Patent LawBiotechnology*

Melanie SzwerasBereskin & 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 - AnimalsHarvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45Facts:•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. 902Facts:

– 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 diseaseRe: 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 CompoundsShell 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 Szwerasmszweras@bereskinparr.com

Bereskin & Parr LLP

Special thanks to Philip Goldbach for assistance with the presentation