ACROSS CANADA

By: Carmela DeLuca, Micheline Gravelle and Amardeep Rana

PATENTING GENES

With our neighbours to the south once again battling in the highest court of their land over whether or not “genes” IN CANADA should be patentable, it is interesting to consider the patent situation in Canada and assess what implications the U.S. situation may hold for Canadian enterprises relying on gene patents.

As most in the diagnostics industry are aware, the U.S. Supreme court is presently hearing a challenge to “gene patents” related to breast cancer-related genes, BRCA1 and BRCA2, owned or licensed to diagnostic giant Myriad Genetics.

“Gene patents” can be described as generally falling into two categories: 1) patents that claim isolated nucleic acid molecules (e.g. “genes” which are specifi c nucleic acid sequences encoded in the form of DNA, RNA, or cDNA nucleic acid molecules); and 2) patents that claim methods using isolated nucleic acid molecules. The fi rst category includes claims to “isolated DNA.” The second category encompasses methods for identifying a condition associated with a defective disease gene (i.e. diagnostic methods) and methods of identifying a therapeutic candidate substance to treat a disease related to a defective gene (i.e. screening methods). One or more of these types of patent claims can be found in a single patent.

Although both categories of gene patents were at issue in the Myriad Genetics dispute, the sole question presently before the Supreme Court is whether or not human genes are patentable.

The attack on the BRCA patents is being led by the American Civil Liberties Union (ACLU) and various other parties who argue that human genes cannot be patented because they are classic products of nature, and that gene patents violate the First Amendment and stifl e diagnostic testing and research. Little empirical evidence seems to support the stifl ing of diagnostic testing and research, but the argument has gained traction in the U.S.

The initial suit was heard in the United States District Court for the Southern District of New York and a fi rst decision, which found all of the contested claims invalid, was rendered on March 29, 2010. Claims to “isolated DNA” containing sequences found in nature were determined to be unpatentable subject matter, and methods involving the comparison of DNA sequences were considered to be abstract mental processes and thus not patent eligible. A drug screening claim was also found unpatentable for covering a “basic scientifi c principle.” Myriad appealed the decision to the Federal Circuit and the appeal was allowed in part, denying claims that involved merely “comparing DNA sequences” as patent eligible, but fi nding that Myriad’s isolated DNA claims were different than the DNA found in nature and that the screening claim was patent eligible as well. A fi rst petition to the Supreme Court followed, which vacated the Federal Circuit decision and required the Federal Circuit to rehear the case in light of the U.S. Supreme Court’s decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 566 U. S. ____, 132 S. Ct. 1289. Prometheus, as reported in the October issue of Biotechnology Focus, has made patenting diagnostic methods that rely on a novel correlation much more diffi cult in the U.S. The Federal Circuit nonetheless held its ground and in August 2012, issued an almost identical decision to its fi rst decision. Tenaciously, the ACLU fi led a second appeal which is now being heard by the Supreme Court. The Court’s decision is expected by the end of June

Patentable subject matter must be something with physical existence, or something that manifests a discernible effect or change. The fact that a claimed method has a practical application is not enough to meet the requirement of physical existence.

2013. Regardless of the direction of the ruling, it is sure to be a landmark in the practice of gene patenting and have heavy implications for diagnostic and personalized medicine patents as well.

Unlike the U.S., Canadian courts have not seen direct challenges regarding the patentability of genes.

The patentability of “genes” (including human genes) is nevertheless well established in Canadian law and has been explicitly affi rmed by the Supreme Court of Canada in Monsanto Canada Inc v Schmeiser, 2004 SCC 34 at 22-24, and implicitly affi rmed by the Supreme Court in Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76.

For example, in Canada claims to “isolated” molecules such as “an isolated nucleic acid,” “an isolated DNA,” “an isolated cDNA” or “an isolated RNA” are patentable. While higher life forms, including plants, and non-isolated molecules which occur in nature are not patentable in themselves, in Monsanto, the Court held that a claim to a gene can be infringed through use without isolating the gene, even if the use occurs within a higher organism (at 77-78):

“It is uncontested that Monsanto’s patented claim is only for the gene and cell that it developed. […] The more diffi cult question — and the nub of this case — is whether, by cultivating plants containing the cell and gene, the appellants used the patented components of those plants. The position taken by Arbour J. assumes that this inquiry is redundant and that the only way a patent may be infringed is to use the patented invention in isolation.

