Michelle Mao is a 2L JD Candidate at Osgoode Hall Law School and an IPilogue Writer.

The distinct smell of brown sugar and cinnamon wafting out of your grandma’s kitchen every time you visit is unique and unmistakable to you. You claim that it is “one-of-a-kind" and it invigorates you to power through until your next visit to grandma’s house. These features of grandma’s cookies give you a bright idea – what if you patent grandma’s cookies? After all, grandma is a sweet old lady who deserves to live a lavish life in retirement and could use the extra money.��

According to the , patents must meet three criteria: (1) new – first in the world, (2) useful – functional and operative, and (3) inventive – showing ingenuity and non-obvious. To you, the cookies are unique (potentially filling the novel requirement), they serve a functional purpose – of filling you with motivation (useful), and no one has figured out how to replicate her secret recipe (non-obvious). So, what are the chances of patenting grandma’s secret recipe?��

Theoretically, it is possible for recipes to be patented if they meet the above criteria, qualifying under the as a “”. However, recipes have , often failing at the non-obvious or novel stage. Patents for recipes that fail at the non-obvious stage are typically recipes with a simple composition, making them easily decipherable. Patents for recipes that fail at the novel stage are typically those for a commonly made dish, where simple adjustments to the proportion or ingredient amounts are not patentable. The unpatentability of these factors is based on practicality, where someone cooking a cultural recipe or using more seasoning is not suddenly and unknowingly infringing on a newly claimed patent.��

Perhaps a suggestion for Grandma could be to patent her unique process of creating such life-changing cookies, whether it is the process of dough-making or cookie-baking. As technology continues to develop, the incorporation of novel techniques such as dehydration of ingredients, nitrogen cooling, and others, this new way of patenting cooking processes may develop. It will be interesting to see how new processes and techniques that change food longevity, cook times, food’s structural integrity, etc. could change the historical patent success rate of recipes. Unfortunately, for now, your grandma can only protect her secret recipes locked away in a box, rather than through patent protection.

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Cannabis breeding is a��. It requires patience, sensory acuity, long-term planning, and a working knowledge of genetics. Through their work, breeders can greatly enhance the commercial value of their product. They can create plants that give greater yields, disease resistance, hardiness, and, of course, drug potency, among many other desirable and profitable traits.

Cannabis breeding can also be expensive. To recoup expenses, developers ��rely on profits from their new strains. If there is nothing preventing competitors from selling the developer’s strain, without first paying the developer for the research and development needed to create the strain, then there is very little financial incentive to develop these new breeds. If Canada is to encourage better, more efficient, and more profitable strains of Marijuana, then the government will need intellectual property laws that can protect the investments of time and money that Cannabis breeders put into their work.

��for novel plant breeds themselves, a legal conclusion which stems����In the landmark 2002 Supreme Court patent case of��Harvard College v Canada (Commissioner of Patents), it was decided that “higher lifeforms”, which include plants, could never be subject to a patent protection per the��Patent Act. This ruling was complicated two years later in��Monsanto Canada Inc. v Schmeiser.��Schmeiser’s ruling decided that, while it was true that a plant itself could not be patented, a man-made gene within a plant could be. If a plant contains such a modified gene then, for all practical intents and purposes, the plant itself could be patented because “where a defendant’s commercial or business activity involves a thing of which a patented part is a significant or important component, infringement is established”.

While these rulings may satisfy Monsanto and the other members of the (extremely limited) genetic-insertion community, they are of little recourse to those who breed new plant strains through more traditional means, like cross-breeding. Patent protection would therefore benefit only the most high-end marijuana breeders.

All hope is not lost, however, for marijuana breeders who don’t engage in genetic insertion, thanks to the 1990 Federal��Plant Breeders Rights Act (PBRA). This Act����to plant breeders if they can demonstrate that a strain they have created is “new”, clearly distinguishable from all existing varieties, stable in its essential characteristics, and sufficiently homogenous across plant generations. To date, a handful of marijuana strains have been protected through the��PBRA, and it has the potential to give some relief to breeders.

