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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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Novo Nordisk Expands Legal Campaign to 50 Cases Against Semaglutide Compounders
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Novo Nordisk (NYSE: NVO) has escalated its legal battles in the healthcare sector by filing a lawsuit against another semaglutide compounder, increasing the total number of such cases to 50. The Danish pharmaceutical giant, along with Eli Lilly (NYSE: LLY), has initiated legal campaigns targeting medical spas, weight loss clinics,…
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China’s NMPA Proposes Rewards for Internal Whistleblowers in Drug and Medical Device Safety Reporting
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The National Medical Products Administration (NMPA) of China has issued a draft proposal for the “Notice on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices.” The bureau is seeking public feedback from October 10 to November 9, 2024. This initiative encourages entities…
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Oxford Nanopore Sets Sights on BGI in UK Courts Over Nanopore Sequencing Technology
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Oxford Nanopore Technologies plc (LON: ONT), a UK-based leader in nanopore sequencing technology, has disclosed in a London Stock Exchange filing its intention to pursue legal action against China’s genomics powerhouse BGI and its affiliates. The company alleges that BGI’s newly launched nanopore-based sequencing platform infringes upon or misappropriates Oxford…
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AbbVie Accuses BeiGene of Trade Secret Theft in BTK Degrader Dispute
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AbbVie Sues BeiGene Over Alleged Trade Secret Theft in BTK Degrader ProgramU.S. pharmaceutical titan AbbVie Inc. (ABBV) has initiated legal proceedings against BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), accusing the Chinese biotech firm of pilfering trade secrets vital to its Bruton’s tyrosine kinase (BTK) degrader program. According to…
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US House Approves Biosecure Act with Implications for Chinese Biotech Firms
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The US House of Representatives has taken a decisive step towards tightening biosecurity measures, voting 306-81 on September 9, 2024, to approve the US Biosecure Act, specifically the version known as H.R. 8333. This legislation, previously endorsed by the House Committee on Oversight and Accountability, mandates that any company receiving…
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AstraZeneca Faces Investigation in China Over Data Privacy and Unapproved Drugs
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, is reportedly under the spotlight in Shenzhen, China, with an investigation involving five current and former employees, as per a report by Bloomberg. The probe is said to center on potential breaches of data privacy regulations and the unauthorized importation of drugs…
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China’s Supreme Court Deals Blow to Sanofi’s Aubagio, Confirms Patent Cancellation
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BEIJING—In a recent development for the pharmaceutical industry, Sanofi’s multiple sclerosis therapy Aubagio (teriflunomide) has suffered a significant setback in China. According to the latest information, three decisions from China’s Supreme Court in May 2024 have upheld the cancellation of Sanofi’s formulation patents for Aubagio tablets, as requested by an…
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Takeda’s Entyvio Receives Historic Patent Term Adjustment in China, a First for the Country
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On August 16, a significant milestone was reached as the China National Intellectual Property Administration (CNIPA) awarded Japanese pharmaceutical company Takeda (NYSE: TAK)’s Entyvio (vedolizumab) a Patent Term Adjustment (PTA) for patent NO. ZL201711310404.0, marking the first case of its kind in China. This decision deviates from the typical Patent…
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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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Astellas Pharma Employee in China Formally Indicted on Espionage Suspicion
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Astellas Pharma Inc., a Japanese pharmaceutical company listed on the Tokyo Stock Exchange (TYO: 4503), is facing a challenging situation as one of its employees, detained in China since March 2023 on suspicion of espionage, has reportedly been formally indicted by Chinese authorities. The news was reported by Reuters, citing…
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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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HuidaGene Secures Patent for Innovative CRISPR-Cas12i System in China
