Knobbe/Martens: Intellectual Property Law

Daniel A. Kamkar

Subscribe to Daniel A. Kamkar's posts

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain gene therapy products” will soon be able to qualify for fast track approval.[1]



Before Reyna, Clevenger, and Wallach.  Appeal from the United States District Court for the District of Colorado

Summary:  Even in a simple mechanical case, a narrow disclosure in the specification of a priority application may not provide adequate written description support for broad, later-issued claims which claim priority to that application.


January 24, 2018 Daniel A. Kamkar and Mark Kachner

Before Newman, Dyk, and O’Malley.  Appeal from the Patent Trial and Appeal Board.

Summary: The PTAB may enter an adverse judgment against a patent owner where, before issuing an institution decision on an IPR petition, the patent owner disclaims all challenged claims but does not request adverse judgment.

Pfizer Accuses J&J of Anticompetitive Business Practices over Remicade Biosimilar

December 4, 2017 Daniel A. Kamkar and Eric Furman, Ph.D.

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar,[1] Celltrion’s partner Pfizer has filed a suit against Janssen’s parent company Johnson & Johnson (J&J) in the Eastern District of Pennsylvania alleging that through anticompetitive pricing and exclusionary contracts with insurers and hospitals, J&J sought to preserve a monopoly over its sale of Remicade.[2]


California’s Drug Price Transparency Bill

October 24, 2017 Daniel A. Kamkar and Michael L. Fuller

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 the price of a medication by 16 percent or more over a two year period, and to justify such increased prices.

Digital Currencies and Blockchain in the Medical Arena

September 11, 2017 Daniel A. Kamkar

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that blockchain technology allows for a distributed and cryptographically secure ledger without the use of traditional banking institutions.

How to Lose an IPR but Amend Your Claims in Reexam and Keep Your Patent

September 13, 2017 Daniel A. Kamkar and Benjamin Anger

On August 30, 2017, the PTAB issued a Final Written Decision in M & P Golf, LLC (d/b/a Cool Clubs) v. Max Out Golf, LLC, IPR2016-00784, Paper 43 (P.T.A.B August 30, 2017), entering adverse judgement on the original patent claims because those claims no longer existed in light of patentably distinct claims obtained by the Patent Owner in a concurrent ex parte reexamination.


Pharmacyclics Receives FDA Approval for Imbruvica in Treatment for Chronic Graft Versus Host Disease

August 15, 2017 Daniel A. Kamkar and Agnes Juang, Ph.D.

On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC.  Imbruvica® is the first FDA-approved therapy for the treatment of cGVHD.[1]

Janssen and Celltrion: Remicade Biosimilar Patent Dance

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition and Innovation Act (BPCIA) “Patent Dance.” Janssen, although arguing it to be unnecessary under the BPCIA, has defensively filed a subsequent suit[1] in Massachusetts federal court against Celltrion in order to avoid the possibility of being barred from recovering lost profit damages and limited to merely royalties. The suit is presided over by Judge Wolf.

Genentech and Roche Secure FDA Approval of Multiple Sclerosis Drug Ocrevus

On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). 

PTAB Grants Rare Motion to Amend

The PTAB issued a Final Written Decision in Amerigen Pharm. Ltd. v. Shire LLC, IPR2015-02009, Paper 38 (P.T.A.B. March 31, 2017) granting a rare motion to amend.  The motion canceled all instituted claims and amended a multiple dependent claim to depend only from non-instituted claims.

Biotechnology Considerations for the Unitary Patent System in Light of Brexit and Other Current Developments

February 6, 2017 Daniel A. Kamkar and Eric Furman, Ph.D.

After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent System. The Unitary Patent System will create a Unitary Patent and a Unitary Patent Court (UPC) system to enforce patents across many European states.

Attorney Finder