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.

The post What Makes It My Molecule: A Look at Professor Ronald Pearlman’s Genome Editing Work appeared first on IPOsgoode.

The case concerned whether Myriad’s patents, describing the composition of isolated DNA molecules and methods of isolating and analyzing genes used to detect certain types of breast and ovarian cancers, are patent eligible in light of the recent ruling of (Mayo). Patent eligibility in the United States is defined by . The United States Court of Appeals for the Federal Circuit had originally reviewed the patents in July 2011, before the United State Supreme Court’s holding in Mayo. During their original review, the Court found that Myriad’s composition based claims, the claims covering the actual isolated genes themselves, were patent-eligible. In contrast, Myriad’s patent claims covering comparison and analysis were almost all patent-ineligible. The original ruling was a 2-1 split decision with Justice Bryson stating in dissent that genes and their fragments were also patent-ineligible. The decision was appealed to the United States Supreme Court.

The Mayo decision was handed down nine months later, in March of this year. In this decision, covered in a guest blog on IP Osgoode , the Supreme Court ruled that the method claims found within Prometheus Laboratories’ patents were not eligible for patent protection because the claims were based on laws of nature, a patent-ineligible subject matter. In light of the Mayo decision, the Supreme Court remanded the Myriad case back to the Court of Appeals for reconsideration. �� expected the Supreme Court decision to remove the legal foundation that the original Myriad ruling was built on, as human genes could be considered products of nature. Instead, the U.S. Court of Appeals for the Federal Circuit respectfully held that the Mayo decision would not alter their judgement against Myriad’s patents.

In the decision by the Court of Appeals, the majority relied on precedent established in (Chakrabarty) and (Funk Bros.) to help determine how patent-eligibility laws, specifically 35 U.S.C. § 101, should be interpreted in regards to Myriad’s composition patents. In Chakrabarty, the U.S. Supreme Court recognized bacteria engineered to break down different components of crude oil as patent-eligible. The Court found that because the claim was to a non-naturally occurring manufacture or composition of matter that was the product of human ingenuity, the claim was patent-eligible. In Funk Bros., the U.S. Supreme Court held that a grouping of unmodified bacteria was not patent-eligible as the aggregation of species did not make any of the species acquire a different property or use. Applying both of these precedents to the case at hand, the Court found that the composition patent claims, covering isolated human genes, were valid under 35 U.S.C. § 101 as they “are markedly different—have a distinctive chemical structure and identity—from those found in nature”. Although stating that the Mayo decision did not modify their holding, it should be noted that the Court of Appeals’ decision to hold the majority of Myriad’s method claims as patent-ineligible falls in line with the Mayo ruling. In Myriad, the Court of Appeals found that method claims that simply ‘analyze’ or ‘compare’ patent-eligible subject matter are not themselves patent-eligible as they only claim abstract mental processes. The only claim that escaped this judgement, claim 20 in U.S. Patent 5,747,282, included “transforming” the inputs of the method before analyzing, which in the Court’s eyes was more than simply applying a law of nature.

Also of interest in the instant case was the conflict between the government’s role and the role of the United States Patent and Trademark Office (USPTO). The USPTO was a defendant, while the government, as amicus curiae, argued that that human-engineered DNA molecules are eligible for patent protection, but isolated and unmodified genomic DNAs, like those targeted by Myriad’s patents, are not. In their ruling, the majority stated a desire to defer the issue to Congress and to allow the USPTO to continue to issue patents relating to DNA molecules as they have been for 30 years. In dissent, Justice Bryson raised an argument that the government’s position undermines that of the USPTO and therefore the issue should not be deferred.

This is a very contentious decision as it involves the patent-eligibility of naturally-occurring human genes. There are strong that this subject matter should not be patentable, while others claim that the subject matter’s “” make it patent-worthy. The ACLU, who was represented in this case, has stated that the ruling “.” Myriad, however, and believes that their gene patents have not hindered research on the DNA sequences that they cover. It is that this case will be appealed to the United States Supreme Court.

Mark Bowman is a JD Candidate at Osgoode Hall Law School.

The post U.S. Court of Appeals Stands Tall on the Subject of Gene Patents in the Wake of the Mayo v Prometheus Ruling appeared first on IPOsgoode.

Genetics, an Icelandic firm that offers customers private DNA tests . Customers would typically take a genetic sample from the inside of their cheek and would mail it to the address provided.�� deCODE Genetics would calculate the chances of a person getting cancer, diabetes, heart disease, and so on. There have been a few purchase offers for deCODE, and some worry about what this means for the privacy of the donors. Here is an explanation .

