Recent Posts in ‘Pharmaceuticals / Biotech / Life Sciences’
« Older EntriesBiotech & Pharmaceutical Patenting
May 21st, 2012
in Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
In a rapidly shifting legal environment for the pharma industry, it has become crucial that biotech companies seek the most practical and competitive strategies for obtaining, extending and protecting their patent portfolios.
The 2012 London Biotech & Pharmaceuticals Patenting forum will focus on latest legal developments affecting biotech companies, with a particular focus on successful techniques and strategies for drafting and filing patent applications in multiple jurisdictions. The event will provide a unique opportunity for you to network with your fellow industry peers, key industry regulators and expert patent attorneys from across globe, allowing you to develop your current biotech practices and remain competitive in today’s rapidly changing market.
C5’s 23rd Forum on Biotech & Pharmaceuticals Patenting brings together experienced in-house counsel from both innovator and generic pharma and biotech companies and their expert legal advisors from various jurisdictions across the globe. Based on their personal experience, the expert panel will lead you through invaluable, practical, and in-depth sessions on:
- The latest case law developments regarding SPCs and the impact on the industry
- The patentability of diagnostic methods and the implications of the Prometheuscase in the US
- A comparison of the approaches in the EU member states on research exemptions in clinical trials
- The use of patent litigation insurance cover to enable smaller life science developers to protect their IP
- The latest strategies and priorities of the EPO
- A comparison of the approaches to inventiveness in different member states in the EU
- Procedural developments in Europe, including developments in evidence collection proceedings
- Analysing the US Biosimilars Framework and developments in the EU
- An update on case law in key jurisdictions including the US, UK, Germany, France and Switzerland
Tags: c5, C5 Publications, Legal, legal conferences, Legal Events, pharma
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Freedom to Operate
April 5th, 2012
in Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
I wanted you to know that based on industry feedback from fellow patent experts we are happy to announce – for your review and early registration – the topics and speaker faculty for our 9th International Forum on Freedom to Operate, which will take place on the 9th and 10th May in Frankfurt, Germany.
This practical forum on the latest strategies for cost-effective, high value and low risk FTO assessments gathers numerous eminent in-house experts from the pharma, biotech and chemical industries. Based on their first-hand experience, the distinguished panel will share their extensive insights and discuss the latest legal and regulatory developments for successful FTO opinion writing.
http://www.c5-online.com/fto
C5’s FTO forum is the only event in Europe specifically designed for IP and Information Science experts involved with FTO practices in pharma, biotech and chemical sectors. In particular learn how to overcome the biggest challenges facing Freedom to Operate (FTO) searches, analysis and opinion writing today and cut through the complexities of:
- Current EPO, US and European National case lawon claim interpretation and validity
- Conducting FTO searches more time efficiently and cost effectively
- Hear best practice approaches to good search strategy by leading in-house experts
- Explore new technology tools and trends
- Assess search strategies for different sized projects
- New developments on SPCs and paediatric exclusivity and how they could threaten your patent strategy
- Stratifying and quantifying FTO risks: how to deal with the grey areas
- Downstream effects of EPO divisional applications and the America Invents Act on your FTO strategy
- New considerations for FTO practice arising from recent gene patenting decisions (Lilly v HGS and Brüstle v Greenpeace)
- Addressing FTO challenges in emerging markets:China, India, Brazil
For more information, check the link below:
http://www.c5-online.com/files/pdf/marketing/511L12-FRA-E.pdf
Tags: c5, pharma
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Pharma Patent Lifecycles
April 2nd, 2012
in Legal, Legal Conferences, Legal Conferences, Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
The pharmaceutical industry stands on the edge of a patent cliff, with many blockbuster drugs going off patent in 2012 and 2013.
This decline in the number of patents not only creates problems for big pharma innovators, but also puts generic companies under pressure to maximise their opportunities. With the cost of research and development continually rising and the need to obtain maximum revenue from existing patent terms, patent lifecycle management is becoming more crucial for the pharma industry than ever before.
At this time it is essential that you know how to modify your lifecycle strategy to legitimately extend revenue streams and take advantage of the changing patent landscape.
