Written Opinions Of Counsel: Valuable Tools for Avoiding Willful Patent Infringement
December 01, 2017
Written opinions of counsel are gaining renewed interest as a valuable tool to limit liability for willful patent infringement. A patent opinion that is competently written by a registered patent attorney sets forth the factual and legal basis for finding a patent not infringed, invalid, and/or unenforceable. However, to be effective, the timing of the rendered patent opinion may be critical.
Exclusion of Evidence: The FDA's 510K Process
December 01, 2017
In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent FDA approval. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
The Food Safety Modernization Act
December 01, 2017
<b><i>Part Two of a Two-Part Article</i></b><p>Last month, the author began discussion of the Food Safety Modernization Act (FSMA), which will have a large impact on the food and feed industry in the coming years. The author continues here with an explanation of some of the effects the FSMA is expected to have on equipment manufacturers and on lenders and lessors.
Unreliable Methodologies Doom Neck Brace Experts
December 01, 2017
A U.S. Magistrate Judge in Indiana recently excluded the opinions of two experts because they did not meet the "reliability" criteria specified in Federal Rule of Evidence 702 and the famous <i>Daubert</i> decision. The rulings doomed the badly injured plaintiff's claim because summary judgment in favor of the defendant quickly followed.
Case Notes
December 01, 2017
Analysis of two key cases, one involving asbestos, the other an intrauterine birth control device.
On the Move
December 01, 2017
Who's doing what; who's going where.
The Food Safety Modernization Act
November 02, 2017
<b><i>Part One of a Two-Part Article</i></b><p>By being proactive in adopting safe food processing operations, such companies hope to protect their reputation and business from the negative publicity and possible financial disaster arising from the sale of contaminated food and non-compliance with the Food Safety Modernization Act (FSMA).
At High Court, Just One IP Case That Matters
November 02, 2017
<b><i>After Several IP-Heavy Seasons, the 2017 Term At the U.S. Supreme Court Looks to Be a Quiet One for Intellectual Property — with One Big Exception</b></i><p>The 2017 term at the U.S. Supreme Court looks to be a quiet one for intellectual property. But with one potential bang in the middle.
Drug & Device News
November 02, 2017
Because the drug-manufacturing defendants seeking federal retention of a case removed from state court were unable to prove the four elements of the U.S. Supreme Court's <i>Gunn</i> test for federal-question jurisdiction, the U.S. Disctrict Court for the Northern District of California remanded the case to state court.
