PERSONALIZED MEDICINE PATENTING CONTROVERSIES

By: Carmela DeLuca and Katherine Bonter

Whether diagnostic and personalized medicine technologies or “gene patents” should be the kinds of inventions that can be patented (e.g. whether they are patentable subject matter) has been under scrutiny in a number of jurisdictions and the potential commercial implications hotly debated. Court challenges have been ongoing in Australia and the U.S. and most recently launched in Canada, bringing the controversy to our back yard.

Here the current state of patent protection in these jurisdictions is explored by comparing and contrasting recent court decisions and the existing legislative environment.

United States

Exemptions to patent subject matter eligibility, as expressed by the U.S. courts, include: fundamental principles, laws of nature, natural phenomenon and abstract ideas, the building blocks of human ingenuity. Judicial exemptions are intended to prevent patents from broadly pre-empting or tying up the use of fundamental ‘building blocks’ and to restrict patents to inventions that are a “product of human ingenuity” (35 USC §101). Recent U.S. Supreme Court decisions have considered if certain inventions involving: a law of nature (Mayo 2012)1, a natural phenomenon (Myriad 2013)2 or an abstract idea (Bilski 20103 and Alice 20134) are pat-

entable. Responding to these decisions, in particular to the 2013 decisions, the USPTO is implementing major changes to how examiners evaluate claims that recite a judicial exemption.

Three examination guidance documents were recently issued by the office: “Guidance For Determining Subject Matter Eligibility Of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products” (March 2014), “Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. V. CLS Bank International, et al .” (June 1014) and “2014 Interim Guidance on Patent Subject Matter Eligibility” (December 2014).5 The March 2014 was strongly criticized by many stakeholders. After formally receiving and considering this criticism6 the December 2014 guidance was issued, replacing the earlier guidance.

According to the December guidance, examiners will apply a three step process: (1) is the claim directed to a process, machine, manufacture or composition of matter, if yes (2) does it recite or describe a judicial exemption and if yes (3) does it recite additional elements that amount to ‘significantly more’ than the judicial exemption. In determining if the invention claimed is ‘significantly more’ examiners are instructed to consider each claim element individually and as an ordered combination (as a whole) and to identify structural or functional differences vs. the corresponding natural product.

For claims that recite a natural product, evaluating ‘significantly more’ involves consideration of structural or functional differences between the invention claimed and the natural product. One notable change, based on the USPTO’s interpretation of the Myriad decision, is that isolated biomolecules like peptides or oligonucleotides that are identical to segments of a larger naturally occurring biomolecule and having the same or a similar function to the ‘parent’ are considered as a natural occurring and not patent eligible. While the same logic can be extended to other types of biomolecules like antibodies, RNA or proteins where the therapeutic applications claimed derive from the natural function of the biomolecule, at present it is not clear how broadly this approach will be applied by the office.

Currently the extent to which DNA primers and probes will be patent eligible is not clear. The March 2014 guidance included an example of a specific pair of primers which was indicated as patent ineligible. Although this same example was removed from the December 2014 guidance, two days after the guidance was released, a Federal Court decision7 found broad claims to pairs of single stranded primers for amplifying the BRACA1 gene indistinguishable from naturally occurring DNA in both structure and function - not patent eligible. However, primers or probes conjugated to a non-naturally occurring label or moiety could be considered as structurally different from naturally occurring DNA and patent eligible under the current guidelines.

Regarding process claims that recite a natural product, the guidance provides an example treatment claim that indicates that such claims should be eligible if they are limited to a specific application e.g. clinical indication. As no example of a diagnostic method claim was provided, it is uncertain if diagnostic method claim that recites a natural product (e.g. oligonucleotide probe), or even multiple natural products, and concrete method steps, as opposed to abstract steps, will similarly be considered patent eligible. As for diagnostic method claims that recite either one or a combination of correlations between a biomarker and a clinical phenotype (a natural association) little guidance is provided by the current guidelines as to what will meet the requirement of significantly more.

In December 2013, the hIgh court of australIa ruleD that methoDs of meDIcal treatment are patent elIgIble In australIa.

Australia

On September 5, 2014, the full bench of the Federal Court in a unanimous decision upheld a lower court decision that found that isolated nucleic acids are patentable subject matter. The challenge had been launched by Cancer Voices Australia and breast cancer patient, Yvonne D’Arcy, against patents owned by Myriad Genetics. Similar to the U.S. case, one of the patents challenged claimed isolated nucleic acid sequences coding for the BRCA1 gene which has been linked to breast and ovarian cancer.

The Australian test for patent eligibility includes assessment of whether the invention consists in an artificially created state of affairs’ that is of economic significance, meaning that its value to the country must be in the field of economic endeavour, and that it must have an ‘industrial or commercial or trading character’.8 Given this, a conclusion that isolated BRCA1 DNA is artificially created could be argued to follow logically. In December 2013, the High Court of Australia ruled that methods of medical treatment are patent eligible in Australia. Accordingly it would seem that patentability of diagnostic and personalized medicine innovations are on relatively solid footing in Australia.