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HuidaGene (Shanghai) Biotechnology Co., Ltd, a China-based biotech firm, has secured patent approval from the China National Intellectual Property Administration for its proprietary DNA editing system, CRISPR-Cas12i, also known as the Cas12Max system. The patent encompasses the hfCas12Max nuclease, which HuidaGene independently developed, as well as the broader CRISPR-Cas12i system…
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China’s SAMR Proposes Antitrust Guidelines to Regulate Pharmaceutical Industry
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The State Administration for Market Regulation (SAMR) in China has unveiled a draft proposal for “Antitrust Guidelines for the Pharmaceutical Industry” and is currently soliciting public feedback until August 23, 2024. This comprehensive document, encompassing 55 articles across seven sections, is designed to clarify the foundational principles of anti-monopoly law…
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Pfizer, Astellas, and University of California Sue Qilu Pharma Over Xtandi Patent Infringement
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Pfizer Inc. (NYSE: PFE), through its subsidiary Medivation, and co-development partner Astellas Pharma Inc. (TYO: 4503), are stepping up their efforts to safeguard the intellectual property of their blockbuster prostate cancer drug, Xtandi (enzalutamide). In a joint legal action with the University of California, the companies have filed a lawsuit…
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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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Pharmaceutical Giants Face UK Industry Code Breach Allegations, Including Novartis and Pfizer
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Several multinational pharmaceutical corporations have been reprimanded for violating the UK’s Prescription Medicines Code, a set of voluntary industry standards established by the Association of the British Pharmaceutical Industry (ABPI) and overseen by the Prescription Medicines Code of Practice Authority (PMCPA). The PMCPA has called out Novartis (NYSE: NVS), Pfizer…
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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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J&J Loses US Court Case Over Asbestos in Cosmetic Products; Ordered to Pay $260 Million
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Johnson & Johnson (J&J; NYSE: JNJ) suffered a defeat in a US court this week, where a 49-year-old mesothelioma patient claimed that the company’s cosmetic products were the cause of her illness. The plaintiff alleged that J&J was aware of the presence of asbestos, a known cause of mesothelioma, in…
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MilliporeSigma Avoids Prosecution in Biochemical Diversion Case: A DoJ First
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Merck KGaA (NYSE: MRK)’s US life sciences division, MilliporeSigma, has been at the center of a US Department of Justice (DoJ) investigation into the fraudulent sale and export of biochemicals, including cocaine and fentanyl, to China. The scheme, which lasted from July 2016 until its discovery in May 2023, involved…
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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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GSK Confronted with Whistleblower Allegations Over Zantac and NDMA Link
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GlaxoSmithKline (GSK; NYSE: GSK), the UK-based pharmaceutical giant, is facing legal action in the form of a whistleblower lawsuit filed by Valisure, a US-based chemical analysis company. Valisure alleges that GSK intentionally concealed the carcinogenic link between its popular antacid Zantac (ranitidine) and N-Nitrosodimethylamine (NDMA), a potentially harmful impurity. The…
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U.S. Judge Dismisses Johnson & Johnson and Bristol-Myers Squibb Lawsuits Against Drug-Pricing Provisions in Inflation Reduction Act
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In a recent legal development, a U.S. federal court judge has rejected the legal challenges brought by pharmaceutical giants Johnson & Johnson (J&J; NYSE: JNJ) and Bristol-Myers Squibb (BMS; NYSE: BMY) against the drug-price negotiations outlined in President Joe Biden’s Inflation Reduction Act (IRA). The companies had filed separate lawsuits…
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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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Abiomed Recalls Over 66,000 Impella Heart Pumps Due to Serious Injury Risk, FDA Classifies as Class I Event
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Johnson & Johnson (J&J, NYSE: JNJ), already embroiled in lawsuits over alleged cancer risks associated with its talcum powder products, faces a new product safety scandal. The company’s medical device subsidiary, Abiomed, has initiated a recall of over 66,000 Impella left-sided heart pumps due to a risk of heart perforation…
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CNIPA Invalidates Novo Nordisk’s Victoza Patent, Opening Door for Chinese Biosimilars
