U of T – Patent Law 2012 - Biotechnology

U of T
–

Patent Law 2012

Biotechnology*

Melanie Szweras

Bereskin & Parr LLP


*Slides adapted from U of T
–

Patent Law 2011 Biotechnology from Michelle Nelles


January 17, 2012

Issues in Biotechnology

1.
Patentable Subject Matter

–
Life forms

–
Medical Treatments

–
Medical Diagnosis


2.
Disclosure/Enablement


3.
Infringement

Patentable Subject Matter

•
No common law patent rights

•
Must look to Patent Act to determine what is
patentable

•
Only those things which fall into categories of
proper subject matter under Relevant Act are
patentable

•
What is patentable may differ in different
jurisdictions

Patentable Subject Matter (cont.)

•
Section 2 of the Canadian Patent Act provides
for the definition of invention as follows:


“
any new and useful art, process, machine,
manufacture or composition of matter
, or any new
and useful improvement in any art, process, machine,
manufacture or composition of matter
”

Composition of Matter

The building blocks for biological inventions:

•
Cells
–

factory




•
DNA
-

blueprints

Life forms (cont.)

•
DNA codes for amino acids (every 3 nucleic acids
code for an amino acid
-

like building blocks)

•
Proteins
–

strings of amino acids
–

proteins
responsible for a variety of functions in the body

Spectrum of Biological Subject Matter

•
There is a spectrum of biological subject
matter that could be the subject of an
invention:






DNA/RNA

genes

plasmids

vectors

viruses

host cells

proteins/enzymes

plants

animals


sequences

Patentability of Life Forms

•
Examples:

–
Enzymes (
Continental Soya Co. v. J.R. Short Milling
Co.
(1942))

–
Microbial Cultures (
Application of Abitibi Co. (Re)
(1982))

–
Mammalian cell lines (
Application for Patent of
Connaught Laboratories (Patent No. 1,139,691)
(Re)
(1982))

Higher Life Forms
-

Plants

Pioneer Hi
-
Bred Ltd. v. Canada (Commissioner of
Patents),
[1989] 1 S.C.R. 1623

•
Claimed a new soya bean plant variety derived
from cross
-
breeding

•
FCA: a variety of soya is not a composition of
matter or manufacture under Section 2 of the
Patent Act

Higher Life Forms
–

Plants (cont.)

Pioneer Hi
-
Bred
(cont.)

•
Not patentable
–

case was decided on the basis
of insufficient disclosure of the invention
–

only
the seed was filed

•
Two kinds of Genetic Engineering:

–
Crossing: relies on natural process
–

exception to
patentability: law of nature (not an act of man)

–
Molecular Manipulation (act of man)

Higher Life Forms
–

Plants (cont.)

•
Plant varieties can be protected under the
Plant Breeders
’

Rights Act

–
Gives the breeder of a new plant variety the
exclusive right to sell the propagating material for
up to 18 years

–
Registration is required

–
Applies to reproductive material such as seeds,
cuttings, bulbs and roots

Higher Life Forms
-

Animals

Harvard College v. Canada (Commissioner of Patents)
, [2002] 4 S.C.R.
45

Facts:

•
Made a transgenic animal that expressed a cancer gene
–

called the
oncomouse

•
The gene was injected into eggs, which were implanted into a female
mouse and offspring were bred to produce mice that express the gene
and are thus prone to cancer

•
Claim 1:
“
A transgenic non
-
human mammal whose germ cells and
somatic cells contain an activated oncogene sequence introduced into
said mammal or an ancestor of said mammal, at an embryonic stage
.
”

Issue:

•
Are claims to an animal expressing this cancer
-
gene patentable? (act
of man?)

Higher Life Forms
–

Animals (cont.)

Canadian Intellectual Property Office:

•
Not patentable under Section 2

•
Second breeding stage not under the control
of the inventor

•
Distinguished Abitibi and draws distinction
between higher and lower life
-
forms

Higher Life Forms (cont.)