An application with the High Court of Australia has been filed for special leave to appeal the decision of the full bench. A decision as to whether the High Court will hear the case is expected in the coming months.

Canada

On November 3, 2014, the gene patent legal controversy spilled into Canada over patents relating to assessing risk of an inherited cardiac disorder, long QT syndrome. The Children’s Hospital of Eastern Ontario (CHEO) commenced a patent proceeding against the University of Utah Research Foundation, Genzyme Genetics and Yale University asking for to a declaration of noninfringement and/or invalidation of a series of patents which claim isolated nucleic acids and methods of assessing a risk for long QT syndrome. It remains to be seen if this case will progress to trial, and if so what direction the Canadian courts will take.

In Canada, whether an invention is patentable subject matter is determined by statute and case-law. The Patent Act prohibits the patenting of “mere scientific principle or abstract theorem” and courts have decided that methods of medical treatment are nonpatentable10, although medical uses that do not require the skill of, or restrict, a medical professional can be patented. In late 2011 the Federal Court of Appeal rejected a test for patent eligibility being applied by the patent office11 and said that whether a claim is patentable subject matter is assessed by whether “the subject matter defined by the claim, [and not the contribution over the art] falls within the definition of “invention”. Shortly thereafter the patent office released a draft guidance document for comment related to Office Practice Respecting Claims to Diagnostic Methods and Medical Uses. The document has yet to be made official and in the meanwhile, examination of diagnostic patent applications has been put on hold. A practice notice on diagnostic claims is expected which will hopefully shed some light on how the patent office views the patentability of such claims

IsolateD Dna Is patentable subject matter anD DIagnostIc claIms that meet the other requIrements of patentabIlIty are at present patentable subject matter.

At present, the patentability landscape in Canada for diagnostic and personalized medicine innovations differs somewhat from that of the United States. Isolated DNA is patentable subject matter9 and diagnostic claims that meet the other requirements of patentability are also patentable.

One category of claims that the patent office has recently provided guidance on is medical use claims that rely on a diagnostic feature for novelty and non-obviousness. A document of examples was released on November 14, 2013 including analysis of a ‘personalized medicine’ claim. The claim - Use of a known compound X to treat a disease Y in a specific patient population having the gene mutation ABC - was found nonpatentable because it restricts the choices (skill) of practitioners on how to use X. This leads to the situation where a claim to a diagnostic assessment could be allowable but use of that same diagnostic assessment in a medical use claim would be not.

Patentability of diagnostic and personalized medicine technologies is an evolving landscape that will require attention to the country specific intricacies when trying to obtain meaningful patent protection. Although patent office guidance documents do not have the force of law, they do affect the examination procedure applied by the Office to patent applications and as such may limit the types of claims that are obtainable for personalized medicine innovations. However, the guidance will ‘evolve’ overtime based on: new court precedent, its application in practice by examiners and applicants successes in overcoming rejections. Gray areas should be clarified in this way going forward and strong pushback form applicants will be beneficial.

References

1. Mayo Collaborative Services v. Prometheus

Laboratories, Inc., 566 U.S., 132 S.Ct. 1289, 101 USPQ2d 1961 (2012) 2. Association for Molecular Pathology v.

Myriad Genetics, Inc., 569 U.S., 133 S.Ct. 2107, 106 USPQ2d 1972 (2013) 3. Bilski et al. v. Kappos, 561 U.S., 130 S.Ct. 3218, 3231 (2010) 4. CLS Bank International v. Alice Corp. Pty.

Ltd., (2013) 5. http://www.uspto.gov/patents/law/ exam/examguide.jsp 6. http://www.uspto.gov/patents/law/

comments/myriad-mayo_guidance_ comments.jsp 7. Myriad Genetics Inc. et al. v. Ambry Genetics

Corp. United States Court of Appeals for the Federal Circuit, December 17, 2014 8. NRDC(1959) 102 CLR 252 at 275. 9. Monsanto Canada Inc v Schmeiser, 2004

SCC 34 at 22-24, and implicitly affirmed by the Supreme Court in Harvard College v.

Canada (Commissioner of Patents), 2002

SCC 76 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). 10. Tennessee Eastman Co v Canada (Commissioner of Patents), [1974] S.C.R. 111 11. Amazon.com Inc v Canada (Commissioner of Patents) 2011 FCA 328

Carmela DeLuca is a partner with Bereskin & Parr LLP and member of the Life Sciences practice group. Her 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. She also has experience advising on regulatory compliance.

Between 2010 and 2014, Katherine Bonter was Director of Promotion and Advocacy at CEPMED, a Centre of Excellence in Commercialization Research created and hosted by the Montreal Heart Institute (MHI). 2011, she has participated in the intellectual property (IP) capture and management activities at the MHI and its affiliate the Beaulieu-Saucier Pharmacogenomics Centre and is presently Director of Intellectual Property at the MHI. Katherine currently leads 2 projects that address research questions related to IP and innovation in personalized medicine, as part of large-scale genomics projects funded by Genome Canada in 2012. Prior to coming to Cepmed, Katherine worked for 15 years in the biopharmaceutical industry in IP and business development, working for small-medium sized companies in the Montreal area.

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