Since the beginning of 2019, the number of biosimilar litigation - particularly those concerning the Biologics Price Competition and Innovation Act (BPCIA) “patent dance” - has drastically increased. One of the notable BCPIA cases that are being closely watched, is Amgen’s legal battle with Novartis’ Sandoz arm over the Enbrel patent, in which the former intends to hold commercial exclusivity for Enbrel until 2029. The legal precedents established in this dispute are expected to impact the biosimilar market as well as the pending and future biosimilar patent lawsuits.
Also known as claim construction hearing, the Markman hearing is a significant proceeding in a patent infringement case. Getting it right is crucial to the success of a case.
Pharmaceutical and biotechnology patents have increased aggressively in recent years. Consequently, this upward trend has posed a greater risk for the U.S. pharma patents. Political and economic troubles such as claims of patent evergreening abuse have also added complexity on existing challenges.
The US Patent & Trademark Office’s (USPTO’s) Inter Partes Reviews (IPR) and Post-Grant Reviews (PGR) proceedings continue to provide patent challengers with a faster and cheaper way to invalidate patents. Thus, patent challengers have made USPTO a forum of choice in disputing patent enforceability and validity.
As the world develops and distributes safe and effective vaccines against COVID-19, the pharmaceutical industry is confronted with additional trade secrets protection challenges. Issues include the increased the burdens of protecting their assets, the immense level of R&D, the substantial impact of remote work, and COVID-related legal restrictions. Pharmaceutical companies must implement effective trade secrets protection strategies to manage threats amidst this crisis.
In the U.S. and Canada, courts have designed the doctrine of obviousness-type double patenting (ODP) to prevent inventors from gaining an unjust extension of their patent rights by obtaining patent on the obvious variants of an invention.
Since its enactment last 2014, the Supreme Court's Alice decision has continuously raised the bar for patent eligibility. Software innovation went up and it has significantly altered the patentability of software, business methods, and e-commerce technologies. In addition, software patent litigations have also changed dramatically.
In January 2019, the United States Patent and Trademark Office (USPTO) issued a revised guidance to be used when evaluating subject matter eligibility and updated same in October 2019. The revised and updated guidelines primarily focus on patent eligibility procedures involving patent claims and applications. By providing new guidance in identifying whether a patent claim or patent application claim is directed to a judicial exception, it aims to bring better clarity and predictability to Step 2A of the Alice/Mayo test.