The Case: An Abbreviated New Drug Application (ANDA) for a Generic Injection Device Ignites Intellectual Property Dispute 

The plaintiff, a leading global healthcare manufacturing company, sued a competing generic pharmaceutical manufacturer after alleging that the defendant’s ANDA application directly infringed upon seven patents covering aspects related to the plaintiff’s injectable medical device and drug, including its active ingredient, pharmaceutical compositions, manufacturing processes, and injection pen components. The defendant sought approval to market a generic version of the injectable, claiming that the patents in question were invalid, unenforceable, or would not be infringed by the commercial manufacturing, use, or sale of their product.

This dispute is reflective of the type of ANDA case being seen more frequently as the claimed coverage extends beyond the drug itself to the methods and devices used to administer it.

The Ask: A Testifying Expert Experienced with Medical Device Patents and Engineering

The plaintiff approached WIT to provide an expert who possessed a general knowledge of injector devices and the mechanics behind their engineering. Further, they wanted an expert witness with prior testifying experience who understood medical device patents and could validate additional expert opinions.

 Why WIT Was Best Suited to Meet the Expert Need

In anticipation of an influx of disputes regarding innovative medical device technology, WIT has actively recruited and retained world-class academics, industry executives, and subject-matter experts to support clients involved in future life sciences IP litigation. For this case, WIT was able to recommend an expert with two decades of experience in materials science and engineering with a specialization in the design of engineering structures and components. This expert is also a registered patent agent with experience in both the patent application process, as well as intellectual property disputes.

The Legal Landscape: Medical Device Litigation and ANDA Approval is on the Rise

As innovation in the MedTech space continues to spark conflicts over product liability, intellectual property, and device security, litigation in this industry continues to expand. And with consumer demand for personalized healthcare rising, industry players and new entrants alike are battling for market share, leading to intense competition and an increased risk of legal disputes.

Considering this ongoing battle for industry dominance, it comes as no surprise that patent disputes involving wearable and medical devices have increased YOY by over 50% from 2019-2022. And, looking at litigation thus far this year, 2023 is shaping up to continue the upward trend with more than 55 patent cases already filed, greatly outpacing 2022’s filing rate.

When it comes to ANDA disputes, it is also important to note that year over year, there has decrease in overall ANDA submissions, but an increase in application approval. Last year, the Office of Generic Drugs (OGD) received 857 applications but only issued 722 approvals; this year, 782 applications were approved while only 733 were submitted. While this could potentially be attributed to industry consolidation, company shifts to more profitable generic medications or moves to the biosimilars market, a continued decrease in applications could create similar legal troubles for those in the generic market.

How Experts Can Assist in ANDA and Medical Device Litigation

When considering the impact of potential conflicts in the wearable and medical device market, engaging with experienced testifying experts will help those prepare for litigation risks as the technology in the space continues to evolve. By collaborating with experts now, industry players can stay ahead of the curve when it comes to innovation and intellectual property development in the industry. Further, professionals who are well-versed in the design and performance of these drugs and devices can offer crucial guidance. Their expertise can assist attorneys in understanding the technical aspects of point-of-care medical devices, evaluate their accuracy and reliability, and assess any potential liability claims related to their use.

At WIT, we understand that the future of ANDA and medical device litigation is poised to increase in complexity. In order to provide those in the space with the best possible insights for their case, we affiliate with skilled technical experts and industry insiders with backgrounds in pharmaceutical sciences, patent law, and FDA regulatory affairs who understand medical devices and the nuances of patent infringement claims, patent validity challenges, and the strategic implications of Paragraph IV certifications. This expert team features:

• Industry insiders who know the healthcare technology landscape and related regulations and standards
• Former FDA officers who understand or oversaw drug approvals for many drugs
• Biomedical engineers knowledgeable about the design, functionality, and intellectual property processes associated with wearable and medical devices
• Medical experts with knowledge about the impact of a medical device on a user’s specific condition

For more information about how WIT’s wearable and medical device experts can help inform your ANDA litigation strategy and to learn more about our expert teams of healthcare technology experts who are highly credentialled scientists, medical doctors, engineers, industry veterans, and former regulators, contact us. Follow us on LinkedIn and Twitter to stay up-to-date on our latest insights.