Patents in biomedical research

Hannes Iserentant

European Patent Attorney, VIB

Quick reminder on patentability:

Art 52 (1) of the European Patent Convention (EPC):

‘European patents shall be granted for any inventions, in all fields of technology, which are new, involve an inventive step and are susceptible of industrial application.’

Inventions?

• Discoveries, scientific theories, mathematical methods

• Aesthetic creations

• Schemes, rules and methods for performing mental acts, playing games or doing business, and computer programs

• Presentations of information

Are not regarded as ‘inventions’:

Examples

• The mere discovery of a gene or a substance existing in nature is not patentable; if however ‘a technical effect’/ ‘a practical use’ is revealed, a gene or a substance might be patentable.

• A painting defined by subjective, aesthetic aspects is not patentable; a painting defined by the kind of cloth or by the dyes used (i.e. defined by technical features having a technical effect) might be patentable.

• Computer programs might be patentable if they solve a technical problem

Inventions

Must be concrete and of technical character (cf. ‘all fields of technology’)

Inventions, but not patentable (Europe)

• Methods to treat humans/animals and diagnostic methods practised on humans/animals (but not products used to treat)

• Inventions contrary to ‘ordre public’ or morality (ex. letter-bombs, human clones,...)

• Plant or animal varieties or essentially biological processes for the production of plants or animals (not microbiological processes)

Not patentable biotech ‘inventions’

• Methods for cloning human beings

• Methods for modifying the germ line genetic identity of human beings

• Uses of human embryos for commercial purposes

• Methods for modifying the genetic identity of animals and genetically modified animals if they are likely to suffer without substantial benefit to man or animal

• The human body or one of its elements including genes (an isolated gene having industrial applicability is patentable)

Patentable (biotech) inventions

1) products: (small) molecules, nucleic acid sequences, amino acid sequences, plasmids, yeast cells, viruses, bacteria, human-, animal- and plant cells, transformed plants and non-human animals,...

2) processes to produce products

3) uses of products to make diagnostic tool, purify proteins, make stress-resistant plants, visualize substances in situ,...

special case: substance X for use in treatment of Y

Patentability

Art 52 (1) of the European Patent Convention (EPC):

‘European patents shall be granted for any inventions, in all fields of technology, which are new, involve an inventive step and are susceptible of industrial application.’

What is “new”?

• An invention is considered new if it does not form part of the ‘state of the art’

• ‘State of the art’ = everything made available to the public by means of a written or oral description, by use or in any other way before the date of filing of the patent application

• All elements should be there. A trivial difference is enough to establish novelty.

What is “new”?

• There should be no bar of confidentiality

– Private meetings are no dislosure

• Object/document should be accessible to the public

– Not important wheteher it was accessed or not, possibility is enough

• Absolute novelty: language is no barrier, truly ‘new to the world’

No publication or presentation prior to filing! (EP)

What is “new”?

• A species is novelty-destroying for a genus; not otherwise

– If Cu is known, “metal” can not be claimed

– If metal is known, Cu can be claimed if it has a technical advantage selection inventions!

• The state of the art also comprises the content of other applications filed (same jurisdiction) earlier than –but published after- the date of filing of the application (= the so-called ‘prior rights’)

New? Example:

• Invention = a Trypanosoma protein A (20 kDa) consisting of the sequence M-S-..-P-R and having immunosuppressive effect

• Filing date of invention: June 28 ’07 __________________________________________ • Is invention novel if: a) The inventor explained his invention via a poster

on May 28 ’07 during a conference? Poster explains the immunosuppressive results in mice but no sequence is shown,

b) A fragment of protein A is published on Jan 5 ’06?

Example (2)

c) Trypanosoma Protein A’ -being 96% identical to protein A- has been published in Russian on May 4 ’05?

d) The invention is published in a journal which was available in the library on June 25 ’07. Up to today, nobody consulted the journal yet?

e) The inventor explained his invention to a US collegue a year ago and told him this was confidential information?

The invention must involve an inventive step:

If, having regard to ‘the state of the art’, invention provides a solution to a technical problem and solution is not obvious to ‘a person skilled in the art’

‘European patents shall be granted for any inventions, in all fields of technology, which are new,

involve an inventive step and are susceptible of industrial application.’

