Tag: patent
FTC Amendments to Premerger Notification Rules: The Who, What & Why
On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a transaction involving the transfer of rights to all or part of a pharmaceutical (including biologics) patent is reportable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”).
The final rule, which is the same as the proposed rule circulated a year ago for public comment, codifies an “all commercially significant rights” test to determine whether a transfer of rights has occurred in an exclusive patent license agreement. Under that rule, if a patent licensor transfers all commercially significant rights to the patent, the transaction may be reportable. The final rule states that if “limited manufacturing rights” are retained by the licensor, then the transaction may also be reportable under the Act.
The final rule, which takes effect on December 16, 2013, is available … Read More »
Navigating the Isolated DNA Patent Eligibility Jungle
Introduction
For over 150 years the Supreme Court has provided three categories of exceptions to patent eligibility under 35 U.S.C §101: abstract ideas, laws of nature, and physical phenomena, since these are the basic tools of scientific and technological work.[1] The Roberts Court has revised the standard for review of “abstract ideas” and “laws of nature” in Bilski v. Kappos and Mayo v. Prometheus, respectively. The Court’s much awaited decision in AMP v. Myriad addressed the “physical phenomena” exception with respect to patents claiming isolated DNA.[2]
The recent decision in Myriad will have an impact reaching far beyond the patentability of isolated DNA. Patent eligibility for isolated DNA is crucial for the continued growth of the biotechnology and diagnostics industries. The decision, disallowing patenting of isolated DNA, will have a chilling effect on these industries. Furthermore, the decision casts a cloud on … Read More »
Five Tips for Dealing with “First Inventor to File”
It’s here.
Thanks to the America Invents Act (AIA), as of March 16, 2013, the U.S. patent system became a “first inventor to file” system. That is, the inventor who files first will get a patent, even if the inventor who first conceived the idea files at a later date. This is very different from the old system, which was a “first to invent” system that awarded patents to the first inventor, even if that inventor was not the first to file.
The new system obviously puts a premium on timely action. The days of lengthy product testing to flesh out and perfect an invention may be gone forever. The system no longer accommodates those who linger. It rewards those who can move quickly.
Here are some suggestions for being ready to move quickly and exploit “FITF.”
File early. By all means, don’t rush … Read More »
Patent War Between St. Jude Medical and Volcano Has Mixed Results
St. Jude Medical and Volcano have been embroiled in a legal battle over patents held by both companies, related to pressure wire technology that is used for heart patients. The battle began over two years ago when St. Jude Medical sued Volcano, in Delaware district court, for infringement of 5 of its patents for pressure guide wire products. The patents in suit were U. S. Patent No. 5,938,624, U.S. Patent No. 6,196,980, U.S. Patent No. 6,112,598, U.S. Patent No. 6,167,763 and U.S. Patent No. 6,248,083. St. Jude requested an injunction and damages for infringement of the five asserted patents.
Volcano replied by counterclaiming, alleging that St. Jude Medical had infringed four of its own patents, but later dropped one of those patents from the suit. The three remaining patents asserted by Volcano against St. Jude were U.S. Patent No. 6,976,965, U.S. … Read More »
Life Sciences – Just Another Way to Say “Intellectual Property”?
There is no corner of the American economy more deeply dependent on intellectual property rights than the life sciences. Of course, we all know that patents have long been central to the success of pharmaceutical and medical device manufacturers, and the unanimous decision in the Prometheus case this past month has brought additional scrutiny to a market segment often misunderstood in the popular press. That said, for players in the life sciences space, patents are only one of many ways that intellectual property shapes their business. In fact, the trademark, unfair competition and copyright laws can be just as critical, and a strategic understanding of their value can provide companies with real ownable distinction in the market.
What is a product with “ownable distinction?” It is the opposite of a generic commodity, and it is the holy grail in the life sciences. It … Read More »