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The China National Intellectual Property Administration (CNIPA) has declared invalid the patent No. 201510572124.1 held by Denmark-based Novo Nordisk (NYSE: NVO) related to Victoza (liraglutide) and its stable preparation of proinsulin peptide. This patent was challenged by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a subsidiary of China’s Huadong Medicine Co.,…
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CNIPA Invalidates AbbVie Patents, Setting New Precedent for Pharmaceutical Disclosure
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The China National Intellectual Property Administration (CNIPA)’s Patent Re-examination Board (PRB) has reportedly invalidated two patents associated with AbbVie (NYSE: ABBV)’s JAK inhibitor, upadacitinib, listed in China’s version of the ‘Orange Book’. This ruling, highlighted by Lusheng Law Firm’s Terry Lu, could set a critical precedent for innovative pharmaceutical companies,…
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BIO Reverses Support for WuXi AppTec Amid Security Concerns, Plans Legislative Shift
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The Biotech Innovation Organization (BIO), a US-based industry lobbying group, has reversed its stance on the Chinese Contract Development and Manufacturing Organization (CDMO) WuXi AppTec (SHA: 603259). In a press release from BIO CEO John Crowley, the organization announced it is taking steps to dissociate from WuXi AppTec regarding its…
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BeiGene Launches Legal Action Against Sandoz and MSN Over Brukinsa Patent Infringement
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BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent infringement proceedings against two generics manufacturers: Switzerland’s Sandoz Inc. (OTCMKTS: SDZNY) and U.S.-based MSN Pharmaceuticals. This legal action follows notifications received from both companies regarding their Abbreviated New Drug Applications (ANDAs) submitted to the U.S.…
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US Senate Committee Backs Bill to Restrict Chinese Biotechnology Firms’ Access to American Genetic Data
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The U.S. Senate’s homeland security committee has voted 11-1 in favor of the Prohibiting Foreign Access to American Genetic Information Act of 2024, a bill that seeks to curb the operations of Chinese research service providers, including BGI and WuXi AppTec (SHA: 603259, HKG: 2359), within the U.S. The legislation,…
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AlzeCure Pharma’s Alzheimer’s Drug Candidate ACD856 Receives Global Patent Awards
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AlzeCure Pharma, a Swedish pharmaceutical company, has announced the receipt of patent approval awards for its clinical drug candidate ACD856 in several countries, including China. The drug, which holds potential as a treatment for Alzheimer’s disease and other cognitive impairment-related disorders, has been granted protection until 2039 in China, India,…
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Sandoz Agrees to $265 Million Settlement in U.S. Generic Drug Antitrust Case
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Sandoz (SIX: SDZ), the Swiss-based pharmaceutical company, announced this week that its U.S. subsidiaries have reached a settlement in a generic drug antitrust class action, agreeing to pay $265 million to the plaintiffs. The settlement is subject to court approval and includes a provision allowing Sandoz to withdraw if a…
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GSK and Peers Respond to FTC Criticism, Withdraw Patent Listings from US Orange Book
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Three pharmaceutical companies, including the UK’s GSK (NYSE: GSK), have responded to the Federal Trade Commission’s (FTC) allegations of “abusive” patents by withdrawing several listings from the US Orange Book. This action follows the FTC’s challenge in November against over 100 patents held by manufacturers of branded asthma inhalers, epinephrine…
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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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Shanghai Medical Products Administration Issues Trial Measures for Pharmaceutical Quality and Safety Personnel
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The Shanghai medical products administration has released the “Measures for the Management of Key Quality and Safety Management Personnel of Drug Production and Operation Enterprises in Shanghai (Trial)”. These measures aim to tackle current issues in managing key personnel responsible for drug quality and safety within enterprises and to bolster…
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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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China’s National People’s Congress Approves Stricter Punishments for Sector-Specific Bribery
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The 7th meeting of the 14th National People’s Congress Standing Committee has passed the latest Amendment (XII) to China’s Criminal Law, which is set to take effect from March 1, 2024. This revision enhances the potential penalties associated with bribery in sectors including healthcare, food and drug industries, and other…
