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Canada News.Net
25-07-2025
- Business
- Canada News.Net
Canada's new drug pricing guidelines are industry-friendly
Share article Print article Drug pricing in Canada just got more industry-friendly. Canadian drug prices are already the fourth highest in the industrialized world. Now, with the release of new guidelines for the staff at the Patented Medicine Prices Review Board (PMPRB) at the end of June, the situation is poised to potentially get even worse. The review board is the federal agency that was set up 1987 to ensure that the prices for patented drugs are not "excessive." Up until now, one of the criteria the PMPRB used in making the decision about what was an excessive price was to compare the proposed Canadian price for a new drug with the median price in 11 other countries. The median is the 50 per cent mark; in other words, the price in half of the other countries was below what's proposed for Canada, and the price in the other half was above the proposed Canadian price. Under the new guidelines, set to take effect on Jan. 1, 2026, the Canadian price can be up to the highest in those other 11 countries. Right now, the median price in the 11 countries Canada is compared to is 15 per cent below the price of patented drugs in Canada. The highest international price, which will be the new standard, is 21 per cent above the median Canadian price, meaning Canadian prices for new drugs will be significantly higher than they otherwise would have been. Sometimes a drug is not available in any of the 11 other countries when it comes onto the Canadian market. In that case, the company can price the drug at whatever level it wants and keep it at that price until it comes up for its annual price review. The executive director of the PMPRB told the Globe and Mail that this would incentivize drugmakers to bring their products to the Canadian market first. Incentivizing drug companies may be a reasonable idea, but that's not part of the mandate of the PMPRB. As laid out in Section 83 of the Patent Act, its mandate is to ensure drug prices aren't excessive. In the past, one of the factors that the PMPRB took into account in determining if prices were excessive was the additional therapeutic value of a new drug compared to what was already on the market. The lower the value, the lower the price. In this regard, the PMPRB was advised by its Human Drug Advisory Panel, an independent group of experts. The ranking of new drugs against existing ones was also of significant value to Canadian clinicians. It helped them to decide on the best treatment option for their patients and countered the hype about new drugs that came from the manufacturers. Since the new guidelines have abandoned looking at therapeutic improvement of new drugs, that leaves only one remaining Canadian source for that type of information, the Therapeutics Letter, a bimonthly publication targeting identified problematic therapeutic issues in a brief, simple and practical manner. Complaints about prices can be made by federal, provincial and territorial health ministers and by senior officials who are authorized to represent Canadian publicly funded drug programs. " Other parties who have concerns about the list prices ... are encouraged to raise their concerns with their relevant Minister(s) of Health or Canadian publicly-funded drug program (sic)." This advice is cold comfort for people working low-wage jobs who aren't covered by provincial and territorial drug plans and don't have any access to their health minister. If there is an in-depth review of a new drug's pricing - a preparatory step to determine whether there should be a formal hearing to investigate if the price is excessive - it is only the manufacturer that is allowed to submit information to the PMPRB. Clinicians who prescribe the drug, patients who take the drug, and organizations and individuals that pay for the drug do not have that same right. Donald Trump's on-again, off-again tariffs are already threatening to drive up drug prices and make prescription drugs inaccessible to many Canadians. Higher drug prices will also almost certainly affect Canada's already limited pharmacare program. Higher prices for new drugs will make an expanded pharmacare plan more expensive and less appealing to the federal government. The new PMPRB guidelines help ensure higher drug prices and no pharmacare expansion.
