HØIBERG
Patent Guide
LIFE SCIENCE
HØIBERG
Patent Guide
LIFE SCIENCE
Contents
Introduction
Why Patent?
What protection does a patent provide?
Who is the rightful owner of a patent?
Criteria for patentability
What can be patented?
Carlsberg
How and when to publish?
Filling - When and where?
Patent application drafting and prosecution
NMD Pharma
International patenting
Extension of patent term
Morten Meldal
Freedom to Operate
IP strategy and business plan
Patent Valuation
Nykode
Collaboration and licensing
Due Diligence
Enforcing patent rights
Glossary
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Impressum
HØIBERG Patent Guide - Life Science
1st edition, 2024
Also available at www.hoiberg.com
PUBLISHER
HØIBERG P/S
EDITOR
Vibeke Bay // HØIBERG P/S
DESIGN & PRODUCTION
Dite Cepule // Gammelbys
HØIBERG P/S
Adelgade 12
1304 Copenhagen K
Denmark
Copenhagen · Denmark
Aarhus · Denmark
Herning · Denmark
Stockholm · Sweden
Lund · Sweden
Tel. +45 3332 0337
www.hoiberg.com
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Introduction
Foreword from
HØIBERG
Patents are an investment. Like any other investment, it must be aligned with
your business strategy. If the investment in a patent is not nurtured it becomes
an expense. HØIBERG was founded with the vision of assisting technology-
based companies in patent-protecting their inventions to add value to their
company. We have been doing this for more than 25 years and have become
the IPR firm of choice for ambitious and innovative companies.
Innovation allows companies to gain a clear market position. Innovation can
differentiate your products from those of competitors, attain premium prices
and create demand. Innovation is therefore directly related to profitability for
technology-based companies. This was reconfirmed in a recent report by
the EUIPO, which mapped the economic performance of companies across
all of Europe. Innovation is increasingly a prerequisite for success given the
increasing competition in the global marketplace, and innovation leaders are
on average more profitable and grow faster than innovation followers.
In turbulent times, companies tend to focus on consolidation rather than
innovation. Changing times should be viewed as an opportunity. Those who
prioritise innovation are those who emerge strengthened following a crisis.
Consequently, companies should develop a clear innovation strategy to
strengthen their competitive position both in times of crisis and in times of
economic growth.
The quality of R&D spending is as important as the quantity – merely
increasing the spending on R&D may not be the optimal solution for driving
more innovation. An effective innovation strategy highlights the importance
of looking beyond traditional product development, for example by focusing
on disruptive technologies, digitalisation opportunities, and restructuring of
existing innovation processes.
We hope that you will read the HØIBERG Patent Guide before developing your
next innovation strategy – we are always available if you have questions.
Keep collaborating, sharing knowledge, and thinking outside the box – just
remember to patent your great ideas first.
We are proud to present the HØIBERG Patent Guide. Intellectual Property Rights
in general and patents in particular are becoming increasingly important to
any firm engaged in product development. No two inventions are the same,
and there is no such thing as a “one size fits all” innovation strategy. We
have created this Patent Guide as a resource for inventors and innovators
to understand the crucial facets of the patenting process because great
inventions require great protection. By sharing our knowledge, you will be able
to reap the benefits of the time and hard work you dedicate to your great
ideas, inventions, and research.
On behalf of HØIBERG
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Why patent?
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A basic principle behind the patent system is that the description of the
invention becomes public and thereby contributes to the general knowledge
of society. In return, the applicant of a patentable invention obtains the right to
prevent others from using the invention for 20 years. Therefore, patents are of
great importance to society, since they both facilitate further development and
research and ensure that the patented invention can be exploited and used.
An alternative to patent protection is maintaining the technology as a trade
secret.
The protection of inventions is particularly important in highly competitive
industrial fields, and hence patents represent a major commercial asset for
innovative companies in the fields of biotech, pharma, and medtech.
A patent can be used to protect an invention, but it can also be regarded as
a strategic asset aimed at improving the competitive advantages and the
earning capacity of a company.
For young companies that are in the build-up phase, patent applications play
a large role in substantiating the major commercial assets of the company
by transforming inventions into tangible assets. A granted patent or even a
filed patent application can make a large difference in the evaluation of the
company and facilitates the attraction of investors.
In seeking to establish contact with key collaborators, it is a major asset that
the technology is protected by a patent application. A patent application
facilitates communication and ensures that the invention can be shown to
other parties, such as investors.
A patent can be used to protect an invention, but it can also be sold or licensed
to other parties, or even used as collateral just like any other property, such as
for example real estate, equipment, or a car.
If the commercial exploitation of the invention requires resources, which the
company does not have or cannot attract itself, it is an option to sell or license
the invention to other interested parties, which have these resources.
As an example, a major part of new innovative companies in the biotech and
medtech fields primarily focus on the pre-clinical phases of research and
development and are heavily dependent on collaborators for the clinical
testing and development of a future product. For such new companies, the
protection of inventions, filing of patent applications, and obtaining patents
are crucial for establishing collaboration and securing return of investment in
research.
