Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
The Hatch-Waxman Act has established a process by which a drugmaker can obtain FDA approval to market a generic drug prior to expiration of patents directed to the corresponding brand drug. In accordance with this process, the generic drugmaker files an Abbreviated New Drug Application (“ANDA”) under 21 U.S.C. ' 355(j). The generic drugmaker must include a certification under 21 U.S.C. ' 355(j)(2)(A)(vii) (“Paragraph IV certification”) with respect to each patent listed by the brand drugmaker in the FDA's Orange Book that will not have expired prior to generic market entry. Specifically, the generic drugmaker must provide a legal and factual basis as to why each claim of each such patent will not be infringed or is invalid. The generic drugmaker must also notify the brand drugmaker of the filing. Under 35 U.S.C. ' 271(e)(2), the act of filing an ANDA that includes a Paragraph IV certification constitutes an act of infringement of the relevant listed patents on which the brand drugmaker may file suit.
The Hatch-Waxman Act provides trial courts with discretion to award attorney fees in exceptional cases involving patent infringement based on ANDA filings. Specifically, ” 271(e)(4) and 285, taken together, provide that reasonable attorney fees may be awarded to the prevailing party in exceptional cases regarding infringement based on filing a Paragraph IV certification. In addition, trial courts may invoke their inherent powers to award additional amounts, such as expert fees. Whether a case is exceptional is an issue of fact requiring clear and convincing evidence, subject to review for clear error, whereas an award of attorney and expert fees in an exceptional case is at a court's discretion, subject to review for abuse of discretion.
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.