Emily Xiang is an IPilogue Writer, a Senior Fellow with the IP Innovation Clinic, and a 3L JD Candidate at Osgoode Hall Law School.

For the first time in decades, the US Supreme Court will engage with enablement in patent applications. On November 4th, 2022, the Supreme Court to review the Federal Circuit’s decision in Amgen v Sanofi, against the . Specifically, Amgen seeks to appeal a , in which the court found Amgen’s patents invalid for lack of enablement. 

The requirement of enablement in US patent law is codified in , which requires that the specification of a patent application “enable any person skilled in the art…to make and use” the invention in question. The in Amgen v Sanofi is whether this statutory requirement governs enablement (that the specification teaches those skilled in the art to “make and use” the claimed invention) or whether it must instead enable those skilled in the art “to reach the full scope of the claimed embodiments” without “undue experimentation” (characterized by substantial “time and effort”). 

In 2014, Amgen sued Sanofi for infringing on its patents concerning drugs for lowering cholesterol. The genus patents specifically cover that bind to the PCSK9 protein in the body. The patents disclose the amino acid sequences for 26 antibodies that bind to one or more of 15 residues found on the PCSK9 protein. Importantly, the claims at issue are considered , in which the antibodies are not claimed based on their structural components but rather on what they do. 

On January 3rd, 2023, many interested parties submitted to offer the Supreme Court their take on the issue to be considered. For instance, in a brief submitted by a group of , it was argued that the Federal Circuit’s standard imposes “an impossible burden” on patentees and that such a decision represents “a categorical shift in thinking away from teaching the PHOSITA and towards a precise delineation of the boundaries of the claim”. The professors further submitted that such a heightened requirement would be especially burdensome for patentees seeking to protect their innovations in the fields of chemistry and the life sciences, as “a chemical genus with any decently large number of species will never be able to satisfy the new enablement standard”. 

Other parties in support of Amgen presented some other reasons as well. In their amicus brief, the stated that the court’s reasoning “leaves patent practitioners guessing about how to advise client-inventors regarding the extent of disclosure required”. The , warned of the adverse impact that the new enablement requirement might have on the effectiveness of patent incentives for investors to contribute towards research and development, especially in the case of startups and smaller companies.

Moreover, the has filed a motion for leave to participate in oral argument, claiming a “paramount and unique institutional interest and perspective” – that is, the perspective of individuals and companies working in the chemical, pharmaceutical, and biotechnology fields. CHAL asserts that the Federal Circuit’s enablement standard potentially jeopardizes the benefits of many modern innovations and that adhering to the plain meaning of 35 USC s. 112 should continue to be the prevailing approach.

The Supreme Court’s decision regarding the enablement standard for functional claims could also have wide-reaching implications that spill over into other fields, such as technology and computer-implemented inventions. By too narrowly focusing on the “full scope of the claim” and “undue experimentation” instead of on what those skilled in the art could determine from the specification, it is unclear how broader claims for (such as those that describe the desired result to be achieved by the AI rather than its structural components or any specific software solutions) might fare in the face of such a standard. 

Amgen v Sanofi is scheduled to be heard by the US Supreme Court in the upcoming Spring Term.

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Videotaping, the Internet and Strike Tactics in the Context of Privacy Legislation

In 2006, workers at the Palace Casino at West Edmonton Mall engaged in a lawful strike which lasted 305 days. During the course of the strike, the Union videotaped and photographed people crossing the picket line. The Union placed signs in the area warning people that images of people crossing the picket line may be placed on a website called www.casinoscabs.ca.

None of the complainant’s photos were actually placed on the website. An image captured of the vice president of the casino, however, was used in a mock “police mug shot poster” and in other satirical ways – although apparently with consent. Yet privacy statutes capture both the use and the collection of personal data. Therefore, even though the materials were never actually disseminated over the Internet, the Union’s activities fell within the application of Alberta’s (“P���ʴ�”).

Nor did the fact that the photos and videotape were taken in public exempt the activities from PIPA. PIPA, like most privacy statutes, dispenses with consent for the collection of publicly available information. Yet the concept of publicly available information is narrowly defined under the . These regulations, which mirror the under PIPEDA, limit the definition of publicly available information to certain information contained in directories and registries when used for a specific purpose, information contained in a judgment or record of a quasi-judicial body, and information contained in a magazine or news publication. As the Court of Appeal noted, “Under the Act, ‘personal’ information is not the same thing as ‘private’ information.”

The Appropriate Remedy for Offending Provisions in Privacy Legislation

All levels of court recognized the need to balance legislation intended to protect an individual’s privacy with constitutionally entrenched concepts of freedom of expression. All three levels of court– , , and the Supreme Court – agreed that the Union's collection of personal information conducted in support of its strike could not be restrained by PIPA.