There are many reasons for seeking protection of intellectual property rights
(IPR) by filing patent applications, and few reasons for not doing it. In a
few cases, it may be better to postpone or even avoid the filing of a patent
application. One example is when it is difficult to enforce the IP right and
How can patents and patent
applications be useful?
In preventing others
from copying or using
your invention.
In transforming major
commercial assets of
innovative companies
into tangible assets.
In facilitating the
build-up of a new
company, for instance by
attracting investors.
In establishing
collaborations and
facilitating dialogue with
future collaborators.
In increasing return of
investment in research
and development.
In selling or
licensing your IPR.
01 WHY PATENT?
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prevent others from using the invention once published. This could be the case
if the invention is a platform technology, such as a screening technique, which
enables further research that leads to development of products or methods. In
some cases, it may be difficult to prove that a third party has used the platform
technology in order to develop its own product or method, since they may be
able to arrive at the same result using a different technique.
Pursuing patent protection in the whole world is very expensive and suing
potential infringers is even more expensive. In most cases, a limited number
of countries are selected for patent protection. However, if the platform
technology is easily transferred to and implemented in countries where there
are no patent rights, it may be an advantage to avoid publication of the
technology and keep it as a trade secret.
Reverse-engineering represents a risk for products that are not protected
by patent applications, since the sale of a single product can destroy the
patentability of the product. In cases where it is impossible to reveal the
composition of a product by reverse-engineering, it may be questioned
whether a patent application should be filed.
It is also advisable to consider postponing the filing of a patent application if
proof-of-concept cannot be provided within a reasonable time-frame. There is
an increasing requirement from the patent authorities that proof-of-concept is
presented in order to proceed to grant of a patent. If proof-of-concept cannot
be properly established within a reasonable time, the risk is that the patent
application only leads to publication of the invention, but does not lead to the
grant of a patent and protection of the invention. Once the patent application
is published, it is part of the prior art for future developments and can therefore
be an obstacle to future patent applications.
If it is decided not to protect an invention by a patent application, it is
advisable to take relevant measures to ensure that the invention is kept secret.
One reason is that the legal protection of trade secrets is dependent on the
efforts made to keep the information a secret.
Measures to be considered when a technology is
not protected by patent applications:
Use non-disclosure agreements (NDA) whenever the technology is
disclosed for employees, collaborators, investors and other parties.
Describe the technology (i.e. the secret) in specific terms and formalise
who is allowed to know about the technology and who is not.
Restrict information access for employees.
An IPR strategy includes detailed policies regarding which inventions are
to be kept secret and measures to be taken to ensure the maintenance of
these secrets.
01 WHY PATENT?
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A patent is an exclusive right as well as a prohibition right. Thus, a patentee can
prohibit others from utilising the patented invention. However, a patent does
not automatically establish a right to utilise the invention. Other factors may
inhibit the patentee from entering the market with the given invention including
existence of dominating patent rights.
Utilisation of an invention could for instance be hindered if it involves utilisation
of a patent-protected product or process technology. In certain instances, it
may be necessary to obtain a licence from other patent owners in order to
utilise a patented invention.
In all member states of the World Trade Organization (WTO), a patent to a
product gives the patent owner the right to prevent others from making, using,
selling or importing the patented product. A patent to a process gives the
owner the right to prevent others from using the process, but the patentee can
also prevent others from using, selling or importing products directly prepared
by the process.
In most countries, there are a few exceptions to the protection conferred by
a patent; for example most countries have a research exemption. Studies for
obtaining a marketing authorization for medicine can also be freely undertaken
without the risk of infringing patents in many countries.
Once a patent owner has brought a patented product to the market, their
patent rights have been exhausted, and a buyer can use the patented product
without infringing the patent in the country of purchase.
A patent is valid for a minimum of 20 years after the filing date provided that
the patent owner has undertaken all required actions and paid all fees.
It is the responsibility of the patent owner to enforce the given patent rights.
Thus, in general, official authorities do not aid in enforcement of patent rights
on their own volition. To enforce a patent, the patent owner must normally take
legal action if no agreement can be reached with an infringer out of court.
What protection does
a patent provide?
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02 WHAT PROTECTION DOES A PATENT PROVIDE?
Product patent
Process patent
In all member states of the World Trade Organization (WTO), a patent
to a product gives the patent owner the right to prevent others from
making, using, selling, or importing the patented product.
A patent to a process gives the owner the right to prevent others
from using the process, but the patentee can also prevent others
from using, selling, or importing products directly prepared by the
process.
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Once an invention has been conceived the rights to a patent on that invention
belong to the person who invented it. Thus, as a starting point a patent simply
belongs to the inventor.
However, even if the starting point is very simple there are many challenges
in assuring correct ownership of a patent. First of all, in order to establish the
ownership of a patent it is very important to identify who is(are) the inventor(s).
Many inventors are contractually obliged to assign their rights to any invention
they make. For example, in many countries employees at universities are
obliged to assign their rights to the university, provided that the university
wishes to take on the patent process. Likewise, most private employees are
obliged to assign their patent rights to their employer. This is usually regulated
through their employment contract or in some countries by law.
