Intellectual Property Flashcards
Three Main Points of Control for Pharmaceutical Market Access:
- Patent Legislation
- Regulatory System
- Pricing and Reimbursement
An intellectual property control
Patent Legislation
Market exclusivity via data protection
Regulatory System
It is via Health Technology Assessment (HTA)
Pricing and reimbursement
The main forms of intellectual property: (4)
- Copyright
- Trademarks
- Data rights
- Patents
Other form of intellectual properties: (1)
- Business secrets or first to market
The principal means of protecting ‘novel’ products and processes is by ___ – a concept that has existed since antiquity
Patents
A patent is an exclusive right: (4)
- Granted in respect of an invention
- That must be susceptible to industrial application
- That is new (novelty)
- That involves an inventive step
Patents are normally valid for ___ from the date of filing (full patent).
20 years
___ are payable at stages throughout the 20 years.
Renewal fees
Confers upon its holder, for a limited period, the right to exclude others from exploiting (making, using, selling, importing) the patented invention, except with the consent of the patent owner
‘Exclusivity’ (Exclusive Right)
Patents encourage innovation by ___ means; they represent a trade-off of disclosure in return for monopoly.
monetary
Patents have the effect of ___ but
at a cost to consumers – they might allow a higher price to be charged than if there were no patent in existence (welfare loss).
incentivising innovation
___ and ___ is involved in securing patents – they have to be secured in every country or territory depending on the local legislation.
Considerable time and expense
Key requirements for patentability: (4)
- Invention
- Novelty (Newness)
- Inventive step
- Capable of industrial application
In Europe, there are many definitions but the test is for the presence of a technical solution to a technical problem. For example, ___ provides this definition:
‘Any new and useful art, process, machine, manufacture, or composition or matter, or any new and useful improvement in any art, process, machine, manufacture, or composition or matter…’
Irish legislation (Patents Act 1964)
___ abound regarding patentability of business practices, software, traditional knowledge, algorithms, as well as various types of biotech and chemical inventions such as stem cells, diagnostic processes, 3D protein and crystalline structures, DNA sequences and animals.
Controversies
Applies when the invention is not already part of the ‘State of the art’.
Novelty
Is everything made available to the public, in the State or elsewhere, by means of a written or oral description, by use or by any other means, plus any prior Patent application.
‘State of the art’
An invention shall be considered as involving an ___ if it is not obvious to a person skilled in the art. It is decided on a case-by-case basis.
Inventive step
An invention shall be considered ___ if it can be made or used in any kind of industry, including agriculture.
Capable of industrial application
Includes any physical activity of a ‘technical character’, that is, it can be interpreted as the useful or practical arts rather than the aesthetic arts.
‘Industry’
PATENT SPECIFICATION
Is the key document filed, which outlines: (4)
- Background
- Scope of the invention
- Description
- Claims
PATENT SPECIFICATION
Abstract
Scope of the invention
PATENT SPECIFICATION
Enough detailed to permit it to be executed after expiry by a person ‘skilled in the art
Description
PATENT SPECIFICATION
Strict legal text that must set out the essential features of the invention in a manner to clearly define what will infringe the patent
Claims
PATENT SPECIFICATION
In deciding when to file the patent, the innovator faces a dilemma – there is invariably a considerable delay between the date of filing and date of grant:
- Filing early may mean the specification is too broad to qualify.
- Leaving it too late may mean the specification has to be narrower in application.
Infringement of a patent (I)
Infringements are enforceable only from the date of grant, but it can be retrospectively enforced to the filing date: (2)
Where the patent is in respect of a product, infringement amounts to making, using, importing or marketing the product without the owner’s consent.
Where the patent is in respect of a process, infringement amounts to making, using, importing or marketing of a the product obtained via the process in the patented territory
Infringement of a patent (II): (3)
- The patent owner must initially establish a sufficient case on the balance of probabilities that infringement has occurred
- The burden then shifts to the accused infringer who must argue that they have not infringed on the basis that
- The patent right is absolute and can be infringed inadvertently
Infringement of a patent (II):
- The burden then shifts to the accused infringer who must argue that they have not infringed on the basis that: (3)
- Their activities are not encompassed by the terms of the patent
- The patent relied on lacks novelty or inventive step
- They benefit from some of the statutory exemptions to infringement
Who can apply for a patent?
