Serena Nath is an IPilogue Writer and a 2L JD candidate at Osgoode Hall Law School.

Controversy and uncertainty in the field of patent eligibility have resulted in decade-long fights over what can be patented and what cannot be, especially regarding diagnostic tests. There is currently a congressional push to let drug companies patent diagnostic tests in the United States. This push comes from Senator Thom Tills. On August 2, 2022, Senator Tills introduced Bill , titled the Patent Eligibility Restoration Act of 2022, which, in part, aims to change currently existing US federal patent law regarding patent eligibility for different classes of inventions. ��

History of Patenting Diagnostic Methods

The bill was largely motivated by several Supreme Court rulings over the past decade, which have created exceptions to patent eligibility in biotechnology and pharmaceuticals. Traditionally, an inventor can gain patent protection for their invention if it is novel, non-obvious, and has utility. However, in 2012, the court in ruled that diagnostic tests that reflect naturally occurring biological phenomena cannot be patented because one cannot have a monopoly on a relationship based on natural principles. This ruling was then reaffirmed later in . This exception in the eligibility of diagnostic tests led to widespread confusion regarding patent eligibility. In particular, the chief judge of the US’s top patent court, Kimberly A. Moore, saying that Federal Circuit judges are now unsure of how to apply the patent eligibility provision. Additionally, these exceptions have led to patents being rejected in the United States but approved in other jurisdictions with similar patent laws, such as Europe, thus discouraging biotech companies from investing in diagnostic methods. In response, Bill S.4734 is being presented to address this confusion and increase innovation in the United States via more specific patent eligibility standards that are likely to expand the ability to patent modified genes and pharmaceutical processes, including diagnostic methods.

The Debate over S. 4734

This proposed bill has drawn much debate. On the one hand, , such as the American Civil Liberties Union, have expressed concern that this bill will allow pharmaceutical companies to take advantage of this expanded patent eligibility by creating monopolies over essential diagnostic methods resulting in decreased access to these methods and overall harm to the health of Americans. However, , such as the Council of Innovation Promotion, argue that the bill will increase investment into diagnostic research, which decreased significantly after the Mayo decision. These groups point to the pharmaceutical industry’s response to COVID-19, arguing that patents were the basis for creating the vaccines.

If the bill can clarify patent eligibility in the US, it may be worth pursuing further. However, I also question the idea that patent eligibility is the driving force behind biotech innovation.�� The Invention-Induced Theory, argued by proponents for S.4734, posits that patents are an incentive for inventors and that absent patents, there will be no inventions. However, this theory fails to account for inventions induced by the market, scientific curiosity, accident, or ego. Additionally, have shown that patents are not a significant driver of most innovations. Thus, there may be a better way to both reward biotech companies for their creation of diagnostic methods and prevent harmful monopolies over essential lifesaving inventions.

Regardless of which side of this debate you fall on, it is still being determined if S. 4734 will be further explored. When this bill was introduced in August 2022, the Tillis planned to hold hearings focused on this legislation if the Republicans took the senate in the November midterm elections. However, with the , the future of this matter remains uncertain.

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Image by Philip Ezze ()��

Emily Xiang is an IPilogue Writer, President of the Intellectual Property Society of Osgoode, and a 2L JD candidate at Osgoode Hall Law School.

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What is Bioprinting?

is an innovative technology that uses cells, organic materials, and biological molecules to create complex models and structures. Its is forming organic tissue constructs with a high degree of repeatability, flexibility, and accuracy. Since its first breakthrough in the health and pharmaceutical industries in the 2010s, the application of 3D bioprinting has grown to include , , , , and . In 2021, the global 3D bioprinting market was valued at and is expected to grow from there.

3D Bioprinting in the Cosmetics Industry

The use of bioprinted tissue by cosmetics companies has seen tremendous growth in recent years. In Europe, following the which banned animal testing for cosmetic purposes, cosmetics companies have had to seek alternative methods of ethical testing on varying skin types that would also produce accurate results. ��Moral advantages are not the only kind of benefit that bioprinting technologies can offer. Since human skin is multilayered and comprised of various cell types, 3D bioprinting presents the unique ability to deposit cells in meticulous arrangements that closely resemble actual human skin, resulting in and faster, cheaper, and more effective testing procedures. Since 3D bioprinting entered the marketplace, global cosmetic leaders such as and have invested significantly into the R&D of bioprinting technologies, with a view to revolutionize the practice of dermatology in the future.