Thus, even though the inventor is, in principle, the owner of the patent, the
employer of the inventor is, in fact, frequently the actual owner of the patent.
Nowadays most inventions are conceived by a team, and thus, as a starting
point, the invention belongs jointly to the people on that team. If all inventors
are employed by the same company, and they are obliged to assign the rights
to their inventions to their employer, then the patent simply belongs to that
company. If the inventors, however, are employed by different companies, the
patent will be co-owned by the respective companies. In case the inventors
are not obliged to assign their rights to the patent, the patent will be jointly
owned by the respective inventors.
The joint ownership creates challenges that are preferably addressed up
front. In Denmark and most other European countries co-owners must act
jointly, which effectively gives each co-owner a veto right with regard to
licensing or selling a patent. In contrast, in the United States each co-owner
can act independently. Thus, it is recommendable to ensure clear agreements
regulating the rights of each co-owner.
If no contracts regulate the joint ownership, then in the United States one
owner can license out the patent, without the consent of the other owners. This
03 WHO IS THE RIGHTFUL OWNER OF A PATENT?
Who is the rightful
owner of a patent?
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may result in reduced license fees, since there will be an internal competition
between co-owners. In addition, it will not be possible for any of the co-owners
to grant an exclusive license without an agreement. In Europe, one owner can
block a license, which another owner may wish to grant. A good contract is
therefore essential.
Prior to embarking on a joint development program, it is thus highly advisable
that the firms involved regulate the rights to any ensuing patents contractually.
This is also true for collaborations with sub-contractors. Even if the research
leading to an invention is paid for by an ordering firm, then the rights to a
patent do not automatically belong to that firm. The rights to a patent belong
to the inventor or possibly the inventor’s employer. Thus, for the ordering firm
it is crucial to ensure that a sub-contractor’s employees are obliged to assign
patents to the sub-contractor and that the sub-contractor is contractually
bound to assign the patent rights to the ordering firm.
In conclusion, in order for a company to control ownership of future patents, it
is important to understand who may be the inventor in the future, and to have
all the right contracts in place that will allow the company to take over the
ownership from the inventors or their employers.
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Criteria for patentability
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In principle, any invention fulfilling the following three basic criteria is patentable.
Thus the invention must be:
• novel
• associated with an inventive step
• industrially applicable
However, there are several exceptions. Some inventions are not patentable for
moral reasons, such as methods for cloning human beings. Other inventions are
specifically exempt from patentability in one or more jurisdictions, for example
plant varieties cannot be patented in many countries.
NOVELTY
A product is novel if an identical product has not previously been disclosed. Thus,
a product is not novel if another product characterised by the same specific
combination of physical and functional features has previously been made
publicly available.
A product can be protected by a patent by claiming its physical features, or its
functional features, or a combination of both. Frequently, at least some physical
features need to be defined, and it is often desirable to claim a product by a
combination of physical and functional features. Functional features frequently
confer a broader protection of the product than the protection which would have
been conferred by claiming physical features only.
04 CRITERIA FOR PATENTABILITY
When evaluating the novelty of methods it is, in general, necessary to consider
more than just the method steps carried out when the method is exercised.
Methods for producing a product can disclose:
A method for producing a product is, in general, novel when either the starting
material is novel, or when the combination of processing steps is novel, or
when the product resulting from the method is novel.
A method for using a product for a particular purpose can disclose:
Frequently, it may be preferable to claim such methods by defining the steps
carried out when performing the method. A method for using a product is
novel when either the product is novel, or when the method steps are novel.
A method for using a product can, in some instances, also be novel when the
technical result is novel.
An evaluation of novelty of an invention must clarify what has been made
available to the public.
a starting material
use of the product for carrying out the method
the method steps carried out when performing the method
the technical results obtained from carrying out the method
one or more method steps for processing the starting material
the result of the method in the form of the end product
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INVENTIVE STEP
An invention complies with the requirement for inventive step if the invention
was not obvious to a skilled person. Thus, inventive step is evaluated based on
what was known at the time of filing the patent application from the viewpoint
of a person skilled in the art. Inventive step can, for example, be based on a
superior effect, an advantageous method, a surprising solution or a result
which would not reasonably be expected.
When evaluating inventive step of an invention, the relevant question to ask is
not whether a skilled person from a relevant technical area could have carried
out the invention, but whether the skilled person would have done so in the
hope of solving the underlying technical problem or in the expectation of some
improvement or advantage.
It is important not to use hindsight when evaluating inventive step. When using
hindsight many inventions could appear obvious, but inventive step must be
evaluated without using the actual knowledge of the invention.
In Europe, a very strict approach is used for evaluation of inventive step, the
so-called “problem/solution approach”:
The prior art document most closely resembling the invention is
identified.
The differences between the closest prior art and the invention are
identified.
The technical effect of these differences is identified.
An objective technical problem solved by the invention is
constructed thereupon.
Finally, it is evaluated whether the difference(s) between the
closest prior art and the invention was obvious to a person skilled
in the art.
