Artificial intelligence is transforming drug design — but it could also disrupt intellectual property law. To realize AI’s full promise, the US may have to reconsider its approach to issuing patents....more
In our earlier post, Public and Regulatory Attention to Forever Chemicals is at an All-Time High, we discussed the expected and upcoming regulation of per- and polyfluoroalkyl substances (“PFAS”). Another chemical expected to...more
The so-called “Lead Compound Analysis” is the primary legal framework for assessing chemical obviousness. Despite the USPTO Patent Trial and Appeal Board’s (PTAB) initial apparent reluctance to operate under this framework,...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
Claims against manufacturers and distributors of per- and polyfluoroalkyl substances (PFAS)-containing aqueous film-forming foam (AFFF) are hurtling forward. Two important developments in this opening salvo of PFAS-related...more
As with virtually every sector, the COVID-19 pandemic heavily impacted the chemical industry—from corporate transactions to supply chains to privacy concerns related to employees working remotely. A team of Womble Bond...more
A growing number of lawsuits and regulations are targeting PFAS (per- and polyfluoroalkyl substances) and the companies manufacturing these chemicals....more
In response to the outbreak of COVID-19, the Food and Drug Administration (“FDA”) has issued guidance for industry that will temporarily expand manufacturers’ ability to legally produce and sell alcohol-based hand...more
As businesses gear up for the busy holiday shopping season and prepare product lines for the new year, manufacturers and distributors of consumer products must be ready to manage new risks that are likely to appear in the new...more
In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more
On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for...more
The PTAB recently rejected a request for rehearing by Bayer CropScience LP (“Bayer”). Bayer Cropscience LP, v. Syngenta Limited, IPR2017-01332, Paper 15 (P.T.A.B. Apr. 2, 2018). The PTAB stated that when the prior art does...more
The United States Environmental Protection Agency (“EPA”) issued a December 4th news release stating that it is initiating a “cross-agency effort” to address per and polyfluoroalkyl Substances (“PFAS”). The announcement...more
The Department of Homeland Security (DHS) Chemical Facility Anti-Terrorism Standards (CFATS) program identifies and regulates high-risk chemical facilities to ensure that security measures are in place to reduce the risk of...more
On March 26, 2015, the U.S. Interior Department's Bureau of Land Management (BLM) published its final rule setting new standards for hydraulic fracturing on onshore federal and Indian lands. The final rule, as published in...more
NICNAS Will Hold Training And Outreach Sessions: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) will be conducting stakeholder training and awareness sessions in major capital cities and...more
The U.S. Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for...more
When is it undue experimentation in practicing the full scope of a claim that contains a genus of chemical compounds and a functional limitation of activity, when the specification provides a method to assess the claimed...more