Knobbe/Martens: Intellectual Property Law

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The Cattle of the Future

February 16, 2018 Loni Morrow and Eric Furman, Ph.D.

When most people think of cattle, they think of Ferdinand the Bull and their favorite steakhouse.  The reality of beef production is far from most consumers’ radar.

Seattle Genetics Acquires Cascadian Therapeutics, Continuing a Strong 2018 Start in Biotech Mergers and Acquisitions

February 12, 2018 Joel L. Broussard and Agnes Juang, Ph.D.

On January 31, two Seattle biotech companies, Seattle Genetics and Cascadian Therapeutics, announced a merger agreement under which Seattle Genetics will acquire Cascadian Therapeutics for $614 million.[1]

 

PTAB Finds that Suing in Federal Court Waives Sovereign Immunity

January 15, 2018 Peter Law and Kerry S. Taylor, Ph.D.

On December 19, 2017, a seven-judge expanded PTAB panel ruled that the University of Minnesota (UM) waived its Eleventh Amendment immunity defense when it filed a patent infringement action in federal district court.  Eleventh Amendment immunity had been the focus of several previous PTAB decisions, but these previous decisions did not involve a sovereign who had filed an infringement action in federal court before an IPR petition was filed.  

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]

 

FDA Approves Zelboraf for Treatment of a Rare Cancer

November 17, 2017 Raj D. Pai, PhD. and Jason J. Jardine

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD)[1].  The FDA approved Zelboraf under Priority Review, Breakthrough Therapy, and Orphan Drug designations for the ECD indication. 

 

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

November 1, 2017 Scott Siera, Ph.D. and Agnes Juang, Ph.D.

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for.  Patents for Humanity is open to patents and applications that address humanitarian challenges, and recognizes the winners with publicity and expedited examination or appeal of any application in which the winner has an ownership interest.  Patents 4 Patients, also known as the Cancer Immunotherapy Pilot Program, offers expedited examination to patent applications that pertain to cancer immunotherapy.

 

Nonprofit Group I-MAK Files IPR Petition Seeking to Invalidate Hepatitis C Drug Patent

In an effort to lay the groundwork for generic entry and reduced drug prices, the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), with the support of the Laura and John Arnold foundation, has petitioned the PTAB seeking Inter Partes Review of Gilead’s U.S. Patent Nos. 7,429,572 & 7,964,580, which purport to encompass sofosbuvir, one of the active components of anti-Hepatitis C drugs Sovaldi®, Harvoni®, and Epclusa®.  

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.

Sovereign Immunity and Inter Partes Review

Sovereign immunity refers to the doctrine that the government cannot be sued without its consent.  Specifically, the 11th Amendment precludes federal courts from exercising jurisdiction over states in suits brought by private citizens or subjects of a foreign state. “Sovereigns” include federal and state governments under the 11th Amendment, as well as, Native American Tribes under treaties.  The U.S. Supreme Court has held that sovereign immunity is also available as a defense in administrative proceedings, which are similar to federal court litigation.  Federal Maritime Comm’n v. South Carolina Ports Authority, 535 U.S. 743.  In 2017, the Patent Trial and Appeal Board (PTAB) has addressed the issue of sovereign immunity several times in the context of Inter Partes Review (IPR) proceedings.  The recent cases, along with the currently pending IPR, Mylan Pharmaceuticals, Inc., et al. v. Allergan Inc., (IPR2016-01127, -1128, -01129, -01130, -01131, -01132) are discussed below. 

Bayer Receives Accelerated Approval for Aliqopa

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa under Accelerated Approval, Priority Review, and Orphan Drug designations. These designations indicate that Aliqopa is a drug for treating serious conditions, fills an unmet medical need, and provides incentives to encourage the development of drugs for rare diseases.

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