#1
#2
#4
#5
#3
In other countries, less formalised approaches are employed to evaluate
whether an invention is obvious or not. However, common to the evaluation of
inventive step is the fictitious character “the person skilled in the art”, which is
presumed to be a skilled practitioner in the relevant field of technology, who
possesses average knowledge and ability, and is aware of what was common
general knowledge in the art at the filing date of the patent application.
04 CRITERIA FOR PATENTABILITY
INDUSTRIAL APPLICABILITY
In Europe, an invention must also be industrially applicable in order to be
patentable. Industrial applicability should be understood in the broad sense, as
including any activity that can achieve a technical result in any industrial field.
As such, most inventions will be regarded as industrially applicable. In the United
States, the standard is slightly different. Instead, the requirement is that the
invention must have utility. The outcome is, however, similar, and most inventions
fulfill this requirement.
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Many countries have chosen to exclude certain subject matter from
patentability for a variety of reasons.
There are many exceptions to patentability in the fields of pharma, medtech
and biotech, however, most inventions in these fields can in fact be patented.
Below, we introduce some examples.
MEDTECH
In the field of medtech most inventions are patentable. Many inventions in
this field are claimed as a device, or as a combination of a device and a
biological entity. Functional features can also be used for protecting inventions
in the area of medtech. Examples of medtech inventions include products
such as e.g. insulin pens, surgical equipment such as lasers, fluid handling
devices exploiting e.g. robot technology for carrying out e.g. diagnostic assays,
immunoblotting devices, microfluidic devices, polymer chips suitable for
contacting biological material, hybridisation arrays, and the like.
However, in many jurisdictions including Europe, methods of treatment are not
patentable. Thus, it may be difficult to patent methods of treatment using a
particular device in these countries.
BIOTECH
Within the field of biotech, the exceptions from patentability vary from country
to country. In Europe, a wide variety of biotechnological inventions can be
patented including living organisms, such as microbes and transgenic multi-
cellular organisms. Examples of other biotechnological inventions that may
be patented include vectors, cell lines, artificially generated tissues and - in
isolated form - cells, proteins (including antibodies), genes, partial gene
sequences, cDNAs and SNPs. In the United States, the aforementioned subject
matter can also be patented provided that it does not exist in nature. Thus,
naturally occurring genes or proteins, and parts thereof, cannot be patented in
the United States.
Biotechnological methods are widely patentable even though there are a few
exceptions. In Europe, biological methods for producing plants or animals
cannot be patented. In the United States, many diagnostic methods cannot be
patented.
What can be patented
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05 WHAT CAN BE PATENTED
a nucleic acid, e.g. a gene of a particular sequence – in the
United States only if it is not a naturally occurring sequence
a vector comprising a gene
transgenic plants – only in some countries
a method for identifying binding partners for a polypeptide
a method for identifying agonists or antagonists for a polypeptide
an antibody
a polypeptide – in the United States only if it is not a naturally
occurring polypeptide
an isolated biological cell – in Europe not an embryonic stem
cell - in the United States not if naturally occurring
a compound e.g. polypeptide or nucleic acid for use in a
method for therapy
a diagnostic method using a nucleic acid or polypeptide –
in the United States with some restrictions
Examples of patentable inventions
in the area of recombinant gene
technology include one or more of
the following claims directed to:
#1
#5
#3
#7
#9
#2
#6
#4
#8
#10
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Carlsberg Group’s Senior
Patent Manager and
HØIBERG break new
ground
CARLSBERG
There are two rather unique things about the Carlsberg Group’s patent
portfolio. First, the wide scope and variety of technical fields covered by the
patents. Second, the fact that a single employee, the Senior Patent Manager,
handles the entire portfolio.
The Senior Patent Manager is a strategic role meant to ensure that Carlsberg’s
patent portfolio creates value for the business. “I handle Carlsberg’s broad
protection which encompasses our core business, through the entire brewing
process,” says Charlotte Utermøhl Lund, Senior Patent Manager at Carlsberg.
THE SENIOR PATENT MANAGER CONNECTS CARLSBERG
AND HØIBERG
According to Charlotte Utermøhl Lund, her most important task is to maintain
the strategic and commercial overview, and thereby ensure that Carlsberg’s
patent portfolio not just aims at protecting the results of the innovation but
also aims at ensuring the return on innovation investments.
“The patents Carlsberg holds must protect our technologies and be aligned
with our commercial and development strategies,” says Charlotte Utermøhl
Lund.
“To ensure that Carlsberg’s patents support the business and strategy, I also
focus on involving relevant stakeholders in the decision-making process and
ensuring that decisions and results are communicated clearly with the key
message front and centre. In my daily work, I wear many different hats - IP
specialist, project manager, communicator, and stakeholder manager. I
gather any loose ends and act as a link between HØIBERG and Carlsberg,” she
explains.
CASE: CARLSBERG
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SKILLS AND PROFESSIONALISM COMPLEMENT EACH
OTHER
Carlsberg’s IP portfolio varies widely across different technologies and
HØIBERG’s skills in biotechnology and mechanics are in high demand.