Federal Court Trial Division
:

•
Agreed with Patent Office

•
Stated that not all of the organs in the mouse had the
genes
–

fundamentally wrong
–

all had the gene but
some did not express it
–

Court stated lack of
controllability and reproducibility (utility)

•
Need proximity between intervention and what you are
getting
–

but when go to whole animal, reproduced by
laws of nature so intervention was too remote and didn
’
t
have sufficient control

•
Noted that it is up to Parliament to change the laws

•
Gave deference to the Patent Office

Higher Life Forms
–

Animals (cont.)

Federal Court of Appeal

•
Allowed Appeal

•
Held that the mouse is a composition of matter

•
Got the science correct

•
Section 2 of the Patent Act should be interpreted
broadly

•
Standard of review of the Patent Office is
correctness in this instance

Higher Life Forms
–

Animals (cont.)

Supreme Court of Canada

Bastarache J. for the Majority (5:4):

•
Appeal Allowed

•
Not patentable
–

not a manufacture or composition of matter

•
Definition of invention is exhaustive
–

not clear that higher
-
life
forms were intended to be patentable

•
A higher life form is more than just a collection of atoms as
opposed to a lower life form which is more
“
chemical
-
like
”

Higher Life Forms
–

Animals (cont.)

Supreme Court of Canada

Binnie J. Dissent:

•
Higher life forms are compositions of matter

•
Every cell in the mouse is different

•
Parliament didn
’
t foresee this but like lower life forms
and computers, they didn
’
t intend to exclude (vs.
majority
’
s intent to include)

•
Line between lower and higher life forms is arbitrary

•
Other countries allow patenting of higher life forms

Higher Life Forms (cont.)

Patent Office Practice Regarding Fertilized Eggs, Stem
Cells, Organs and Tissues
-

Issued June 20, 2006

•
Animals at any stage of development, from fertilized eggs on, are higher life
forms and are thus not patentable. Totipotent stem cells, which have the
same potential as fertilized eggs to develop into an entire animal, are
considered to be equivalents of fertilized eggs and are not patentable.
Embryonic, multipotent and pluripotent stem cells, which do not have the
potential to develop into an entire animal, are patentable.

•
Organs and tissues are not compositions of matter and are not patentable.

•
Artificial organ
-
like or tissue
-
like structures, generated substantially through
the hand
-
of
-
man may be considered to be compositions of matter and
therefore patentable subject matter.


Life Forms Recap

•
Although whole organism is not patentable,
can patent:

–
Gene/gene product

–
Cell

–
Vector

•
Does it matter that whole organism is not
patentable?

–
Monsanto Canada Inc. v. Schmeiser
, 2004 SCC 34

Patentable Subject Matter
–

Medical
Treatment

•
Section 2 of the Canadian Patent Act provides
for the definition of invention as follows:


“
any new and useful art,
process
, machine,
manufacture or composition of matter, or any new
and useful improvement in any art, process, machine,
manufacture or composition of matter
”


•
Are processes performed on an animal
patentable?

Medical Treatments (cont.)

Tennessee Eastman Company et al. v. Commissioner of
Patents
, SCC [1974] R.C.S. 111

•
Method of surgically bonding tissues using a certain
compound (new use for an old compound)

•
Decided under Old Patent Act (s. 41)
–

no claims for medicine
unless claimed along with a specific process of manufacture

•
Methods of medical treatment such as a process of surgery
or therapy are unpatentable because such methods do not
produce an essentially economic result in relation to trade,
industry or commerce.

•
Also noted that methods of surgery relied on professional
skill and would not come under
“
Art
”
.

Medical Treatments (cont.)

Imperial Chemical Industries Ltd. v. Canada
(Commissioner of Patents),
FCA [1986] 3 F.C. 40;
9 C.P.R. (3d) 289

•
Treatment of dental caries

•
Found not patentable
–

although treatment of
cavities is cosmetic, it also has a medical
function

•
Affirms that

section 41 is not the issue

Medical Treatments (cont.)