This position fl ies in the face of century-old patent law, which holds that where a defendant’s commercial or business activity involves a thing of which a patented part is a signifi cant or important component, infringement is established. It is no defence to say that the thing actually used was not patented, but only one of its components.”

There are some peculiarities to Canadian patent law concerning gene patents. Functional sequences with greater than 80 per cent identity to an isolated nucleic acid can often be obtained, as can functional sequences that hybridize under stringent conditions. However, in Canada it is necessary to defi ne the “stringent conditions” in the claims.

Diagnostic methods are generally patentable in Canada. However, there are two specifi c concerns that must be considered. First, to be patentable, a diagnostic method must not be a method of medical treatment. Typically, diagnostic methods will not be considered methods of medical treatment if they do not have a direct therapeutic effect. Exceptions to this rule include if the method involves surgery or excision of tissue/organs/tumour samples.

Second, the diagnostic method claims as drafted must constitute patentable subject matter under s.2 of the Patent Act. The recent Federal Court of Appeal case of Canada (Attorney General) v Amazon.com Inc, 2011 FCA 328 provides the most current statement of the law in this area. In Amazon.com, the Court endorsed a broad defi nition of “invention” under s.2 of the Patent Act as “the application of [a] new knowledge to effect a desired result which has an undisputed commercial value.” While Amazon.com did not establish a single defi nitive test for patentable subject matter, leaving individual cases to be determined on a case-by-case basis, the Court did provide some guidance. According to the Court, it is an error in law to parse a claim into novel and non-novel elements and then assess patentability solely on the basis of the novel elements. The proper analysis requires identifying if “the subject matter defi ned by the claim,” and not the contribution over the prior art, falls within the defi nition of “invention” in the Patent Act. Patentable subject matter must be something with physical existence, or something that manifests a discernible effect or change. The fact that a claimed method has a practical application is not enough to meet the requirement of physical existence. Ultimately what is required when assessing method claims is that the subject matter of a claim purposively constructed must be more than a “mere scientifi c principle or abstract theorem.”

Contrary to the U.S., a diagnostic method involving a new correlation should be patentable in Canada if it recites a physical step (for example a step of assaying the status of a biomarker in a subject), even if the steps are otherwise known and obvious.

Not surprisingly however, the U.S. situation, combined with some home grown case-law, has had some infl uence on how the Patent Offi ce assesses what is considered patentable subject matter in the gene patent arena.

In response to the FCA’s decision in Amazon.com, the Canadian Intellectual Property Offi ce (CIPO) issued three draft practice notices regarding “Diagnostic Methods and Medical Uses”1 (DMMU) “Inventive Concept,”2 as well as “Statutory Subject Matter under the Patent Act.”3 The draft notice pertaining to “Inventive Concept” has been revised and was implemented on March 8, 2013 as practice notice “Examination Practice Respecting Purposive Construction.”4 According to the practice notice, examination is to be based on purposive construction consistent with Amazon, and all reference to “inventive concept” has been removed.

The other two draft practice notices have not been implemented at this time.

The DMMU draft notice set a high bar for patentability of diag-

nostic methods, similar to that required in the US. According to the DMMU draft notice, a purposive construction is to be performed on the claim in order to determine the inventive concept. For a diagnostic claim to be considered statutory, the inventive concept “must provide a solution to a technical problem and either have physical existence or manifest a discernible effect or change.” This requirement raises some concerns in regards to diagnostic method claims, which often contain only data acquisition and analysis steps. However in light of U.S. jurisprudence, recent drafting practice generally includes one or more physical steps. The DMMU draft notice further indicates that the step of physically assessing an analyte (or biomarker) could be suffi cient to render the claim statutory. However, statutory subject matter is not present merely because a physical step is identifi ed in the claim. If a known analyte (e.g. gene variant) has been previously assessed using equivalent analytical techniques, the inventive concept of the claim may be limited to the “signifi cance or interpretation of the acquired data, which is considered to be an abstract method, and therefore not statutory subject matter” (DMMU, at pg. 2). This position is a departure from previous Canadian practice and seems to be infl uenced by U.S. case-law.