��of Plant Breeders Rights is that the protections they give are weaker than those protections given by the Canadian patent regime. A patent grants the right to prevent others from using, selling, offering for sale, and importing the patented invention into Canada for a period of 20 years. By comparison, Plant Breeders Rights exclude others from selling, producing, exporting, importing, making repeated use of, conditioning, and stocking the seeds of the plant, also for a period of 20 years. While these collections of rights are superficially similar, Plant Breeders Rights come with some major exceptions not shared by a patent. Anyone can use the seeds and product of a protected plant for private non-commercial purposes, for experimental purposes, and for breeding purposes. At the same time, the “farmer’s privilege” allows for farmers to replant the seeds from plants they have obtained legitimately in perpetuity.

While Plants Breeders Rights are a good start, full patent protection is necessary if Canada wants to fully encourage large-scale development and experimentation in marijuana breeding. Full Patent protection would be an excellent way to encourage the investment of time and money that breeding requires, and would allow for smaller corporations to protect their investments better than the current gene-insertion protections. While it is true that this could result in initial monopolization of certain desirable strains, the benefits of breeding protection would extend to the cannabis-enjoying population after just 20 years. Extending these rights would not be unprecedented, as plant strain patents are available both��, and in the����Canada should take example from the successful plant strain patents found in the international community, instead of letting a potentially valuable incentive for agricultural development go up in smoke.

Keenan Fast is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

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As , partner with McCarthy Tétrault in the Toronto office and a Member of the IPOsgoode Advisory Board, , “Patent law is based upon the social and economic rationale of balancing encouraging innovation and the avoidance of monopolies which can stifle competition.” In general, these principles have been extended into the realm of software as a means of rewarding and protecting the fruits of the inventor's labour in the hopes of stimulating and fostering further advances and discoveries through public disclosure mechanisms. Patents, and software patents, are, therefore key elements of the contemporary economic system.

However, while software may be generally similar to other types of inventions, the nature of software industries and software itself make the application of existing patent laws somewhat problematic. Economist and former Non-Resident Fellow at the Brookings Institute argues, in , that there are three dissimilarities that must be recognized when dealing with software: 1) detailed descriptions of a software often constitute the program itself, making it hard to distinguish between ‘ideas’ and ‘implementation’; 2) software are pieces of mathematics, which courts agree are not patentable; and, 3) software is written and produced by vast categories of users and programmers, making restrictions to competition problematic (at pp. 4-5).

These three issues entail disproportionate levels of competitive and monopolistic advantage to whoever acquires a patent right first. For example, a patent holder is able to extract burdensome rents from a competitor who wishes to build off of the works of others or create interoperable technologies based on previously existing patented discoveries.

In the SCOTUS was tasked with determining whether the patents at issue in the case, held by Alice Corps', were eligible for patent protection or whether they were simply ‘abstract ideas’.

The case centered around a computerized process for limiting “settlement risk” during financial exchanges between two parties by employing a computer system as a third-party intermediary. This 'third-party' creates and tracks digital account ledgers that mirror the balances that the exchanging parties hold in their ‘real-world’ accounts in order to determine whether or not a given transaction can be processed and supported by the parties' assets. As states, "In sum, the patents in suit claim (1) the foregoing method for exchanging obligations (the method claims), (2) a computer system configured to carry out the method for exchanging obligations (the system claims), and (3) a computer-readable medium containing program code for performing the method of exchanging obligations (the media claims)".

In 2007, CLS Bank filed suit against Alice Corps in the hopes of obtaining a declaratory judgment that the patents at issue��were invalid and, therefore, not infringed by CLS Bank’s use of a similar business practice. Following a SCOTUS decision in 2010, (561 US 593), the parties filed cross-motions for summary judgments on whether the patents were eligible under the .

Section 101 of the Patent Act defines patents as eligible for: “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title” (). However, since 1972, the SCOTUS has held that "abstract intellectual concepts are not patentable” (, 409 U. S. 63, 67). As recently as 2011, in , the Court has upheld this principle out of concern that “patent law not inhibit further discovery by improperly tying up the future use of laws of nature” (Mayo, 566 US 16).

