Lecture 1 – introduction Eric
There is currently a lack of innovation or efficiency decrease.
Public support: Strong support by national governments and authorities with creating a
favorable regulatory and funding environment.
From bench to bedside: 4-12 years.
The cost to develop one new medicine is increasing.
Examples of trade secrets that might be considered for incorporation into a pharmaceutical
regulatory filing:
• Manufacturing processes or techniques
• Product formulas
• Ingredients and recipes
• Assays
• Names of vendors and suppliers
• Unique combinations of generally known concepts
If the information can be determined from the item to be sold, it will not be protectable as a
trade secret after marketing approval. Even for products that are never approved, if the
clinical trial work was done with e.g. NIH/public funding, the design and results from those
trials will/might need to be disclosed, which hinders trade secret protection.
Intellectual property rights: IPR
- Industrial rights (registration with governments): patent law, brands & trademarks,
drawings and model rights
- Other rights (no registration necessary): copyright, databases, trade secrets
Copyright can exist next to portrait right
The right of publicity, often called personality rights, is the right of an individual to control
the commercial use of his or her name, image, likeness, or other unequivocal aspects of
one's identity. It is generally considered a property right as opposed to a personal right, and
as such, the validity of the right of publicity can survive the death of the individual.
The intellectual property rights on photographs are protected in different jurisdictions by
the laws governing copyright and moral rights. In some cases photography may be restricted
by civil or criminal law. Publishing certain photographs can be restricted by privacy or other
laws. Photography can be generally restricted in the interests of public morality and the
protection of children.
Copyleft (a play on the word copyright) is the practice of offering people the right to freely
distribute copies and modified versions of a work with the stipulation that the same rights
be preserved in derivative works down the line. Copyleft software licenses are considered
protective or reciprocal, as contrasted with permissive free software licenses. Copyleft is a
form of licensing, and can be used to maintain copyright conditions for works ranging from
computer software, to documents, to art, to scientific discoveries and instruments in
medicine. In general, copyright law is used by an author to prohibit recipients from
reproducing, adapting, or distributing copies of their work. In contrast, under copyleft, an
author may give every person who receives a copy of the work permission to reproduce,
adapt, or distribute it, with the accompanying requirement that any resulting copies or
,adaptations are also bound by the same licensing agreement. Copyleft type licenses are a
novel use of existing copyright law to ensure a work remains freely available.
Patent procedure: (patents valid for +- 20 years)
Pharmaceutical patent term extension
- The part of the act codified as 35 U.S.C. 156 was designed to create new incentives for
research and development of certain products subject to premarket government approval
by a regulatory agency. The statute enables the owners of patents on certain human drugs,
food or color additives, medical devices, animal drugs, and veterinary biological products to
restore to the terms of those patents some of the time lost while awaiting premarket
government approval from a regulatory agency.
- The maximum term extension is five (5) years, provided that the extension does not result
in a total remaining patent term of more than fourteen (14) years. This 14-year period is
measured from the date the drug product received regulatory approval up to the date of
patent expiration (with term extension). Any term extension granted under the statute is
applied from the original expiration date of the patent.
In view of predetermined patent life:
- In a small blockbuster market of 1 billion annual sales a delay of one day has a huge impact
- Gross turnover loss almost 3 million daily!
- At royalty rate of 3% that is 82.000 per day for licensor
- 100 M market 8200
- 10 M market 820 day or 24.600 per month!
Product – lifecycle extension 2nd and 3rd patent
,Risk corrected diagram
Clinical trials in drug development:
Simplified business model: Payment on license deal
, Payments by type in time: examples
Stand still option agreement
Disclosure fee
Signing fee
Toxicology and/or pre-clinicals
IND filing
Start phase 2
Start phase 3
BLA or file submission
Acceptance by FDA (or EMEA)
More milestones is sharing royalties
Advantages of cash frontloading:
- Thermometer function
- Respects content and persons in primary process
- Need for strong proposition
- ‘Free’ Start money
-‘New’ cash in
There is currently a lack of innovation or efficiency decrease.
