The Post-Mayo World Of Life Sciences Patents
The Post-Mayo World Of Life Sciences Patents

To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101.  In this three-part series, we will look at how the U.S. Supreme Court’s jurisprudence on patent eligibility has evolved, examine the impact of its March 2012 decision in Mayo Collaborative Services v. Prometheus Labs, Inc. on life sciences patent litigation in lower courts, and discuss what it means for patent eligibility of biologic and biosimilar patents.  

  • Biosimilars Face New Destiny Under Medicare Part B Revision
    Biosimilars Face New Destiny Under Medicare Part B Revision

    Starting in 2018, CMS will heed calls to change its existing Medicare Part B policy. Though only time will tell the true impact of these changes, biosimilar makers, patients, and physicians stand to benefit in a few key ways.

  • Tips For Success In the Indian Biosimilar Market
    Tips For Success In the Indian Biosimilar Market

    Although the biosimilar space is still growing and evolving in the U.S., it is comparatively well-established in India. According to the Generics and Biosimilars Initiative (GaBI), the first “similar biologic” was approved and marketed in India in 2000 — some 15 years before the U.S. approved its first biosimilar. India also has a much more mature biosimilar manufacturing ecosystem and regulatory environment than most other parts of the world. As such, the country can provide valuable lessons about what it takes to establish a thriving biosimilar market in terms of accessibility, competition, regulatory strategy, and other facets.

  • What Value-Based Reimbursement Means For Drug Development
    What Value-Based Reimbursement Means For Drug Development

    Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.

  • How This Medicare Part D Proposal Gives Biosimilars Chance To Shine
    How This Medicare Part D Proposal Gives Biosimilars Chance To Shine

    Establishing new language requiring a portion of rebates to be passed on to consumers at the point-of-sale could bode well for biosimilar makers, and especially those that provide a competitive price.

  • Will EU Patent System Changes Speed Market Entry For Biosimilars?
    Will EU Patent System Changes Speed Market Entry For Biosimilars?

    In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The goal is to achieve a balance between extension of patent protection and patent exemptions that make it easier to bring products to market in regulated industries. The commission specifically addressed the consultation to stakeholders in the biosimilar industry, among other regulated industries. The policy questions underlying patent extensions and research exemptions could have far-reaching impact on how quickly a biosimilar sponsor can get a product to market.

  • Why The FTC, FDA Collaboration Should Interest Biosimilar Makers
    Why The FTC, FDA Collaboration Should Interest Biosimilar Makers

    A recent FTC workshop on competition in prescription drug markets reflected a particularly interesting and exciting evolution within the regulatory space. And that has to do with what I consider to be growth in the FDA’s purview as a regulator.

  • CMS’ Decision On Coding For Biosimilars: A Deeper Look
    CMS’ Decision On Coding For Biosimilars: A Deeper Look

    The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive?

  • The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers
    The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers

    Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.

  • How Biosimilar Companies Can Meet Patients’ Education Needs
    How Biosimilar Companies Can Meet Patients’ Education Needs

    What do patient groups want from biosimilar manufacturers, and what advice can they give companies to help shape their initiatives to educate stakeholders?

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

More From Biosimilar...

TRAINING COURSES

Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template December 18, 2017
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Best Practices for Deviation Investigations: Cost-Effective Problem Correction January 8, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement January 16, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
13th Biosimilars Summit January 23 - 24, 2018
Alexandria, VA)
Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ICH E6 Addendum R2 Team Training and Action Planning February 5, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum February 12, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template December 18, 2017
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Best Practices for Deviation Investigations: Cost-Effective Problem Correction January 8, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement January 16, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!

LIFE SCIENCE EVENTS

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training
More Events...

LIFE SCIENCE INDUSTRY EVENTS

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training
More Industry Events

ABOUT BIOSIMILAR DEVELOPMENT

Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.

Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.