Re: Application No. 947803
[1974] C.D. 194, 32
C.P.R. (2d) 236 (PAB)

•
Claims to composition that could be used to treat animals,
including humans

•
Medical treatment claims that excluded humans still not
patentable

Medical Treatments (cont.)

Re:
Senentek

77 C.P.R. (3d) 21

•
A method to prevent aging

•
Found patentable because aging is natural and
not considered a disease

Re: General Hospital Corporation

74 C.P.R. (3d)
544

•
A method to prevent pregnancy

•
Found patentable because pregnancy is a natural
condition, not a disease


Medical Treatment vs. Use

•
A method of treating condition Y by
administering compound X. (not patentable)

•
But can get around this issue by drafting use
claims:

–
A use of compound X for treating condition Y.
(Canadian Style)

–
A use of compound X in the preparation of a
medicament for treating condition Y. (Swiss style)

–

Compound X for use in the treatment of condition
Y. (New European Style)


New Uses of Known Compounds

Shell Oil v. Canada (Commissioner of Patents)
(1982), 67
C.P.R. (2d) 1 (SCC)

•
not a method of medical treatment

•
chemical compounds (new and old) mixed with an adjuvant
discovered to be useful as plant growth regulators

•
A new
use

for an old compound is patentable.


Re: Application for Patent of Wayne State University
(1988)
22 C.P.R. (3d) 407 (PAB)

•
Applicant determined that an old compound could be used
for reducing metastasis and neoplastic growth (cancer).

•
A new
medical use

for an old compound is patentable.

Dosage Regimes

•
The law in Canada currently appears to be unsettled.

•
See, for example: DE Schwartz & GA Gaikis,
“
The
Patentability of Pharmaceutical Dosage Regimes in
Canada
”

26 CIPR 295.


Janssen Inc. v. Mylan Pharmaceuticals ULC
, 2010 FC
1123 (appeal dismissed for mootness 2011 FCA 16
without considering issue of patent law raised)

•
Claims relating to a dosage regime for a known use of a
known compound held to cover an unpatentable
method of medical treatment.


Diagnostic Methods

•
Courts have distinguished between methods
of medical treatment (not patentable) and
diagnostic methods (generally patentable)


Re: Goldenberg
22 C.P.R. (3d) 159

–
Case involved detection of radioactive substances
after injection into the human body

–
Found patentable

Diagnostic Methods (cont.)

•
Diagnostic methods have come under fire recently in the
United States

–
Challenged as non
-
patentable as abstract mental processes

–
Cases: Myriad Genetics, Prometheus v. Mayo, Classen v. Biogen

•
In Canada, the recent Amazon decision (2010 FC 1011,
aff
’
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business methods but its decision has implications for
diagnostic methods
:

–
The Court rejected the technological requirement for patentable
subject matter

–
The focus for
Amazon

is on the practical application that the
method as a whole provides, on the new and inventive method
applying skill and knowledge and on whether such method
yields a commercially useful result

Summary of Patentable Subject Matter

•
Methods of Medical Treatment
–

not patentable

–
Does claim cover treatment of illness or disease OR
diagnostic treatment or treatment of a condition?

–
Can re
-
draft into use style claim but need to avoid
“
administering
”

or other active steps

•
Methods of Surgery
–

not patentable

–
Considered to depend on the skill of the practitioner

–
Doesn
’
t matter if not treatment of a disease (e.g.
cosmetic surgery; excision of tissue, organ or tumour
samples from the body)
MOPOP
, section 17.02.03

Disclosure

•
The patent system is primarily a first
-
to
-
file
system and in order to get funding, often it is
important to file a patent application

•
However, if you file too early, there can be
pitfalls especially in biotechnology with
respect to adequate support

•
Thus there is the difficult question of:

–
Race to file the application vs. waiting for enough
data to support the types of claims that you want

Disclosure (cont.)

Apotex v. Wellcome
, SCC [2002] 4 S.C.R. 153

•
AZT
–

new use for an old compound

•
Issue: could the data in the patent support claims
to the treatment and prevention of HIV?

