Patents for second medical indications and their potential impact on pharmacare in Canada.
Bibliographic record
Abstract
Introduction The practice of granting patents for second medical indications of known drug compounds is not new in Canada. However, a recent court decision has brought into focus the implications of this practice for pharmacare programs in Canada. In Apotex v. Ontario (Minister of Health), the Superior Court of Ontario upheld a decision by the Ministry of Health and Long-Term Care (hereinafter Health Ontario) to list a generic formulation of sertraline hydrochloride as interchangeable for only one of the brand name drug's three approved indications. The decision by Health Ontario, which was unprecedented in Canada, came following pressure by Pfizer Canada, the maker of the brand name version of sertraline hyrdrochloride called Zo1oft[TM]. While the patent on Zoloft[TM] for treatment of depression had expired, a valid patent remained on Zoloft[TM] for use for other approved indications. The subsisting patent formed the basis for Pfizer's opposition to full interchangeable status for Zoloft[TM]. Although the case is current ly under appeal, it is expected that similar pressure may be brought to bear on other provincial health departments to begin listing drugs in formularies as being only partially interchangeable where one patent on a given drug has expired but others remain in effect. This issue of second medical indication patents and their implications is an important one, as it has the potential to raise costs significantly for already cash-strapped provincial drug programs. It may also have implications for privately funded drug plans, and hence for the cost of private drug insurance programs. At the very least, it may impose costs on provincial health departments to defend themselves in any potential patent infringement actions taken against them. It has also been argued that to list drugs as only partially interchangeable in provincial drug formularies will place difficult burdens on pharmacists and those who prescribe drugs, and may expose them directly to patent infringement liability. This paper considers both the issues raised by the decision in Apotex v. Ontario, and the implications for health departments, doctors and pharmacists. The first part of this paper explores the relevant patent issues. These issues do not receive any direct coverage in Apotex v. Ontario; nevertheless, they underlie the decision in that case. The bar on patenting of medical treatments is considered as well as the means by which drug patents are distinguished from methods of treatment. The legal basis for granting second medical use patents is also assessed. These issues are considered with some comparison to other jurisdictions and in light of Canada's international obligations. The second part of the paper consists of a closer look at Apotex v. Ontario and its implications for provincial pharmacare programs. It includes a consideration of the relevant legislative and regulatory scheme in Ontario, and incorporates a consideration of the various liability issues that may arise for provincial health departments, doctors and pharmacists. I. Patent Issues. A. Methods of Medical Treatment under Patent Law In Canada, methods of medical treatment of humans and animals are not patentable. (2) This is not expressly stated in the Patent Act, (3) but rather has evolved as a matter of interpretation. The leading case on the issue is Tennessee Eastman Co. v. Canada (Commissioner of Patents). (4) In Tennessee Eastman, the Supreme Court of Canada found that the discovery that a known adhesive compound could be used to close wounds was a method of medical treatment, and therefore not patentable. There are policy reasons underlying the exclusion of medical treatments from patentability, as explained by David Vaver: The exception for medical treatment springs from ethical or emotional reasons based on a desire not to hamper the saving of life and the alleviation of suffering. …
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".