COVID-19 Impacting Patent Litigation, From Exclusivity Forfeiture To Launch Delays

Pandemic poses new hurdles for Hatch-Waxman and BPCIA litigants as they navigate US FDA approval times, sponsor filing deadlines and biosimilar launch dates.

question marks judge gavel Coronavirus Covid-19 symbolic 3d-illustration
COVID-19 Raises Numerous Questions In Biopharma Patent Litigation

The COVID-19 pandemic raises a host of questions for biopharma companies engaged in patent litigation, such as whether generic manufacturers can avoid forfeiture of 180-day exclusivity and whether biosimilar sponsors might agree to delay product launches.

Goodwin Procter attorneys discussed the challenges in navigating Hatch-Waxman and biologic litigation during the pandemic in a 23 April webinar....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By 

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By 

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

More from Pink Sheet

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By 

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."

World’s First Hemato-Oncology Microbiota Therapeutic Among Latest New EU Filings

 

The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By 

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.