No level of court had difficulty concluding that the videotaping and photographing of individuals near the picket line constituted free expression within the meaning of s. 2(b) of the Charter. Nor could the application of the ������’s restrictions to the Union’s activities be justified under s. 1. While the restrictions put in place by PIPA were rationally connected to its aim of protecting personal information, the means by which the Act protected this information were not proportionate.

The constitutionality of these restrictions on the Union’s speech was hardly a controversial issue. The key difference between these decisions, however, is the manner in which the differing levels of courts attempted to provide an outcome consistent with the rights guaranteed in the Charter. In the initial appeal of an adjudicator's decision to the Queen's Bench, The chambers judge attempted to use existing exceptions under PIPA in order to avoid the application of the statute and a finding of constitutional invalidity. She included the Union’s activities under the definition of “journalism”, which the Act exempts from its application entirely.

At the Court of Appeal, the court characterized the chambers judge’s attempt to remedy the breach of the Union’s constitutional right as “expansive and somewhat artificial.” Analyzing the situation as “journalism” was not particularly helpful, as not every piece of information posted (or intended to be posted) on the Internet qualifies as journalism. However, the Court of Appeal declined to strike out or read down the statute in any way. It instead issued a declaration that the application of the Act to the Union’s activities was unconstitutional.

In contrast, the SCC, at the request of the Government of Alberta and the Privacy Commissioner, declared the entire statute invalid to allow the legislature to redraft it as a whole.

The remedy granted by the Supreme Court shows the importance of well drafted, balanced privacy legislation. By invalidating the legislation entirely, rather than striking out portions or expanding definitions, the Court has allowed the Province to draft legislation which fits within the delicate framework in which privacy protection operates. Following the reasoning in UFCW, appropriate legislation would sufficiently recognize exceptions to the statutory scheme which allow entities affected by the Act to exercise their freedom of expression, while still preserving protections for individuals from organizations which seek to misuse personal data.

Moreover, a finding of invalidity more closely follows well established Supreme Court precedent. While the courts are the guardians of the Constitution and the individual rights protected by it, it is not up to the courts to provide details that would “”

What’s Next for Privacy Legislation in Canada?

There are important implications for this Decision. Most apparent, the offending sections of PIPA closely resemble the federal privacy statute PIPEDA. Like PIPA, PIPEDA contains no exceptions which would permit a union to use personal information in order to gain an economic advantage during the course of negotiations.

As was noted by the SCC, PIPA was inspired by . Its stated purpose is “almost identical” to the federal act. However, the Court maintained that the scope of PIPA was considerably broader than that of PIPEDA. Unlike PIPEDA, PIPA does not restrict its application to activities undertaken for commercial purposes. Yet it is unclear how this restriction could render PIPEDA constitutional, as an of in shows that the protection of freedom of expression includes commercial speech. While the scope of PIPEDA is more limited than its Albertan counterpart, it remains unclear if the similar provisions in the federal statute would survive a similar constitutional challenge.

Similar problems exist for a recent federal law popularly known as (“CASL”). CASL applies to a broad category of activities classified as “commercial electronic messages.” In order to soften the impact of the law, various exceptions have been created to its application through regulations. However, given the potentially broad scope of the legislation, CASL will probably lead to significant litigation once it is enacted. Once again, the courts will attempt to determine the proper balance between the harms addressed by such statutes and the rights restricted through the statutes’ application - and whether or not these protections are a proportionate response to the harms they seek to address.

David Bowden is an IPilogue editor and a JD Candidate at Osgoode Hall Law School.

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Is there a Material Difference Between a Gene that Has Been Isolated from a Human and One that Has Not?

As previously covered by the IPilogue (,��, and ), at issue is a pair of genes known as BRCA1 and BRCA2.  Mutations in these genes have been positively correlated with an increased risk in the development of breast and ovarian cancer in women.  The University of Utah owned the patent rights to both (1) the method of analyzing and comparing the isolated DNA sequences in order to detect mutation in the BRCA genes and (2) the composition of matter that included the genes themselves.  Myriad Genetics was the exclusive licensee of these patents and was responsible for chemically isolating that genetic sequence.  The bulk of the method patents were by the Federal Circuit Court and that decision is now final given the USSC’s refusal to revisit the issue.