Any person can apply for a patent, but right initially belongs to: (3)
- the inventor
- someone to whom the inventor transferred the right in law (usually inventor’s employee)
- a legitimate successor
The ___ is automatically seen as the inventor on many countries if the employee has discovered the invention ‘in the course of employment’. It may be necessary to examine the contract of employees to establish this.
employer
Difficult decisions arise when ___ discover an invention that is not related to their research but which could be of benefit to the pharmaceutical company.
research workers
PROCEDURES FOR SECURING PATENTS: (2)
- European Patent Convention (EPC)
- Patent Cooperation Treaty (PCT)
It is a bundle of national patents. A single application to the ___ office secures patient rights in a number of European countries*
European Patent Convention (EPC)
Includes most EPC countries plus members in North and South America, Africa and Asia Pacific. A single application can be filed for multiple members.
Patent Cooperation Treaty (PCT)
They are valid, applicable and enforceable in the territories where they are approved. Separate applications in every country are
costly and time-consuming.
Patents are territorial
Has approved the creation of a common European Union Patent system, which will cover all member states except Italy and Spain initially
The European Parliament
DIFFERENCES IN WORLDWIDE PATENT SYSTEMS
There are notable differences between the national systems in Europe, as well as those of the EPC and the US patent system:
- For ___ , if prior disclosure are made up to one year prior to the filing of the patent application, it does not serve to destroy novelty in the invention.
National US patents
DIFFERENCES IN WORLDWIDE PATENT SYSTEMS
There are notable differences between the national systems in Europe, as well as those of the EPC and the US patent system:
- In ___ , only if a prior disclosure was unauthorised will novelty be retained.
Europe
DIFFERENCES IN WORLDWIDE PATENT SYSTEMS
There are notable differences between the national systems in Europe, as well as those of the EPC and the US patent system:
- The US systems work on ___
rather than ‘first to file’.
‘first to invent’
DIFFERENCES IN WORLDWIDE PATENT SYSTEMS
There are notable differences between the national systems in Europe, as well as those of the EPC and the US patent system:
- ___ are more stringently applied in the US.
Requirements for a full and detailed disclosure of the invention
DIFFERENCES IN WORLDWIDE PATENT SYSTEMS
There are notable differences between the national systems in Europe, as well as those of the EPC and the US patent system:
- ___ are more expensive to obtain due to translation requirements.
Patents obtained by the EPC and PCT systems
An extension to the patent term available for certain types of patent (including human or animal use or plant protection) to compensate for the reduction in the effective patent life due to regulatory approval timelines
Supplementary Protection Certificate (SPC)
The period that elapses between the filing of an application for a Patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the Patent insufficient to cover the investment put into the research. Governed by Council Regulation
Supplementary Protection Certificate (SPC)
The duration of the SPC is calculated as a term equal to the period between the date on which the application for the patent was lodged, and the date of the first authorisation to place the product on the market in the Community, reduced by five years.
The SPC has a maximum duration of 5 years:
- If the first marketing authorisation (MA) is issued <5 years after patent filing, ___ .
no SPC is granted
The duration of the SPC is calculated as a term equal to the period between the date on which the application for the patent was lodged, and the date of the first authorisation to place the product on the market in the Community, reduced by five years.
The SPC has a maximum duration of 5 years:
- If first MA is issued >5 years but <10 years after Patent filing, the SPC will be equal to the patent filing to the MA issue date ___ .
minus 5 years
The duration of the SPC is calculated as a term equal to the period between the date on which the application for the patent was lodged, and the date of the first authorisation to place the product on the market in the Community, reduced by five years.
The SPC has a maximum duration of 5 years:
If first MA is issued >10 years after patent filing, the SPC will be ___ .