Canada News.Net
25-07-2025
- Business
- Canada News.Net
Canada's new drug pricing guidelines are industry friendly
Share article Print article Drug pricing in Canada just got more industry-friendly. Canadian drug prices are already the fourth highest in the industrialized world. Now, with the release of new guidelines for the staff at the Patented Medicine Prices Review Board (PMPRB) at the end of June, the situation is poised to potentially get even worse. The review board is the federal agency that was set up 1987 to ensure that the prices for patented drugs are not "excessive." Up until now, one of the criteria the PMPRB used in making the decision about what was an excessive price was to compare the proposed Canadian price for a new drug with the median price in 11 other countries. The median is the 50 per cent mark; in other words, the price in half of the other countries was below what's proposed for Canada, and the price in the other half was above the proposed Canadian price. Under the new guidelines, set to take effect on Jan. 1, 2026, the Canadian price can be up to the highest in those other 11 countries. Right now, the median price in the 11 countries Canada is compared to is 15 per cent below the price of patented drugs in Canada. The highest international price, which will be the new standard, is 21 per cent above the median Canadian price, meaning Canadian prices for new drugs will be significantly higher than they otherwise would have been. Sometimes a drug is not available in any of the 11 other countries when it comes onto the Canadian market. In that case, the company can price the drug at whatever level it wants and keep it at that price until it comes up for its annual price review. The executive director of the PMPRB told the Globe and Mail that this would incentivize drugmakers to bring their products to the Canadian market first. Incentivizing drug companies may be a reasonable idea, but that's not part of the mandate of the PMPRB. As laid out in Section 83 of the Patent Act, its mandate is to ensure drug prices aren't excessive. In the past, one of the factors that the PMPRB took into account in determining if prices were excessive was the additional therapeutic value of a new drug compared to what was already on the market. The lower the value, the lower the price. In this regard, the PMPRB was advised by its Human Drug Advisory Panel, an independent group of experts. The ranking of new drugs against existing ones was also of significant value to Canadian clinicians. It helped them to decide on the best treatment option for their patients and countered the hype about new drugs that came from the manufacturers. Since the new guidelines have abandoned looking at therapeutic improvement of new drugs, that leaves only one remaining Canadian source for that type of information, the Therapeutics Letter, a bimonthly publication targeting identified problematic therapeutic issues in a brief, simple and practical manner. Complaints about prices can be made by federal, provincial and territorial health ministers and by senior officials who are authorized to represent Canadian publicly funded drug programs. " Other parties who have concerns about the list prices ... are encouraged to raise their concerns with their relevant Minister(s) of Health or Canadian publicly-funded drug program (sic)." This advice is cold comfort for people working low-wage jobs who aren't covered by provincial and territorial drug plans and don't have any access to their health minister. If there is an in-depth review of a new drug's pricing - a preparatory step to determine whether there should be a formal hearing to investigate if the price is excessive - it is only the manufacturer that is allowed to submit information to the PMPRB. Clinicians who prescribe the drug, patients who take the drug, and organizations and individuals that pay for the drug do not have that same right. Donald Trump's on-again, off-again tariffs are already threatening to drive up drug prices and make prescription drugs inaccessible to many Canadians. Higher drug prices will also almost certainly affect Canada's already limited pharmacare program. Higher prices for new drugs will make an expanded pharmacare plan more expensive and less appealing to the federal government. The new PMPRB guidelines help ensure higher drug prices and no pharmacare expansion.
Hindustan Times
12-07-2025
- Health
- Hindustan Times
India's patent model a benchmark for access and innovation
Equitable access to safe, effective, and affordable medicines remains a crucial public health challenge. According to the WHO, nearly two billion people worldwide—many in low- and middle-income countries and even some in developed economies still lack access to essential medicines. Patent(Photo used for representational purpose) This global inequity raises a critical question: How can countries foster pharmaceutical innovation without making life-saving medicines inaccessible? India's experience offers a compelling answer and in 2025, the country will mark 20 years since it institutionalised that approach. When India amended its patent law in 2005 to align with the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, it did more than fulfil international obligations. It established a patient-first model that balances innovation with access a model that continues to shape global thinking. From being almost non-existent in the 1970s, the Indian pharma industry has come a long way to being one of the largest and most advanced pharma industries in the world. This success stems from entrepreneurial drive supported by policies like the Patent Act, 1970. A major shift came in 1995 when India joined the WTO and committed to aligning its IP laws with TRIPS, including product patents for pharmaceuticals. For a country with a strong generics base, this was a significant transition. However, India struck a careful balance—encouraging innovation while safeguarding public health. The pharmaceutical industry adapted quickly to this new global IP framework. The amended Patents Act in 2005 aligned with minimum standards set by TRIPS Agreement and using TRIPS flexibilities included crucial safeguards: patentability criteria that would prevent evergreening, pre-grant opposition to ensure