3D Bioprinting & Canadian Patent Law

From an intellectual property law perspective, could 3D bioprinted material be patented? While the scope of patentable subject matter in Canadian patent law is generally considered ��quite broad, products and techniques related to bioprinting between the living and the non-living, which could complicate matters. In , the Court held that “higher life forms,” such as genetically modified plants or animals, were not patentable but affirmed the patentability of the genetically modified genes in question. Since the decision, the Canadian Patent Office has more clearly delineated the distinction between higher and lower life forms in the , which defines lower life forms as unicellular and higher life forms as being multicellular. In Chapter 17.02.02 of the MOPOP, the Patent Office states that “[a]rtificial organ-like or tissue-like structures that are distinct from true tissues and organs and that have been generated by human intervention through the combination of various cellular and/or inert components may be considered, on a case-by-case basis, to be manufactures or compositions of matter with the scope of section 2 of the Patent Act.”

While some ambiguity remains regarding the patentability of bioprinted materials, there has been some success in patenting associated with bioprinting. Despite these patents, however, bioprinting technology can still be said to be distinct from, for example, more cutting-edge , for which the core of the technology can be patented and can thereby lead to intellectual property disputes. In contrast, the core elements of bioprinting derive from that are already free from patent protection, providing innovators working with bioprinting technology some more leeway to appropriate the existing methodologies in the field.

Conclusion

While cosmetics companies constitute some of the more recent actors to leverage the new technology, bioprinting has gained in the industry in recent years, with interest no longer being restricted to academic circles but also gaining traction in the marketplace. As the research and development of 3D bioprinting continues to evolve, the need for the law to take a more explicit stance on the subject matter will become increasingly apparent.

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What is CRISPR?

Some scientists believe the design and development of new biomolecules is as much an art as it is science. The ��discussed, and used, by Dr. Pearlman capitalizes on an adaptive immunity system found naturally in bacteria and archaea that uses clustered, regularly interspaced short palindromic repeat (CRISPER) DNA segments to fend off invading viruses. In naturally adapting to a virus invading the cell, CRISPR associated proteins (Cas proteins) will create a spacer unit of genetic code that is unique to the invading virus and incorporate this spacer into the CRISPR region of the cell’s genome. This unique spacer unit will then be transcribed (that is, converted from double stranded DNA to RNA), associate with Cas proteins to form a functional complex, and then target and inactivate the very same type of virus that led to the creation of the spacer unit.

In the laboratory, genome editing uses the functional complex found in this adaptive immunity mechanism to insert or remove genetic code from the genome of a cell. By attaching a synthetic, guiding portion of RNA (sgRNA) to Cas proteins they can be directed to a portion of the genome, through complimentary base pairing with the sgRNA, where Cas will recognize a portion of the genome and cut it to either insert a new region or to remove a portion and disrupt the expression of a gene. By cutting out sections of DNA a gene can be disrupted and lose its functional expression in the cell. In other words, it will no longer be able to produce the molecular products responsible for its former physical trait. By inserting new regions of DNA, the genome can be expanded to confer resistance to invading pathogens, such as viruses, or to express new protein products that can add or enhance the cell’s function. For example, a new portion of DNA may be inserted that codes for a digestive protein not normally found in the cell and, consequently, grant a new molecular digestive mechanism.

What does Genome Editing have to do with Law?

Dr. Pearlman noted that there has been an explosion of scientific literature covering the CRISPR system of genome editing since 2010 and it appears that the momentum will only grow in the coming years. The ability to edit genomes can allow for the expression of new protein products that can be of great commercial value as well as pave the way for new medical treatments that circumvent traditional pharmaceuticals. Additionally, Dr. Pearlman noted that the CRISPR system can be used to produce heritable traits – that is, changes that can be transferred from a parent to their offspring. With this sort of molecular modification becoming more pragmatic, it becomes paramount to have a thorough understanding of the biochemical expression pathways that govern genomic expression to keep an eye on the ethical implications of modification. If human genome editing were to become available, should those with advantageous genomic modifications be treated differently by public health systems? To whom should these technologies be made available, if ever? These questions are beyond the scope of current genomic technology but, with the growing pace of CRISPR methodologies, designs may soon start to reach more readily into the macroscopic domain.

What Makes Scientific Designs Different?

With the cost of biochemical research and development increasing and a billion-dollar entry fee for the drug and biomolecular development market it follows that when an industrially relevant molecule is finally created the developer should be able to recuperate their investment and benefit from their work. Normally, the boundaries of property rights require contextual understanding: what is the nature of comparable products, if the new product’s design is generic or obvious, and if the new product can have a place in its intended market. The differentiating criteria of the sciences become pronounced when considering the esoteric nature of the discipline. How can one reasonably expect a thorough consideration of the distinguishing criteria for obscure scientific concepts, like base pair fidelity, when the requisite knowledge is held only by a few people, like Dr. Pearlman, who have committed years, if not decades, to the study? The nuanced nature of genetics can make innovations in genome editing or CRISPR technology appear to be near imitation; however, the modification of a single nucleotide in the genetic code can have a profound impact on the success and possible application of a biotechnology.