George Nathanael in his on IP Osgoode discusses the conflict between privacy and the need for research in genomics. Should the genetic information of patients be fully protected, for privacy’s sake? Or should we allow researchers to access anyone’s genome at leisure for the benefit of the ill? Experts argue that the kinds of treatments needed for diseases such as cancer and��Alzheimer’s, would benefit greatly from access to patients’ genetic information. On the other hand, Nathanael points out that the genetic profile of an individual is far more private and unique when compared to standard medical information. The entities that might administer these new treatments or tests are not traditional health care providers. Nathanael suggests that the current legislative framework such as the (PIPEDA) might not be sufficient to regulate this industry.

Looking at its framework and applying it to the situation illustrated by deCODE Genetics, does PIPEDA fall short? If it does, where does this leave us?

Section 7(2)(b) in PIPEDA allows an organization to use an individual’s health record in case of emergencies threatening a person’s life. Section 7(2)(c) in PIPEDA speaks about using personal information for research. However, this can be done if it is the only way to achieve this purpose, the information is used in a manner that ensures confidentiality, and it is impracticable to obtain consent beforehand. Also, the organization has to inform the Commissioner that this information is being used. However, does ‘health information’ cover genetic profiles? Personal ‘health information’ under section 2(1) of PIPEDA refers to a wide range of definitions. The one that could concern deCODE Genetics is section 2(1)(c). This is health information from “any body part or any bodily substance of the individual or information derived from the testing or examination of a body part or bodily substance of the individual”.

PIPEDA seems to cover the situation in deCODE Genetics. Health information is categorized broadly enough to cover a genetic profile, referring to information derived from the testing of a bodily substance. This personal information could then be used for research, as long as the necessary conditions are fulfilled and the Commissioner is informed. However, some concerns do arise. For instance, a genetic profile is by no means confidential under most circumstances. Due to its uniqueness it could be matched with a medical record. Furthermore, does research include the selling of information to another company?

Does PIPEDA have any teeth? Upon receiving a complaint, the Commissioner under s. 12(1) has the powers to investigate, call any witnesses, and gather any necessary evidence. This is placed in the Commissioner’s report, which also outlines any agreements reached between the parties. Under s. 14(1) a complainant may apply to the Court following the Commissioner’s investigation into any alleged breach.�� Based on s. 16(c) a Court may award damages to the complainant.�� PIPEDA leaves it up to the Courts to impose damages, which may be��a long and uncertain journey. Furthermore, the process appears to be claimant driven. This presupposes that the claimant is or somehow becomes aware of the breach of his/her privacy.

PIPEDA is��a start. However, the manner in which it would ensure privacy over such sensitive and unique information as a person’s genetic profile is at best uncertain. Furthermore, the legislation itself lacks any real teeth, and the dispute process is claimant driven; a long uncertain road in the Courts. Indeed, the regulation of this industry needs to go beyond that which is offered in current legislation. Hence, we are left with one question. Do we wait and see what happens, or do we impose further restrictions before genetic profiles become widespread? So far it seems we are opting for the former.

The post A Wait and See Approach to privacy in Genomics appeared first on IPOsgoode.

Andrew Wood was photographed as he was leaving the annual general meeting of , which owns Spearhead Exhibitions, a company that hosts arms trade fairs. Wood is the media officer for and Wood had purchased a single share in Reed, to enable himself to attend shareholder meetings. Reed hosted an arms trade fair that CAAT objected to.�� Therefore Wood’s attendance at the fair was considered controversial by some onlookers. While the court said that taking the photographs was not a breach of Wood’s privacy, the fact that the police retained the photos for days after the event with full knowledge that no crime had been committed, or allegation of inappropriate behaviour, was the issue before the court. Two out of the three judges deemed the retention of the photos was a breach of privacy as per

In his judgment, Lord Justice Dyson effectively articulates the core of the argument within the case:

“In my judgment the interference with the appellant’s article 8 rights was disproportionate. In deciding whether the interference is necessary, the court must have regard to the nature of the Convention right in issue, its importance for the individual, the nature of the interference and the object pursued by the interference.”

