Job Summary

Drive the US IP strategy for the business unit, biosimilars. Act as guiding counsel for all US IP litigations for biosimilars; prioritize legislative policies for the Gov Affairs team to lobby, work on projects for VP IP, create US IP litigation strategies that meet business goals within budget constraints; define the level of risk tolerance for US launch at risk; devise IPR strategy and timing.

Global IP Lead for selected molecules. Responsible for designing and implementing the global IP strategy for selected molecules that will de-risk the launch, maintain competitive timelines for launch in key markets around the world and build a portfolio of commercially valuable IP. Act as IP representative at development/commercial team meetings.

Responsibilities

Main Tasks:

Drive US IP strategy for BU Biosimilars

• Report to VP Patents Biosimilars and drive the US IP strategy for the business unit, biosimilars.
  
• There will be a dotted line report from two patent attorneys to the Chief IP Counsel Biosimilars US. These two patent attorneys report directly to VP Patents Biosimilars and act as global IP leads for two molecules each. However, the US IP strategies for their molecules will be supervised and guided by the Chief IP Counsel Biosimilars US.
  
• Act as guiding counsel for all US IP litigations for biosimilar products and devices. Participate in patent settlement negotiations with competitors.
  
• Create US IP litigation strategies that meet business goals within budget constraints; define the level of risk tolerance for US launch at risk; devise IPR strategy and timing.
  
• Work closely with the US Government Affairs team to prioritize policies that will lead to a favorable US legislative environment for the biosimilars business. Support lobbing efforts.
  
• Work on projects for VP IP and act as substitute in her absence
  

Global IP lead for biosimilar assets

• Work closely with cross-functional project teams, in particular to support the following functions and activities:
  
• Development team: Map global IP landscape for each project molecule and devise paths to market having favorable freedom to operate (e.g. country of manufacture, patent design-around space, patent oppositions, licensing)
  
• Commercial Team : Positioning of go-to-market strategy with IP risks/timelines, patent strength forecasting, country prioritization, country launch sequence
  
• Regulatory Team : Alignment between IP and Reg strategies – labeling & carving a path to market
  
• Legal Team : Support contract drafting and negotiations
  
• R&D Team : Guide early design around of formulation and process patents. Ensure FTO of supply chain. Provide key input on choice of country for manufacture.
  
• Manage multi-jurisdiction litigations and patent office procedures to clear a path to market for selected, including US litigations under the BPCIA, as well as IPR and PGR proceedings. Align the cases with counterpart litigations abroad and coordinate outside counsel.
  
• Responsible for monitoring and surveillance of the third-party global patent landscape covering selected molecules. Assess relevance of patents and draft Freedom to Operate (FTO) opinions. Advise the development/commercial teams on the freedom to operate risk. Prepare and present updates to the development/commercial teams.
  
• Collaborate in aligning the strategies of IP, regulatory, supply and commercial to devise routes to key markets.
  
• Devise life cycle management and creative IP strategies for biosimilar assets, including capturing patentable inventions, drafting and prosecuting patent applications. Work towards obtaining grant of FK IP around the world, especially in the US and Europe.
  
• Manage multi-jurisdiction litigations and patent office procedures to enforce Fresenius Kabi IP against competitor companies, in line with business goals.
  

INTERNALLY :

Development Teams and Commercial Teams for selected molecules; Regional Intellectual Property teams, All Functional Units within the BU, including Project Management Team, R&D Team, Business Development Team, Commercial Team, Finance Team, Legal Team

EXTERNALLY :

Outside Counsel from over 30 countries

REQUIREMENTS

• Juris Doctorate from accredited law school and licensed to practice in Washington DC.
  
• U.S. Patent Attorney and Patent Litigator
  
• Post graduate qualification in Chemistry or life sciences
  
• Undergraduate degree in Chemistry or field of life sciences
  
• U.S. Patent and Trademark Office registration required.
  
• Excellent command of English
  

PROFESSIONAL & TECHNICAL SKILLS

• 10 years’ experience in pharmaceutical IP, including leadership position
  
• Proven ability to work in a pressured environment
  
• Strong communication skills to explain complex concepts to non-IP professionals
  
• Strong analytical and problem-solving skills
  
• Innovative mindset
  
• Detailed and organized in work product and methodologies
  

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.