Synthesis, Structure, and Industry

What amount of scientific knowledge is sufficient in legal practice? that a special breed of IP lawyer will arise to confront the high demands of contemporary science and technology patents. Considering the high financial stakes and the significant likelihood that a new molecule or molecular technique will fail the requisite safety tests at any of a multitude of stages, a lot of designs are left in the laboratory. A re-engineering of the approach or scrapping the project in its entirety may follow, meaning product patents should not be initiated until after the molecule has been proven safe for its regular use instead of when it is first designed or synthesized in the lab. Additionally, research and development can indirectly prioritize self-benefit over scientific collaboration since scientists rely on design details to learn about their ever-developing field and most details are kept secret until after a patent has been granted.

This is where innovation becomes conservative and structure becomes especially important. Does a single elemental substitution in the genetic code constitute a new product if the application remains the same? What about changing a single gene to modify a physical characteristic that relies on multiple genes? While certain business practices, such as non-competition deals, are commonly found outside of the sciences, unique can arise from small chemical modifications which effectively extend a patent beyond its expiry date through the issuing of a new patent for a highly similar molecule. Furthermore, patents may be sought for generic parts of biotechnology procedures that are nonessential to its action, prohibiting competitors from including strategies in their approach and significantly , or even demolishing, a competing synthesis. Lastly, meeting the testing and safety demands of different communities poses an for introduction into a global market due to different national regulatory standards.

So, What Makes It My Molecule?

The same fundamental concepts that apply to patents outside of genome engineering also apply to those inside the discipline but with a stringent demand to understand the nuances of molecular design. An integration of mechanistic knowledge may prove to be key when evaluating possible distinguishing criteria among patents filed for similar compounds but it is ultimately up to practicing lawyers to integrate sufficient scientific knowledge to accurately capture the scope of their client’s designs.

Dominic Cerilli is the Content Editor for the IPilogue and a JD Candidate at Osgoode Hall Law School.

[1] Dr. Pearlman's talk was organized by The 91��ɫ Collegium for Practical Ethics and The 91��ɫ Centre for Public Policy and Law under the leadership of Ian Stedman.�� Support for the event was provided by IP Osgoode, McLaughlin College, 91��ɫ - Faculty of Health, 91��ɫ - Faculty of Science, and 91��ɫ's Office of the VPRI.

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Whenever a new technology has the potential to be ground-breaking and extremely valuable, there are bound to be disputes about invention and ownership. From to the , scientists and inventors are often driven into competition and conflict. Recently, one such conflict has arisen over one of the biggest of the Twentieth Century.

Clustered regularly interspaced palindromic repeats () are a molecular system whose harnessing is transforming the science, with important applications in medicine, biotechnology and other areas. By repurposing the natural biological system, scientists are able to target and make precise changes to specific strands of DNA at a more cost-efficient and faster rate than ever before. While CRISPR has spurred the development of a host of new technologies, there has been significant controversy over who actually owns the “invention.” A winner-takes-all dispute over the technology’s patent rights is in full swing between the Broad Institute and the University of California, Berkeley, and the spoils are plenty.

Serendipity and bacterial immunity

First discovered in Japan in , CRISPR was subsequently shown to be an adaptive system used by bacteria to defend against viral infection. Francisco Mojica identified these repeating sequences of DNA in 1993, while working as a graduate student in Santa Pola, Spain. Mojica isolated CRISPR loci in over forty different microbes and identified their key features.

Just as Mojica was publishing his paper, Gilles Vergnaud—at the time, a geneticist for the French ministry of defence—was also completing research illuminating the function of the CRISPR system. Vergnaud found that the CRISPR locus often contained new spacers similar to those in prophages in bacterial genomes. It was Vergnaud and his colleagues who first hypothesized that CRISPRs serve as a defence mechanism for viral infection.

Subsequent work by researchers such as Philippe Horvath and Rodolphe Barrangou, working in the dairy industry to identify bacteria in yogurt and cheese production, developed our understanding of the cas9 protein. A by Marrifini and Sontheimer, two researchers then at Northwestern contributed to identifying DNA as the target of CRISPR. These researchers were also the first to predict that CRISPR could be used for genome editing.

, which involved scientists working in industries as diverse as defence and food processing, predated the work done by the Berkeley’s , and of the Broad Institute. These varied fields which led to the development of the CRISPR-Cas9 system are telling of the wide impact the CRISPR system could have.