“It’s difficult to cover every specialist skill internally because Carlsberg’s
technology is so wide-ranging. By working with HØIBERG, we can balance
value and competencies. HØIBERG’s employees are the specialists. They are
incredibly skilled in IP and the technologies that are relevant to Carlsberg’s
business, while I am the generalist focused on the strategic and business-
related overview for Carlsberg. Our skills and professionalism complement
each other by combining the specialist with the generalist,” says Charlotte
Utermøhl Lund.
WORKING WITH HØIBERG STRETCHES BEYOND THE
AVERAGE CLIENT RELATIONSHIP
The personal aspect of the working relationship with HØIBERG is essential to
Charlotte Utermøhl Lund.
“To facilitate a working relationship that creates value, an effective
interpersonal relationship is crucial, and we recognise the fact that we depend
on each other to achieve the best results. You need to feel safe enough to
express that there are things you don’t know, to ask questions, to challenge
each other, and to reach out. The relationship is very important to me.”
“My working relationship with HØIBERG stretches beyond the average
customer/client relationship. Both sides have invested the time required to
grow a close professional relationship and create a space for confidential
discussions and sparring. HØIBERG is very skilled, and they are very open. We
trust each other and I am confident that HØIBERG will solve any task at hand in
the best possible way,” says Charlotte Utermøhl Lund.
HØIBERG HAS BEEN A LIFESAVER MANY TIMES
Carlsberg and HØIBERG have worked together on the Carlsberg patent portfolio
for more than 15 years.
“I highly value that I can access the history and every detail of Carlsberg’s
patent portfolio, going back years, due to HØIBERG’s structured and detailed
case management. In my job, I must be able to answer a lot of questions, for
example, what was the idea behind a specific patent ten years ago, or provide
details about our brewing method,” says Charlotte Utermøhl Lund.
“I rely on specialist knowledge from HØIBERG so I can focus on maintaining an
accurate overview of the IP strategy and make sure that all aspects fit into the
big picture. HØIBERG has been a lifesaver many times when it comes to gaining
crucial information regarding Carlsberg’s portfolio and history,” Charlotte
Utermøhl Lund states.
CASE: CARLSBERG
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MANAGING CARLSBERG’S PORTFOLIO GLOBALLY
Throughout their many years of collaboration, HØIBERG has ensured the
issuance of many different patents on behalf of Carlsberg and has handled
their portfolio globally.
“HØIBERG has handled patents for Carlsberg on a lot of different inventions
in many different countries. Even though Carlsberg is globally present, my
only point of contact is HØIBERG. HØIBERG handles Carlsberg’s portfolio in all
countries through their international network of agencies that they collaborate
with and instruct, for example, in relation to our patent applications.”
ACHIEVING IMPORTANT RESULTS FOR CARLSBERG’S
BUSINESS
With so many patents across the world, it is unsurprising that Carlsberg’s
patents have been challenged repeatedly.
“HØIBERG has provided great support and valuable counsel for Carlsberg when
they’ve handled opposition proceedings for us. HØIBERG’s experts are adept
at countering objections, whilst ensuring that the argumentation does not
create problems in other countries. HØIBERG can expertly handle and balance
the dialogue with Carlsberg’s collaborators during opposition proceedings,”
concludes Charlotte Utermøhl Lund.
Brewing for a better today and
tomorrow
Established in 1847 by brewer J.C. Jacobsen, the Carlsberg Group is one of
the leading brewery groups in the world, with products sold in 150 markets.
The Group’s beer portfolio spans both local and international premium
brands, including Carlsberg, Tuborg, 1664 Blanc and Grimbergen, strong
local power brands and alcohol-free brews.
In addition, its portfolio of other beverages includes both alcoholic and non-
alcoholic beverages such as ciders, including Somersby, soft drinks, and
energy drinks.
The Group’s purpose is brewing for a better today and tomorrow. Doing
business responsibly and sustainably supports that purpose – and drives
the efforts to deliver value for shareholders and society.
CASE: CARLSBERG
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Patents protect Carlsberg’s
core business through the
entire brewing process
Isolation of yeast is just one of the inventions and innovations
that Carlsberg has developed to support its core business. Other
inventions and innovations include:
Raw materials: e.g., plant patents on the
cultivation of barley and hops
The brewing process: e.g., biotech patents on
organisms for, and methods of, fermentation
Machines and technology: e.g., mechanical
engineering patents on equipment, valves, and
cooling systems for the brewing process or
draught beer installations
INTERNATIONAL PATENT APPLICATIONS
REQUIRE DEEP INSIGHT INTO NATIONAL LEGISLATION
The potentially long-lasting competitive advantages provided by inventions
and innovations need to be protected internationally. HØIBERG ensures that it is
possible to protect Carlsberg inventions globally through a single international
(PCT) patent application, which can be converted to national applications in
most of the world’s industrialised countries.
The PCT application timeline provides time to validate the invention, mature
the product, test the market and/or find commercial partners before Carlsberg
invests larger sums in the national stage of the patenting process.
HØIBERG ensures that the initial draft of a PCT application considers individual
national regulations to secure the strongest possible protection of each
national patent.
“HØIBERG is very skilled,
and they are very open.
