Gene Patents – Partially Saved
June 14, 2013
Authors: Melanie Szweras, Carmela De Luca and Matthew Cahill
The Supreme Court of the United States issued its highly anticipated decision in the Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. case on June 13th 2013. Myriad Genetics Inc. (“Myriad”) obtained several patents after discovering that the human genes BRCA1 and BRCA2 were linked to an elevated risk of a variety of cancers, most notably breast cancer. This decision partially overturned the United States Federal Circuit Court of Appeal’s August 2012 decision in which the Federal Circuit held that isolated genes are not products of nature and are thus patent eligible. (Please click here for further details.)
The Supreme Court held that claims to isolated DNA are not patentable. The Court stated that the principal contribution by Myriad was the “uncovering of the precise location and genetic sequence” of the BRCA1 and BRCA2 genes and they did not “create or alter the genetic structure of DNA”. The Court held that isolating the DNA from the chromosome was insufficient to distinguish the product from the naturally occurring DNA.
The Court took a more favourable view of the claims related to BRCA cDNAs. They were of the view that “…the lab technician unquestionably creates something new when cDNA is made”. In particular, the Court reasoned that since cDNA (which is a synthetic version excluding parts of genes called introns) does not only contain parts of the gene as they are found in nature, and since it can only be made in the laboratory, it cannot be a product of nature. Based on this reasoning, the Court held that claims to cDNA are patent eligible under § 101.
The decision on cDNA is good news and brings some much needed clarity to innovative biotech industries as commercially cDNA may be the most important form of DNA used in biotechnology.
However, it would seem that uncertainty still remains for shorter segments of cDNA and other naturally occurring molecules.
When discussing fragments of synthetic DNAs, the Court noted that a short cDNA may be indistinguishable from natural DNA and hence patent ineligible. This results in the strange situation where short sequences of cDNA that are useful for example for synthesizing or sequencing cDNA (e.g. primers) or for detecting specific mutations (e.g. probes) or naturally occurring microRNA, siRNA and mRNA molecules whose sequences correspond to naturally occurring sequences may not be patent eligible but those that span intron-exon junctions or include non-gene sequences would likely be acceptable.
Based on the Court’s reasoning, chemical modifications or other human manipulations of naturally occurring biomolecules that make them different from the natural form may provide a basis for patentability. For example, engineered DNAs and/or other engineered biomolecules would appear patent eligible. What level of modification or manipulation is sufficient to render the biomolecule patentable, remains to be defined.
The Court may have left another door open. Compositions of DNA (or other naturally occurring molecules) and specific diluents not found in nature are not “naturally occurring” and the Court clearly stated when referring to Myriad’s objected to claims that “Myriad’s claims are simply not expressed in terms of chemical compositions” (p. 14).
It also remains to be seen whether the Court’s reasoning about isolating DNA from its surrounding environment being insufficient to distinguish DNA from a product of nature, will be extended to other types of “isolated” biomolecules, including proteins, cells, organisms and other natural products. The Court does caution at page 11 of its decision that “[t]he rule against patents on naturally occurring things is not without limits”, since all inventions at some level can be traced to a law of nature and citing previous case law added “patent protection strikes a delicate balance between creating “incentives that lead to creation, invention and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention”” (p 11). What the Court does say is that Myriad’s claims “are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA”. The Court is of the opinion that the claims in question merely focus on the genetic information encoded by the genes. Accordingly, it is conceivable that the decision’s “limit” may be “isolated genes” as indicated in the Court’s conclusion: “[W]e merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material” (p. 18).
Rather than address the potentially broad implications of this decision, the Court focuses on what is not implicated in the decision, including method claims such as methods of manipulating genes, and applications of knowledge about the breast cancer genes. The Court acknowledges that many of Myriad’s unchallenged claims are limited to applications using knowledge of BRCA1 and BRCA2. They also emphasize that they are not commenting on the “patentability of DNA in which the order of the naturally occurring nucleotides have been altered”, as this would be a separate inquiry.
The decision ends with the Court emphasizing that genes and the information that they encode “are not patent eligible…simply because they have been isolated from the surrounding genetic material”.
The United States Patent Office (“USPTO”) was quick to issue its preliminary guidance based on the Myriad decision and has provided some guidance for what will be allowed in pending applications. According to the USPTO memorandum, claims clearly limited to non-naturally occurring nucleic acids such as cDNA are patent eligible. No comment is made on short cDNA sequences or other biomolecules. It is also unclear how the USPTO will treat method claims.
It will be important going forward, that claims be drafted to include claims that differentiate DNA molecules from naturally occurring DNA. For example, claims should be directed to cDNA, vectors or other constructs, non-naturally occurring degenerate or optimized DNA sequences, or cells and perhaps compositions comprising said sequences as mentioned above. For example, claiming a protein, DNA, RNA, purified natural product as a composition of matter along with a carrier, such as a pharmaceutically acceptable carrier would arguably render the composition something different from its naturally occurring counterpart, leaving the more appropriate question of patentability, i.e. whether it is novel and obvious to be determined. Shorter DNA sequences could be claimed with modifications such as labels, or tags to distinguish them from naturally occurring counterparts. Adding method claims, including methods of making or using the DNA, is also highly recommended.
Since proteins are typically described in terms of the identification of the amino acid sequence similar to DNA molecules being defined in terms of the nucleotide sequence, it may be useful to add claims that would further distinguish isolated proteins from the natural product. For example, in addition to the strategies mentioned above for DNA claims, use of the terms “recombinant” or “synthetic” for a protein could also be used in addition to “isolated”, which is still acceptable in many jurisdictions.
In the case of naturally occurring cells, such as stem cells, there are clear arguments that they are distinguishable from the products of nature based on the fact that they would need to be grown in culture in cell media, are extensively manipulated in the culture system, and would be a purified product, which would likely be devoid of unwanted contaminants found in cells from the “natural” environment. However, in light of this decision, it would be prudent to include claims that reflect such manipulations, for example, an isolated stem cell cultured in media or a composition of cells and a carrier, such as media.
Regarding issued and allowed patents claiming “isolated DNA” and perhaps other “isolated” naturally occurring molecules, review of claims in light of the Myriad decision may be warranted. If a continuation is pending, pursuing claims limited to “cDNA” or comprising a label or tag may be a good way to hedge whether claims to “isolated DNA” that could encompass cDNA and non-cDNA molecules will remain patentable. If no continuation is pending, reissue may be an option.
As full genome sequencing has led to the disclosure of most human DNA sequences, the effects of the decision may be circumscribed if the reasoning is limited to isolated naturally occurring DNA. Identifying disease mutations however is an important and active area of biotech research and investment. One effect of the decision is that it may make patenting early-stage research identifying DNA mutations more difficult and could encourage patentees to pursue greater secrecy over those early stage discoveries.
Melanie Szweras, B.Sc., Ph.D. (Genetics), LL.B., is a partner in Bereskin & Parr LLP's Biotechnology & Pharmaceutical practice group
Carmela De Luca, Ph.D. (Exp. Med.), J.D. is an associate lawyer with Bereskin & Parr LLP's Biotechnology and Pharmaceutical Practice group
Matthew Cahill, B.Sc. (Biology), PhD (Bacterial Genomics), J.D./MBA, is a Summer Student at Bereskin & Parr LLP, from the University of Toronto
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