Benchmark your strategies for patent lifecycle extensions with your direct peers and gain an advantage over your competitors.
For more information, check the link below:
http://www.c5-online.com/files/pdf/marketing/509L12-LON-E.pdf
Tags: c5, Legal, Legal conference, legal conferences, patent law, pharma
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Paragraph IV Disputes
March 12th, 2012
in Legal Conferences, Legal Conferences, Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
Brand name and generic pharmaceutical companies are beginning to feel the initial impact of the patent cliff:
the pecuniary perils of patent loss and the economic consequences associated with the decline of Hatch-Waxman market exclusivity. As a result, the industry has entered an era of “extreme” Paragraph IV litigation where the monetary ante has never been higher.
To help you respond to the challenges of this new era, ACI’s 6th Annual Paragraph IV Disputes conference will guarantee your access to the leading legal minds in this area. A “who’s who” of Hatch-Waxman litigators — for both brand names and generics — will help you conquer the patent crisis of 2012 by addressing such industry shaping topics as:
- The impact of the AIA on Hatch –Waxman litigation
- Carve-outs, use codes and labeling
- Claim construction
- Prior art obviousness and obvious-type double patenting
- Inducement of infringement and divided infringement
- Inequitable conduct
- Damages
Hear also from renowned federal jurists and a key official from the Federal Trade Commission. Learn firsthand how the bench analyzes the theories of your case and what the FTC deems as “fair and foul” in the settlement of pharmaceutical patent disputes.
Complete your professional training by attending one or more of thesecustomized Working Groups, Workshops and Master Classes:
Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals which will provide the patent and regulatory backdrop for the more in-depth Hatch-Waxman litigation controversies discussed in the main conference;
A Working Group Session on Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation which will address how new pre- and post issuance procedures may alter certain components of Paragraph IV litigation and parallel proceedings between the Federal Courts and PTO; and
The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics which will give practical and hands-on strategies for drafting and negotiating settlement agreements that will pass muster with the FTC.
Tags: c5, legal conferences, Legal Events, pharma
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Biotech Patenting
March 6th, 2012
in Legal, Legal Conferences, Legal Conferences, Litigation, Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
Our 22nd Biotech Patenting forum will bring together key regulators from Germany, Spain, the EPO and USPTO, leading in-house representatives from GSK, Bayer, Pfizer, Merck, UCB, Ipsen Pharma, Qiagen, GE Healthcare (and many more) and their legal advisers from different European jurisdictions and the US.
This outstanding expert panel will provide you with up-to-the-minute information on the latest case law in Europe and the US to make sure you have the best patent strategy in place to deal with new and emerging challenges in biotech patent practice.
And our timely focus day on the US patent reform and its implications for European life sciences companies will highlight what you need to consider when enforcing and protecting your IP rights in the US.
You will hear directly from your industry peers on best practice approaches and their first hand experiences with current industry challenges regarding the entire patenting process throughout the patent cycle, from obtaining, extending to protecting. Issues addressed will include:
• G2/10 decision: analysing its impact on the biotech disclaimer practice across Europe
• Cross-border litigation: developing successful strategies
• Case law developments in double patenting: from a European and US perspective
• New patenting and marketing strategies to overcome the challenges of filing your SPC applications at an earlier stage
• Latest decision on patentability of stem cells: to help you examine the outcome of the CJEU decision in Brüstle
• Patentability of gene sequence patents: evaluate recent Eli Lilly v HSG decision and latest developments in the US regarding the Myriad, Prometheus and Classen cases
• US Patent Law reform: discussing the impact of the America Invests Act on European biotech firms
For more information, check the link below:
http://www.c5-online.com/files/pdf/marketing/660L12-MUN-E.pdf
Tags: c5, Legal, Legal conference, legal conferences, Legal Events
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Pharma Patent Lifecycles
February 15th, 2012
in Legal, Legal Conferences, Legal Conferences, Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
Patent life cycle management is becoming more crucial for pharmaceutical companies with the cost of research and drugs continually rising and companies constantly trying to obtain the maximum financial benefit from existing patent terms. In addition to protecting existing IP rights and seeking methods to extend current patent lifecycles, pharmaceutical companies are faced with the challenge of inventing new drugs and diversifying portfolios to replace sales on older and generic drugs.
