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BeiGene Reaches Patent Settlement with MSN Pharmaceuticals for Brukinsa
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China-based BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), which is in the process of changing its name to BeOne Medicines Ltd, has announced a patent settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. concerning its oncology drug Brukinsa (zanubrutinib). The agreement stipulates that MSN’s generic version…
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Windtree Therapeutics Secures Hong Kong Patent for Istaroxime Heart Failure Treatment
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US biotechnology company Windtree Therapeutics, Inc. (NASDAQ: WINT) has announced the receipt of a patent approval in Hong Kong for its drug istaroxime. The patent, titled “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF),” covers formulations comprising istaroxime and methods of use, either alone or in combination with…
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Peking Union Medical College Innovates with Angle Positioning Device Patent Sale
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Peking Union Medical College Hospital (PUMCH) has announced its intention to transfer the patent for its “Angle Positioning Device in Hip Replacement Surgery” to Chinese medical firm AK Medical for RMB 550,000. This innovative device features components for positioning, forward tilt angle measurement, abduction angle measurement, and adjustment mechanisms, enabling…
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Novartis Intensifies Legal Action Against FDA Over Entresto Generic Approval
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Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors for its heart failure and hypertension medication, Entresto (valsartan + sacubitril), following the U.S. FDA’s approval of a generic version from India-based MSN Laboratories on July 24. A federal court judge in Delaware recently denied…
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Sirnaomics Ltd Forms JV with Gore Range Capital to Pioneer Medical Aesthetics Innovations
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Sirnaomics Ltd (HKG: 2257), a biopharmaceutical company specializing in RNAi therapeutics, has announced the formation of a joint venture named Sagesse Bio, Inc. with US investment firm Gore Range Capital. This strategic partnership is complemented by a patent transfer and license agreement that will see Sirnaomics transferring specific intellectual property…
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U.S. Senate Passes Affordable Prescriptions for Patients Act to Limit Patent Thicketing
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In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150) last week. This legislation is designed to foster greater competition from generic and biosimilar drugs against their brand-name counterparts. The act’s primary objective is to impose a limit…
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Biocytogen Secures US Patent for RenLite Fully Human Common Light Chain Mouse Platform
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Biocytogen (HKG: 2315), a biopharmaceutical company based in China, has announced that it has been granted a patent by the United States Patent and Trademark Office (USPTO) for its independently developed RenLite fully human common light chain mouse platform. The RenLite mice, developed utilizing Biocytogen’s proprietary Size-Unlimited and Precise Chromosome…
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China Invalidates Heart Failure Patent for Dapagliflozin, Maintains Protection for Kidney Disease Use
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The China National Intellectual Property Administration (CNIPA) has announced a pivotal decision concerning the patent status of Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor co-developed by Bristol-Myers Squibb and AstraZeneca. The patent (ZL202011290859.2) related to heart failure has been completely invalidated, while the chronic kidney disease patent (ZL202210071080.4) remains intact.…
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BeiGene’s Q1 2024 Revenue Jumps 68% YOY on Strength of Brukinsa and Tislelizumab Sales
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BeiGene, Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has released its financial results for the first quarter of 2024, revealing a total revenue of USD 752 million, marking a 68% year-on-year (YOY) increase. Product revenue specifically soared 82% YOY to USD 747 million. Notably, US sales experienced a significant surge,…
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Kind Pharmaceuticals Resolves Trade Secrets Dispute with Fibrogen Amid HIF-PHI Pipeline Development
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Kind Pharmaceuticals LLC, a Sino-US pharmaceutical company, along with its Chinese affiliate Hangzhou Andao Pharmaceutical Ltd, has announced an amicable resolution to a trade secrets dispute with Fibrogen Inc. (NASDAQ: FGEN). The dispute originated from a lawsuit initiated by Fibrogen in November 2022 against Andao, Kind Pharma, and individual defendants…
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China’s CNIPA and USPTO Pledge to Deepen Intellectual Property Cooperation
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Shen Changyu, Director of the China National Intellectual Property Administration (CNIPA), met with Kathi Vidal, Director of the United States Patent and Trademark Office (USPTO), in Beijing this week for high-level discussions. The meeting focused on exchanging updates on intellectual property (IP) protection efforts in both countries and resulted in…
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China’s CNIPA Upholds Patent for Nobel-Winning CRISPR/Cas9 Gene Editing Technology
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The China National Intellectual Property Administration (CNIPA) has upheld a key patent surrounding the CRISPR/Cas9 gene editing technology, rejecting an invalidation challenge. The decision was announced by ERS Genomics Ltd, an Ireland-based company founded by Dr. Emmanuelle Charpentier, the Nobel prize-winning co-inventor of the technology, to manage and license access…
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CDE Streamlines Patent Dispute Resolution for Generic Drug Filings with New Online Submission Process
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The Center for Drug Evaluation (CDE) has announced a new initiative aimed at enhancing the efficiency of resolving patent disputes during the review process for generic drug market filings. Patent holders, stakeholders, and generic drug applicants can now directly submit applications for setting a waiting period, as well as acceptance…
