Zuykov and partners’ Post

Since its launch on June 1, 2023, the Unified Patent System has received 28,246 requests for a Unitary Patent, reflecting 19.4% of granted European patents, which percentage has increased to 24% in 2024. In the biotechnology sectors, the percentages of granted European patents for which Unitary effect is requested are notably higher: 31.9% for biotechnology and pharmaceuticals, and 30.7% for medical technology (in 2024). This demonstrates a steady start to the UPC’s tenure, showing awareness of the benefits in terms of reduced costs, broader country coverage, and simplified procedures. Upon the top-users, The Netherlands ranks 5th with respect to the number of applications per million inhabitants, following Switzerland, Sweden, Denmark, Finland, and just ahead of Germany and Austria. Recently, also Romania has ratified the Unitary Patent System, and any Unitary Patent registered on or after 1 September 2024 will thus cover the territory of 18 countries! (Figure below shows the current 17 countries) See for statistics: https://lnkd.in/ef6_R_xC EP&C Patent Attorneys, Unified Patent Court #patent #lifesciences #innovation

As Sanovel, we are on the Turkishtime ‘R&D 250 Research’ and the European Patent Office’s ‘List of the Top 25 Companies with the Most Patent Applications’! ⭐ In the Turkishtime R&D 250 Research, we ranked 2nd among the ‘Top 50 Companies by the Number of Brands Acquired in the R&D Center’ and 42nd among the ‘Top 50 Companies According to the Number of Female Personnel Working in the R&D Center’. In the sector-based ‘List of Top 25 Companies with the Most Patent Applications’ published annually by the European Patent Office, we ranked 18th in the Pharmaceuticals field according to the number of patent applications filed in 2023, becoming the only Turkish company on the list. We are taking firm steps towards to the future with our strong R&D studies, competence in intellectual property and patent achievements. Wishing to achieve many more successes together...

Here's my BIGGEST piece of advice when patent searching 🔎 in the life sciences and pharmaceutical sectors 💊🔬 : 📢 BEWARE the alpha's, beta's and gamma's on molecule names 📢 When searching🔎 for molecules such as "IL1α" there is a host of issues that can arise, making your patent search potentially incomplete! The α symbol (and others) is not usually present in the patent text available on typical patent databases, and therefore can't be searched. In MOST circumstances, the symbols are represented as letters, like so: α - a β - b γ - y In this circumstance you can simply overcome the issue by substituting a letter. However, this isn't always the case, occasionally, the databases will be unable to recognise the symbol at all. The craziest substitution I've seen is a "?". 👀 This seems insane, but when double checking the PDFs of the patents in question, I've seen the molecule written correctly with the symbol. In order to account for those instances and conduct a thorough FTO search I've used the * wildcard, written as IL1*. This, combined with other key words and/or patent classifications helps to limit the number of irrelevant hits. Do you know of crazy obstacles you need to overcome when patent searching in a particular field? Please feel free to share them below! #ip #patentsearch #research #patent #fto #innovation #intellectualproperty #lifesciences #medical #pharma

Here's the USPTO's Patent Pendency Data for January 2024, showing significant increases across the patent corps as compared to May 2023. The corps-wide oscillation pattern, with the steep decline that overlaps the end of the fiscal year, perhaps indicates management's emphasis on meeting their date case goals. Notably, TC1600, which examines biotech, chemical and pharmaceutical applications, is missing from this chart. Mintz's study of TC1600 four year pendency rates found significant increasing delays in traditional application pendency from 11.8 months in Nov 2019 to 16.2 months in June 2021. https://lnkd.in/gXA8zckK The USPTO's traditional patents pendency, which does include TC1600, shows an increase for TC1600 from ~24.5 months in January 2022 to ~28 months in August 2023. https://lnkd.in/gTmQif75 For another perspective on the USPTO's average rate of examination across the patent corp, Volpe Koenig's Image That IP Law Blog by Joshua Schmid with suggestions here. https://lnkd.in/gDg_uvCs #USTO, #patent, #patentquality, #inventor

Pα+ Psychedelic Patent Analysis: A Mebufotenin Melee (Dec ’23 & Jan ’24) Here, we take a deep dive into recent patent-related developments at two companies that are both pursuing 5-MeO-DMT for treatment-resistant depression (TRD): GH Research plc and Beckley Psytech. This case study raises questions not only about how these two specific companies’ IP might shake out, but also about how other types of exclusivity—such as data and market exclusivity—interact to generate a complicated competitive landscape for drug developers pursuing approvals for drug products that would be first-to-market. https://lnkd.in/euZie323

