Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug...more
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more
The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through...more
There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more
The Committee on Internal Market and Consumer Protection of the European Parliament has adopted its report on the “Single Market Strategy” – a strategy that aims to consolidate industries in European countries under one...more