Posts Tagged ‘biotechnology news’

Fed. Cir. Rules Requirements for Direct Infringement by Multiple Parties

Friday, August 14th, 2015

CAFC Decides Akamai v Limelight–Holds For Infringement By Limelight–Defines Criteria For Directing And Controlling Customers’ Performance

iStock_000005967663_SmallIn Akami Technologies v. Limelight Networks, App. No. 2009-1372, -1380, -1416, -1417 (Fed. Cir., August 13, 2015), the court, sitting en banc after a remand from the S. Ct., set out the requirements for direct infringement involving acts by two or more parties under s. 271(a). The unanimous ruling held that an entity is responsible for others’ performance of method steps (1) where that entity directs or controls the acts of another, or (2) where the actors form a joint enterprise. (A copy of this decision is found at the end of this post.)

The court explained:

“… we have held that an actor is liable for infringement under s. 271(a) if it acts through an agent … or contracts with another to perform one or more steps of a claimed method. See BMC, 498 F.3d at 1380-81. We conclude, on the facts of this case, that liability….can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance…. In those instances, the third party’s actions are attributed to the alleged infringer such that the alleged infringer becomes the single actor chargeable with direct infringement.”

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FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents.

You can find the article here.

“Precision Medicine” Initiative Leaves Patents “Lost in Space”

Wednesday, February 18th, 2015

iStock_000009217209_SmallOn January 30th, the White House released a press release expanding upon President Obama’s mention of “precision medicine” in his State of the Union Address. Not surprisingly, the details are pretty much what we who are involved in various aspects of “personalized medicine” would expect – an emphasis on the use of genomic diagnostics to improve treatment selection – especially for cancer patients. The largest of the “Key Investments” listed would be to the NIH to develop what looks like the creation of a reference data base “through engaged participants and open, responsible data sharing.” The NCI would get $70 million to “identify genomic drivers in cancer” and develop more effective approaches to treatment.

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Myriad Settles – Questions Remain

Tuesday, January 27th, 2015

Yesterday, Myriad announced it has settled the BRCA assay litigations that had been ongoing—and not going well– with Pathway Genomics, Invitae and Gene by Gene (and I assume….Ambry and Labcorp). Although I was just about at the brink of shouting “Stop The Madness” – the settlements mean that the IP community will not learn if Myriad had any patent-eligible claims in any of their assay patents. Would claims directed to mutations at specific positions of the BRCA1 or 2 genes have passed muster as that elusive “inventive concept” that both the Fed. Cir. and the S. Ct. extracted from Mayo as the standard by which to judge assays reciting abstract ideas or natural phenomena (which one is it?)?

You can read an article about the settlement on the GenomeWeb page by clicking here.