Standards of Review in Patent Appeals to the Federal Circuit Court of Appeals 

Introduction By statute, the Court of Appeals for the Federal Circuit has appellate jurisdiction over appeals from the administrative boards of the Patent & Trademark Office (appeals from the Patent Board and the Trademark Board) and the various district courts. The Federal Circuit also has appellate jurisdiction over other subjects such as the Court of […]

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 […]

A Lack of Essential Testing Method Parameter in Patent Claims Led to Indefiniteness, but Inequitable Conduct Is Hard to Prove – Lessons from Sun v. Lupin

In a recent District of New Jersey decision, Chief Judge Wolfson found a patent indefinite, obvious, and not infringed (due to a failure of proof). Sun Pharma v. Lupin, 2021 WL 4473411 (Sept. 30, 2021). However, the court did not find inequitable conduct by clear and convincing evidence, despite the inventor’s “hubris” and incorrect understanding […]

Inequitable Conduct Defense During Patent Litigation
in a 505(b)(2) NDA Context

The § 505(b)(2) regulatory pathway gives a smaller pharmaceutical company, a start-up company even, the opportunity to submit and obtain FDA approval of a new drug application (NDA) without breaking the bank. A 505(b)(2) NDA may rely heavily on data from an already-marketed drug product and information in published literature to demonstrate the safety and […]