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Daiichi Sankyo and Esperion Therapeutics Amend Collaboration on Antilipidemic Drugs
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Daiichi Sankyo (TYO: 4568)’s European subsidiary, a Japanese pharmaceutical company, has entered into a collaboration amendment agreement with US-based Esperion Therapeutics (NASDAQ: ESPR) concerning Esperion’s antilipidemic drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid + ezetimibe). The revised agreement stipulates that Esperion will receive an immediate payment of USD 100…
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Servier Faces $475 Million Penalty Over Banned Antidiabetic Drug Mediator in France
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French pharmaceutical company Servier has been ordered by a French court to pay €430.6 million ($475 million) in a partial reversal of a 2021 decision concerning its now-banned antidiabetic drug, Mediator (benfluorex). The new ruling has found Servier guilty of fraud, improper acquisition of regulatory authorizations, aggravated deception, and involuntary…
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J&J Shareholders Cleared to Sue Over Hidden Asbestos Risks in Talc Products
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A US federal court has granted permission for certain Johnson & Johnson (J&J; NYSE: JNJ) shareholders to initiate a class action lawsuit against the company for allegedly concealing the presence of oncogenic asbestos in its talc products. The decision, which impacts stock price events between 2017 and 2018, covers stockholders…
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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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Medtronic Exits $738 Million Deal to Acquire EOFlow Amid Regulatory and Legal Challenges
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U.S.-based Medtronic plc has announced its withdrawal from a previously agreed deal to fully acquire South Korea’s EOFlow (KOSDAQ: 294090), a developer of wearable insulin pumps. According to a recent SEC filing, the original agreement, signed in May 2023 and valued at up to USD 738 million, included separate share…
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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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Bayer Halts Late-Stage Trial for Asundexian After Underperformance
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Germany-headquartered Bayer (ETR: BAYN) announced the termination of a late-stage trial for its antithrombotic candidate asundexian. Asundexian, once considered a potential blockbuster, was outperformed by the standard of care in preventing stroke and systemic embolism in patients with atrial fibrillation, the most lucrative indication for the drug, with an estimated…
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Novartis Seeks Access to Takeda’s Business Records Over Confidentiality Concerns
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Swiss pharmaceutical giant Novartis (NYSE: NVS) filed a complaint with a US court last week, seeking discovery to gain access to certain business records of Japan-based Takeda (TYO: 4502). Novartis aims to determine whether Takeda has potentially benefited from confidential documents that may have been inappropriately transferred by a former…
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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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EU Chamber of Commerce in China Releases Position Paper, Addresses Pharma and Healthcare
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The EU Chamber of Commerce in China has released its bi-annual “European Business in China Position Paper 2023/2024,” which compiles recommendations from over 1,700 member companies. The document aims to foster constructive dialogue between Europe and China, enhancing engagement between European firms and Chinese stakeholders for mutual benefit. The paper…
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Eli Lilly Sues US Sellers of Counterfeit Mounjaro Products
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Pharmaceutical giant Eli Lilly (NYSE: LLY) has filed a lawsuit in the United States against medical spas, wellness centers, and compounding pharmacies that are selling unregistered products claiming to be Mounjaro (tirzepatide), the company’s GLP-1 agonist. Mounjaro has recently gained popularity for its off-label use as a weight-loss drug, prompting…
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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…
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Jiangsu Hengrui Medicine Entangled in Legal Disputes with BeyondSpring and Reistone
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) is currently entangled in legal challenges involving two partner companies. The firm has initiated a lawsuit against US-based biotech BeyondSpring Inc. (NASDAQ: BYSI) over a failed partnership deal, while also facing potential disbandment of its subsidiary, Reistone Biopharma (Hong Kong) Ltd, amid…