Using the two-part test set out in Mayo, the Court found that “because petitioner’s system and media claims add nothing of substance to the underlying abstract idea, we hold that they too are patent ineligible under §101” (Alice Corp., 573 US 17). In the concurring statement Justice Sotomayor, joined with Justices Gisburg and Breyer, agreed that “any claim that merely describes a method of doing business does not qualify as a ‘process’ under §101’” (Alice Corp., 573 US 1). The Court found that “there is no meaningful distinction between the concept of risk hedging in Bilski and the concept of intermediated settlement at issue here. Both are squarely within the realm of ‘abstract ideas’ as we have used that term” (Alice Corp., 573 US 10).

The decision in is careful not to extend this principle too far, which would run the risk of making all software patents ineligible. The Court recognizes that “an invention is not rendered ineligible for patent simply because it involves an abstract concept” (Alice Corp., 573 US 6). Applications of abstract ideas that are “to a new and useful end” (Alice Corp., 573 US 6) remain eligible for patent protection.

The SCOTUS decision in this case represents another step in the evolution of American intellectual property laws, in commercial contexts, in adapting to new technological and social circumstances. The Court has not defined what types of software and business practices are eligible for patent protection. Instead, it has reaffirmed long-standing principles about what types are not: those that monopolize the building blocks of human knowledge and invention, such as abstract ideas, and prevent further innovation.

In doing so, the decision in is another precedent in favour of competitive markets and the avoidance of the deleterious affects of excessive rent-seeking by patent holders that make overly broad claims on the tools necessary for human development and innovative creations.

Joseph F. Turcotte is an IPilogue Editor, a PhD Candidate and SSHRC Doctoral Fellow in the Communication & Culture Program (Politics & Policy) at 91��ɫ, and a Nathanson Graduate Fellow at the Jack & Mae Nathanson Centre on Transnational Human Rights, Crime and Security at Osgoode Hall Law School.

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Are computer-implemented inventions patentable subject matter?��

This case between Alice Corporation Pty Ltd (Alice) and CLS Bank International (CLS) is one of many recent disputes stemming from the ambiguity of the patentability of software and business processes in the United States. (The IPilogue has previously covered a similar issue��in����.) The patents in question all involve a computerized system for processing financial transactions.��A particularly contested area��in the��dispute is the scope of patentable subject matter, and the various legal tests involving abstract ideas and inventive concepts in patent claims. The question poses is:

Whether claims to computer-implemented inventions – including claims to systems and machines, processes, and items of manufacture – are directed to patent-eligible subject matter within the meaning of 35 U.S.C. § 101 as interpreted by this Court.

Title 35 U.S.C. § 101 is a provision of that provides:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Alice is essentially asking the court if computer implemented inventions are patentable subject matter as processes, machines and items of manufacture under US patent law. this appeal to the Supreme Court as inevitable after��the decision in the��appeal to the Federal Court��resulted in 6 separate decisions spanning��, all applying different legal analyses to the issue of patentability.

Who is interested?

This case has generated an extraordinary , including 11 briefs filed at the petition stage where the court decides if it will hear the appeal, and 41 briefs at the merits stage where the court makes a decision. In addition, the US Solicitor General was granted permission to participate in the oral arguments. The amount of interest is indicative both of the ambiguity in the current law, and the extent of the interests at stake.

Software and business process patents in general have garnered much attention recently, particularly in the US which is one of the most lucrative worldwide. Much of the debate over these kinds of patents stems from the overriding concept in patent law about the difference between implemented inventions and abstract ideas. All patent law systems share the common feature that abstract ideas and scientific principles cannot be patented. Only novel inventions that actually perform a real-world function are patentable. There are numerous areas where this distinction comes up, but it is most notable in software patents.

In many jurisdictions, including the US, pure software algorithms are . Written software code is protected by��copyright, but this only protects against verbatim reproduction. Copyright does not protect the underlying ideas, or against independent invention. As such, many software companies have looked for ways to patent software, thus expanding their monopoly beyond the literal code.