We trust each other
and I am confident that
HØIBERG will solve any
task at hand in the best
possible way”
CHARLOTTE UTERMØHL LUND
Senior Patent Manager, Carlsberg.
CASE: CARLSBERG
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One very common prejudice against the patent system, is that it precludes
free sharing of information by preventing scientists from publishing their
science. The fact is that the patent system actually forces inventors to publish
their findings, because patent rights are only granted in exchange of a written
description of the technology behind the invention. The word “patent” comes
from the Latin word “patere” which means “to lay open” – in other words to
make what is disclosed in the patent available to the public. In the absence of
patents, many private corporations would never publish their research.
There is nothing that prevents a scientist from filing a patent application in
addition to publishing their research in peer-reviewed scientific journals so
that they can reach their publication goals and be judged by their scientific
contributions.
Corporations that are not dependent on making scientific publications also
need to take precautions before they render their inventions publicly available.
Corporations may need to publish the content of patent applications as part of
their marketing efforts. Putting a product of a patent application on the market
also constitutes a publication as the word is understood by the patent law.
Showing, speaking or writing about a product may be considered as a launch
or marketing of the product. At any product launch there is a risk of infringing
third parties intellectual property rights. Before going public with your invention
you should therefore carefully consider:
How and when to publish
publishing your research article including a description
of the product
sending abstracts including description of the product
to conferences
sending project applications including description of the
product to reviewers
publishing abstracts including description of the
product on your website
handing out marketing material such as brochures
describing the product
PUBLISHING BEFORE FILING
A key requirement to obtaining a patent on an invention is novelty. The
invention can only be patented if it is new, i.e. not disclosed to the public
and not part of the prior art. Publishing an invention before filing of a
patent application is therefore detrimental to patentability. This cannot be
emphasized enough. This applies to all kinds of publications, whether an article,
an abstract, a lecture, a brochure, a pamphlet, sales materials or offering a
product for sale. All of these are considered publications as they all serve to
convey information about the product to the public.
An invention is considered public or prior art if it was available in any way -
written, orally, displayed, or just temporarily published on the internet - to at
least one person of the public, i.e. just one person not bound by confidentiality.
This means that novelty of your invention - and thereby your chance of
patenting is challenged by any of the following acts:
#1
#2
06 HOW AND WHEN TO PUBLISH
Is patent protection relevant?
Does the product infringe any third party rights, or is there
freedom to operate?
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A display or a discussion with potential public access is novelty destroying.
It may not be discovered by the patent authorities, and a patent may even
be granted. However, the disclosure will be a threat to the validity of the
patent throughout its lifetime. Investors often require that you disclose any
known reasons for invalidity during a due diligence. Hence, the validity and
enforceability of the patent right will be associated with uncertainty.
If you have disclosed your own invention, all hope is not lost. Some countries
provide a grace period for the inventors’ own disclosures, i.e. the inventors
cannot accidentally destroy the patentability chances for themselves. The
grace period is usually 12 months and begins at the first public disclosure. If a
patent application is filed in this period, the publication made by the inventors
themselves will not be considered prior art. The invention may thus still be
patentable, despite the public display by the inventors - but only in countries
with a grace period. The grace period is governed by national law and
therefore varies between countries. In the US the grace period is 12 month.
PUBLISHING DURING THE PRIORITY YEAR
Once the priority founding patent application has been filed it is normally safe
to publish the invention and a subsequent display or description of the product
will not be prior art. The priority founding patent application provides protection
against publications made during the priority year but only to the extent that
the later pursued patent claims are fully supported by the priority founding
patent application. If the priority founding patent application is a high quality
patent application with the necessary level of details, definitions, support and
fall back positions, a publication during the priority year should do no harm.
If not, then there is limited protection against a publication during the priority
year.
Whenever the need for publication arises during the priority year, it should
always be checked that the intended publication disclose only details included
in the filed priority founding patent application. If something is missing, the
patent application can be updated and re-filed. Often the amount of updating
is limited and can be done very quickly so the publication need not be
postponed.
A meeting with potential investors and partners should also be regarded as a
potential publication unless the investor or partner has signed a confidentiality
agreement. If any confidential information is provided to the investor/partner
it is strategically wise to update the patent application shortly before the
meeting.
PUBLISHING AFTER THE PCT APPLICATION
HAS BEEN FILED
Normally, at the end of the priority year, a PCT application and/or one or more
national applications are filed, which is the last opportunity to update the text
and data included in the patent application. Once this application has been
filed the text can no longer be changed. At this stage a publication cannot
count as prior art against the patent application. Still one needs to be cautious
before publishing: During the 6-month period between filing and publishing
of the PCT application a new patent application can be filed claiming even
a trivial variant of the invention disclosed in the priority founding patent
application. Until its publication, the PCT application does not count as full prior
art and a new patent application filed at this stage need only be novel – not
inventive – over the PCT application.
If new discoveries are made during this period, one should consider whether
a so-called second generation patent application should be filed before
publication of the patent application and before publication of the new
findings. In fact, corporations often file this type of patent application just
before the patent application is published in order to protect commercially
important variants and potentially also to extend duration of exclusivity as the
second generation patent application will expire some 12 to 18 months later
than the priority founding patent application.