The “Examination Practice Respecting Purposive Construction” appears to have now recognized that “inventive concept” is not to be used to determine patentable subject matter, as the use of an “inventive concept” for this purpose was expressly rejected by the FCA in Amazon.com (at 47). Assuming the draft notices are implemented, it is expected that the “Diagnostic Methods and Medical Uses” and the “Statutory Subject Matter under the Patent Act” practice notices will be updated to remove reliance on the “inventive concept” in accordance with the current examination practice notice requiring purposive construction.

In addition to meeting the threshold of whether a gene patent is patent eligible, obtaining protection for gene patents requires a demonstration of utility–that the isolated sequence has a useful function and that it does what is promised. The utility must be found in application. It can be demonstrated or based on sound prediction at the Canadian fi ling date. But you need to be careful with what you promise!

It is now standard practice, at least with respect to pharmaceutical patents, to attack patent as lacking utility on the basis that the claimed compound does not deliver the promise of the patent. The courts have found that “[i]f the inventors do state a specifi c promise in the patent, the court must evaluate utility against this promise. Just a mere scintilla of utility is insuffi cient in the face of a specifi c promise that requires more” (Teva Canada Ltd v Novartis AG, 2013 FC 141 at 169).

As for all inventions, suffi cient and enabling disclosure is also a necessary requirement for obtaining protection. For isolated nucleic acid molecules this typically involves disclosing the gene sequence and a description of the nucleic acid used.

Although Canadian protection for gene patents seems situated on sounder footing, Canadian biotechs rely on the U.S. market. An alternative to patenting is the use of trade secrets. Trade secrets have the benefi t of never expiring although protection is lost if an invention is reverse engineered or otherwise revealed. Despite these risks, companies like Coca-Cola have demonstrated that trade secrets can be very valuable protection.

But what is to prevent innovators from utilizing trade secret protection for their diagnostic innovations? This may already be happening. Myriad, for example, has developed a proprietary database at their own cost cataloguing new mutations it has identifi ed in patient samples. The database is not available to the public. Myriad has used this information to the benefi t of its patients and reduced the frequency with which it reports a variant of unknown signifi cance compared to European BRCA testing services.5 Such proprietary information could provide companies like Myriad with much greater protection for their investment.

Given the uncertainty and diminishing protection for diagnostic patents in light of Prometheus and other cases in the U.S., Canadian diagnostic companies who want to develop a U.S. presence may choose to forego patenting and keep gene variants that are diagnostic or associated with disease risk as trade secrets, possibly providing an in house service for assessing risk similar to Myriad. Of course, if another identifi es the variant, exclusivity is lost but this may be a risk worth taking where patent protection is diminished. Alternatively, diminishing patent protection could cause decreased investment in diagnostics and personalized medicine, with enterprises avoiding investing in development of such tests due to possible lack of return. Only time will tell.

References:

1. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03443.html 2. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03442.html 3. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03444.html 4. http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/ eng/wr03628.html 5. Cook-Deagan et al, The next controversy in genetic testing: clinical data as trade secrets? European Journal of Human Genetics doi: 10.1038/ejhg.2012.217

Carmela DeLuca is an associate and registered patent agent at Bereskin & Parr LLP. Carmela’s practice focuses on patent matters, including advising on the management of patent portfolios in Canada and abroad, the preparation and prosecution of patent applications in the life sciences and the analysis of patent issues such as validity, infringement and freedom to operate.

Micheline Gravelle is a partner, registered patent agent, and head of Biotechnology & Pharmaceutical practice group at Bereskin & Parr LLP. Micheline has work experience in the chemistry, microbiology, immunology and molecular biology fi elds and has worked in the industry for multinational companies, government agencies and in a hospital laboratory.

Amardeep Rana in an articling student with Bereskin & Parr LLP.

