e-Pharmatimes

Generic Drug Approval Process in Russia. The approval process for generic drugs in Russia followed a similar pathway to many other countries. The process generally involves the following steps: 1. Documentation Submission:   The generic drug manufacturer must submit a dossier containing detailed information about the drug's safety, efficacy, quality, and manufacturing processes to the Russian regulatory authority, the Ministry of Health of the Russian Federation. 2. Review and Evaluation:  The regulatory authority reviews the submitted documentation to ensure compliance with the relevant regulations and guidelines. They assess the quality, safety, and efficacy data of the generic drug compared to the reference (originator) drug. 3. Clinical Trials:  In some cases, the generic drug manufacturer may need to conduct local clinical trials in Russia to support the drug's safety and efficacy claims. 4. Registration:  If the generic drug meets all the regulatory requirement...

China Patent Litigation China has a legal system in place for patent litigation, which involves resolving disputes related to patents through the court system. Patent litigation in China typically occurs when there is an alleged infringement of a granted patent, and the patent owner seeks remedies for the infringement. Key points regarding patent litigation in China include: 1. **Jurisdiction**:  Patent infringement cases are typically heard by specialized intellectual property (IP) courts, such as the Beijing IP Court, Shanghai IP Court, and other regional IP courts. 2. **Procedures**:  Patent litigation in China follows specific procedures, including the filing of complaints, exchange of evidence, court hearings, and judgment. The court will assess whether the asserted patent is valid and whether the alleged infringement has taken place. 3. **Remedies**:  If the court finds in favor of the patent owner, remedies for patent infringement in China may include injuncti...

China Patent Prosecution : China has its own patent prosecution system for granting patents to inventors and applicants. Patent prosecution in China involves the process of applying for a patent, examination by the Chinese Patent Office (China National Intellectual Property Administration - CNIPA), and, if the application meets the necessary requirements, the issuance of a patent. The main steps in the patent prosecution process in China typically include: 1.Application Filing:  The first step is to file a patent application with the CNIPA. The application can be for an invention, utility model, or design patent. 2.Examination:  After filing, the CNIPA will examine the application to determine if it meets the necessary requirements and whether the invention is novel, non-obvious, and industrially applicable. This examination process can be quite thorough and may involve back-and-forth communication with the patent examiner. 3.Publication:  Once the application is dee...

"Invalidity" and "non-infringement" are two important concepts in patent law, often considered in the context of patent disputes or litigation . 1:Invalidity refers to the legal determination that a patent is not valid, meaning that it should not have been granted in the first place. A patent can be invalidated for various reasons, such as: - Lack of Novelty : The invention was not new or was publicly disclosed before the patent filing.- -Lack of Inventive Step (Obviousness) : The invention would have been obvious to a person skilled in the relevant field. -Lack of Industrial Applicability: The invention does not have a practical and useful application. -Insufficient Description (Lack of Enablement): The patent specification does not enable a person skilled in the art to carry out the invention.- -Violation of Patent Requirements: The patent application did not meet certain formal or procedural requirements. If a court or a relevant authority determines that a ...

Patent Prosecution in Brazil: 1. Filing : To obtain a patent in Brazil , an application must be filed with the Brazilian Patent and Trademark Office (INPI - Instituto Nacional da Propriedade Industrial). 2. Examination: INPI will examine the patent application to determine if the invention meets the patentability criteria, including novelty , non-obviousness , and industrial applicability. 3. Granting: If the patent application meets the requirements, INPI will grant the patent, and the patent holder will have exclusive rights to the invention in Brazil for a limited period. Patent Litigation in Brazil: 1. Disputes: disputes can arise if someone believes that a granted patent is invalid or if their rights are being infringed upon by another party. 2. Court System: Patent litigation is typically resolved through the Brazilian court system. 3. Possible Outcomes: The court may uphold the patent's validity, declare it invalid, or rule on infringement claims. Remedies for infringemen...

The guidelines aim to help patent examiners assess whether an invention is non-obvious , which is a key requirement for obtaining a patent. The determination of  obviousness  involves a legal analysis of whether the claimed invention, as a whole, would have been obvious to a person having ordinary skill in the art at the time the invention was made, based on the prior art available. The MPEP outlines several steps that examiners should follow: 1. Identify the Prior Art: The examiner must locate and consider the relevant prior art that existed before the filing date of the patent application. Prior art includes patents, published patent applications, scientific publications, and other publicly available materials. 2. Determine the Differences: The examiner needs to identify the differences between the claimed invention and the prior art. These differences are known as the "claimed invention features" and are used as a basis for the obviousness analysis. 3. Establish the Level ...

