On Monday January 14th, 2013, the Centre for Intellectual Property Policy at McGill hosted a lecture with Patent Agent Dr. S. Serge Shahinian, titled “The evolution of patenting in the life sciences: Where have we come from and where are we going?”. During the lecture, Dr. Shahinian explained how patents are currently being applied in the realm of the life sciences and the possible health law repercussions this practice can have. The cases mentioned involved companies attempting to patent, and therefore gain an exclusive market over, scientific innovations including medical treatment methods and diagnostic tools. Shahinian explained the policy concerns from this practice, including the possibility of excluding people from receiving the highest quality of care because of high prices.
WHAT DOES THE FUTURE HOLD?
According to Dr. Shahinian, it remains to be seen what the role of the courts will be in determining what is patentable. Currently, the court decides if the subject of a potential patent fits the definition of “invention” found in the Patent Act:
any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.
However, it is still unclear to what degree the courts will, and should, include public policy considerations, such as the cost of manufacturing medication and the availability of treatment to those in need, when making these far-reaching decisions.
CASES OF NOTE INCLUDE:
- Tennessee Eastman Co. v. Commissioner of Patents, a 1974 case, in which the appellant sought to patent a surgical method for bonding wounds together using glues instead of stitches. The Supreme Court denied the patent, however, claiming the process was not a new innovation, and that a method of treatment itself is not patentable in Canada.
- In Janssen Inc. v. Mylan Pharmaceuticals ULC (2010 FC 1123), the Federal Court found that an optimum dosing regime for an Alzheimer’s medication was not patentable since it was a method of treatment and still required doctors to use their professional skill and judgment when prescribing the medication.
- In Mayo Collaborative Services v. Prometheus Laboratories, Inc(566 U.S. ___ 2012), the Supreme Court of the United States ruled that a new method of calibrating the dosage of a drug was not patentable because assessing the proper dosage and possible reactions of the drug was simply a “natural law” and thus not an innovation.
- Association for Molecular Pathology v. Myriad Genetics(ongoing) concerns the patentability of modified genes used to diagnose breast cancer. The Supreme Court of the United States will decide on the issues of whether isolated DNA is patentable.