•
If you have not shown demonstrated utility, you
can still be supported if there is a sound prediction,
which requires:

–
Factual basis

–
Sound line of reasoning

–
Proper disclosure

Disclosure (cont.)

•
Novopharm Ltd. v. Pfizer Canada Inc. et al.
, 2010 FCA 242 (aff
’
朠㈰〹⁆䌠㘳㠩

•
appeal from proceeding under
Patented Medicines (Notice of Compliance)
Regulations

–

Federal Court had prohibited Minister of Health from issuing
Notice of Compliance to Novopharm until expiry of the patent at issue
–

NOC would enable Novopharm to market a generic version of Viagra®

•
On appeal, Novopharm alleged Pfizer
’
s patent claiming a new use of
sildenafil (a known compound; now marketed as Viagra) was invalid for
lack of utility and insufficient disclosure
–

FCA dismissed appeal


•
Teva Canada Limited v. Pfizer Canada Inc., et al.

(appeal from 2010 FCA
242; scheduled to be heard by SCC on February 7, 2012)

•
SCC will likely have the opportunity to consider:

–
sufficiency of disclosure under s. 27(3) of the Act

–
disclosure requirements (if any) relating to sound prediction and demonstrated utility

•
Factums on SCC website

Disclosure of Biological Material

•
Biological Deposits

–
It is possible and sometimes necessary to satisfy
disclosure requirements under Section 27(3) of
the Patent Act using living matter

–
Materials that are capable of self replication can
be deposited in an International Depository
Authority pursuant to s.38.1 of the Patent Act

–
Examples:

•
Cell lines; microorganisms; hybridoma cell lines; etc.

Disclosure of Biological Material
(cont.)

•
If the patent application contains any DNA/RNA or
amino acid sequences, there are specific requirements

–
Previously
–

had to be filed in both paper and computer
readable form (s. 111 of the Old Patent Rules)

–
Now
–

will not accept paper copy
–

must be filed in
electronic format only (s. 111 of the Patent Rules)

–
Any application containing an unbranched nucleic acid
sequence with 10 or more nucleotides or an amino acid
sequence with 4 or more amino acids must be
accompanied by a sequence listing (PCT sequence listing
standard)

Infringement in Biotechnology

Monsanto Canada Inc. v. Schmeiser
, SCC [2004]
S.C.R. 902

Facts:

–
Monsanto sells Round
-
Up ready Canola seeds to
farmers in order to grow plants that are resistant to
Round
-
Up and Monsanto licensed farmers to use the
Round
-
Up Ready Canola

–
Some seeds blew onto Schmeiser
’
s neighbouring
farm and he saved the seeds for the following year
’
s
crop

–
Schmeiser never sprayed Round
-
Up on his crop but
still is sued for infringement

Infringement in Biotechnology (cont.)

Monsanto (cont.)

Issues:

–
Remember that plants are not patentable
(Harvard mouse case), thus could use of the seeds
and growing the plants be an infringement of
Monsanto
’
s cell and gene claims?

–
Does the intent of Schmeiser (the alleged
infringer) matter?

–
Should profits be awarded to Monsanto?

Infringement in Biotechnology (cont.)

Monsanto (cont.)

Held:

–
5:4 Claims to the gene and plant cells would protect
use of the plant containing them (effectively overturns
Harvard mouse case?)

–
5:4 Finding of infringement (section 42 of the Patent
Act
–

exclusive right to make, construct, use, sell, etc.)

•
The Court took a broad view of infringement: anything that
interferes with the monopoly granted to the patentee

•
Intent is irrelevant to infringement

•
Schmeiser used the invention

Infringement in Biotechnology (cont.)

•
Remedy:

–
Monsanto asked for an accounting of profits. Since
Schmeiser
’
s use of the plants didn
’
t include
spraying of Round
-
Up on the crop, there were no
profits attributed to the invention

–
Monsanto did not get legal fees

Thank You

Melanie Szweras

mszweras@bereskinparr.com

Bereskin

& Parr LLP


Special thanks to Andrea Berenbaum for assistance with the presentation