PUBLISHING AFTER PUBLICATION OF THE PATENT
APPLICATION
At this stage the priority founding patent application can no longer be updated
and any new findings to be pursued in a new patent application will need to be
patentable in its own right in view of that publication.
At this stage, one only needs to make certain that a publication does not
question the findings in the earlier patent application or casts doubts on
the data presented there. While quite rare, it does happen that a scientific
publication at this stage harms the prosecution of the patent application.
06 HOW AND WHEN TO PUBLISH
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Filling – When and where?
07
The date of filing and the content of a patent application are among the critical
factors to be considered when formulating an effective patent strategy. There
is often a natural wish to file a patent application as early as possible. In some
circumstances this may be the sensible thing to do, but several factors should
be considered before deciding when to file.
PRIORITY DATE
After filing a first patent application, the applicant can within one
year – the priority year - file additional patent applications claiming
priority from the first application (the priority application). The
date of filing of the first patent application is known as the priority
date, and the priority date is decisive for determining the state of
the prior art. Thus, anything published before the priority date may
be taken into account when determining novelty and inventive
step of the claimed invention. Furthermore, the priority date can
be used for determining who has first filed a patent application. If
two parties claim patent rights to the same invention, the rights to
the invention will be awarded to the party who has filed the patent
application first (“first-to-file” principle).
An updated patent application can claim priority from one or
more earlier patent applications, provided that the earliest patent
application is filed less than one year prior to the filing of the
updated patent application. If the updated application introduces
new aspects of an invention, the new aspects will not have the right
of priority. However, the updated application can contain new data
supporting the invention and still retain the priority date.
Early filing of a patent application gives rise to an early priority
date and the benefits associated therewith. However, at least two
factors may favour a later filing date, namely the requirement for
an enabling description and the wish for a longer patent term.
DESCRIPTION OF THE INVENTION
It is a requirement that the patent application discloses the
invention in such a way that a skilled person can carry out the
invention based on the disclosure thereof in the patent application.
In many countries it is not sufficient to describe how an invention
can be carried out, it is also a requirement to demonstrate that the
invention in fact has been carried out.
If the patent authorities consider that the requirement of an
enabling disclosure is not fulfilled, the patent application risks being
rejected for lack of an enabling disclosure. Such an objection can
be difficult to remedy after filing.
Accordingly, it is generally recommended not to file a patent
application before sufficient experimental data is available to
support the invention. If the invention is a well-defined specific
invention then a single example demonstrating the invention
may be sufficient to support the invention. However, if broader
claims are desired, the patent application should provide several
examples demonstrating different ways of carrying out the
invention.
It is not a requirement that a patent application provides actual
proof that the invention works. However, the application should
at least render it credible. Thus, for example in the field of
pharmaceuticals, data from clinical trials are not required. It is
sufficient to provide data from an established in vitro model or from
animal studies.
WHEN TO FILE DOCUMENTATION
SUPPORTING THE INVENTION
The need for an early priority date may thus have to be weighed
against the fact that a broader and/or stronger patent protection
can be obtained, when the applicant is capable of providing a
more detailed disclosure of the invention.
During the priority year it is possible to file an updated application,
which may comprise additional data supporting the invention.
Thus, up to one year from the priority date it is possible to
supplement a patent application with additional data supporting
the invention while maintaining the priority date.
07 FILLING – WHEN AND WHERE?
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After the priority year has passed it is no longer possible to add
additional data to a patent application. However, in some instances
it is possible to file additional information on the invention directly
to the patent authorities. It varies greatly between different
countries to what extent additional data can be supplied after filing
of the patent application.
In general, data can only be supplied after filing if they support the
assertions already made in the patent application. In many East
Asian countries, the effect of post filing data is very limited, whereas
the practice in Europe and United States is much more liberal.
PATENT TERM
With a few exceptions a patent expires 20 years after filing provided
that all fees have been paid. In relatively slow progressing fields,
such as in the fields of biotech or pharma, it is frequently the last
years of the patent term, which are the most valuable.
For that reason it may be desirable to delay patent expiry by filing
the patent application as late as possible. The term of 20 years is
calculated from the actual filing date of the patent application, and
not from the priority date. Thus, for the longest possible patent term
it is desirable to exploit the full priority year.
WHERE TO FILE
The priority application can be filed in any country, which is a
member of the Paris Convention. Currently, 179 countries are parties
to the Paris Convention and thus a priority application can, in
principle, be filed almost anywhere.
Some countries have legal restrictions regarding where to file
priority applications, but for Scandinavian inventions the applicant
generally has freedom to choose where to file. For practical
reasons, priority applications originating in Scandinavia are
frequently filed with the Danish, the Swedish or the European Patent
Offices.
During the priority year, a decision must be made about where
to file patent applications. The international (PCT) route is often
chosen, because the need for deciding where to file can be delayed
(see more details in the chapter “Patent application drafting and
prosecution”).
