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California’s Drug Price Transparency Bill

On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17. The new law requires pharmaceutical companies to give 60 days’ notice to state and health insurers if they plan to raise...more

Litigation Misconduct Helps Render a Patent Unenforceable

In March 2014, Regeneron Pharmaceuticals, Inc. sued Merus B.V. for allegedly infringing U.S. Patent No. 8,502,018 (“the ’018 Patent"). The ’018 Patent generally relates to using vectors to modify genes and chromosomal loci...more

Federal Circuit Finds That Fetal Diagnosis Claims Survive Written Description Attacks

Stanford University v. The Chinese University of Hong Kong. Federal Circuit Appeal No. 2015-2011. Decided June 27, 2017. In an appeal from the Patent Trial and Appeal Board (PTAB), the Federal Circuit held that claims...more

Multi-level Encryption Patent Survives § 101 Challenge in District Court

On May 23, 2017, the District Court for the Eastern District of Virginia (“District Court”) denied a motion for summary judgment that the patent claims asserted in a lawsuit brought by TecSec, Inc. (“TecSec”) are invalid...more

FDA Approves Keytruda as First Cancer Treatment Based on a Genetic Biomarker

The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

Northern District of California Finds Claims Directed to Device Pairing Patent Eligible

Is a patent directed to electronic communications between computing devices patent eligible? As with many legal questions, the answer to this question is not black and white. In the recent Fitbit, Inc. v. Aliphcom decision,...more

Preparing Biotech Patent Applications - Ten Strategies for Success

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

PTAB Convinced by Secondary Considerations to Find Claims Non-Obvious in IPR

On January 19, 2017, the Board issued a final written decision in World Bottling Cap, LLC v Crown Packaging Technology, Inc. (IPR2015-01651) finding the challenged claims were not unpatentably obvious over the references...more

Antisense Oligonucleotide SPINRAZA Wins FDA Approval

On December 23, 2016, the U.S. Food and Drug Administration approved SPINRAZA™ (nusinersen), an antisense oligonucleotide directed to survival motor neuron-2 (SMN2) transcripts for the treatment of spinal muscular atrophy...more

Federal Circuit Finds Three Intellectual Venture’s Patents Invalid under the Mayo/Alice Framework

The Federal Circuit recently decided a case concerning three patents owned by Intellectual Ventures I LLC (“IV”). Intellectual Ventures I LLC v. Symantec Corp., Case Nos. 2015-1769, 2015-1770, 2015-1771 (Fed. Cir. Sept. 30,...more

University of Minnesota Sues Gilead Sciences for Infringement of Hepatitis C Patents

On August 29, 2016, the Regents of the University of Minnesota (“the University”) filed suit against Gilead Sciences (“Gilead”) for patent infringement in the District Court for the District of Minnesota. According to the...more

U.S. Appeals Court Finds a Software Patent Valid Even Under the Supreme Court’s “Alice” Test

A recent Federal Circuit decision in Bascom Global Internet Services, Inc. v. AT&T Mobility LLC, gives patent owners another illustration of patent subject matter eligibility under section 101....more

Can we patent products found in nature? It's complicated. An update on Australia's Myriad decision...

It remains to be seen if this new Myriad decision in Australia will be extended as it was in the U.S. to prevent virtually any product found in nature from being patented....more

The PTAB May Be Taking a More Balanced Approach in Biotech and Pharmaceutical IPRs

Patent challengers were first able to file inter partes review (IPR) petitions on September 16, 2012. Since then IPRs have become an increasingly popular way of challenging the validity of patents. In the first three months...more

Biosimilars Webinar - July 23, 2013

On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more

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