The 2012 Pharma Patent Lifecycles Forum will focus on recent cases across Europe and the US and their impact on the latest regulatory developments and strategies for patent lifecycle extensions. Our outstanding panel of experts will provide you with practical guidance on the most effective ways to successfully apply for patent term extensions and overcome the strategic challenges when dealing with the various patent offices and regulatory authorities. In addition, key regional experts will examine the current legal and regulatory processes and procedures to extend patent lifecycles in the BRIC countries, providing you with the information you need to maximise the scope of your patent portfolio.
C5’s 11th Annual Forum on Pharma Patent Lifecycles brings together eminent in-house counsel from the world’s largest pharma and biotech companies and their expert advisors from a range of jurisdictions, including the US, Europe and Asia.
Be where your industry will be on 20th and 21st June 2012 and don’t miss out on this unique opportunity to hear from and network with prominent judicial authorities, regulatory experts and industry specialists.
Tags: c5, legal conferences, Legal Events, Litigation, pharma
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EU Pharma Law & Regulation
January 25th, 2012
in Legal, Legal Conferences, Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
In times of growing competition in the pharma industry for tighter healthcare budgets, of stricter national pricing and reimbursement laws and increased scrutiny from the regulators, it is – now more than ever – crucial for legal professionals to keep abreast with regulatory developments as well as benchmark against industry best practice.
This focused and practical conference on EU Pharma Law & Regulation brings together eminent in-house counsel from the world’s largest pharma and biotech companies, top legal practitioners and regulatory experts in an outstanding speaker panel. Based on their first-hand experience, the distinguished panel will provide you with invaluable practical and strategic guidance on the most current regulatory and legal developments in the EU pharma sector.
Gain in-depth knowledge about the latest regulatory developments in EU Pharma law and hear best practice approaches to successfully managing your legal and compliance risks!
Based on your feedback, every session at C5’s EU Pharma Law and Regulation conference is designed to help you fully understand the latest developments in EU legislation and the most important recent case law with regards to SPCs, advertising, pricing & reimbursement, pharmacovigilance and competition law obligations.
Tags: c5, CLE, legal conferences, Legal Events, pharma
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Pharma & Biotech Patent Litigation
January 16th, 2012
in Legal Conferences, Litigation, Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
Pharma and Biotech patent law continues to evolve rapidly, perhaps faster than patent law in any other field, with numerous significant case law developments arising from new tactics being employed by generics in recent times. Given the highly competitive and lucrative nature of the industry, it is more important than ever that patent/IP departments and patent attorneys stay abreast of recent court decisions on a global level, as well as current litigation tactics, to ensure they are implementing the most competitive strategies to protect and defend their patent portfolios and maximise revenues on inventions.
The 2012 Pharma & Biotech Patent Litigation forum will focus on the latest case law developments on pharma and biotech patents across Europe and the US and how decisions in the various national courts will inevitably impact on the litigation strategies you employ. You will walk away with fresh insights, tactics and tools to strategise your litigation techniques and remain competitive in today’s constantly changing patent landscape.
C5’s 4th Annual Forum on Pharma & Biotech Patent Litigation brings together key regulators and judicial authorities, distinguished in-house counsel from the world’s largest pharma and biotech companies, and their expert legal advisors from across Europe and the US. Based on their first-hand experience in recent pharma and biotech patent litigation, the expert panel will provide you with important case law updates and invaluable strategies to combat the latest challenges.
Key issues to be addressed include:
- The enforceability of gene sequence patents in light of HGS v Lilly
- SPC references and recent opinion by the Advocate General: what you need to know to file your SPC applications
- EPO update on pharma and biotech patent litigation in Europe
- The interplay between insufficiency of disclosure and future embodiments in biotech inventions
- The significance of case law developments across Eastern Europe and what they mean for your patent litigation strategies
- The impact of recent launch strategies by generics on evolving preliminary and interim injunctions across Europe
- Developing a successful strategy for pan-European patent enforcement following recent case law developments on cross-border injunctions
- Recent US developments in pharma and biotech patent litigation
- How should you instruct scientific experts in your patent litigation proceedings in light of recent case law?