Inventive step: skilled person

‘a person skilled in the art’

=

ordinary practitioner aware of ‘common general knowledge’ in the technical field at the relevant date; has access to all items of prior art; he possesses no inventive capability (not creative, no fantasy) unlike an inventor.

One way to assess inventive step (Europe):

Problem-solution approach:

1) determine closest prior art (first prior art search)

2) establish technical problem to be solved

3) consider whether skilled person would be incited to modify the closest prior art in order to solve technical problem (second prior art search)

Example 1: inventive step

• Invention: use of nanobodies to visualize proteins in situ

• Closest prior art: use of antibodies to visualize proteins in situ

• Technical problem: provide alternative to antibodies which are more stable in reducing conditions

• A skilled person –faced with the technical problem- would consult the antibody literature and would learn that nanobodies are more stable in reducing conditions due to the lack of S-S bridges. Hence, he would be incited to modify closest prior art so that no inventive step can be acknowledged. He just employs known properties.

Example 2: inventive step

• Invention: Use of Lactococci expressing trefoil peptides for the preparation of a medicament to treat GI diseases

• Closest prior art: Direct administration of high levels of trefoil peptides in the gut to treat GI diseases.

• Technical problem: Providing an alternative manner to administer trefoil peptides to the GI tract.

• A skilled person would not be incited to consider to use Lactococci as he would know from the art that the amount of peptides that can be produced in situ by Lactococci would be normally insufficient to have a curing effect. Hence, it is surprising that the invention actually works so that an inventive step should be acknowledged.

And now for some exercise!

Is the invention industrially applicable ?

• If invention can be made or used in any kind of industry, including agriculture.

• Requires that the invention can be manufactured (e.g. not against physical laws)

• Gene sequences ? No speculative function, credible use required.

‘European patents shall be granted for any inventions, in all fields of technology, which are new, involve an inventive step and are susceptible of industrial application.’

So now you now what’s patentable...

...how do you know your invention is new?

Searching prior art

DIY:

• General searches

– Internet (meta) search engines

• Scientific literature

– Pubmed, agricola

• Patent literature

– Free data bases: Espacenet, USPTO, WIPO

– Providers: STN, Questel

Or...

• Ask a professional

Why search for patents?

• Lot of information that is never published in scientific literature

• In estimation yearly 20 billion $ lost in Europe by duplication of research

• Many examples of university groups repeating patented research without knowing it

• Patents are especially rich source of sequences

Why search for patents?

• Data are reliable, due to exigency of sufficient disclosure

• In principle, patent text should be sufficiently clear so that person skilled in the art can repeat the experiments

Where?

• Free databases from patent offices

– Espacenet, USPTO, WIPO, Japanese patent office….

– Reliable, but not always search friendly

– Limited search engines compared with commercial databases

• Free databases from other

– Google patent search, Patent lens….

– May give additional information (e.g. available for license)

– Not sure how complete and reliable the data are

Where?

• Espacenet – http://worldwide.espacenet.com/

– EP, PCT, US, Japanese and several other national applications and/or patents

– User friendly search menu

– Key word searching on title and abstract

– Limited wild cards and truncation (only right hand)

– Full text and scanned documents available

– Useful links to juridical status and register

– Indication of patent family (but not all family members are listed in the results list)

Where?

• USPTO

– http://www.uspto.gov/patft/index.html

– Only US patents and applications

– Search engine more powerful than in Espacenet, but less user friendly

– Full text available

– Key word searching on title, abstract, description and claims (full text searching) possible

Where?

• WIPO – http://www.wipo.int/patentscope/search/en/search.j

sf

– Search engine similar to (but different from) USPTO

– Alternative drop down search menu similar to Espacenet

– Full text searching possible (title, abstract, description, claims)

– Take care: not all applications are in English!

Where?

• Alternative free services

– http://www.google.com/patents

– http://www.freepatentsonline.com

– http://www.lens.org/lens/search

– Limited added value

– Patent lens allows sequence searches:

• http://www.lens.org/lens/bio/sequence

Where?

