Transcript Slides - JurisDiction

Patent Law
Biotechnology*
Melanie Szweras
Bereskin & Parr LLP
*Slides adapted and updated from U of T – Patent Law 2011 Biotechnology from Michelle Nelles
April 21, 2014
Issues in Biotechnology
1. Patentable Subject Matter
– Life forms
– Genes and Proteins
– Medical Treatments
•
Dosage regimens
– Medical Diagnosis
2. Disclosure/Utility
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
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.)
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.)
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
Higher Life Forms (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?
Higher Life Forms (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
Higher Life Forms (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
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.
•Note: In Europe, cannot patent an invention that required destruction of
human embryos or their use as a base material
Genes
• The Myriad Decision in the United States –
genomic DNA is considered a product of
nature but cDNA is patentable subject matter
because not found in nature
•
? Implications for proteins, primers, probes, etc.
• Isolated proteins and nucleic acids including
human genes are patentable in Canada and
Europe
 Not aware of any Myriad-style challenges currently
before the courts in Canada
Biologics: Antibodies
• Functionally defined class of antibodies =
patentable
– AbbVie Corporation et al. v. Janssen Inc., 2014 FC 55
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)
•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
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 Regimens
• Many dosage regimen limitations have been
held invalid:
– a dose of 13 to 15 mg/kg/day (Axcan v
Pharmascience, 2006 FC 527)
– a dose of 50 to 300 units (PAB Decision no. 2009)
– 5 mg wherein the period between administrations
is about one year (Novartis v. Cobalt, 2014 FCA 17;
upholding 2013 FC 985)
• Any variability in claim will likely be rejected
Dosage Regimens
• Limitations that have been upheld
– 1.0 mg tablet as a daily dose (Merck v
Pharmascience, 2010 FC 510)
– 70 mg on a once-weekly basis (Merck v Apotex,
2005 FC 755)
• Limitations which claim “vendible product”
are allowable
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 or natural phenomenon
– Cases: Myriad Genetics, Prometheus v. Mayo,
Classen v. Biogen
• Court’s Reasoning: don’t want to tie up the further
use of a law of nature. Need to have additional
elements that integrate the natural principle into
claimed invention such that natural principle is
practically applied.
USPTO Guidance on Laws of
Nature/Natural Products
1. Is The Claim Directed To One Of The Four Statutory
Categories of 35 U.S.C. § 101?
 If Yes…
2. Does The Claim Recite or Involve A Judicial
Exception? (incl. laws of nature/natural products)
 If Yes (or Maybe)…
3. Does The Claim As A Whole Recite Something
Significantly Different Than The Judicial
Exception(s)?
Diagnostic methods in Canada
• In Canada, the Amazon decision (2010 FC 1011,
aff’d in part 2011 FCA 328) addressed
patentability of 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
Diagnostic Methods and Medical
Treatment– Prosecution Suggestions
• Remove any steps of surgery or therapy in
Canada and Europe
• Avoid “administering” language even if phrased
as a use claim
• Provide kit claims wherever possible
• Provide specific details of applications of the
diagnostic method – e.g. specific primers,
methodology, etc. (additional elements?)
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 Requirements
• Sufficiency of disclosure – Patent Act, s.
27(3)
I.
Correctly and fully describe the invention and
its operation or use;
II. Enable a person skilled in the art to make and
use it;
III. For a machine, describe the best mode;
IV. For a process, explain necessary sequence.
Viagra® - Teva v. Pfizer (2012 SCC 60)
• Pfizer’s patent claimed the use of particular
compounds for treating ED
• series of cascading claims:
– claim 1 sets out formula 1 which includes 260
quintillion possible compounds
– claims 6 and 7 are to use of a single compound
– claim 7 is directed to Sildenafil which is the
active compound in Viagra
Viagra® - Teva v. Pfizer (2012 SCC 60)
• the patent states that “one of the especially
preferred compounds induces penile erection
in impotent males”
– In man, certain especially preferred compounds
have been tested orally in both single dose and
multiple dose volunteer studies. Moreover, patient
studies conducted thus far have confirmed that one
of the especially preferred compounds induces
penile erection in impotent males.
• nothing in the application states that Sildenafil
is the compound that works
Viagra®
“The disclosure in the specification would not
have enabled the public “to make the same
successful use of the invention as the inventor
could at the time of his application”, because
even if a skilled reader could have narrowed the
effective compound down to the ones in Claim 6
and Claim 7, further testing would have been
required to determine which of those two
compounds was actually effective in treating ED.”
(Teva v. Pfizer, 2012 SCC 60)
Viagra® - Drafting Suggestions
• Disclose as much information as possible
• Identify compounds and their specific activity
– For example:
• Compound 1 is methyl benzene and has IC50 of 5 nM; or
• Compound 1 (methyl benzene) is one of the preferred
compounds and induces penile erection.
• Claim one specific compound in claims or
make sure to have data for each compound
claimed individually
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)
Utility:
Demonstrated Utility
• No actual data needed in application as filed
• If no data, application as filed must include
reference to a study supporting claimed utility
• Utility must be proven upon challenge
• Support for utility must be present at
Canadian filing date
(Pfizer v. Novopharm, 2010 FCA 242)
Utility – Sound Prediction
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
Utility: Sound Prediction
• Canadian filing date is date for determining sound
prediction
(Aventis Pharma v. Apotex, 2006 FCA 64)
• Facts and reasoning must be in the application
(Eli Lilly v. Apotex, 2009 FCA 97; Apotex v. Pfizer, 2011 FCA 236)
• Federal Court decision suggests common general
knowledge can be used to bridge “gap” in disclosure
re line of reasoning
(Teva Canada Ltd v. Novartis AG, 2013 FC 141)
Thank You
Melanie Szweras
[email protected]
Bereskin & Parr LLP
Special thanks to Philip Goldbach for assistance with the presentation