The Role of Prior Art in Patent Law – Old and Admitted Prior Art

Despite the promulgation of the American Invents Act (AIA) in 2012, the concept of prior art has basically stayed the same. Section 102 embodies two different concepts. First, the concept of novelty embodies that there are things other people do to destroy the novelty of the patent applicant’s claimed invention. These include publishing the subject […]

The 505(b)(2) Application and the ANDA – Similarities and Differences

FDA’s 505(b)(2) Application The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is […]

Understanding Product-By-Process Claims in Patent Law

Typical patent claims are to products or processes but not both. But product-by-process claims exist and have existed for decades. Plainly, the typical product-by-process claim is designed to claim a product when made by a particular process. It is a hybrid type of claim. But questions arise of how product-by-process claims are interpreted when considering […]

Upadhye Tang LLP – In Case You Missed It

Upadhye Tang LLP was founded a few years ago to focus on our core competencies: IP and FDA law. We know the life sciences business and clients trust us for our advice. And given the fierce competition, we are tough fighters for our clients. Let’s recap who we are and what we are about.  We […]

The Role of Prosecution History (File Wrapper) in Patent Law

In patent litigation, most attorneys focus on the patent document itself. After all, the patent is being asserted in the litigation so it makes sense. But the patent document is not born in its final form. Rather, it starts as a patent application filed at the USPTO. The Examiner and applicant engage in the typical […]

Attorney Fee Awards in Patent Litigation

A lawsuit that goes to the bitter end will result in a winner and a loser. And with the win in hand, the winner then thinks it’s entitled to fees and costs as reimbursement. The typical situation in American court litigation is that everyone pays his or her own legal fees. This default standard is […]

Opinions of Counsel & Freedom to Operate: Are They Relevant Again?

An Opinion of Counsel or Freedom To Operate (FTO) opinion though not legally required often, is a good business practice. First, a company may seek the FTO opinion for due diligence, merger & acquisition, and for other deal-making needs. For many companies, a question exists: “If we launch this product into the marketplace, will we […]

2021 Post-COVID Trends in Patent Litigation

Though we don’t know when, someday life will return to normal. And we may redefine what the new normal is. But we do know that patent litigation will persist. Therefore, we can examine some post-COVID trends.  In-Person Court Hearings and Trials Over the last year, we got used to conducting all hearings and even trials […]

Patent and FDA Strategies for Psychedelics, Psilocybin, and Cannabinoids

Magic mushrooms and pot. Yes, currently people use them for illicit reasons. But the compounds in them are now being investigated for typical pharmaceutical therapeutic properties. And how can investigators protect that R&D investment? We look at some strategies relating to psilocybin (the prime compound in magic mushrooms) and cannabidiol (CBD) found in pot to […]

Patent Appeals to the Federal Circuit Court of Appeals

The U.S. Court of Appeals for the Federal Circuit (CAFC) has exclusive jurisdiction over patent law appeals. That means that it is the sole appeals court for appeals out of the Patent Office and out of the federal trial courts. An appeals court is exactly that; a court of appeals, not another court of first […]