The Patentability of Biotechnological Inventions - SLING Diffusion

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Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Patenting Biotechnology in
the UK


Dr Philip Mountjoy

Patent Examiner


March 2012

Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk


EC Directive on the Legal Protection of
Biotechnological Inventions (98/44/EC)


Implementation in the UK


Practice in the UK Intellectual Property Office
(IPO)


Topics

Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Implementation

of Directive


In the United Kingdom


Articles 1
-

11 implemented as The Patents
Regulations 2000 (SI 2000/2037)


essentially as
Schedule A2 to the Patents Act 1977


Articles 13
-

14 implemented as The Patents
(Amendment) Rules 2001 (SI 2001/1412)


Repealed and incorporated into Patents Rules 2007
(SI 2007/3291)


Article 12 implemented as The Patents and Plant
Variety Rights (Compulsory Licensing) Regulations
2002 (SI 2002/247)


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

The Patentability of Biotechnological
Inventions


Article 3(1) EC Directive

"……….. inventions which are new, which
involve an inventive step and which are
susceptible of industrial application shall
be patentable even if they concern a
product consisting of or containing
biological material or a process by means
of which biological material is produced,
processed or used."


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Patentability


Normal tests of novelty, inventive step, etc apply


Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1
[2007]
RPC 7 (
Aerotel/Macrossan
)


Patentability in Section 1(1) should be considered using
a “four step approach”,



(1) Properly construe the claim;




(2) identify the actual contribution;



(3) ask whether it falls solely within the excluded
subject matter;




(4) check whether the actual or alleged contribution
is actually technical in nature
.

Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Novelty


Novelty destroying disclosure must be
"enabling" if what is disclosed is to be
regarded as being "made available to the
public"



Asahi's Application
[1991] RPC 485


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Novelty


Article 3(2) EC Directive

"Biological material which is isolated from its
natural environment or produced by
means of a technical process may be the
subject of an invention even if it previously
occurred in nature."


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Inventive step


Patents will not be granted merely for
laborious and costly effort


Obviousness objection well founded if goal
is known and if sufficient theory and
practice known for the applicant to predict
where he is going


Wellcome Foundation v Genentech

[1989] RPC 147


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Inventive step


Obvious


to identify previously unknown members of a known
family if only arbitrary selection without a surprising
result is involved


to identify a gene in a database based on known
structural information about the corresponding protein


to assign a function to a gene by homology
comparison with gene(s) of known function


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Methods of treatment or
diagnosis



Exclusion of methods of treatment of the
human or animal body by therapy or
surgery, or methods of diagnosis (Section
4A Patents Act 1977)


First and second medical use claims


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Sequence claims
-

requirements


Where the specification of an application
for a patent discloses a sequence, it must
include a sequence listing (Rule 13(2))


No formal requirements for applicants to
file sequences electronically


Rule 13(6) states that the applicant should
file sequence listings in electronic form
‘where reasonably possible’


Sequences are published where they are
deemed to be an essential part of the
invention and where the sequence listing
is not excessively long


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Database searching for sequences


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Sequence claims


The context in which a polynucleotide sequence is
published can have a bearing on whether an earlier
publication will destroy the novelty of a later claim for
that sequence


If a claim for an isolated polynucleotide embraces the
polynucleotide as part of an unrestricted larger
sequence, it might be anticipated by a larger isolated
polynucleotide, and possibly even the associated
chromosome if this has been isolated


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Industrial application of a gene
sequence

“6.

The industrial application of a
sequence or partial sequence of a gene
must be disclosed in the patent application
as filed
.”


Schedule A2 to Patents Act 1977


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Disclosure of industrial application


USPTO Utility Examination Guidelines


“specific, substantial and credible”


EPO Examination Guidelines (C
-
IV, 4.6)


“In cases where a sequence or partial
sequence of a gene is used to produce a
protein or part of a protein, it is necessary to
specify which protein or part of protein is
produced and what function the protein or part
protein performs.”


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Industrial application


Eli
-
Lilly


Eli
-
Lilly v Human Genome Sciences


Eli Lilly & Co v Human Genome Sciences Inc [2008] EWHC 1903 (Pat) (Patents
Court)
-

found the patent to be invalid


Eli Lilly and Company v. Human Genome Sciences Inc, [2010] EWCA Civ 33 (Court
of Appeal)
-

found the patent to be invalid


Human Genome Sciences Inc v Eli Lilly & Co
[2011] UKSC 51 (Supreme Court)


overturned decisions of lower courts


patent valid


Supreme Court decision provided 15 principles (based
on a summary of UK and EP case law) that can be
applied on a case
-
by
-
case basis where industrial
application may be an issue. It also ensured that UK
practice was consistent with that of the EPO.


