Posts Tagged: "biotech"

What to Know About the European Patent Office 2021 Guidelines for Examination: Part II – Biotech

As discussed in Part I of this article, the European Patent Office (EPO) recently published its Guidelines for Examination 2021, which came into force on March 1. In the previous article, we detailed changes affecting computer-implemented inventions and with respect to procedural matters. Here, we will address the Guidelines’ changes for biotech. In addition to some specifications regarding the interpretation of terms relating to amino and nucleic acid sequences and the definition of the concept of “therapy” and of the products that can be claimed in view of their new medical use, the main additions that have been made to the part of the Guidelines relating to biotechnological inventions concern the exclusions from patentability, and in particular the ineligibility of inventions relating to plants or animals and human embryos. A full section has also been added relating to the patentability of antibodies.

Efforts to Villainize Biotech, Pharma over COVID-19 are Political Theater and Opportunism

If the objective is to beat this virus as fast as possible it simply isn’t helpful to talk about the compulsory licensing of drugs that don’t yet exist and the patents that can’t possibly be issued by the United States Patent and Trademark Office for at least the next two to three years. The COVID-19 crisis will be long since over by the time the first patent issues relating to anything specifically related to COVID-19. Yet somehow it is viewed as productive to demand compulsory licensing of vaccines, treatments and cures for COVID-19 that do not exist?

Latest CAFC Ruling in Cleveland Clinic Case Confirms That USPTO’s 101 Guidance Holds Little Weight

On Monday, April 1, the Court of Appeals for the Federal Circuit issued a decision in Cleveland Clinic Foundation v. True Health Diagnostics affirming the invalidity of patents covering medical diagnostic tests for determining a patient’s risk for cardiovascular disease. The decision, which is nonprecedential and was decided along similar lines to another 2017 decision between the two parties, is yet another depressing sign that U.S. patent law is woefully inadequate when it comes to supporting important innovations in the biotech fields. Of particular note is the Federal Circuit’s finding against Cleveland Clinic’s argument that the district court didn’t give appropriate deference to subject matter eligibility guidance published by the U.S. Patent and Trademark Office (USPTO) as required by the U.S. Supreme Court’s 1944 decision in Skidmore v. Swift & Co. Although this argument related to USPTO guidelines published in 2016, it would seem to call into question the USPTO’s more recent revised subject matter eligibility guidance issued earlier this year by USPTO Director Andrei Iancu. This gives voice to fears that the “Iancu Effect” on subject matter eligibility won’t matter much if the Federal Circuit and other courts don’t adhere to the USPTO’s views on patent eligibility under Section 101.

Patents in the Crosshairs During House Drug Pricing Debate

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House Committee on Oversight and Reform—how to lower the price of prescription drugs. And it didn’t take long to make it clear that patents are right in the middle of the scrum. The role of patents was a prominent part of the House hearing. While cursory nods were made to the importance of encouraging innovation, the witnesses discussed how patent exclusivity, thickets, and evergreening drove up prices while promoting the greater use of Patent Trial and Appeal Board (PTAB) reviews against drug patents. The Committee was assured that curtailing patents wouldn’t harm innovation because the National Institutes of Health (NIH) is such an important funder of life science R&D.

PTAB Trends: More Orange Book Patents Are Surviving the ‘Death Squad’

Since its inception, the Patent Trial and Appeal Board (PTAB) has been a frequent venue for patent challenges in the pharmaceutical and biotechnology industries. By the end of the U.S. Patent and Trademark Office’s (USPTO’s) 2018 fiscal year, patents in those fields were targeted in nearly 10% of all petitions for inter partes review (IPR), totaling approximately 900 individual petitions. Of these 900 petitions, roughly 5% challenged patents listed in the FDA’s Orange Book for approved drug products. The remaining petitions challenged biologic drugs (1.3%) and other biologic-, biotechnology-, or pharmaceutical-related patents (3.5%). Many of these petitions have ultimately resulted in the cancellation of all challenged claims, including those of a significant number of Orange Book patents. Based on the PTAB’s initial high rate of claim cancellation in pharma and other areas, critics of the PTAB were quick to deem it a patent “death squad.” Does the PTAB still deserve the “death squad” label when it comes to Orange Book patents? In this article, we examine the rates of challenge, institution, and final written decision outcomes for patents listed in the Orange Book, from the PTAB’s inception through the end of its 2018 fiscal year.