[Ip-health] Patent approval linkage and bio-medicine

Biotech. Info. Inst. biotech at biopharma.com
Tue Dec 2 05:22:15 PST 2014

As I read this, it does not apply to U.S.-approved biologics (BLAs), since there is no notification of the approving authority (FDA) regarding product/agent-related patent terms (no Orange Book-like reporting of patents claimed to cover biologics).  

Even U.S. patent extensions based on time in clinical trials are presumably irrelevant, with the approving authority here being the patent office, which as part of the process obtains confirmation of dates from FDA (as I recall).  

Also, biosimilar BPCIA-designated patent disclosures do not involve FDA as an approving or even as an informed authority, with patent information only exchanged between the biosimilar applicants and reference product companies.

But this would apply to products approved by FDA as drugs (NDAs), products covered by the Orange Book.  

Does the term “pharmaceutical product” here include medical devices?

Ronald A. Rader
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  biotech at biopharma.com
Web sites:  www.bioinfo.com; www.biopharma.com; 
   www.biosimilarspipeline.com; www.biopharmacopeia.com

On Dec 2, 2014, at 12:44 AM, Heesob Nam <hurips at gmail.com> wrote:

> There is a debate on whether the patent-approval linkage is applied to
> biological product in the U.S. Here the linkage is within the meaning
> of Article 18.9:5 of the Korea-US FTA.
> Article 18.9:5 Where a Party permits, as a condition of approving the
> marketing of a pharmaceutical product, persons, other than the person
> originally submitting safety or efficacy information, to rely on that
> information or on evidence of safety or efficacy information of a
> product that was previously approved, such as evidence of prior
> marketing approval in the territory of the Party or in another
> territory, that Party shall:
> (a) provide that the patent owner shall be notified of the identity of
> any such other person that requests marketing approval to enter the
> market during the term of a patent notified to the approving authority
> as covering that product or its approved method of use; and
> (b) implement measures in its marketing approval process to prevent
> such other persons from marketing a product without the consent or
> acquiescence of the patent owner during the term of a patent notified
> to the approving authority as covering that product or its approved
> method of use.
> My view is that the US does not implement the linkage under the FTA
> (as there is no obligation to do so) because two elements of the
> linkage, ie, notification and prevention of marketing, are not
> codified in the BPCI Act.
> But the Korean government posits that it is controversial and tries to
> expand the linkage to cover all of the biological product.
> Best,
> Heesob
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