One way to achieve this is by incorporating the software or business process into a larger invention, which builds upon other patentable subject matter. This has lead to the "do it with a computer" argument, where patents granted for otherwise��ineligible��subject matter simply through the addition of an integrated device.

What is on the line?

Much has been written recently about the scope of patent protection, particularly in light of (NPE), some of which are pure innovation��companies, and others who obtain patent rights with the sole intent of enforcing them against infringing parties. These NPEs have been��criticized��by some industry members and�� [see 16:02-18:39] alike for��taxing��innovation, and abusing the patent system without adding any benefit. This��phenomenon��has been particularly pronounced in��software��patents, which are for being broad, ambiguous, or obvious.

Conversely, many industries are increasingly deriving and from their business processes and software algorithms. As industry increasingly shifts to a knowledge economy, businesses have more incentive to pursue monopolies through intellectual property law for their processes and algorithms.

What is the answer?

As with many areas of intellectual property law, the best decision will balance the needs of all stakeholders involved. The very nature of intellectual property is granting a time-limited, state-enforced monopoly in exchange for innovation and investment. The overriding policy goal is to encourage future developments by balancing the economic incentives of a monopoly with the need to avoid making that monopoly so broad that it stifles innovation. Hopefully the US Supreme Court, assisted by volumes of supporting briefs from a wide spectrum of parties, will be able to strike that balance for software and business process patents.

Alex Buonassisi is an IPilogue Editor and a JD Candidate at the University of British Columbia.

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, after discovering the exact location and sequence of the genes BRCA1 and BRCA2 – mutations of which may increase the risk of breast and ovarian cancer – was able to isolate these genes, enabling, inter alia, the identification of genetic predisposition to these cancers. Only a subset of��nucleotides can code for amino acids and consequently generate a protein ("exons"), while other nucleotides ("introns")are not able to perform this function.�� Myriad created synthetic DNA sequences (so-called "complementary DNA" or "cDNA"), in which the natural introns are removed and only the exons remain, providing significant advantages for genetic examinations and other scientific purposes. On this basis, Myriad obtained patents on isolated genes BRCA1 and BRCA2, as well as patents relating to their synthetic DNA sequences. After obtaining these rights, various stakeholders filed actions against Myriad and the , claiming the invalidity of patents based primarily on patent ineligibility of products of nature.�� The case made its way through the District and Federal Courts, and all the way to the U.S. Supreme Court. (For some of the IPilogue's past coverage on this story, click and .)

In its decision, the U.S. Supreme Court�� stated that:

a) Laws of nature, natural phenomena and abstract ideas are not patentable under ;

b) Isolation of genes without any creation or alteration of genetic information is not an act of invention. Despite the great scientific relevance of Myriad's discovery, the isolated BRCA1 and BRCA2 genes and their genetic information are merely a product of nature, and therefore are not patentable under § 101; and

c) Unlike the genes BRCA1 and BRCA2, cDNA molecules, consisting only of exons, are not naturally occurring, but a result of human inventiveness. Even if the nucleotide sequence of cDNA is dictated by nature, it is unquestionable that the lab technician creates something new when cDNA is made. Therefore, cDNA is distinct from the DNA from which it was derived, so that it is patentable under § 101.

The U.S. Supreme Court also distinctly��pointed out that this case did not involve method patents, new applications of knowledge about BRCA1 and BRCA2, and alteration of order of naturally occurring nucleotides, thereby��preventing any��implication��of this case to these endeavors.