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Sufficiency / Support

“….. the Patent Office ought to have very clearly in mind
that it is undesirable to allow claims the subject of which
is to cover a wide and unexplored field or where there is
no disclosure in the specification which is in any way
coterminous with the monopoly indicated in the claims."



Court of Appeal in
Genentech

at page 236



Biogen v Medeva
[1997]

RPC 1


Generics (UK) Ltd and others v H Lundbeck AS [2009]
UKHL 12


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Kirin
-
Amgen and product by
process



“I think that it is important that the United Kingdom should apply the
same law as the EPO and the other member states when deciding
what counts as new for the purposes of the EPC.”


“It would be most unfortunate if we were to uphold the validity of a
patent which would on identical facts have been revoked in
opposition proceedings at the EPO.”


Kirin
-
Amgen Inc. and others v Hoechst Marion Roussel Ltd and
others

[2005] RPC 9 (House of Lords)



Rejection of product by process claims where the product is known,
on the basis that they lack novelty


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Plant and animal varieties


Article 4 EC Directive:

1.
The following shall not be patentable:


(a) plant and animal varieties;


(b) essentially biological processes for the production
of plants or animals.


2. Inventions which concern plants or animals shall be
patentable if the technical feasibility of the invention is
not confined to a particular plant or animal variety



Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Essentially Biological Processes

EBoA decisions
-

G 2/07 (broccoli), G 1/08 (tomato):


1.
“A non
-
microbiological process for the production of plants which contains or consists
of the steps of sexually crossing the whole genomes of plants and of subsequently
selecting plants is in principle excluded from patentability as being "essentially
biological" within the meaning of Article 53(b) EPC”


2. “...process does not escape the exclusion...merely because it contains...a step of a
technical nature which serves to enable or assist the performance of the steps of
sexually crossing the whole genomes of plants or of subsequently selecting plants”



Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

EBoA decisions
-

G 2/07 (broccoli), G 1/08 (tomato):


3. Not excluded if process includes “...additional step of a technical nature which...by
itself introduces a trait into the genome or modifies a trait in the genome...so that the
introduction or modification of that trait is not the result of the mixing of the genes of
the plants chosen for sexual crossing...”


4. When deciding whether a process is excluded “...it is not relevant whether a step of a
technical nature is a new or known measure, whether it is trivial or a fundamental
alteration of a known process, whether it does or could occur in nature or whether the
essence of the invention lies in it”


Essentially Biological Processes

Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk


Article 6 EC Directive

1.
Inventions shall be considered unpatentable
where their commercial exploitation would be
contrary to
ordre public

or morality; however,
exploitation shall not be deemed to be so
contrary merely because it is prohibited by law
or regulation.

(Article 53(a) EPC, S1(3) of Patents Act)


Morality

Intellectual Property Office is an operating name of the Patent Office

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Morality


Article 6 EC Directive

2. .........., the following, in particular, shall be considered unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human
beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are
likely to cause them suffering without any substantial medical benefit
to man or animal, and also animals resulting from such processes.


(Rule 23d(d) EPC, Para 3(e) of Schedule A2 of Patents Act)


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Stem Cells







UK’s previous position was as set out in the Practice Note
of February 2009 following the decision in
WARF/Use of
embryos (G 0002/06))




C
-

34/10
-

Oliver Brüstle v Greenpeace


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

C
-

34/10
-

Oliver Brüstle v Greenpeace



1. What is meant by the term 'human embryos' in Article
6(2)(c) of Directive 98/44/EC?


2. What is meant by the expression 'uses of human
embryos for industrial or commercial purposes'?


3. Is technical teaching to be considered unpatentable
pursuant to Article 6(2)(c) of the Directive even if the use
of human embryos does not form part of the technical
teaching claimed with the patent, but is a necessary
precondition for the application of that teaching…


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

C
-

34/10
-

Oliver Brüstle v Greenpeace



The CJEU found that:


...Article 6(2)(c) of Directive 98/44 excludes an invention
from patentability where the technical teaching which is
the subject
-
matter of the patent application requires the
prior destruction of human embryos or their use as base
material, whatever the stage at which that takes place
and even if the description of the technical teaching
claimed does not refer to the use of human embryos.


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Deposit of Biological Material


Articles 13 & 14 EC Directive


EPC Rule 28


Applicants may refer to deposits made by others


The Patents (Amendment) Rules 2001 Articles
13 & 14 EC Directive


Intellectual Property Office is an operating name of the Patent Office

www.ipo.gov.uk

Conclusions


Objective of EC Directive was to harmonise the legal
protection of biotechnological inventions in the EU


EC Directive had very little impact on what is patentable
in the UK


EC Directive largely clarifies application of existing
provisions to biotechnological inventions


Practice in relation to some Articles still being clarified
e.g. Art. 6


stem cells


http://www.ipo.gov.uk/biotech.pdf