Posts Tagged: "genentech"

Federal Circuit Clarifies Injury in Fact Standing to Challenge Final Agency Decision in IPR

In appealing from a final IPR decision, the appellant must have standing, based on evidence of record or supplemental evidence showing an “injury in fact.” Alleged economic injury must be specific and proven, and does not arise just from statutory appeal provisions or from IPR litigation estoppel when appellant’s infringement of the challenged patent is not a potential issue.

Joseph Robinson & Robert Schaffer

January 13, 2017

Is Nome, Alaska ready for Paragraph 4 ANDA litigation? How about San Juan, Puerto Rico?

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.

Jennifer Mauri

September 2, 2016

CAFC OKs Transfer Despite Forum Selection Clause

In a non-precedential opinion issued October 18, 2013, the Federal Circuit decision calls into question the overall utility of forum selection clauses in contractual relationships. In fact, Eli Lilly lost its bid to have its dispute with Genentech and City of Hope heard in the Northern District of California despite having a forum selection clause in the governing contract that stated the parties would litigate any dispute in the Northern District of California.

Gene Quinn

October 20, 2013

FDA: No to Breast Cancer Drug, Could Cost Genetech $1 Billion

Contrary to the FDA, the European Medicines Agency confirmed that the benefits of Avastin® in combination with paclitaxel outweigh the risks, further determining that the combination of Avastin® and paclitaxel remains a valuable treatment option for patients suffering from metastatic breast cancer. If the FDA is successful in removing the breast cancer indication from Avastin® Genentech (a member of the Roche Group and the maker of Avastin®) could lose $1 billion of its $6 billion in annual sales of Avastin® due to the lost sales associated with use to treat breast cancer.

Gene Quinn

December 16, 2010

Patents in the Real World

But looking back, what strikes me is the surprisingly-variable role that patents played in the growth and success of the half-dozen trailblazing startup companies that I helped lead. For these startups, which collectively created more than 2,500 jobs, I raised approximately $1 billion from strategic and venture investors (who ended up with $3 billion in returns). And in the majority of cases, owning patents proved to be crucial to the funding and commercial success of my startup. But this wasn’t always the case. In several startups, patents were almost completely irrelevant to either the financing or the ultimate fate of the company. Understanding why this was so may offer some insights into both the value and the limitations of patenting.

Henry R. Nothhaft

October 10, 2010