To see this story online visit www.biotechnologyfocus.ca/patenting-genes-in-canada/

Microspectrophotometer Elliot

Scientific now offers the new 20/30 PV™ Series UV-Vis-NIR Microspectrophotometer from CRAIC Technologies. This latest product excels in rapid, non-destructive analysis of many types of sub-micron or larger samples from the deep ultraviolet to the near infrared. The Microspectrophotometer features touch-screen tools, calibrated variable apertures, a highresolution digital imaging system, and an

extended spectral range. Ideal for use in thin film metrology, surface Plasmon resonance, and protein crystal measurement to name just a few. Web: www.elliotscientific.com/442-0/ CRAIC-Technologies/

Laser Diode Oclaro announces the first ever high-power red laser diode to offer an inbuilt monitor photodiode at a lasing wavelength of 637nm. System designers can control optical power output by monitoring the photodiode current and adjusting power variants and temperature. The laser diode operates at a temperature range of up to 50oC at 100mW in the 637nm visible wavelength band in a TO industry standard 5.6mm package with N type pin configuration. Oclaro releases its second laser diode, the HL65051DG, operating at up to 60oC and delivers 120mW in the 660nm wavelength band in a 5.6mm diameter TO industry standard package. Web: www.oclaro.com

Sterisonic incubator Panasonic’s

MCO-19AIC Sterisonic® UVH cell culture incubator sets a new standard for advanced sterilization and decontamination cycle time. It is designed for a wide array of applications in biomedical, pharmaceutical, medical research and clinical laboratory settings. The Sterisonic incubator has a documented two-hour in situ H2O2 sequence and features interior components with a CO2 sampling loop that are sterilized in situ with no additional need for removal or separate autoclaving.

Web: www.panasonic.com/biomedical

Extractor Supercritical Fluid Technologies introduces its new pilot scale supercritical extractor for the processing of natural products. The SFT-NPX-10 performs supercritical fluid extractions in single or dual 10L sample vessels with single or dual separators. The Coriolis mass flow meter and pneumatic CO2 pump with an integral pre-chiller guarantee precision and efficiency. A programmable controller upgrade is available. The use of supercritical CO2 provides high diffusivity and pressure tunable solvency power without annoying residual solvents. Web: www.supercriticalfluids.com

Pipettes Mettler Toledo presents its next generation of Rainin multichannel pipettes. The manual Rainin Pipet-Lite XLS+ and electronic Rainin E4 XLS+ offer users durable, lightweight liquid ends and new mechanical designs that all but eliminate hand strain while ensuring the highest channel-to-channel consistency. To prevent cross-contamination, pipettes have reduced stiction (piston stickiness), which helps to eliminate splash-up. Web: www.mt.com

Shaking incubator Bibby Scientific

introduces its new SI600C cooled shaking incubator, the latest addition to the Stuart range of benchtop science equipment. The SI600C is a combined shaker and incubator, with a separate recirculating chiller to extend the achievable temperature range. With the inclusion of this chiller, the SI600C incubator can now run at 15˚C below the ambient temperature of the room, to a minimum internal temperature of 5˚C. The SI600C cooled shaking incubator can hold up to six 2L flasks of various types without requiring tulip clamps or tools. BioCote antimicrobial protection guards against contamination and reduces the risk of sample loss.

Vented Enclosure Air Science introduces a new series of Vented Enclosures for the containment of airborne particulates during manipulation and transfer of potent compounds. The turbulent-free design ensures precise and safe use in every situation. Ventilated Enclosures come in custom sizes with ductless and carbon/HEPA-filter technology for added safety. They fea-

ture an easy-to-change filtration system and without ducts, the Enclosures can be installed almost anywhere. Web: www.airscience.com

Peristaltic Pump Aalborg releases its new TPV RP Adjustable RPM with Dispensing Peristaltic Pumps designed to pump liquids of low to high viscosity. The new models can start and stop dispensing liquids at up to seven time relay intervals. Pumps can run from 0 to 300 RPM, with a flow range of 0-5000 mL/min with 0.5 in. of ID tubing. The TPV RP Models feature a compact and versatile design, a 24 VDC brushless motor, an adjustable tubing subassembly, and a programmable timer. The pumps are ideal for laboratory, processing, and OEM applications.

