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The availability of modern therapies and patented medicines is better in a few countries, so the interplay between industry and regulatory companies will be a critical issue in the coming years.
FREMONT, CA:The new pricing factors involving pharmacoeconomic considerations and transparency have made manufacturing leaders become more aware of unique pricing systems. These systems and the necessity of patents are the data factors influencing decision-makers on whether to commercialise in a few countries.
The pharmaceutical industry expects this forward-looking due diligence to continue as manufacturers look to commercialise their products. Eventually, modern therapy availability and patented medicines will be better for a few countries. The interplay between the industry and the patent companies will be an important issue in the coming years.
Landmark Transforms to Pharmaceutical Patent Litigation System
When the system governing the patent litigation for patented medicines was overhauled, the impact was unpredictable. Such changes transformed the duplicative process of contesting infringement and patent validity issues in a paper record hearing and requiring a full trial with live witnesses. Today the results are in on the new system, highlighting a dramatic reduction in cases taken to trial.
IP Rights Remain Strong to Support Innovation
The patent filings wave for vaccines and therapeutics relating to the pandemic underlines the health of countries' intellectual property (IP) regimes. Few countries continue to have manufacturers seek out and enforce their IP rights.
Although government policies have not been clear on whether to waive world trade organisation IP protection and compel public access to these inventions, IP rights have certainly not been waived. Instead, few governments implement their biomanufacturing and life science strategy and favourable measures by industry, such as announcing a vaccine facility in some regions. These countries should continue pressing forward with a favourable IP agenda if they want to see the investments that can flow from promoting and protecting IP rights.
Fees Increasing in Patent Prosecution
Some countries will have new patent examination rules. This will lead to a few primary changes. The first includes excess fees due when an examination is requested if there are more than 20 claims. Another change is that the lengthy prosecution with more than three office actions will need a request for a continued examination fee. Although these may seem like minor changes, the cost consequences of these changes over an entire patent portfolio can be substantial.