Instead, the Court will focus on the main point of disagreement in . In that ruling, the 2-1 majority (which consisted of Judges Lourie and Moore) upheld their that isolated DNA molecules are indeed patentable subject matter. It is a of American patent law that substances found in nature are not patentable; however the USSC’s decision in  also established that a product of nature that is “markedly different from naturally occurring ones” with a “distinctive name, character and use” may be patentable as it is a “non-naturally occurring composition of matter”.  Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concluded that breaking those bonds to isolate the BRCA genes turned the isolated genes into materials that are markedly different from the naturally occurring genes in humans and thus eligible for patent protection.

Judge Bryson dissented with the majority on this point stating: “There is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered”  (at 7 of Bryson’s ruling). Judge Bryson then goes on to compare the isolation of human genes with the extraction of newly discovered minerals from the earth’s crust.

“In this respect, the genes are analogous to the 'new minerals discovered in the earth' or the 'new plant found in the wild' that the SC referred to in Chakrabarty.  It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant.  But that does not make those naturally occurring items the products of invention.”

Like some minerals, Bryson J argues, genes are hard to extract from their natural setting.  Also like minerals, genes can be used for purposes that would be infeasible if they remained in their natural setting.  Furthermore, the process of extracting minerals or the picking of plants, like the process of isolating genetic material, can result in some physical or chemical changes to the natural substance.  But such changes do not make extracted minerals or plant pickings patentable. Thus they should not have that effect for isolated genes.  In each case, merely isolating products of nature by extracting them from their natural location and making alterations attendant to the extraction process does not give the extractor the right to patent the products themselves.

Looks Like It’s Going to Be An Interesting Summer For The American Genetic Industry

It is expected that the Supreme Court will hand down its ruling in June of 2013. By granting this appeal, the Supreme Court may finally settle the central point of dispute in a series of lengthy rulings that have wound through the Federal Circuit since . Whichever way the USSC rules, it seems the summer of 2013 will be an interesting one for the American Genetic Industry.

Beatrice Sze is a JD Candidate at Osgoode Hall Law School.

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In the , the Association for Molecular Pathology v Myriad Genetics (Myriad), Myriad Genetics alongside the University of Utah, isolated two genes, BRCA 1 and BRCA 2, which are associated with breast and ovarian cancers.  Furthermore, it developed a test that examines the DNA extracted from the genes  for mutations that signify risk of developing breast or ovarian cancer.  The patent of the two genes grants Myriad Genetics a monopoly on testing for mutations and thus prevents other laboratories from performing such tests.

An action brought by the American Civil Liberties Union and the Public Patent Foundation on behalf of various medical groups, patients and researchers that Prometheus’ patent on the human genes were invalid as they were products of nature, and the ensuing monopoly granted prevented women from garnering confirmatory tests. A United States District judge in New 91��ɫ conceded and the patents in 2010.  Nonetheless, this victory for the American Civil Liberties Union and association was short lived, as the Court of Appeal for the Federal Circuit the ruling, holding that the DNA isolated from the body was patentable since it was “markedly different” in a chemical structure from the DNA within the body.  On appeal to the Supreme Court, the case was remanded to the Court of Appeal for the Federal Circuit for review.

On review, the Federal Court will be required to resolve whether isolating genes BRCA 1 and BRCA 2 merely describes a law of nature or whether it is “.” As mentioned earlier, and pursuant to Section 101 of the , laws of nature, natural phenomena, and an abstract idea are not patentable.  This provision is one that is seemingly simple to grasp, however, upon further interpretation, becomes complicated and abstract.  Patents sought by individuals who are able to demonstrate that their particular invention involves a of an abstract idea or law of nature are entitled to patent protection.  Therefore, Section 101 patent analysis is oriented towards what constitutes an application.  In Prometheus, patent protection for the diagnostic test that looked for chemicals formed when drugs used to treat gastrointestinal diseases were broken down in the body was  since the test merely recited and applied a law of nature. The future success or failure of Myriad Genetics’ patent may be foreshadowed utilizing the lesson learned from Prometheus, with greater accuracy depending on the degree of alignment between both cases. 

Perspectives on whether the fate of the Prometheus patent foretells a grim tale for  Myriad are rather varied and stratified. lawyers and patent experts believe that the ruling in Prometheus is not easily transferable to the present case since Myriad’s patents are compositions of matter while Prometheus’ were methods of testing. Dr. Robert Cook-Deegan, director of the program on genome ethics, law and policy at Duke University the logic to be different since the present case is about a thing, as opposed to a method.  believe that the ruling in Prometheus is opposed to the rationale used by the appellate court to uphold Myriad’s patents.  Daniel Ravicher of the Public Patent Foundation opined, “the isolation of DNA is a trivial, well-understood step…A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation” is not sufficient to obtain patent protection.

Irrespective of outcome, both Prometheus and Myriad have generated useful dialogue about the ethical and economic challenges facing the Unites States patent system in an age of biotechnology and the increasing monetization and exploitation of genetics.