As a consequence of the decision, Myriad no longer has exclusive rights to the BRCA1 and BRCA2 genes, thereby allowing competitors in the biotechnological sector to recreate and use them. This will have important implications both socially and economically.�� Firstly, the free use of the genes by various companies increases the opportunity for development and innovation for identification and treatment of cancer and for the discovery of new functions for the genes. In this way, public health can potentially obtain a number of additional��long-term benefits.�� Secondly, due to the competition exerted by other companies, the price of tests for identifying��susceptability��to��cancer is expected to be reduced. Currently, the price of��a complete test��is around , making the test an unfeasible option for many people. The real economic benefits of the decision, however, are still questionable because (1) Myriad's patent on the cDNA was upheld and (2) Myriad likely has a number of�� related to mutations of the BRCA1 and BRCA2, guaranteeing it significant exclusivity in this sector.�� It will be necessary to observe the development of the market in the coming months to draw more concrete conclusions.

Despite its advantageous practical effects, the decision deserves criticism for some inconsistencies. In order to support the non-patentability of the genes BRCA1 and BRCA2, the U.S. Supreme Court emphasized that since the genetic information of these genes was not created or changed by Myriad, it should be considered as a product of nature and, consequently, ineligible for patentability. In order to support their conclusions on the patentability of the cDNA, however, the Court did not apply the same logic. Although the elimination of introns does not occur naturally, the genetic information contained in exons is pre-existing and results from purely natural processes, and by the Supreme Court's logic��applied to BRCA1 and BRCA2, should be considered non-patentable. Furthermore, even while recognizing the possibility that a molecule similar to cDNA may possibly occur naturally by an unusual and rare phenomena caused by viruses, the��Court confirmed its patentability as a composition of matter (§ 101) without providing a reasoned analysis of their opinion. Finally, the Court suggested that if the patent claims were focused merely on the chemical composition of the molecules of BRCA1 and BRCA2 instead of the actual genetic information of these genes, patentability may be possible; a statement which does not seem to be well-supported by the judiciary in light of § 101 and of the law of nature exception. In short, the U.S. Supreme Court did not exactly establish��a boundary between the concepts of "product of nature" and "the result of human inventiveness", and as a result there is still legal uncertainty with respect to��biotechnological patents.

Apart from the criticisms, it is important to note that the decision in Myriad under U.S. law��is opposite to��the current law in the European Union. states that isolated DNA sequences are patentable. Many scholars dispute whether the scope of protection provided by these patents is absolute (comprising all applications of the chemical compound) or purpose-bound (comprising only the applications indicated by the patent applicant). On this, the European Court of Justice decided prima facie that the scope of protection of biotechnological patents is purpose-bound (see ). This difference in legal treatment in the EU is favorable to holders of patents related to DNA sequences, who can still enjoy legal protection in several European countries.

In my opinion, the decision by the U.S. Supreme Court is, to some degree, appropriate. The acknowledgment that the isolated genes occur naturally is correct; if the product itself is not a result of the human inventiveness, but only found in the nature, it is not an invention. This view excludes the patentability of DNA sequences and promotes development and innovation by competitors. If the isolation of genes constitutes an inventive step, the methods of isolation may be considered patentable, but not the chemical compound itself. The novelty of the isolated genes, however, is questionable since its existence is known before isolation. In spite of this, there remains some well-founded criticisms of the decision, which the Court will need to address them in future cases.

The decision of the U.S. Supreme Court in Myriad creates an important precedent for cases related to the patentability of biotechnological inventions in the USA and, considering its subject-matter, can serve as a model for improvement for legislatures and judiciaries in other countries.

Pedro Henrique Dias Batista is an IPilogue Editor and a PhD student at Ludwig Maximilian University of Munich.

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The criticisms from Australia concerning the patenting of genes echo those expressed throughout the North American battle. The primary attack on assigning patents of genetic materials to a company surrounds the invention component of the patent. Australian patent lawyer and proponent for ‘free trade’ of genetic materials, , likens companies such as Myriad to ‘cartels’, emphasizing that the genes are not something that anyone has invented. that allowing gene patents will permit patents on any biological materials that are artificial, irrespective of their source.