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Luye Pharma’s Paliperidone Palmitate NDA Avoids Patent Lawsuit, Clears Path for FDA Approval
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) submitted to the US FDA via the 505(b)(2) route for its paliperidone palmitate extended-release injectable suspension (LY03010) has not faced a patent infringement lawsuit in the US. This follows the FDA’s acceptance of…
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Eli Lilly’s Olumiant Patent Invalidated in China, Generic Version Approved
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The China National Intellectual Property Administration (CNIPA) has declared the compound patent CN200980116857.7 for Eli Lilly’s (NYSE: LLY) JAK inhibitor Olumiant (baricitinib) invalid in its entirety, as per a recent public document. The decision came after a challenge from Nanjing SiPake Pharmaceutical Technology Co., Ltd. Baricitinib, a JAK1/JAK2 inhibitor originally…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
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In a surprising turn of events in the ongoing intellectual property dispute, the US Patent and Trademark Office (PTO) has invalidated a 2020 patent for conjugation compounds used in antibody-drug conjugates (ADCs), which was held by Pfizer’s (NYSE: PFE) subsidiary Seagen and contested by Japan’s Daiichi Sankyo (TYO: 4568). The…
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Shanghai Enhances Biomedicine IP Protection with New Procurement-Linked Measures
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The Shanghai Intellectual Property Administration (SIPA) has issued a notification highlighting the city’s intensified efforts to protect intellectual property (IP) rights within the biomedicine industry. This strategic move comes on the heels of several high-profile administrative rulings on biopharmaceutical patent infringement disputes in Shanghai, underscoring a commitment to a linkage…
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WuXi Biologics’ Innovative Bispecific Platform WuXiBody Secures US Patent
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WuXi Biologics (HKG: 2269), a leading China-based Contract Research, Development, and Manufacturing Organization (CRDMO), has announced that the US Patent and Trademark Office (USPTO) has granted a patent for its proprietary engineering platform, WuXiBody. This platform is designed to significantly enhance the developability characteristics of bispecific antibodies, marking the first…
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Sino Biopharmaceutical Ltd Secures Exclusive Rights for Generic Everolimus in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis AG’s Afinitor (everolimus). This achievement marks a significant milestone as the company’s product is set to enjoy…
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CNIPA Releases Updated Patent Law Rules with Pharma Industry in Focus
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The China National Intellectual Property Administration (CNIPA) has announced the “Decisions of the State Council on Amending the Patent Law Implementation Rules,” set to take effect from January 20, 2024. These amendments are particularly significant for the pharmaceutical sector, as they provide detailed regulations on patent compensation terms that were…
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Biocytogen Pharmaceuticals Secures US Patent for Fully Human Antibody Mice Platform RenMab
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based Contract Research Organization (CRO), has announced the receipt of patent approval in the United States for its proprietary core technology, the fully human antibody mice platform RenMab. This U.S. patent award comes on the heels of a similar award in China…
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AbbVie Sues to Protect Rinvoq from Generic Competition in the US Market
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AbbVie (NYSE: ABBV) has initiated legal action in the US to safeguard its blockbuster drug Rinvoq (upadacitinib) from generic market entries by Switzerland-based Sandoz (SWX: SDZ) and Indian pharmaceutical companies Aurobindo Pharma (NSE: AUROPHARMA), Hetero Labs, Intas Pharmaceuticals, and Sun Pharmaceutical (NSE: SUNPHARMA). Despite holding patents on the JAK inhibitor…
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European Commission Proposes Overhaul of Pharmaceutical Legislation
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The European Commission (EC) is advancing an update to Europe’s 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a…
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China’s State Council Unveils Plan to Boost Patent Commercialization by 2025
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China’s State Council has recently approved the “Special Action Plan for Patent Commercialization and Utilization (2023-2025),” outlining ambitious targets for the commercialization of high-value patents in China by 2025. The plan is designed to significantly increase the commercialization rates of patents held by universities and research institutes. Commercialization Targets and…
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CNIPA Upholds Alnylam’s PCSK9-Targeted siRNA Patent Against Junshi Biosciences Challenge
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The China National Intellectual Property Administration (CNIPA) has rejected another challenge from Junshi Biosciences (SHA: 688180) against an Alnylam Pharmaceutical (NASDAQ: ALNY) patent (ZL201810143112.0) related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. This decision ensures the patent’s validity remains intact until December 5, 2033. Details of the Patent…
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CNIPA Upholds Alynlam Pharmaceutical’s PCSK9 siRNA Patent Against Junshi Biosciences Challenge
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The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences (SHA: 688180) against a patent held by Alynlam Pharmaceutical (NASDAQ: ALNY), which is related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. CNIPA’s decision to fully maintain Patent No. 561449, associated with application number…
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South Africa’s Competition Commission Investigates J&J for MDR-TB Drug Pricing and Evergreening
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The Competition Commission of South Africa has announced an investigation into Johnson & Johnson (J&J; NYSE: JNJ) concerning allegations of profiteering on the multidrug-resistant tuberculosis (MDR-TB) drug Sirturo (bedaquiline) and employing evergreening practices to extend its patent until 2027. Investigation Details and Pricing ConcernsThe government currently pays ZAR 5,400 (USD…