Not your average scientific debate

It is not surprising that arguments arose over the ownership of rights to CRISPR-based inventions which contributing to . “Cancer-fighting” and are attention-grabbing phrases, and the implications and value of the science are both . For instance, there has been much debate over the to allow a research team to engage in germ line editing of human embryos. The —usually infrequently interested in complex scientific discussions—is attune to the importance of the and the stakes.

So, what is the problem? The problem is that two major academic and scientific institutions, along with their scientists, cannot agree about the patents for CRISPR technology.

Big league players

The debate is more an institutional one than one between competing scientists. At the highest level, it is and the who are fighting a patent (and ) war over CRISPR. At issue are patents filed by Broad’s Zhang and Berkeley’s Doudna. Whoever owns the technology can expect a windfall in .

The researchers

In 2012, Doudna et al. published that elaborated on the mechanism used by the associated CRISPR system to insert breaks in target DNA. In this publication they discussed the possibility of applying the CRISPR-Cas9 system to genome editing in eukaryotic cells. However, as confirmed by , a biologist at 91��ɫ, this paper described only the possibility of using CRISPR Cas9 for genome editing in eukaryotic cells and in that paper, the authors did not in fact do genome editing in eukaryotic cells.

Zhang et al. appear to have been first utilizing the CRISPR system to accomplish genome editing in mammalian cells. Soon after, George Church, a leading geneticist from Harvard, ��published that outlined possible applications of CRISPR in editing human cells. that, while Doudna and Zhang were instrumental in the application of CRISPR technology, the gene-editing project was a collaborative effort. However, aside from this anecdotal evidence, it is not clear that this was the case.

The patents

The Berkeley application was filed on March 15, 2013 by Doudna and . Zhang filed his application seven months later on October 15, 2013. Zhang expedited the review of his application (under a “”), which would otherwise as conflicting with the earlier one. He was in April 2014.

In addition to determining who filed first, there are further questions concerning the scope of the patent claims in question. As New 91��ɫ Law School’s notes, Doudna’s initial application “”, while Zhang’s “.” Although Doudna’s initial filing may not have conflicted directly with Zhang’s, her , because—her lawyers argue—the application covered gene-editing in mammalian (including human) cells.

Science goes to court

In April 2015, Doudna (Berkeley) took the issue of the competing patents to the and, in early January of this year, . An interference proceeding is used to assist in the determination of priority: “.”

Administrative Patent Judge Deborah Katz, who declared the interference, now refers the matter to the Board of Patent Appeals and Interferences, which will consider evidence from both parties (such as laboratory notes and publications from both parties) in order to determine dates of invention. Today, the United States has a “” patent system, but at the time Doudna filed her patent application, it was “first to invent,” so the interference proceedings will go forward on that basis.

The decision of the panel will determine who, if anyone, owns , based on . This interference has lessened the possibility of a The panel can decline to award the patent to either party.

Moreover, the decision may be appealed to the US Court of Appeals for the Federal Circuit. Recently, for the interference proceedings, though the patent board trial judge has yet to rule on them. So, while the dispute may have moved from the lab to the courts, it is far from over for the institutions or their scientists.

Big money anxiety

Though the Broad Institute has made the technology to the research community, a lot of money remains at stake in the control of these patents, especially for founded to develop the technology. Interference proceedings are , making them unusual for academic institutions. While the technology is , commercialization is another matter altogether.

The commercial applications of this technology mean that more than just academic institutions are taking notice. As , CRISPR-related companies are already making significant investments in the technology. For instance, (founded by both Zhang and Doudna) has planned a $100 million IPO. Other biologics firms, such as CRISPR Therapeutics, Intellia and Caribou Biosciences (which has raised nearly $90 million) are partnering with large pharmaceutical companies.

All of this raises questions about the benefits and drawbacks regarding the ownership of science, especially when there may be so much to be gained for peoples’ health. Researchers and start-ups alike appear to have every intention of of the technology, but the uncertainty engendered by the does little to advance the science.

CRISPR clearly has the potential to be a game-changing medical technology, but clearly even ground-breaking discoveries have to wade through the legal muck sometimes.

Recent updates

The Patent Trial and Appeal Board on several motions on March 17, from both Berkeley and Broad. Broad will be able to argue that there was no interference because of the specificity of its patents as to eukaryotic cells, while Berkeley will not be able to argue malfeasance on Zhang's part at this time but will be allowed to argue for a reworded count. These early rulings are not determinative and serve to show how unpredictable the outcome is at this stage.

Sebastian Beck-Watt and Daniel Quainoo are IPilogue Editors and JD Candidates at Osgoode Hall Law School.

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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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