In an extremely accessible and , the Court surveyed the biological principles necessary to consider gene patents (this comprises more than half of the decision, and I strongly recommend it to anyone without a strong background in biological or medical sciences). The Court accepted the arguments of Myriad’s Australian lawyers, who leaned heavily on the arguments put forward by Myriad in the (although it noted that due to differences in the patent legislation and jurisprudence the American case itself was neutral, benefitting neither party). It was held that:

(1)�� because the genes are not naturally occurring DNA or RNA as they exist within the cells of the human body (which are not patentable, per ), they are not precluded from being the subject of a valid patent, and

(2)�� the patent claims to the genes are indeed to a manner of manufacture as required by .

With respect to (1) above, the Court was very conscious of the legislative intentions in drafting s. 18 of the Patents Act. In para 112 of the decision, it was acknowledged that a proposal was brought and subsequently rejected that would have included isolated DNA and RNA in the s. 18(2) provision. As such, it was left to the Courts to deal with the issue of gene patenting by establishing jurisprudence.

The Court found that because the patented nucleic acid sequences for BRCA1 and BRCA2 are independent and isolated for native DNA, it is patentable. Furthermore, because the sequences could not exist in isolation without human intervention, the patented matter consists of “an artificial state of affairs” (see paras 101-110), a necessary condition for invention in the Australian legislation. Even if it has been removed from a biological cell, the Court held that it is reasonable to deem the isolation ‘artificial’, emphasizing the process of isolation rather than the extracted material.�� Addressing broader concerns, Myriad’s counsel also emphasized that��the screening process of the patent, which includes the diagnostic component of comparing normal and mutated genes, could not be used .�� However, in my opinion, this does not address the important issues of access to medicine and the potential detriment that the patents pose to scientific progress.

The present case was in the form of a lawsuit brought by a national organization representing cancer patients, , and a Brisbane cancer survivor concerned with the impact that the gene patents will have on breast cancer diagnosis and treatment. I share these concerns. Indeed, I have about Myriad’s monopolization of the market and the conflation of trade secrets and patents, so I would direct your attention there for this discussion. However, for those opposed to the patenting of genetic codes and the processes for isolating genes, this Australian decision certainly gives reason for concern. That said, Myriad’s victory down under may be short-lived, as Cancer Voices Australia announced on March 3, 2013 that they to the decision of the Federal Court.��

Ryan Heighton is 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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Canada has been described as a functional food ��because of our academic expertise, raw agricultural materials, and proximity to the US.�� In fact, Osgoode’s home base recently topped a number of globally innovative cities with the USPTO.

Given the patent system’s supposed ability to , should we look to patents to drive R&D to create healthier foods?

Functional Food Patents

Functional food inventions can be if they fall under patentable subject matter and are new, non-obvious, and useful. The discovery of a functional food that already exists in nature will not be patentable (e.g. pomegranates). Also, blueberries may not pass the innovative mustard. Higher life forms, for example a, are barred from patenting while have squeaked through. ��Examples of functional food patents that have met the legal requirements include a of preparing probiotic cereal flour and fish proteins.

Overall, it appears that functional food patents are a relatively market. ��Considering their potential, why are inventors only starting to��focus on functional food patents in Canada?

Patent Claims vs. Health Claims:

To redeem the significant financial investment required to obtain a patent, intellectual property owners often look for a market to sell or licence their invention. In Canada, functional foods are regulated under the ��as either a (NHP).

Depending on the food or NHP categorization, functional foods will be subject to different for safety, labelling, advertising, and post-market surveillance. Both regulatory regimes what can be said about health on labels and other promotional materials and bar false and misleading claims.

In addition, new functional foods (and ingredients) must go through a government approval process for safety and a separate process for new health claim approval. The food and NHP (to a lesser extent) regulatory environments may prevent or severely limit IP owner’s ability to tell customers about health benefits.�� Ultimately, this may represent a and could factor into the cost/benefit ratio for investing in R & D and the patent process.

Ethical Eating?

Patenting food cooks up similar ethical and moral pressure points as patenting pharmaceuticals and biotechnology, such as increased costs, barriers to life saving treatment, and bio-piracy.

Obesity and chronic disease are now a global problem that affect medium to low income countries. Higher food costs related to patents could increase food insecurity and inhibit further economic development in poorer countries burdened by healthcare costs.