• Global search engines – In some cases, a global web search can be useful

– A lot of patent related information can be found on the internet

– Specially useful if one want to link a brand name to a company

– Can be useful to trace back inventors

– Try meta search engines, such as dogpile: http://www.dogpile.com/info.dogpl/

Where?

• Professional databases, by providers

– STN, Questel

– More than only patent information (but also literature databases and economical data)

– Powerful search engines (far better than in the free sources) but sometimes using specific search language

– Beside boolean operators and truncations, also proximity searches possible

– Only safe way to find patented sequence (not all are in public databases)

– Expensive!!!

Where?

• Providers: examples

– http://stneasy.fiz-karlsruhe.de/html/english/login1.html

– STNeasy is user friendly, helps to limit cost

– http://stnweb.fiz-karlsruhe.de/html/english/

– Powerful, but expensive

– Possibility of sequence and structure searches

– Expensive: database connection cost, time cost, cost per question and answer

Where?

• More detailed information in patent register (European patent applications)

– Legal status

– Full text of the application

– All correspondence including examination reports and claim amendments

– https://register.epo.org/espacenet/regviewer

How?

• Information available as “bibliographic” data

– Title

– Abstract

– Publication number

– Application number

– Priority number

– Priority date

– Assignee

– Inventors

– Classification code

How?

• Basic search strategy not essentially different from searching scientific data bases

• Search on keywords and authors (=inventors) is identical

• Due to patent peculiarities, alternative search strategies are possible (such as assignee, priority date, classification code…)

• Patent classification code can be powerful tool

• Keyword search – Most simple way of searching

– Definition of good keywords is essential: avoid commonly used words (e.g. cell) or words with double meaning (e.g. plant)

– Search in title, abstract, description, claims

– Full text search gives often too much background, abstract search is more relevant

– Boolean operators (and, or, not) are useful if available

How?

How?

• Inventor search

– When one want to know if data of publication are patented, first and last author are most likely inventors (essential contribution)

How?

• Assignee

– Difficult: company commercializing the invention may be different from patent holder

– Company may have different divisions with different names

– Even more complicated by frequent fusions and takeovers in Biotech

How?

• Classification code

– In principle, powerful search tool: every class of inventions (products, methods) has own number

– Similar, but different systems: IPC, CPC (former ECLA…)

– CPC system more elaborated than IPC

– Before CPC, US had its own classification system

– Very useful in settled technologies, incomplete for rapidly evolving technology like Biotech; classification is not always consequent yet

– Classification may help in combination with ambiguous keywords

How?

• Classification code

– Take care: not all documents have CPC or IPC classification code

How?

• Classification code: example in CPC

– Chemistry, metallurgy: C

– Biochemistry, Beer, Spirits, Wine, Vinegar, Microbiology, Enzymology, Mutation or genetic engineering: C12

– Micro-organisms or enzymes, compositions thereof: C12N

– Mutation or genetic engineering; DNA or RNA concerning genetic engineering: C12N15

– …

How?

• Classification code: example in CPC

– Meaning of code as well as code belonging to keyword can be searched

– Main problem is scattering: e.g. antibody is distributed in 10 classes

– CPC code:

http://worldwide.espacenet.com/classification?locale=en_EP

Patents can be fun…

• http://www.colitz.com/site/wacky/wackyold.htm

(november 1996...!)

• http://www.ipwatchdog.com/obscure-patents/

You think you have a patentable invention:

• Provide TT team with a Record of Invention (ROI):

– a ‘formal’ document (see example)

– a first draft of a scientific paper,

– a poster,

– a set of experimental data with extra background info,

– a telephone call followed by said written documents...

When TT receives your ROI:

• Your tech transfer team will:

-search again your ‘research finding’ for prior art

-evaluate the patentability, market and feasibility

-inquire whether you’ve used material from 3th parties (MTA’s...) or were financed by an external source (FWO, EU...)

-preliminary inquire who the inventors are

-consider to draft a patent application,

-file a patent application with a recognized national (BE), regional (EP) or international (PCT) IP Office

Researcher & tech transfer team draft together:

- draft: - background information

(= prior art)

- examples

(= materials & methods and

results)

- detailed description

invention/definitions

- claims (→ scope of

protection)

by researcher

by TT

Questions?