Knobbe/Martens: Intellectual Property Law

Agnes Juang, Ph.D.

Natural Alternatives International, Inc. v. Creative Compounds, LLC.: Dietary Supplement Containing A Natural Product Incorporated into a Dosage Form is Patent Eligible

In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of California that granted a judgment on the pleading holding the asserted claims invalid as not patent eligibile.


Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate.  While the wave of new health technologies emerging from this research rises, companies working in the microbiome space have had to confront a number of unique, interlinked technical, intellectual property, and regulatory issues that threaten to derail this extraordinarily promising area of development.  

Proposed Legislation: The Hatch-Waxman Integrity Act

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA).  Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development,” (ii) “prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design,” and (iii) “ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications.”  Press Release dated June 14, 2018.  Specifically, the proposed legislation would amend certain sections of the Food, Drug, and Cosmetic Act that provide the current framework for generic pharmaceutical and biosimilar product approvals. 


Bayer and Monsanto Deal Gets Blessed

April 23, 2018 Loni Morrow and Agnes Juang, Ph.D.

Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants.  Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its blessing to combine the companies.


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]


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.


District Court Finds Mallinckrodt Patents Claim Unpatentable Natural Phenomena

The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the court found U.S. Patent Nos. 8,795,741 (“’741 patent”), 8,282,9668,293,2848,431,163, and 8,846,112 (collectively, the "HF patents") to be invalid.

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.

Melinta Therapeutics Receives FDA Approval for Baxdela in Skin Infections

On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone antibiotic, Baxdela® (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI).  Approval of Baxdela®, which is effective against resistant organisms such as MRSA, will provide physicians another tool to combat growing antibiotic resistance. 

Tesaro Receives Early FDA Approval for Ovarian Cancer Drug Zejula

On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer following complete or partial response to platinum-based chemotherapy.

Matching Claim Language with Label Language Ensnares Infringers

On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of induced infringement.  Specifically, the Court relied upon product labeling, which instructs doctors and patients on the dosage ranges and schedules recited in the asserted claims of the ’209 Patent. 

Not Just a Formality? USPTO Sequence Rules May Impact Existing Biotech Portfolios

December 21, 2016 Scott Siera, Ph.D. and Agnes Juang, Ph.D.

Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols.  The United States Patent and Trademark Office (USPTO), in conjunction with the World Intellectual Property Organization (WIPO), is participating in an international effort that, if implemented, would dramatically change the requirements for sequence listings for the first time in 18 years.

Getting the Most from Biotech Patents in Europe Without Breaking the Bank: Selecting the Right Countries for Validation

October 27, 2016 Agnes Juang, Ph.D. and Scott Siera, Ph.D.

Once a European patent application has been granted, all patentees must then choose to validate the granted application in one or more European countries.  Such a decision may have long-term business and legal consequences.  Upon payment of the grant fees to the European Patent Office, patentees will be awarded a European patent.  The European patent is unenforceable until it becomes validated in the selected countries of the European Patent Convention.

Federal Circuit Relies on Robust Disclosure to Save Priority Date

On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the summary judgement that Abbott’s U.S. Patent No. 5,344,915 (“the ’915 Patent”) was sufficiently supported by the written description of its priority application (“Priority App”) and thus entitled to the Priority App filing date.  The ’915 Patent is directed to a protein, TBP-II, that binds to and neutralizes TNF-alpha.  However, the Priority App discloses only a partial N-terminal sequence of the claimed protein (9 of 15 residues), along with other properties of the protein, including molecular weight, biological activity, and trypsin-degradation characteristics. 

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