Fruit, Vegetables, and Whole Grains Already Exist!

Unlike infectious diseases, we can often obesity and chronic diseases by eating a healthier diet, exercising, and reducing stress. Why do we need more innovative foods when the old ones still work and are pretty cheap? Furthermore, patenting foods may go against the grain of and other local, organic, and simple ingredient food movements.

Safety and Health Washing:

The recent recall demonstrates the importance of safe food. While our food regulatory system may be cumbersome, there is likely a strong rationale for safety precautions and scientific and administrative barriers. In addition, allowing generally unhealthy food (high in salt, sugar, or fat) to carry health claims related to patents could open a whole new can of sour worms!

Wherever you stand on patenting as a means of driving R & D investment into healthier food, it is something we need to continue to explore. If Canada is truly a functional food powerhouse, we may be missing opportunities to improve our health, grow our economy, and create jobs. On the other hand, the patent system may be the wrong tool and could have negative health, economic, and ethical consequences.�� Either way, hopefully others will continue to chew and digest on the potential use of the patent system to stimulate R & D into healthier food.

Amanda MacNaughton is a JD candidate at Osgoode Hall Law School and is currently enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program.�� As part of the program requirements, students are asked to write a blog on a topic of their choice.

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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.

The post The Patentability of Gene Sequences: Myriad Genetics’ Day in the United States Supreme Court appeared first on IPOsgoode.

The justification for patent incentives reaches a high point when it solves a ravaging health problem, such as proving a cure for malaria, AIDS, or Lyme disease. It dips to its nadir when it interferes with research or interferes with professional judgment or practice. However, patent owners want profit from patents. If they can, they would like to control competitors. of Santa Clara University summarizes the situation:

While each patent dispute is unique, most fit the profile of one of a limited number of patent litigation stories. When an independent inventor sues a large company, for instance, a David v. Goliath match-up results. In contrast, if the parties are more evenly matched, comprising two large private or publicly traded corporations, the result can be patent warfare, potentially of global dimensions.…the strategic use of patent litigation by well-established large companies against their smaller, less-established rivals has been called predatory. , 87 N.C. L. Rev. 1571, 1577 (2009).

Congress has power to enlarge patent law to “include anything under the sun that is made by man.” However, it is extremely unlikely to contradict the Supreme Court's "bright-line prohibition against patenting laws of nature, mathematical formulas and the like.” Applying this principle, the Court rejected the United States government's amicus argument that the case ought these claims ought to be judged on the basis of novelty (), obviousness (), or specificity (), rather than on the fundamental uestion of patentability per se. Congress�� has always acquiesced in the Supreme Court interpretation of permissible scope. See also, .

The world patent picture

United States patent laws and practices cast a long shadow in world intellectual property. Entities that seek to promote high capital value for patent rights have been able to draw on United States patent policy as an example of strong proprietary rights. The Bilski and Mayo cases provide a basis to push the other direction, in favor of access rights.

The great mass of humanity needs access to medical advances now more than even. However, in the international patent regime created by the current and the (“Trade Related aspects of Intellectual Property”) loads the dice against such access. states that this treaty structure does little, however, "to explicitly safeguard the interests of those who seek to use protected works. In some ways, this structure is not surprising. Because the free traders who negotiated the GATT worked in an environment in which the core concern, reducing market barriers, was viewed as producing (at least in the long term) unmitigated welfare gains." Rochelle Cooper Dreyfuss, .

Scope for medical advance

The Court patent laws must not interfere with research and practice. It stated:

The patent claims at issue implicate this concern. In telling a doctor to measure metabolite levels and to consider the resulting measurements in light of the correlations they describe, they tie up his subsequent treatment decision regardless of whether he changes his dosage in the light of the inference he draws using the correlations. And they threaten to inhibit the development of more refined treatment recommendations that combine Prometheus' correlations with later discoveries.

Doctors and small companies now have a better chance to move ahead with constructive practices and innovations.

All in all, March 20 was a good day for the public.

is a United States attorney, law professor, and writer. He has previously written for the IPilogue and .

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