Public support: Strong support by national governments and authorities with creating a
favorable regulatory and funding environment.
From bench to bedside: 4-12 years.
The cost to develop one new medicine is increasing.
Examples of trade secrets that might be considered for incorporation into a pharmaceutical
regulatory filing:
• Manufacturing processes or techniques
• Product formulas
• Ingredients and recipes
• Assays
• Names of vendors and suppliers
• Unique combinations of generally known concepts
If the information can be determined from the item to be sold, it will not be protectable as a
trade secret after marketing approval. Even for products that are never approved, if the
clinical trial work was done with e.g. NIH/public funding, the design and results from those
trials will/might need to be disclosed, which hinders trade secret protection.
Intellectual property rights: IPR
- Industrial rights (registration with governments): patent law, brands & trademarks,
drawings and model rights
- Other rights (no registration necessary): copyright, databases, trade secrets
Copyright can exist next to portrait right
The right of publicity, often called personality rights, is the right of an individual to control
the commercial use of his or her name, image, likeness, or other unequivocal aspects of
one's identity. It is generally considered a property right as opposed to a personal right, and
as such, the validity of the right of publicity can survive the death of the individual.
The intellectual property rights on photographs are protected in different jurisdictions by
the laws governing copyright and moral rights. In some cases photography may be restricted
by civil or criminal law. Publishing certain photographs can be restricted by privacy or other
laws. Photography can be generally restricted in the interests of public morality and the
protection of children.
Copyleft (a play on the word copyright) is the practice of offering people the right to freely
distribute copies and modified versions of a work with the stipulation that the same rights
be preserved in derivative works down the line. Copyleft software licenses are considered
protective or reciprocal, as contrasted with permissive free software licenses. Copyleft is a
form of licensing, and can be used to maintain copyright conditions for works ranging from
computer software, to documents, to art, to scientific discoveries and instruments in
medicine. In general, copyright law is used by an author to prohibit recipients from
reproducing, adapting, or distributing copies of their work. In contrast, under copyleft, an
author may give every person who receives a copy of the work permission to reproduce,
adapt, or distribute it, with the accompanying requirement that any resulting copies or
,adaptations are also bound by the same licensing agreement. Copyleft type licenses are a
novel use of existing copyright law to ensure a work remains freely available.
Patent procedure: (patents valid for +- 20 years)
Pharmaceutical patent term extension
- The part of the act codified as 35 U.S.C. 156 was designed to create new incentives for
research and development of certain products subject to premarket government approval
by a regulatory agency. The statute enables the owners of patents on certain human drugs,
food or color additives, medical devices, animal drugs, and veterinary biological products to
restore to the terms of those patents some of the time lost while awaiting premarket
government approval from a regulatory agency.
- The maximum term extension is five (5) years, provided that the extension does not result
in a total remaining patent term of more than fourteen (14) years. This 14-year period is
measured from the date the drug product received regulatory approval up to the date of
patent expiration (with term extension). Any term extension granted under the statute is
applied from the original expiration date of the patent.
In view of predetermined patent life:
- In a small blockbuster market of 1 billion annual sales a delay of one day has a huge impact
- Gross turnover loss almost 3 million daily!
- At royalty rate of 3% that is 82.000 per day for licensor
- 100 M market 8200
- 10 M market 820 day or 24.600 per month!
Product – lifecycle extension 2nd and 3rd patent
,Risk corrected diagram
Clinical trials in drug development:
Simplified business model: Payment on license deal
, Payments by type in time: examples
Stand still option agreement
Disclosure fee
Signing fee
Toxicology and/or pre-clinicals
IND filing
Start phase 2
Start phase 3
BLA or file submission
Acceptance by FDA (or EMEA)
More milestones is sharing royalties
Advantages of cash frontloading:
- Thermometer function
- Respects content and persons in primary process
- Need for strong proposition
- ‘Free’ Start money
-‘New’ cash in