Web: www.Aalborg.com

Syringe Pump CMA Microdialysis delivers its new CMA 4004 Syringe Pump designed for microdialysis applications in pre-clinical research. The Syringe Pump holds up to 4 syringes with flow rates from 0.54 pl/min to 11.70 ml/min. It includes a built-in syringe library containing the most commonly used microdialysis syringes. Web: www.harvardapparatus.com

Chromatin Detection EMD Millipore

introduces their Magna ChIP® HiSens chromatin immunoprecipitation kits that detect specific regions of chromatinassociated DNA. Two versions of the kit exist: The Magna ChIP® HiSens kit contains reagents, buffers, beads for ChIP, materials for chromatin preparation and isolation; The EZ-Magna ChIP® HiSens kit includes positive and negative control antibodies and a validated qPCR primer set in addition to the standard kit’s contents. Researchers can also ChIP from 10,000 to 1,000,000 million cells or cell equivalents with the kit’s single buffer system, delivering low backgrounds and high signal-tonoise ratios for ultra-sensitive detection. Web: www.millipore.com/catalogue

Metering Pump Fluid Metering, Inc. releases its STH and STQ Duplex metering pumps for the unidirectional flow of

liquids in diagnostic and analytic instrumentation. The variety of adjustable pump heads can be combined to achieve a displacement ratio anywhere between 1:1 and 500:1. The single, solid ceramic piston in the pump’s fluid path acts as both a pump and a valve performing maintenance-free cycles at ±1 per cent precision without recalibration. Web: www.fmipump.com

Power Supply Hoefer, Inc. introduces their new 600 Volt Power Supply (PS600) designed for electrophoresis and blotting techniques. This new model has three different power levels including 600 V, 750 mA, and 150 W, and can operate continuously or as set on its 999 timer. The PS600 is safe and reliable, with its open circuit detection, short circuit protection, and automatic recovery in the event of a power failure. Web: www. HoeferInc.com

Warming Plate Scienceware® unveils its new CultureTemp™ 37oC Warming Plate, optimal for trypsinizing cells during cell passaging. It maintains a temperature of 37oC (±1oC), which reduces the risk of cell death and the need to enter CO2 incubators. The plate’s small size, merely 7 x 8”, allows it to be easily installed anywhere in the lab. The CultureTemp™ plate also features a 15-minute count down timer

and UV-resistant polypropylene housing that resists damage under germicidal UV lights. It is water resistant and safe for cleaning for Ethanol or IPA. Web: www.belart.com

LED Light L.J. Star breaks ground with its LED Luminaire Series 55-EX now including six LED lights to produce up to 138 per cent more light output depending on the output angle. This light is ideal for illuminating the interior of process vessels, such as tanks, reactors, hoppers, and pipelines. The Series 55-EX boasts about its 50,000 hours of maintenance-free light without heat. Its compact size and lack of delicate filaments make it shock and vibration resistant, which is ideal for harsh applications. Available in fall 2013. Web: www.ljstar.com

Small Centrifuge Thermo Fischer

Scientific, Inc. launches its new Thermo Scientific small benchtop centrifuge with the flexibility to adapt to the needs of clinical and research applications. This centrifuge offers an easyto-use auto-lock rotor exchange, Thermo Scientific ClickSeal biocontainment lids for one-handed sample protection, and a glove- and detergentfriendly interface featuring one-touch operation and optional password protection. The Thermo Scientific small benchtop centrifuge is built for safety, versatility and reliability. Web: www.thermoscientific.com/ smallbenchcentrifuge

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offers lightning/surge protection for amplified models, fused polyurethane cables, premium temperature performance, compensated temperature range, protective nose cones and customizable cable lengths. The pressure transducers make mV/V, 0 to 5Vdc, 0 to 10Vdc, and 4 to 20 mA outputs available and include a 5-point NIST Traceable Calibration. The PX709GW transducers come in 0.20 per cent standard accuracy or 0.08 per cent high accuracy models for precise depth or level measurements in water-related applications. Web: www.omega.ca

Sanitary Mixer Sharpe Mixers announces their new line of USDA-approved sanitary mixers custom-built to suit the customer’s needs. The Sharpe Portable Sanitary Mixers feature the M5 Quick-Lock mounting system and a hex base that can hold open-ended wrenches. All models are built with an off-the-shelf motor, shaft, and impeller options. The Portable Sanitary Mixers blend liquids from 50 to 50,000 gallons at viscosities from 1.0 to 50,000 cps. Shafts for the mixers are available 0.75”,

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