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Patient Protection and Affordable Care Act (PPACA) › Patent Infringement

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
Troutman Pepper

Building on Successful Judicial Assignment Reform in Texas

Troutman Pepper on

More than 16 months ago, the two ranking members of the Senate Judiciary Committee asked Chief Justice John Roberts to direct the Judicial Conference of the United States to study forum shopping in patent litigation,...more

Womble Bond Dickinson

Basics of the BPCIA

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The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Mintz - Health Care Viewpoints

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Mintz - Health Care Viewpoints on

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

Snell & Wilmer

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

Snell & Wilmer on

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

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The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Polsinelli

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute

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The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

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