07 FILLING –WHEN AND WHERE?
Eventually, the applicant must, however, decide in what countries to seek
patent protection. Several factors are important for this decision. First of all, it
is important to cover the main markets, which may depend on the particular
invention. It is important to remember that patents may be valid for up to 20
years, and thus it is possible that emerging markets can be main markets
before expiry of the patent. Furthermore, it may be desirable to have patent
protection in the home countries of the most relevant competitors. Another
factor to consider is potential production countries. For almost all inventions in
the fields of biotech and pharma, patent protection is sought at least in Europe
and the United States. The countries then most often considered for patenting
is India, China and Japan closely followed by South Korea, South Africa,
Canada and Australia. Brazil and Mexico are also common countries in which
to seek patent protection.
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08
This chapter describes many of the activities an applicant must deal with, from
drafting a patent application until a patent is finally granted.
BEFORE FILING A PATENT APPLICATION
It is recommendable to obtain a patentability assessment of an invention,
which for example can be prepared by a patent attorney. This evaluation is
essential for determining whether to apply for patent protection, and is also
very helpful for drafting the patent application.
A pre-filing evaluation can for example be used:
•
to determine whether an invention is patentable
•
to determine the probable scope of a patent
•
as inspiration, before launching new development activities
•
as a basis on which to assess the possibilities of new activities in the
area
•
to assess the commercial viability of a new product
•
to acquire knowledge of the relevant operators within a given field
•
to obtain information on whether the rights of others will be infringed
THE PATENT APPLICATION
The single most important document in the patent process is the patent
application. Accordingly, it is of paramount importance that the patent
application is of good quality. A good quality patent application is
characterised by the following features:
•
Broad patent claims
•
Narrow claims specifically defining the preferred aspects of the
invention
•
Claims of intermediate scope
•
Alternative claim language
Patent application
drafting and prosecution
MONTHS
12
18
30
National filings
(30 MONTHS)
Optional:
Response to written
opinion
ISRWO and publication
(18 MONTHS)
Filing PCT and
national applications
(12 MONTHS)
Updating application
Optional:
Search Report
Filing priority
application
(0 MONTHS)
Drafting priority
application
Initial assessment
EUROPE, USA, CHINA ETC.
Preparatory work
Priority year
International phase
National phase
08 PATENT APPLICATION DRAFTING AND PROSECUTION
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•
Concise claim language that clearly defines the scope of protection
•
Carefully-drafted claim structure providing basis for multiple
combinations
•
Enabling disclosure of the invention
•
Examples to support the claims
•
Prioritised fall-back positions
•
Description of the technical effect of alternatives
In addition the patent application should set the scene for the invention and tell
the story of the invention based on sound scientific reasoning. This will facilitate
other peoples’ understanding of the invention. It is also important to draft the
application in an understandable language using common terms within the
given field. The terminology should be consistent and any unclear terms should
be defined. The most relevant prior art may also briefly be discussed.
As described in the previous chapter (Filing – When and where) it is generally
advantageous first to file a priority patent application and then follow up
with an updated application in the priority year. Preferably, both the priority
application and the updated application should contain the features listed
above. Thus, even if an update can be made, the priority application should be
of good quality.
(EPO). This can be achieved by filing the priority application as a
European patent application or by filing the priority application with
either the Danish or the Swedish Patent Office and requesting that
the application is subjected to an international type search by EPO. A
novelty search performed by the EPO renders it possible – before filing
an updated patent application – to judge the novelty of the invention
and the inventive step thereof on the basis of the patent claims filed.
THE PATENT COOPERATION TREATY (PCT)
When taking advantage of the PCT system, an applicant needs initially
only to file a single, updated patent application in the form of a PCT
application. The PCT application can later be converted into national
patent applications in the 157 countries, which are presently members
of the PCT.
FILING AN UPDATED PATENT APPLICATION
It is possible to update a priority application, if this takes place no later
than 12 months after the filing of the priority application. The updated
application can be filed nationally in the countries of interest and/or
as an international application (PCT application) depending on the
strategy chosen.
Filing a PCT application secures an applicant the right to file national
or regional patent applications in PCT contracting states at a later
stage. One advantage of filing a PCT application is that the application
will initially be prosecuted in a centralised, international phase of
the procedure, and only later entered into the national or regional
phase. The entry into the national or regional phase involves the filing
of national or regional patent applications, which is one of the most
expensive steps of patent prosecution. The cost of filing national
or regional patent applications can thus be postponed by initially
filing a PCT application. Prior to filing a PCT application, it should be
considered to file national patent applications in the few states not
party to the PCT.
In the following, the procedure for prosecution of a PCT application is
outlined in more detail.
PRIORITY PATENT APPLICATION
The first patent application describing an invention is a priority-
founding patent application, establishing the priority date. In order to
establish the best possible priority basis for the filing of an updated
patent application, a priority patent application should be an
application of good quality and contain the features described above.
In case new, important knowledge concerning the invention is
acquired within the priority year, it is recommended that such new
aspects be described in a new priority patent application or in an
updated patent application to be filed before expiry of the priority year.
It is recommended that a priority patent application be subjected to
a novelty search carried out well in advance of expiry of the priority
year by a patent authority, for example, by the European Patent Office
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