Tag Archives: patents

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA, and Antitrust Terrain

Photo of BakerHostetlerBy BakerHostetler on Posted in Uncategorized
Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory, and antitrust … Continue Reading

As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials

Photo of Laura GordonBy Laura Gordon on Posted in Uncategorized
Pharmaceutical companies have reason to be pleased with the United States Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office, No. 15-446 (Cuozzo). The Supreme Court has agreed to review … Continue Reading

IP Provisions of the TPP May Not Satisfy the Pharmaceutical Industry

By Maurice Valla on Posted in Uncategorized
On October 5, 2015, agreement was reached on the text for the Trans-Pacific Partnership (TPP) trade agreement. The 12 signatories (United States, Canada, Mexico, Australia, New Zealand, Japan, Malaysia, Vietnam, Singapore, Brunei, Chile, and Peru) now have two years to ratify the agreement in order for it to take effect. The White House released the … Continue Reading

Applying for a Patent? Tell a Good Invention Story!

Photo of Aaron RabinowitzBy Sarah Dukmen and Aaron Rabinowitz on Posted in Uncategorized
What do Huckleberry Finn, Catcher in the Rye, and a well-drafted patent application have in common? They all tell good stories, of course! Telling a good story in a patent application is especially important for inventions in high volume areas, such as those that relate to healthcare. In these crowded areas, claims will commonly recite elements … Continue Reading

Did Recent Changes in the Patent Laws Turn the Page on the Need for Accurate Laboratory Notebooks?

Photo of Tracy Palovich, Ph.D.Photo of Aaron RabinowitzBy Tracy Palovich, Ph.D., Maurice Valla and Aaron Rabinowitz on Posted in Uncategorized
With the enactment of the Leahy-Smith America Invents Act (AIA), the U.S. patent system moved to a “first inventor to file” approach for examining all applications having an effective filing date on or after March 16, 2013. Under the new law, in most circumstances it is no longer possible to remove a critical prior art … Continue Reading

What Do Early Investors Really Expect of an Emerging Technology Company?

By John W. Caldwell on Posted in Uncategorized
Emerging technology companies – at their core – will usually have a great scientific or engineering breakthrough or improvement coupled with at least one stellar individual talent. The company will usually have credible proof of concept and often a working prototype. It will never have enough money or enough time or enough boots on the … Continue Reading

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for Brand-Name Biologics

Photo of Ron KernBy Rik Parker and Ron Kern on Posted in Uncategorized
On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar products may be brought to market. In Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499), a divided panel of the Court of Appeals for the … Continue Reading

How an Insufficiently Detailed Provisional Patent Application Can Hurt You

Photo of Aaron RabinowitzBy Aaron Rabinowitz on Posted in Uncategorized
In today’s world, there are a few things most people can agree on: Sean Connery was the best James Bond, ice cream is the perfect dessert for any season – and patent applications are expensive! Because even a run-of-the-mill patent application may, depending on the invention’s complexity, cost several thousand dollars, life science entities may … Continue Reading

What Constitutes Patentable Subject Matter in Biotechnology?

By Maurice Valla on Posted in Uncategorized
With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo holding that claims directed to the mere application of naturally occurring products and phenomena constitute unpatentable subject matter. Sequenom’s U.S. … Continue Reading

Pharmaceutical Association Calls Out FTC in Filing Seeking to Enjoin New Rule Targeting the Industry

By Jonathan Lewis and Lee Simowitz on Posted in Uncategorized
Editor’s Note:  This post originally appeared on BakerHostetler’s Antitrust Advocate blog. Last November, the Federal Trade Commission (FTC) with the “concurrence” of the Antitrust Division of the Justice Department, and over the strenuous objection of Pharmaceutical Research and Manufacturers of America (PhRMA), issued final changes to the Hart-Scott-Rodino Act premerger notification rules limited solely to … Continue Reading
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