Key litigation aspects for US patents can significantly impact their strength and enforceability. When involved in patent litigation in the United States, the following aspects are crucial to consider: 1. ** Validity Challenges **: The defendant may challenge the patent's validity, claiming that the patent does not meet the necessary legal requirements for patentability. Common challenges include prior art (existing public knowledge or patents), lack of novelty, obviousness, and insufficient written description. 2. **Infringement**: The plaintiff must demonstrate that the defendant's product or process infringes on the patented claims. Infringement can be literal or under the doctrine of equivalents. 3. **Claim Construction**: Courts often interpret the language used in the patent claims to determine their scope and meaning. Claim construction significantly influences the outcome of patent litigation. 4. **Defenses**: The defendant may assert various defenses, such as non-infri...

In Portugal, the regulatory authority responsible for the approval of generic drugs is the Infarmed - National Authority of Medicines and Health Products. The approval process for generic drugs in Portugal generally follows the guidelines and regulations set by the European Medicines Agency ( EMA ) and the European Union. The regulatory timeline for generic drug approval typically consists of the following stages: 1. Pre-submission phase: The generic drug manufacturer conducts research and development to demonstrate the bioequivalence of the generic product with the reference (innovator) drug. This phase can take several years. 2. Application submission: Once the generic drug is ready for approval, the manufacturer submits a Marketing Authorization Application (MAA) to Infarmed. The application should contain comprehensive data on the safety, quality, and efficacy of the generic drug. 3. Validation: Infarmed reviews the submitted application to ensure that all necessary documents and ...

The term "prosecution history estoppel" is a legal principle that applies to patent law in the United States. It is also known as "file wrapper estoppel" or "estoppel by prosecution history." Prosecution history estoppel limits the scope of a patent's claims during patent litigation and affects the rights of a patent holder. Here's an explanation of prosecution history estoppel: 1. Patent Application Process: When an inventor seeks to obtain a patent for an invention, they submit a patent application to the United States Patent and Trademark Office (USPTO). During the examination process, the patent examiner reviews the application and may issue rejections or objections based on prior art or other reasons. 2. Amendments and Arguments: To overcome rejections or objections, the patent applicant may amend the claims of the patent application or make arguments to convince the examiner that the invention is patentable over the prior art. These amendment...

Patent prosecution in Italy refers to the process of obtaining a patent for an invention within the Italian legal framework. It involves various steps and interactions with the Italian Patent and Trademark Office (UIBM - Ufficio Italiano Brevetti e Marchi) or the European Patent Office (EPO) if seeking protection through the European Patent system. Here are the key stages involved in the patent prosecution process in Italy: 1. **Patent Application Filing:** The process begins with the filing of a patent application with the UIBM or the EPO. The application should include a detailed description of the invention, claims defining the scope of protection, and any necessary drawings or figures. 2. **Formal Examination:** After receiving the patent application, the Italian Patent and Trademark Office (UIBM) or the European Patent Office (EPO) will conduct a formal examination to check if all necessary documents and fees have been submitted correctly. If any deficiencies are found, the applic...

Brazilian patent prosecution refers to the process of applying for and obtaining a patent in Brazil. It involves various steps and interactions with the Brazilian Patent and Trademark Office (Instituto Nacional da Propriedade Industrial or INPI) to seek protection for an invention and have it granted as a patent. The patent prosecution process in Brazil typically includes the following steps: 1. **Patent Application Filing**: The first step is to file a patent application with the INPI. The application must include a detailed description of the invention, claims defining the scope of protection sought, and any necessary drawings or diagrams. 2. **Formal Examination**: The INPI conducts a formal examination to check if the application meets the necessary formal requirements, such as proper documentation, payment of fees, and correct filing procedures. 3. **Publication**:  After passing the formal examination, the patent application is published in the Brazilian Official Gazette. Thi...

In Canada, the litigation processes related to NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) are legal proceedings that may occur when disputes arise between brand-name and generic drug manufacturers. These litigations can involve issues such as patent infringement, data protection, or market exclusivity. Here's an overview of the NDA and ANDA litigation processes in Canada: 1. NDA Litigation Process: Step 1: Patent Protection and Listing on the Patent Register When a pharmaceutical company develops a new drug, it may seek patent protection for the drug's active ingredient, formulation, or method of use. The patent holder can list the patents on the Canadian Patent Register, a publicly accessible database managed by Health Canada. Step 2: Notices of Allegation (NOA) If a generic drug manufacturer intends to market a generic version of a brand-name drug before the expiration of the listed patents, it must submit a Notice of Allegation (NOA) to the brand-...

