The moral duty not to infect others can be wide ranging: preventing transmission of the flu to preventing transmission of HIV, for example. frames the issues as to “what extent do individuals have a moral obligation to avoid spreading disease?” He is particularly interested in the duty to accept influenza vaccines to protect the vulnerable, like the elderly or the chronically ill. It is easy to see how this argument applies to our current situation; our physical distancing and wearing of masks helps prevent the spread of COVID-19 and reduces the potential risks of harm to others. Even if a disease is not harmful to us – say, we happen to be – we would still have a moral duty to mitigate harm to others. We can understand this duty in terms of beneficence. This arguably includes a duty to get vaccinated, physical distance, wear masks, and install COVID Alert.

Still, as suggest, what is required by morality is not absolute, and there are other considerations to take into account. One trivial example of this is the common cold: “unless there is reasonable financial compensation, such as illness allowance, one cannot expect a sick person to stay at home for the sake of her colleagues." This general picture of morality, which understands morality in terms of “prima facie duties”, is most famously expounded by philosopher . The basic idea is that different moral duties (e.g. a duty of beneficence, a duty of justice, a duty of non-maleficence, etc.) can conflict with one another given our varied circumstances, and one single duty is not absolute. For instance, if the Kantian is faced with a murderer who inquiring about the location of your friend, the Kantian must obey the moral duty to tell the truth to the murderer; however, according to Ross, the duty to save your friend might “override” the duty to tell the truth. There are certainly problems of “” (or morality asking too much of us) if we understand our moral duty as mitigating any and all risks – even driving a car poses significant risks of harm to others, but risk-to-reward weighs in favour of driving. Nevertheless, the slight inconvenience of physical distancing, wearing masks, or installing is insignificant compared to .

provides an excellent analysis of the legal and ethical issues with the previous SARS outbreak. He frames the issue as a conflict between “the duty to protect the public, which is a collective good, and the individual rights of privacy and liberty,” particularly with regards to surveillance, isolation or quarantine, and restriction of movement. On the ethical side, we might turn to and ask how actions could be justified such that nobody could reasonably reject them. We could use voluntary measures rather than coercive ones, take “softer” approaches to , or make use of “.”

On the legal side, these issues around COVID-19 laws are a live question for constitutional jurisprudence. I foresee many academic articles around this topic, especially in the Canadian context with respect to balancing legitimate public health purposes with Charter rights and freedoms. In any case, we have an individual moral duty to physical distance, wear masks, and, in my opinion, install the . As Douglas Adams said, “The single raindrop never feels responsible for the flood.” It is important to be a good moral citizen and to do our part to contribute to our community, nation, and world.

(This blog post draws on a presentation given for a graduate seminar on Applied Ethics with Professor Claudia Emerson at McMaster University in 2017.)

Written by Dan Choi, a second year JD Candidate at Osgoode Hall Law School and an IPilogue Contributing Editor.

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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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������ that Myriad has been retaining clinical data concerning BRCA1/2 mutations as trade secrets, stemming from their control over BRCA1/2 research. By claiming mutation information from clinical trials as proprietary, Myriad is failing to disclose valuable information that is secondary to their patent of the initial genes, and potentially impeding research on the genes that could result in life-saving developments. This brings concerns around the circumvention of the parameters and breadth of their initial patent, as well as the convolution of the patent as a means of shrouding their company data in trade secrecy.

Typically,��; in exchange for disclosure of the information surrounding the invention (which is in the interest of furthering innovation), patent holders are granted legal protection from others using their patented invention. Trade secrets do not afford legal protection, and anyone obtaining the secrets (typically excluding those under contract) may use them freely. Of the greatest concern is that even if the BRCA1/2 patents are invalidated in court in the Spring, Myriad will still be privy to the clinical data collected under the invalid patent. Such unconscionable use of the patent system directly violates the  on which the system was built.

The primary public health consideration in Myriad’s decision to retain clinical data as trade secrets is the  that has resulted from their retention of mutation information. This is a particularly great concern, as Myriad  with BRACAnalysis. By retaining clinical BRCA gene mutation information in America, but not releasing it publicly, Myriad has ensured that consumers utilizing their test will receive more reliable results. At present, it has been reported that as a result of the vast mutation data and algorithms that Myriad has collected since releasing the BRACAnalysis test, only 3% of mutations will be of unknown significance. This contrasts unknown variant rates of 20% using other tests, including those presently in use in Europe. This means that Americans utilizing Myriad tests have a significantly greater chance of having their genetic variants identified, which is essential to therapeutic counseling. Further, as a result of this trade secret ‘loophole’ in the American patent system, which mirrors our own in Canada, Myriad will possess an inherent competitive commercial advantage over European BRCA tests despite not holding a BRCA patent in Europe. By allowing this type of action, a dangerous precedent is set in the field of biotechnological research, where research facilities may use patents as swords in order to protect vast trade secrets and monopolize a market, contrary to the public interest.

Beyond commercial interests, the primary function of scientific research in society is to serve the public good. This is particularly true in the case of medical research, as the ultimate goal is to benefit patients and improve diagnostics, treatment, and preventative medicine. Patents have become , in order to encourage innovation and provide commercial protection and incentive for researchers who make significant breakthroughs. However, in the United States, it has been shown that  as of 2005, with most “inventors” overstating their discoveries surrounding the code, while others were granted protection for genes that had not been “discovered” yet (e.g., mutated or isoforms, with no description of the genes).

In my opinion, Myriad Genetics is a company benefitting from relatively lackadaisical biotechnology patenting standards. In addition to holding a (thus far) valid patent on the two primary diagnostic genes for breast and ovarian cancer,�����ٳ���dzܲ�����, which has been described as the most efficient breast cancer test commercially available. Holding the American patents for the BRCA genes has ensured that Myriad has been able to turn a profit after pouring millions of dollars into research and development, and has in turn improved the diagnostic potential of medical practitioners. However, with this advancement in medicine has come at great cost to the public. By creating geographical inequalities (resulting from the limited scope of Myriad’s services), Myriad is effectively compromising the therapeutic services provided to women worldwide, solely to advance their economic interests. Thus, despite creating an incredibly useful database of mutation information and algorithms, Myriad has effectively created a monopoly, and, in my view, has violated the promotion of innovation and discovery that the patent system is designed to serve.

�ճ�𾱰���, combined with what is regarded as an unreasonably high cost for the BRCA testing has led to allegations that Myriad is engaging in  by compromising the interests of public health in order to turn a profit. In my opinion, while the patent system certainly serves as a means of providing financial restitution to researchers and facilities that take financial risks in the interests of innovation, there comes a point when the public interest is being jeopardized out of greed. Such compromise of the public interest, especially in a medical research context, is contrary to the spirit of the patent system, which is to provide information to the public to improve transparency in innovation.

With the completion of the , the United Nations identified the risk of abuse of advancing biotechnology, and the  took effect. Of particular importance is Article 12, which indirectly relates to gene patenting and freedom of research. It takes specific note of the unique nature of the genome, which is within all humans, and declares that the genome should be free to research in the interest of advancing bioscience and medicine. Additionally, and in my view damning to Myriad’s trade secrets and imposed geographical inequality, it declares that the benefits of advances in genetics and medical science be made available to all. Although this is not a binding legal document, it was carefully considered, is highly persuasive, and contemplates essential concepts in bioethics which may factor into the Supreme Court’s 2013 ruling.

Ryan Heighton is a JD candidate at Osgoode Hall Law School.

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