Knobbe Martens Olson & Bear LLP

Wearable Medical Devices Market Trending Upwards

New reports, such as the Global Diagnostic Wearable Medical Devices Market 2016-2020 Report, bring good news to the rapidly growing wearable medical device market. According to the Report, the diagnostic wearable medical device…more
| Health, Science, Computers, & Technology

First Extended-Range Intraocular Lens Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tecnis Symfony Intraocular Lenses (IOL) for treating cataracts. According to Abbott, the Tecnis Symfony lenses are currently the only lenses in the United States…more
| Health, Science, Computers, & Technology

Revenge of the Present Invention

Patentees suing alleged infringers have learned from a long history of federal district court and Federal Circuit rulings that (paraphrasing the Miranda warning given to criminal suspects) “anything you say [in the patent or…more
| Administrative Law, Intellectual Property, Science, Computers, & Technology

Federal Circuit Rules for The Medicines Company in Patent Litigation

In an en banc decision on July 12, 2016 in The Medicines Co. v. Hospira, Inc., the Federal Circuit established the circumstances under which a product manufactured according to product-by-process claims is invalid under the “on…more
| Commercial Law & Contracts, Intellectual Property, Science, Computers, & Technology

Is Brexit an IP Exit?

Voters in the U.K. recently passed a referendum paving the way for the U.K. to leave the European Union (EU). In response, British Prime Minister David Cameron resigned on Wednesday, July 13, 2016, with Theresa May as his…more
| Intellectual Property, International Law & Trade

FDA Approves First MRI-Guided Ultrasound Device to Treat Essential Tremor

The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands,…more
| Health, Science, Computers, & Technology

USPTO Creates New Alternative For Responding to Final Rejections

The new Post-Prosecution Pilot ("P3") program provides a pathway for patent applicants to make an in-person presentation to a panel of patent examiners as an alternative to existing options for responding to final rejections…more
| Administrative Law, Intellectual Property

VA Partners with IBM’s Watson for Genomics

IBM’s Watson for Genomics and the U.S. Department of Veterans Affairs (VA) just announced a public-private research partnership to study genomics and provide tailored medical solutions to patients. This partnership is poised to…more
| Government Contracting, Health, Science, Computers, & Technology

The Brexit Effect on Medical Devices

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should remain…more
| Intellectual Property, International Law & Trade, Science, Computers, & Technology

Medtronic Acquires HeartWare for $1.1 Billion

Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash. According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments…more
| Mergers & Acquisitions, Health, Science, Computers, & Technology

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory text…more
| Consumer Protection, Health, Science, Computers, & Technology

Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who…more
| Civil Remedies, Commercial Law & Contracts, Intellectual Property, Science, Computers, & Technology

Federal Circuit Affirms Invalidity for Exergen’s Non-contact Thermometer Patent

In a per curiam decision the Federal Circuit upheld the U.S. District Court for the District of Massachusetts’ holding that certain claims of Exergen Corporation’s U.S. Patent No. 7,787,938 was invalid as being directed to an…more
| Intellectual Property, Science, Computers, & Technology

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices…more
| Consumer Protection, Health, Intellectual Property, Privacy, Science, Computers, & Technology

FDA Approves AspireAssist Obesity Device

On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. According to a press…more
| Health, Science, Computers, & Technology
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