Canada's pharmaceutical patent system is designed to strike a balance between encouraging innovation in the pharmaceutical industry and promoting access to affordable generic drugs for the Canadian population. The system provides patent protection to innovative pharmaceutical products while also allowing for the timely entry of generic versions of these drugs once the patent protection expires. Here are the key aspects of Canada's pharmaceutical patent system: 1. Patent Protection for Innovative Drugs: In Canada, pharmaceutical inventions can be protected through patents granted by the Canadian Intellectual Property Office ( CIPO ). Pharmaceutical companies can apply for patents to protect the chemical compounds, formulations, methods of manufacture, and medical uses of their innovative drugs. The duration of patent protection for pharmaceuticals is typically 20 years from the date of filing, subject to certain adjustments and extensions under specific circumstances. 2. Patent ...

Novo Nordisk, Eli Lilly and Boehringer Ingelheim back bill to bring Obesity drug inclusion to Government health care. Notwithstanding the inescapable promotion encompassing new and strong corpulence medications, the medications are still too far for some Americans who could benefit. One explanation is that under current regulations, American insurance is banished from covering corpulence drugs. Yet, comprehend regulation supported by Novo Nordisk, Eli Lilly, Boehringer Ingelheim and numerous different associations, a gathering of legislators plans to change that. Sens. Bill Cassidy, M.D., R-Louisiana, and Tom Carper, D-Delaware, plus Reps. Brad Wenstrup, R-Ohio, and Raul Ruiz, D-California, have proposed the Treat and Reduce Obesity Act, which would step up the government's fight against the obesity epidemic. As the administrators note, numerous normal circumstances, for example, coronary illness and diabetes are related with stoutness. They say the bill would "work to straigh...

Patent litigation in Australia is governed by the Australian Patents Act 1990 and is primarily heard in the Federal Court of Australia. Here's an overview of patent litigation in Australia: 1. **Federal Court of Australia**: The Federal Court is the principal forum for patent litigation in Australia. It has the jurisdiction to hear and determine patent infringement and revocation actions. 2. **Patent Infringement Claims**: To bring a patent infringement claim, the patent holder (plaintiff) must demonstrate that someone else (defendant) has exploited their patented invention without authorization. The court will consider whether the defendant's product or process falls within the scope of the claims of the patented invention. 3. **Challenging the Validity of a Patent**: A defendant in a patent infringement case may counterclaim for the revocation of the patent, challenging its validity on various grounds, such as lack of novelty, inventive step, or insufficient description. 4...

Prosecution history estoppel is a legal doctrine that applies to patent law. It is a principle that limits the scope of patent claims based on the statements made by the patent applicant or the patent office during the prosecution (examination) of the patent application. The doctrine is designed to prevent a patent applicant from making inconsistent or contradictory arguments to the patent office to secure broader claim scope during prosecution and then asserting a different, narrower interpretation of the claims in later infringement litigation. When a patent application is being examined by a patent office, the applicant and the examiner engage in a back-and-forth process called prosecution, where the applicant amends and argues the scope of the patent claims. The applicant may make arguments to distinguish their invention from prior art references or to overcome rejections based on prior art. Prosecution history estoppel comes into play if, during the prosecution, the applicant volu...

Obviousness and novelty are important concepts in patent law that can be used as grounds for invalidating a patent. When a patent is granted, it implies that the invention is novel, non-obvious, and meets other patentability requirements. However, if it is later proven that the invention lacks novelty or is obvious, the patent may be invalidated. 1. Novelty : Novelty refers to the requirement that an invention must be new and not publicly disclosed before the filing date of the patent application. If the invention was previously known or disclosed to the public in any form, such as in prior patents, published articles, or public demonstrations, it may lack novelty, and the patent could be invalidated on those grounds. 2. Obviousness: Obviousness, on the other hand, refers to the requirement that an invention must not be obvious to a person skilled in the relevant field of technology at the time of filing the patent application. If the invention is merely a combination of existing elem...