the genuineness and quality of patent and to weed out frivolous patent applications, if any, and provisions for compulsory licensing in the public interest. Over the past two decades, India's patent framework has become a global example of balancing innovation with access to medicines. For instance- the pre-grant opposition mechanism, used to prevent the grant of patents on salts, polymorphs, formulations, and other derivatives that do not meet patentability criteria set by Indian Patent Act This ensures weak applications are rejected during examination itself. As a result, Indian companies have been able to launch generic versions of drugs immediately after the primary patent expires, ensuring timely access to affordable medicines. Without this safeguard, patients would have faced delays and higher costs. Over the last two decades, India has demonstrated that a balanced intellectual property (IP) framework can drive innovation while safeguarding access to medicines. In 2005, only three pharmaceutical product patents were granted in India; by 2008, this number rose to 1,369. Today, India is among the world's fastest-growing IP jurisdictions, with a 15.7% increase in patent filings in 2023, ranking sixth globally. Pharmaceuticals and Medtech now account for around 15% of filings, reflecting the sector's growing innovation capacity. However, this balance is under increasing strain. Several countries are pushing for TRIPS-plus provisions in trade agreements—extending patent terms, introducing data exclusivity, and patent linkage all which risk delaying generic entry. Additionally, some innovators are using both patent and regulatory frameworks to extend monopolies through tactics like patent thickets and product hopping. Such practices threaten to increase medicine prices and limit access, particularly for India and many countries dependent on Indian generics. India has resisted these pressures, recognising the risks to domestic and global health security. Protecting this calibrated IP framework is critical for sustaining affordable access to medicines. Meanwhile, India's pharmaceutical industry has expanded from $3 billion in 1999 to $58 billion in 2024 cementing its role as the pharmacy of the world. Net foreign exchange earnings surged from $1.1 billion to $19.5 billion. The Covid-19 pandemic further underscored India's importance, as it supplied medicines to over 150 countries. Globally, even developed regions like the EU and US are rethinking their pharmaceutical IP policies to curb abuse and ensure access. In the US, legislative efforts like the Affordable Prescriptions for Patients Act and the Drug Competition Enhancement Act aim to curb practices such as patent thickets and product hopping. With over $250 billion worth of global drug patents expiring between 2022 and 2030, Indian companies have a major opportunity in biosimilars, complex generics, and innovative therapies. In last two decades, the country's IP model continues to serve as a global benchmark for balancing innovation with public health. India's philosophy remains rooted in a simple principle: innovation and access are not competing goals; they are complementary imperatives. Good health policy isn't about choosing between science and society; it's about designing systems where both can thrive, and India's IP framework proves it's possible. This article is authored by Archana Jatkar, associate secretary general, Indian Pharmaceutical Alliance.
The Hindu
01-06-2025
- Business
- The Hindu
Himachal Pradesh HC refuses to quash FIR against P&G in patent case
The Himachal Pradesh High Court has refused to quash an FIR registered against Procter & Gamble (P&G) in a case involving allegations of cheating by using the patented idea of an Indian innovator for commercial exploitation. The FIR of January 2024, lodged on a complaint by Rajiv Rai Sachdev, alleges that P&G invited him to collaborate by submitting a patented innovation as part of its 'Connect + Develop Programme'. Mr. Sachdev claims he shared a proprietary method of dyeing textiles using neem and holy basil extracts — a technology he had patented in India, the U.S., and Europe. While P&G later expressed disinterest in a formal partnership, Mr Sachdev claimed the company went on to launch a product — Whisper Ultra Clean (with herbal oil) — allegedly using the technology submitted by Mr. Sachdev. The innovator said he sent a cease-and-desist notice to the company on May 13, 2022, alleging infringement of his patent and trademark. In response, P&G argued that the process used in their product was entirely different and did not infringe upon the patented method. The multi-national company further contended that the product in question did not follow the innovator's process and merely added herbal oil containing neem to the inner layers of sanitary napkins. The company also said the innovator cannot claim a monopoly over the use of neem, which has been used in India for thousands of years. It challenged a trial court order dated December 30, 2023, which had directed the police to register an FIR against the company. The trial court had also held that the allegations in the application showed that the accused had used the idea of the informant for commercial exploitation. Before the high court, the counsel appearing for P&G emphasised that the allegations, at best, amounted to a civil dispute and that criminal proceedings were unwarranted. 'There can be no dispute with the proposition of law that the civil dispute cannot be turned into criminal proceedings, however, it does not mean that no civil action can give rise to a criminal action,' the high court noted. The High Court further clarified that the availability of remedies under the Patent Act does not preclude recourse to criminal law in cases where fraudulent inducement and misappropriation are alleged. While the company submitted that it never used the technology/process submitted by Mr. Sachdev, the high court said, 'These are the questions of fact which require investigation' 'The allegations in the FIR, if believed to be correct, prima facie show the offence of cheating, and it is impermissible to quash the same. Therefore, the present petition fails, and the same is dismissed,' the high court said in its May 28 judgment.
