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19 March 2020AmericasSarah Morgan

Biogen takes Creative Biolabs to court over antibody

Biogen and the University of Zurich have accused New York-based Creative Biolabs of unlawfully selling copies of Biogen’s aducanumab antibody.

In a suit filed at the US District Court for the District of Massachusetts yesterday, March 18, Biogen claimed that Creative Biolabs’ alleged infringement threatens to cause irreparable damage to Biogen, and that it would damage investigators who might mistakenly use the unauthorised copycat products in their scientific and clinical research.

Biogen’s patent protected aducanumab antibody is being investigated for the treatment of early Alzheimer’s disease. More than 40 million people worldwide are living with Alzheimer’s disease and related dementias.

As part of its work on novel approaches for the treatment of Alzheimer’s disease, Biogen licensed aducanumab from Swiss biopharmaceutical company Neurimmune Therapeutics. Neurimmune itself had licensed the technology and IP rights from the University of Zurich, which owns the patent-at-issue, US number 8,906,367.

Biogen is pursuing regulatory approval from the US Food and Drug Administration for aducanumab for treatment of early Alzheimer’s disease.

If approved, aducanumab would become the first therapy available in the US to reduce the clinical decline of Alzheimer’s disease. Approximately ten million Americans might qualify for treatment, according to the claim.

Creative Biolabs is allegedly offering to sell Biogen’s aducanumab via its website and is

citing Biogen’s clinical trials as evidence of its applicability to the treatment of Alzheimer’s disease, using the term BIIB037 to identify its product (which Biogen uses both internally and externally to signify aducanumab).

By using ‘Biogen’ and BIIB037 in connection with the advertising of its aducanumab products, Creative Biolabs is also violating Biogen’s trademark rights, alleged the claim.

“Through its website, defendant advertises its purported expertise in manufacturing and selling aducanumab. It publicly claims to offer aducanumab for sale to researchers to support their research projects on Alzheimer’s disease,” added the suit.

While Creative Biolabs doesn’t disclose information regarding the purity of its aducanumab products or its manufacturing processes, Biogen said it believes that the company doesn’t make its products using the same “rigorous manufacturing controls” that Biogen uses.

The claim added: “Accordingly, the sale of defendant’s purported aducanumab, on information and belief, would pose a likely public health hazard if it were confused with the aducanumab Biogen manufactures for its clinical trials.”

Biogen has asked the court to stop Creative Biolabs from selling its purported aducanumad products, order the removal of all references to Biogen and BIIB from the website, and damages.

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9 July 2020   In the high stakes world of life sciences, the strength of a company’s IP portfolio can determine the value of a corporate transaction, argue Jonathan Harris and Nisan Zaghi of Axinn, and Ian Lodovice of Biogen.
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More on this story

Americas
9 July 2020   In the high stakes world of life sciences, the strength of a company’s IP portfolio can determine the value of a corporate transaction, argue Jonathan Harris and Nisan Zaghi of Axinn, and Ian Lodovice of Biogen.
Biotechnology
30 July 2020   Swiss company Roche has partnered with Belgium-based biopharmaceutical company UCB to develop an antibody treatment for people living with Alzheimer’s disease.
Americas
9 December 2020   The University of Southern Denmark has accused biotech Creative Biolabs of infringing its patent-protected monoclonal antibody, HG-HYB 7-5.