- The stem cell patent landscape: overcoming the commercial obstacles
- Commercial strategies to combat recent cross-border detention challenges
- Capitalising on research tool patents: scope and enforcement
- Disclosure of prior art and antitrust issues in the settlement of pharma patent disputes
- Second medical use claims: back in the spotlight
Tags: c5, CLE, legal conferences, Legal Events, Litigation, pharma
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Biosimilars Forum
January 9th, 2012
in Pharmaceuticals / Biotech / Life Sciences, Pharmaceuticals and Biotech |
The rise of Biosimilars has provided challenges and opportunities in equal measure for innovators and applicants. EMA guidelines have already led to a wave of approvals and with a host of other biologics going off-patent in the next few years there are surely more to follow. Many complex big molecule products are not yet viable candidates for biosimilars but progress in advanced technologies means that it is only a matter of time. Whilst Europe enjoys a relatively progressive approach to biosimilar approval, a lack of appropriate legislation in the United States has left a black hole waiting to be filled. When the FDA finally publishes guidelines the whole regulatory landscape will change.
There are many questions that both innovators and biosimilar applicants are looking to answer: How should comparability of products be measured? What is an acceptable level of data exclusivity and information exchange? What are the clinical implications of demonstrating novelty? If you are looking for answers, then this is an opportunity to find them.
C5’s Biosimilars Forum will bring together a leading faculty of expert speakers with different perspectives and backgrounds. A series of exclusive presentations will help innovators to understand what future developments in legislation might mean for their products. They will also help applicants who want to expand their knowledge of barriers blocking the pathway to approval. Use this opportunity to benchmark your practices and pick up critical knowledge from industry associates, regulators and service providers. When the event is over you can walk away with practical business solutions and an increased knowledge base, helping you to set a decisive agenda in uncertain times.
Topics to be covered include:
- Overview of biosimilar technologies and their potential for more advanced products
- Comparison of the legislative and regulatory frameworks in Europe and the United States
- Patent litigation requirements and addressing due diligence on both sides
- Achieving cooperation between the innovator and the biosimilar maker
- Taking the leap from developing a biosimilar to developing a biobetter
- Setting parameters for data exclusivity
- The extent to which SPCs can be exploited by innovators
Food Safety, Health Claims and Regulation in Europe
November 25th, 2011
in Pharmaceuticals / Biotech / Life Sciences |
The food and beverage industry is one of the most highly regulated and competitive sectors in the world. Retailers, manufacturers and distributors are constantly searching for ways to gain a competitive advantage with innovative products, packaging, and marketing campaigns. The imminent Regulation on the provision of food information to consumers, along with the EU framework on health and nutrition claims, contain significant legal and regulatory developments that will have extensive implications for food and beverage companies across Europe.
C5’s Forum on Food Safety, Health Claims and Regulation in Europe will focus exclusively on the implementation of the forthcoming Regulation on food information to consumers and the EU framework on health and nutrition claims. The event will present the first opportunity to hear from the regulators and industry associations, experienced in-house managers, and expert lawyers from across Europe as they walk you through the most competitive tools and strategies to overcome the inherent challenges in the proposed EU Regulations.
Key issues to be addressed include:
- The forthcoming EU Regulations on nutrition and health claims and what impact the Regulations will have on your compliance strategies
- Guideline Daily Amounts: knowing what you can and can’t claim on your labels
- Analysing the origin labelling and specific EC legal framework forgeographical indications and designations of origin
- The re-evaluation of the food additives, enzymes and flavourings Regulation and the establishment of a harmonised authorisation procedure in Europe
- Proposed requirement for mandatory inclusion of allergenic foods on labels: are you prepared?
- Food information to consumers: overcoming the new challenges for advertisers
- Recent developments in EU legislation on food contact materials: ensuring food safety and avoiding penalties for non-compliance
- The intended abolition of the concept of “dietetic foods” and the use of botanicals in foodstuffs in the EU
- Executing product recalls and reputation management: mitigating costly consequences