5 years
SUPPLEMENTARY PROTECTION CERTIFICATES APPLICABILITY
Under the EU law, SPCs are granted in respect of products.
Are defined as the active ingredient or combination of active ingredients, of a medicinal product and in respect of which a marketing
authorisation (MA) has been granted.
Products
SUPPLEMENTARY PROTECTION CERTIFICATES APPLICABILITY
Under the EU law, SPCs are granted in respect of products.
The ___ benefits the MA holder – this does not have to be the same person as the patent holder.
SPC
The patent holder can also apply for a SPC, but only ___ can be granted in respect of each patent. The SPC has the same effect as the patent.
one SPC
Have been required to clarify applicability of the SPC.
Court cases
EXTENSION OF THE SUPPLEMENTARY PROTECTION CERTIFICATES
Under the ___ , an extension of the SPC by ___ months is possible for products.
EU Paediatric Regulation (1901/2006)
Under the EU Paediatric Regulation (1901/2006) , an extension of the SPC by 6 months is possible for products meeting several conditions:
The ___ with the agreed ___ is included in the MA
Compliance Statement; Paediatric Investigation Plan (PIP)
Under the EU Paediatric Regulation (1901/2006) , an extension of the SPC by 6 months is possible for products meeting several conditions:
There is an ___ in all member states.
authorisation of the medicinal product
Under the EU Paediatric Regulation (1901/2006) , an extension of the SPC by 6 months is possible for products meeting several conditions:
The ___ is updated with the results of studies conducted in accordance with the agreed PIP (even if use in children is not recommended).
Summary of Product Characteristics (SmPC)
___ have to be applied for with each National Patent Office where the product is protected by a Patent that qualifies for an SPC EU Paediatric Regulation
(1901/2006)
Extensions of the SPC
A separate system of intellectual property protection exists irrespective of patent law under European regulatory provisions. It affords a period of data exclusivity (and hence market) to the company generating the non-clinical and clinical trial data supporting a marketing authorisation application (MAA).
Data Exclusivity
Covers all data for the product, including registration, subsequent indications and formulations for 8 years. After data exclusivity expiration, a generic product may receive a label for all indications and formulations, regardless of when the data for the innovator product was filed during the life cycle.
Data Exclusivity
May be extended to 11 years if a significant new indication was added during the first 8 years on the market. Market exclusivity for orphan medicinal products (10
years) may be extended by 2 years for fulfilment of certain conditions regarding compliance with the PIP under the paediatric regulation.
Market Exclusivity
Protect the underlying invention for a certain period of time.
Patent
The patent owner generally ___ and ___ its patents.
enforces and defends
A patent period is ___ , with the possibility of an SPC for a maximum of 5 years.
20 years from date of filing
Patents are ___ and apply only in the territory where granted.
nationally issued
It prevents reference to the pre-clinical and clinical data for a certain period of time.
Data Exclusivity
The regulatory authority makes the decision to validate a competitor ___ where the data exclusivity has expired.
Marketing Authorisation Application (MAA)
Data exclusivity is ___ from the date of first authorisation within the EU, with the possibility of 1 additional year for a new indication.
8 years
Market exclusivity applies to the ___ regardless of whether the Marketing Authorisation is centrally or nationally issued (‘exhaustion of right’).
whole of the EU
An exception to Patent rights that is more applicable to Europe than the US.
Exhaustion of rights
The ___ states that when a product is put into the market in any European country by the owner of the patent or with their consent, the owner cannot subsequently object to the movement or marketing of the product within other member states of the EU – their right is deemed exhausted once it is placed on the market in any one country.
principle of exhaustion of rights
Exhaustion of rights arises due to ___ , whereas free movement of goods is allowed across borders in the EU (Articles 28-30 of EC Treaty).
‘conflict’ between the facts that patents are nationally limited in scope
Price differentials between member states (particularly price controls on pharmaceuticals) give an incentive to import from cheaper to more expensive member states – this is called ___ .
parallel importing