On January 10, 2024, the USPTO released guidelines for assessing enablement in light of recent court cases, particularly Amgen v. Sanofi. The guidelines emphasize that they do not signify significant changes to USPTO practices, but rather integrate insights from the Amgen ruling and subsequent enablement court decisions that align with existing USPTO policy. The guidelines are intended to provide clarity and direction for patent examiners and applicants in the wake of the Amgen decision. The USPTO's approach appears to be focused on maintaining consistency with established policies while incorporating relevant legal developments. These guidelines are likely to have implications for patent prosecution and enforcement practices in the biotechnology and pharmaceutical sectors, and potentially influence future patent litigation strategies.

The UPC's only pharma dispute, between Amgen and Sanofi/Regeneron, is a fascinating late chapter in the decade-long PCSK9 patent war between the parties. Not only has it produced the court's first preliminary decision and its first Court of Appeal ruing. The spat will likely give rise to some of the UPC's earliest full first instance infringement and validity rulings, and could lead to multi-jurisdiction injunctions being imposed. The UPC actions also have an interesting strategic role to play alongside ongoing proceedings in Germany and Japan. And they represent Amgen's last realistic chance of scoring a victory in the PCSK9 wars. This follows a series of catastrophic setbacks which reversed the Californian company's previously dominant position in the dispute, which it initiated in 2014. One by-product of these setbacks was a US Supreme Court decision that is perhaps the most important US pharma patent ruling to be handed down in recent decades. I have provided a detailed analysis of the UPC spat, ongoing Amgen-Sanofi proceedings elsewhere, and the history of the PCSK9 wars, in my latest IAM article. You can read it by subscribing or registering (to read three articles for free): https://lnkd.in/eTHnGNkv

Obviousness-Type Double Patenting in the Spotlight Again I recently wrote a Patently-O post about an interesting district court decision related to obviousness-type double patenting (OTDP) in the pharma space. The case - Acadia Pharms v. MSN Pharms - involves Acadia's Parkinson's drug Nuplazid and competing summary judgment motions about whether the patent covering the drug should be invalidated based on OTDP. The court ended up siding with Acadia and putting forth two two justifications: 1. No "Patricide" Allowed: The court held that a later-filed, later-issued patent generally cannot serve as an OTDP reference to invalidate an earlier one -- even when the earlier has a later expiration date. 2. Divisional Application Safe Harbor: The court also ruled that the allegedly invalidating patent qualified for the divisional application safe harbor even though its divisional status was not formalized until after the statutory safe harbor date. This case highlights some unsettled nuances around obviousness-type double patenting - especially regarding patent terms, filing dates, restriction requirements, and the 121 safe harbor. It will likely be appealed to the Federal Circuit, so we may see new precedent established. The case also includes a contingent terminal disclaimer filed by the patentee. https://lnkd.in/gSZzPPNP What are your thoughts on the issues here?

Excellent analysis highlighting key ambiguities around OTDP application in pharmaceutical patents. This Acadia ruling reveals interpretative gaps regarding interplay between statutory safe harbors, restriction requirements, patent terms, and filing timelines. The no "patricide" justification and broad safe harbor eligibility afforded to the divisional patent seem plaintiff-friendly stances. We may see the Federal Circuit recalibrate either doctrine with tighter contours. But most intriguing is Acadia's prescient filing of a contingent terminal disclaimer as a precautionary fallback. This shows sophisticated legal maneuvering to hedge against potential OTDP vulnerabilities. Even if the terminal disclaimer gets triggered upon appeal, the resulting shortened monopoly may be a worthwhile tradeoff to preserve exclusivities under threat. After all, clearly no generic fiercely wishes to litigate this landscape's evidentiary burdens around double patenting validity before launch. You lay bare key litigation advantages patent owners enjoy amidst doctrinal uncertainty. Generic challengers must surmount both substantive legal hurdles and procedural delays posed by doubtful double patenting fact patterns. This case epitomizes the power of that deterrence dynamic. Great spotlight on an evolving area!

🔒 Patents incentivise drug-makers to innovate, but they also allow these companies to maintain a stronghold with high-priced medications until cheaper generics can enter the market.  ⌛ Some firms extend their exclusivity by creating "patent thickets"—multiple patents on minor variations such as dosing schedules or injection devices. 🎨 This chart I've created below highlights key EU and USA patent expirations for the top 10 selling drugs of 2023. Source: BioPharmaDive Database