The Court of Appeal decision extends farther than police retention of photographs. , Michael Marper recently won the right to have his DNA records that were held by the UK Government destroyed. Marper was never charged with the crime that his records were held for. In response, the UK Government plans to make legislative changes that require records be destroyed 12 years after a person is arrested but not convicted of serious violent or sexual crimes and 6 years after all other crimes. that the proposed changes do not effectively distinguish between those who are convicted, under suspicion, or completely innocent. The government also did not outline a minimum standard for the destruction of DNA profiles and samples. In the 2006 case , the Supreme Court of Canada upheld the legality of police DNA databases, which includes retroactively collecting samples.��

DNA evidence is not used just for criminal investigations, but helps police identify victims of mass disasters using hereditary information from surviving family members. Family information can also be used to convict suspects. In April 2004, a United Kingdom resident became the first person to be convicted of a crime after the police . Cases such as these no doubt raise issues of genetic privacy. Even though a common argument for people who are in favour of police retaining information about suspects later cleared of charges is that the innocent should theoretically have nothing to hide, cases such as the one described above are a clear example that a breach of privacy of one person could have implications for another. While there is some evidence of trends within families towards criminal behaviour, such arguments would be quite controversial. Clearly the heart of the controversy involves the conflict between victim’s rights and offender’s rights. Organizations such as argue that, “Victim's rights should mean far more to all of us than the rights of those who victimize,” a standpoint that would likely be hard fast to survive in court. Should DNA testing be done when suspects are charged or only after conviction? Waiting until after conviction means that often those charged with crimes who fail to appear at trial could theoretically never have their DNA put into the database. It is also doubtful that obtaining samples at the time of arrest would survive a Charter challenge in Canada.

While the debate of obtaining DNA samples from suspects is not exactly the same as the debate about police retaining photos, both issues highlight the fact that the technology age is posing a new series of concerns for privacy that are unprecedented. As information is becoming more easily accessible and quickly transferrable from one person to another, privacy rights will be an ongoing issue both here in Canada and the United Kingdom.

The post Privacy Rights Violated by Police Holding Photos appeared first on IPOsgoode.

This issue had already been addressed in Canada. In R v. RC [[2005] 3 S.C.R. 99, 2005 SCC 61], the Supreme Court stated that keeping someone’s DNA records would have a disproportionately negative impact on their privacy, compared to the benefit to criminal justice. In particular, Fish J. noted that DNA contains information of the highest privacy, since it is “capable of revealing the most intimate details of a person’s biological makeup.” Thus, taking and retaining a DNA sample was considered a “grave intrusion” on a person’s privacy.

The European Court encountered this issue after a complaint from two English suspects. Local police had retained their DNA samples after their arrest, even though they had been cleared of any criminal wrongdoing. This issue fell within the scope of , which protects the privacy of individuals, but makes allowances for the public interest such as security and crime prevention. The Court commented on the scope of the DNA records, noting that police retained a sample regardless of the gravity of the offense, for an indefinite amount of time, without any independent review of their decision-making processes. Thus, the European court’s conclusion was much like the SCC, focusing on an appropriate balance of interests:

“The Court finds that the blanket and indiscriminate nature of the powers of retention of the fingerprints, cellular samples and DNA profiles of persons suspected but not convicted of offences, as applied in the case of the present applicants, fails to strike a fair balance between the competing public and private interests and that the respondent State has overstepped any acceptable margin of appreciation in this regard. Accordingly, the retention at issue constitutes a disproportionate interference with the applicants' right to respect for private life and cannot be regarded as necessary in a democratic society.”

The influence of other jurisdictions cannot be discounted. Along with Canada, several member-nations of the Council of Europe were cited in contrast to England’s “indiscriminate” practices. to retain a DNA sample only from suspects who have been convicted. This shows how democratic countries have a responsibility to one another. When setting policy in new and controversial areas, they are leading their peers by example.

A DNA database can have a potentially dangerous impact on privacy. The notes that keeping an arrested person's DNA on record can threaten their presumption of innocence in future investigations. The council also highlights the disproportionate number of minority arrests in the U.S. and the UK, many of who are released due to a lack of evidence. Thus, keeping a record of every arrested person would have an imbalanced effect on the privacy of racial minorities. There is also the issue of expanding use (and potential misuse) of such samples. Alabama has already authorized the use of such DNA samples for medical research, and the report notes several other states with open-ended authorizations. With several other potential issues, it is reassuring that the European Court��of Human Rights��(and Supreme Court of Canada) has been so diligent in weighing the costs and benefits of DNA records.

The post Human Rights Court rules against UK's DNA database appeared first on IPOsgoode.