The Doctrine of Equivalents is a legal principle that is relevant to patent law, particularly in the United States, and it helps protect inventors' rights even when minor changes or substitutions have been made to a patented invention.  When an inventor applies for a patent, the claims in the patent document define the scope of protection for the invention. These claims outline the specific elements or features of the invention that are considered unique and non-obvious. If another party copies or uses the patented invention without permission, it may be considered infringement. However, in some cases, the accused infringer may make slight modifications to the invention that fall outside the literal scope of the patented claims. The Doctrine of Equivalents comes into play here. It allows the patent holder to assert that the accused infringer's modified version is still equivalent to the patented invention and, therefore, falls within the scope of the patent protection. For the ...

Patent litigation refers to the legal process of resolving disputes over patents through the court system. Patents are legal protections granted to inventors or creators of new and innovative inventions, giving them the exclusive right to make, use, and sell their invention for a specified period, typically 20 years from the filing date. When someone believes that a patent has been infringed upon, meaning that another party is using, making, or selling the patented invention without permission, they may file a lawsuit in court to assert their rights and seek remedies for the infringement. Conversely, the party accused of infringement may also defend their actions by challenging the validity of the patent or arguing that no infringement occurred. The patent litigation process generally involves the following steps: 1. **Filing the Complaint**: The patent holder, known as the "plaintiff," initiates the lawsuit by filing a complaint with the appropriate court. The complaint ou...

Introduction: Stress is an inevitable part of life, and while some level of stress can be beneficial, chronic or excessive stress can have a detrimental impact on both our physical and mental well-being. In this article, we will explore the effects of stress on the body and discuss effective stress management techniques that can help mitigate its negative consequences. Understanding the Physiological Effects of Stress:  a. The Stress Response: Fight or Flight b. The Role of Stress Hormones (Cortisol, Adrenaline) c. Effects on the Cardiovascular System d. Impact on the Immune System e. Influence on Digestive Health f. Effects on Sleep Patterns The Psychological and Emotional Consequences of Stress: a. Anxiety and Panic Disorders b. Depression and Mood Disorders c. Cognitive Impairment and Memory Problems d. Relationship and Social Impact e. Impact on Overall Mental Well-being Effective Stress Management Techniques:  a. Lifestyle Modifications:  i. Regular Exercise and Phy...

After Novo Nordisk's well known stoutness medication Wegovy went into short inventory, individuals went to the organization original weight reduction drug, Saxenda, for treatment. Presently, the organization is battling to deal with interest for that item. Saxenda will have restricted accessibility through the finish of 2023 in view of flooding interest, as per an update posted Tuesday on the FDA's medication deficiency list. It seems the issue could endure longer than only this year, as well. In a proclamation, a Novo Nordisk representative said the organization keeps on seeing interest for Saxenda increment "at a significant rate." Despite the fact that the organization is transporting all its accessible infusions to wholesalers and retail drug stores, it expects "numerous patients will experience issues filling their Saxenda remedies until the end of 2023 and then some." The representative didn't say whether Novo expects the Saxenda's lack will in...

In a consistent decision, over of two years really taking shape, the Full Court of the Federal Court of Australia has affirmed that the Australian Government isn't qualified for pay for the deferred section of conventional clopidogrel into the Australian market. In doing as such, the Full Court excused the Public authority's allure from a prior choice of Equity Nicholas. Key action items It stays open to the Public authority to bring a case for remuneration under an endeavor as to harms where an interlocutory directive to limit the send off of a nonexclusive (or biosimilar) drug has been wrongly conceded, because of a patent later being nullified. Effectively asserting on the endeavor is complicated: the Public authority should show adequate proof (contemporaneous archives, declaration of applicable chiefs from the Public authority and conventional) to lay out that the interlocutory directive caused the postponed decrease of repayment costs. Current realities in the current cas...

Cipla, which was as of late hit with a 23-page Form 483 documenting from the FDA, is adding to the albuterol supply strain with a U.S. review of six clumps of the asthma drug. The organization's deliberate review of albuterol sulfate inward breath spray is a consequence of a compartment imperfection, Cipla said in a recording with the Bombay Stock Trade. In particular, a market protest hailed spillage in one inhaler, the organization said. The break was seen in the inhaler valve, driving Cipla to pull all of the loads of the medication that pre-owned that equivalent bunch of valves from U.S. racks. The organization took the action "with the goal of being as safe as possible," it noted in the delivery. The parcels were made in November of 2021 and terminate this November. "Cipla keeps up with rigid quality cycles to survey quality imperfections and security issues," the organization said in the recording. "Cipla conducts normal examination and evaluation by ...