e-Pharmatimes

Patent litigation in Singapore. The process involves several steps: 1. Filing a Writ of Summons: The plaintiff initiates the litigation by filing a Writ of Summons, outlining their claims and relief sought. This officially starts the lawsuit. 2.Serving Court Documents:  The plaintiff serves the court documents to the defendant, who responds by filing a Memorandum of Appearance to indicate their participation in the case. 3.Pleadings and Statements of Case:  Both parties exchange their statements of case, including the Statement of Claim by the plaintiff and the Statement of Defence by the defendant. Further statements and counterclaims might also be filed. 4.Case Management Conference (CMC):  The court schedules a CMC to manage the case's progress, including issues like discovery, evidence, and trial dates. 5.Discovery:  Each party gathers and discloses relevant documents and evidence that will be used during the trial. This can include expert reports, technical docu...

Armenia Pharmaceutical patent litigation. Pharmaceutical patent litigation in Armenia typically follows a legal process similar to that of other countries. Here's a general outline of the steps involved: 1.Identification of Patent Infringement:  The patent holder identifies a potential infringement of their patent rights by a generic drug manufacturer. 2.Cease and Desist Letter:  The patent holder may send a cease and desist letter to the alleged infringer, requesting them to stop manufacturing, selling, or marketing the allegedly infringing generic drug. 3.Legal Action Initiation:  If the dispute is not resolved through negotiation, the patent holder may initiate legal action by filing a lawsuit against the alleged infringer in the appropriate court. This may be the Intellectual Property Court or another relevant court. 4.Defendant's Response:  The defendant, in this case, the generic drug manufacturer, responds to the lawsuit by presenting their arguments and evide...

Creating a competitive landscape for a pharmaceutical generic product involves analyzing the market and identifying key players, their strengths, weaknesses, and market positioning. Here's a simplified outline: **Competitive Landscape Analysis for Pharmaceutical Generic Product:** 1. **Market Overview:**    - Size of the pharmaceutical generic product market.    - Growth trends and forecasts.    - Regulatory environment and barriers to entry. 2. **Key Players:**    - List the major pharmaceutical companies producing the generic product.    - Include both global and regional players. 3. **Market Share:**    - Percentage of market share held by each major player.    - Trends in market share changes over time. 4. **Product Portfolio:**    - Types of generic products offered by each player.    - Variations in strengths, dosage forms, and delivery methods. 5. ** Competitive Advantage :**    - ...

Singapore has a robust legal framework for patent litigation. The process involves enforcing and defending patent rights through the court system.  Key points about patent litigation in Singapore include: 1. **Specialized Court**: Singapore's High Court has a specialized Intellectual Property (IP) list that handles patent disputes. This ensures that cases are managed by judges with expertise in IP matters. 2. **Patent Infringement**: If someone believes their patent is being infringed upon, they can initiate a lawsuit against the alleged infringer. The court will then consider the evidence and arguments from both sides before making a decision. 3. **Revocation Actions**: In addition to patent infringement cases, the Singapore court can also handle revocation actions, where someone challenges the validity of a patent. This is an important aspect of ensuring that only valid patents are enforced. 4. **Evidence and Proceedings**: Like any litigation, parties will present their evidence...

The patent prosecution process in Norway is as follows: 1. **Filing:**  Submit a patent application to the Norwegian Industrial Property Office (NIPO). The application can be a national application, a regional (European) application designating Norway, or an international (PCT) application entering the national phase. 2. **Formal Examination:**  NIPO conducts a formal examination to ensure the application meets all requirements, such as correct documentation and fees. 3. **Substantive Examination:**  If requested, NIPO conducts a substantive examination to assess the patentability criteria, including novelty, inventive step, and industrial applicability. 4. **Publication:**  If the application meets the requirements, it is published 18 months from the filing date or priority date. 5. **Third-Party Observations:**  Third parties can submit observations on the patentability of the application within a certain timeframe after publication. 6. **Grant or Refusal:**...

Patent Litigation Steps in Italy .  In Italy, the patent litigation process typically involves the following steps: 1. Pre-litigation Phase: This stage involves parties attempting to resolve the dispute through negotiations or alternative dispute resolution methods before initiating formal litigation. 2. Filing the Lawsuit : If pre-litigation efforts fail, the patent holder (plaintiff) files a lawsuit against the alleged infringer (defendant) in the appropriate Italian court. 3. First Instance Court Proceedings : The court examines the evidence and arguments presented by both parties and issues a decision on the validity of the patent and infringement claims. 4. Appeals : If either party is dissatisfied with the first instance court's decision, they can appeal to a higher court, usually the Court of Appeals. 5. Cassation : Further appeal can be made to the Supreme Court of Cassation if there are issues of law that need to be clarified. 6. Injunctions : During the litigation proce...

Patent Prosecution in Italy. In Italy, patent prosecution refers to the process of applying for and obtaining a patent from the Italian Patent and Trademark Office (UIBM - Ufficio Italiano Brevettie Marchi). The patent prosecution process typically involves the following steps: 1. Patent Application:  File a patent application with UIBM, either directly or through the European Patent Office (EPO) if applying for a European patent that designates Italy. 2. Formal Examination:  The UIBM will conduct a formal examination to ensure the application meets all the necessary requirements. 3. Substantive Examination:  The patent application will undergo a substantive examination to assess its novelty, inventive step, and industrial applicability. 4. Publication:  Once the application is deemed in order, it will be published in the Official Gazette of the Italian Patent and Trademark Office. 5. Opposition Period:  After publication, there is a window during which third pa...

How to Launch Generics in Russia , when the RLD is approved . If the reference listed drug (RLD) is not available in Russia, launching a generic version can be a more complex process compared to countries where the RLD is already marketed. Here are some steps and considerations to keep in mind: 1. Market Research:  Conduct thorough market research to understand the demand for the generic drug and potential competitors in the Russian market. 2. Regulatory Approval : Seek approval from the Russian regulatory authority, the Ministry of Health of the Russian Federation, to market the generic drug. You will need to submit a comprehensive dossier containing safety, efficacy, quality, and manufacturing data, even if the RLD is not available in Russia. 3. Clinical Trials:  In some cases, local clinical trials may be required to support the safety and efficacy claims of the generic drug. 4. Patent Considerations:  Ensure that there are no patents or exclusivity rights that could ...