Recently, the U.S. Patent and Trademark Office announced that they have completed a comprehensive patent fee review, concluding that fees must go up—some of them significantly. This is primarily due to the discounts provided...more
On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new program for expediting certain COVID-19 related patent applications. Under the COVID-19 Prioritized Examination Pilot Program, the USPTO...more
The U.S. Food and Drug Administration (FDA) recently published new guidance (the Guidance) related to actual or potential medical device shortages during the COVID-19 pandemic The Guidance is meant to implement Section 506J...more
On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new program for expediting certain COVID-19 related patent applications. Under the COVID-19 Prioritized Examination Pilot Program, the USPTO...more
Prosecuting and maintaining a patent portfolio costs many organizations millions of dollars. These costs should be continuously managed and controlled. However, many organizations allow these tasks to slip when times are...more
In a follow up to our alert issued on April 2, 2020, in accordance with The Coronavirus Aid, Relief and Economic Security Act (CARES Act), on April 28, 2020, United States Patent and Trademark Office (USPTO) Director Andrei...more
On March 31, 2020, in accordance with The Coronavirus Aid, Relief and Economic Security Act (CARES Act), United States Patent and Trademark Office (USPTO) Director Andrei Iancu issued a public notice regarding the extension...more
The COVID-19 pandemic has had an impact on patent and trademark offices and operations globally. Below is a summary of changes seen over the past few weeks.
United States Patent and Trademark Office (USPTO)
The United...more
It is very likely the U.S. President will soon sign the newly amended United States-Mexico-Canada Agreement (USMCA), which is intended to replace NAFTA. Mexico has already ratified the amended USMCA and Canada is expected to...more
The U.S. Food and Drug Administration (FDA) announced plans to withdraw the approval of 249 Abbreviated New Drug Applications (ANDAs) since their manufacturers have failed to submit annual reports. This should serve as a...more
The Food and Drug Administration (FDA) recently enhanced its Paragraph IV (PIV) Certifications List with additional data fields. The PIV Certification List regularly publishes information regarding the 180-day exclusivity...more
In an important decision for the personal care and ingredients industries, the U.S. Court of Appeals for the Federal Circuit recently vacated a district court decision that held patent claims invalid as being directed to...more
As an addition to our ongoing series designed to help board members properly discharge their fiduciary duties in relation to company intellectual property, our next topic is the board’s obligations relating to executive...more
There are three types of Premarket Notification 510(k)s that may be submitted to the U.S. Food & Drug Administration (FDA): traditional, special and abbreviated. Under the recently finalized Safety and Performance Based...more
This past December, the U.S. Food and Drug Administration (FDA) issued a biosimilar industry guidance on a variety of topics. Mostly overlooked was a Q&A regarding safety protections in a 351(k) application. The FDA...more
The Sixth Annual Best Practices in IP Conference in Tel Aviv, which covered global best practices for issues affecting companies' IP, was another great success. Attendees benefited from top-notch educational opportunities and...more
Intellectual property can present operational risks - knowledge and protocols can help.
While keeping boards apprised of developing risks that materially threaten company operations, are you considering operational risks...more
Although one might occasionally come across an article touching on intellectual property (IP) concerns in the corporate boardroom, not enough has been said on this topic. This article is the first in a series of articles that...more
The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for medical devices.
According to FDA Commissioner Scott Gottlieb, the guidance...more
The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more
The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications (ANDA) and 505(b)(2) applications. Both sections were added to the FD&C Act...more
The European Patent Office recently revised its Examination Guidelines. These Guidelines are primarily directed to the patent examiners and formalities officers of the EPO, but they are also helpful to anyone practicing...more
Generally, a patent owner's rights are exhausted after an authorized sale; the patent owner cannot sue a downstream customer who purchased an authorized patented product from a third party reseller. So how can a patent owner...more
The U.S. Supreme Court recently held in a recent decision in Life Technologies Corp v. Promega Corp. that the "supply of a single component of a multicomponent invention for manufacture abroad does not give rise to §...more
In the recent decision Trading Technologies International, Inc., v. CQG, Inc. et al., the Federal Circuit affirmed a district court's ruling that a software patent on a graphical user interface was patentable subject matter,...more