disclosure of your invention by anyone anywhere in the world will irrevocably destroy your invention’s patentability. Be careful with publications, conference talks, etc. as these may damage/destroy the patentability of your IP.

Has my invention already been invented/claimed in the jurisdictions/target markets I aim to operate? — Infringement

Are there any therapies/devices/invention out there similar to mine? If so, can those patent holders prevent my use, manufacture or sale of my TERM therapeutic?

Jurisdiction matters! For example, if your competitor has patented the invention in Europe, you may be able to manufacture and sell your TERM therapeutic in the US without infringing on your competitor’s patent.

Patent validity also matters: Has the patent expired? If it has, you will not be infringing on the rights of the patent holder.

“Patent landscaping” can be performed to determine who owns what in a specific IP domain, see what the competitors are doing, identify potential collaborators and detect infringers. It is highly recommended to perform at least basic patent landscaping from the start!

Some useful tools for patent landscaping:

· Patents.google.com

· Worldwide.espacenet.com

· Proprietary databases: Patsnap, Thomson Innovation

Note that during your search you may come across “A” specifications (A SPEC) and “B” specifications (B SPEC). They look similar but are not to be confused: “A” specifications are patent applications, granted patents are “B” specifications.

How to spot IP value and maximise it?

It is highly recommended to have strong discussions early on involving all levels of the company management on where the IP lies. There may be a large amount of hidden IP associated your invention/product/technology that is not obvious, but could be highly lucrative.

What are the key parts of your invention? Which parts bring the greatest profit margin? Perhaps these are the aspects of your IP that should be protected.

For example, the haemodialysis machine of a company has no profit margin. However, the filters and specialist bags, that are essential for the machine and have to be changed regularly, bring in a huge profit. Therefore, the IP associated with the filters and specialist bags are much more valuable, and it is much more important to protect it.

In the case of TERM products the most valuable part of the IP may not be the therapeutic product itself, but some part of the process preparing that therapeutic product.

Timing your patent is important. As it takes time to turn a TERM product into a clinically used therapy (due to, for example, market authorisation), value of your invention may maximise years after the invention itself was made. As patents have a limited duration, you do not want them to run out before the value of your IP has maximised.

It also has to be decided which aspects of the IP are best protected through a patent, and which should be kept as a confidential trade secret and know-how.

Who owns the IP?

Is it the inventor? The employer of the inventor? A contractor? A collaborator?

Not always straightforward, but very important!

A clear paper trail must accompany the IP from the beginning detailing the ownership of the various aspects of the IP.

If it has to be determined retrospectively who owns what part of the IP, it will get messy and expensive! Friends can also become enemies when the IP becomes valuable. It may be best to pay them off early and secure the IP. Jointly owned IP sounds like a nice idea but creates problems.

IP Strategy Options

You can:

· Protect every new product with appropriate IP or Protect only core products with limited IP

· Exclude competitors from the entire market or Exclude competitors from the core market

· Aggressively defend your market by the application of your IP (this can be costly) or Only use your IP rights defensively

You should match the amount you spend on the protection of a certain IP to its benefits.

Know your product and how the IP maps onto them, and know your market and your competition. All of these should be recorded in a continuous manner.

Protecting your IP

Maintaining confidentiality is an essential aspect of protecting your IP. Make sure non-disclosure agreements (NDAs) are in place when discussing your IP with external partners/collaborators.

Employees should sign agreements regarding the IP and confidentiality. Ensure that your employees understand the limitations of these agreements.

Only disclose what is strictly required! Do not disclose unnecessary details, and make sure your employees know to do the same! A small amount of extra disclosed information can lead to springboard patents being filled that build on your IP, but do not infringe upon it.

To view the webinar click on the recording below:

For more information and further useful webinars related to commercialisation in the TERM fields please see:

Useful links:

Patents.google.com

Worldwide.espacenet.com