Tracy Ayodele is a JD Candidate at Osgoode Hall Law School.

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The next step in the well documented Bilski case took place on Nov. 9 when the United States Supreme Court heard from both parties. As a quick reminder, the issue revolves around the patenting of business methods; in this case, the subject matter concerned  a method of hedging risks in commodities trading. In its decision, the U.S. Court of Appeals for the Federal Circuit reverted to the "machine or transformation" test, narrowing the scope of patentable subject matter and throwing the validity of thousands of patents granted under the old State Street rule into question. This case has seen extensive attention in the blogs already; click for a more extensive look at its history and for its potential consequences in Canada.

Acting as Counsel for Bilski, Mr. Michael Jakes began in his opening statement by arguing that the machine or transformation test has no statutory basis nor common law precedent backing it. Jakes argues that should be interpreted broadly, with a presumption of patentability outside of the recognized exceptions that are covered in the decision. When Justice Scalia suggests that s. 101 and its "new and useful art" provision was always thought to deal with machines or inventions, Jakes argued that although the majority of historical patents concerned machines or manufacturing, this is simply a consequence of history and not because method patents were precluded. He followed by stating that, as a matter of policy, these methods should be patentable as they encourage disclosure of ideas and stimulate useful inventions.

The justices had multiple problems with Jakes' proposed interpretation of patentable subject matter. They proposed several hypothetical situations, inquiring into the bounds of patentability. Justice Breyer was particularly memorable in inquiring whether his novel method of teaching antitrust law that (amazingly) keeps 80% of students awake would be patentable, assuming it could be reduced to a series of steps. Jakes said that this may potentially be patentable. He advocated a return to Diehr, saying that standalone abstract ideas are not patentable, with the distinction between abstract ideas and patentable methods being the ability to break down the method into concrete steps requiring people to do actual things.

This led to a long discussion of how the Bilski patent could be reduced to physical steps. Jakes seemed unconvincing in his justification, claiming that a bunch of ordinary actions such as initiating a series of transactions via a phone call was sufficient to satisfy the physical step requirement. This caused a line of questions asking why, if these methods with incidental physical steps could be patented, that all sorts of methods of the sort were not patented hundreds of years ago. Justice Scalia gave an example of a horse whisperer who had his own method of training horses. Jakes replies that this could have been patented, but because it was an industrial based economy and because there would be enforcement problems, nobody bothered with these patents until recently.

As counsel for the respondant, Mr. Malcolm Stewart began by picking up on what he saw as a weak point of the Bilski argument by asserting that patents must be in the realm of the physical. Stewart alleges that Bilski's patent is ineligible for two reasons: first, because the method of commodities trading fails the machine or transformation test and second, because it is an abstract idea. While Stewart seemed to feel fairly certain that the court would find ineligibility based on the abstract idea proposal, he clearly stated that it would be more desirable to win on the machine or transformation test.

In doing so, Stewart argued that the test is not overly rigid. He said that all that needs to be done is to satisfy the test is to establish "some link to a machine or a transformation of matter", addressing a fear of Justice Sotomayer. Further, Stewart acknowledges that it is possible that some new technology will be invented in the future that is deserving of patentability but lies outside the bounds of the machine or transformation test. Still, Stewart makes it clear that his goal is simply establishing a return to the machine or transformation test, and that the "hard questions" of determining what constitutes a machine-implemented process or what constitutes sufficient transformation for later. This did not sit well with the court. In particular, Chief Justice Roberts took issue with an assertion Stewart made in his footnotes that although the Bilski patent is not eligible because it did not involve a machine, if a computer were involved to identify the parties then it may satisfy the test. Roberts equated this tangential proposition with a hypothetical situation where the patentability of a process hinged on the distinction of using a calculator or mental arithmetic to make a simple division. Stewart wisely backtracked, acknowledging that such fleeting use of a machine would be insufficient. In turn he said that the line of patentability would be closer in situations where a machine is programmed with new software related to the process in question.

The future looks grim for any hopes of Bilski being granted patent protection, especially in light of the Court's seeming reluctance to accept Mr. Jakes' proposal of the physical steps involved in the Bilski method. However, the adoption of the machine or transformation test seems less of a certainty. The court was not enthralled with Mr. Stewart's proposal to answer the "hard question" about the boundaries of what satisfies the test at a later date. And, as is pointed out in , it is likely that by accepting to hear this case the Supreme Court was looking to modify or set aside the test as set out in the Court of Appeal decision. Thus, although the future for Bilski looks bleak, the broader question regarding the patentability of business methods is still far from decided.

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