[Ip-health] Lack of transparency of patent landscape for Genentech's Lucentis

[Ron Rader]

--
[ Picked text/plain from multipart/alternative ]
Lack of transparency regarding biopharmaceutical patents is the norm,
like patents in most every industry.  Generic drugs and the Orange
Book are a major exception.  [Note, Lucentis is regulated as a
biologic and the Orange Book, Hatch-Waxman Act, etc., exempt biologics].

In fact, I am surprised you got a response from Genentech.  In my
experience (I am the author of the only reference book concerning
biopharmaceuticals; see http://www.biopharma.com) when asking for
information about products (vs. medical/use information and company
hype which are readily available), the predominant response from
(bio)pharmaceutical companies is none, i.e., >95% of the time rude/
crude neglect, no response at all, not even a no thank you or
dismissal, including after speaking with a designated contact who
almost always says relevant information will be sent.

The active agent in Lucentis is ranibizumab, a Fab fragment of a
recombinant humanized IgG1 kappa isotype murine monoclonal antibody
(Mab) with binding specificity for vascular endothelial growth factor
(VEGF-A) expressed by transformed Escherichia coli (E. coli)
bacteria.  Besides composition-of-matter (gene/protein sequence)
patent(s), which might take some time to differentiate from those
covering bevacizumab, an analogous fuller-sized recombinant VEGF Mab
that is the active agent is Avastin also from Genentech, the product
is almost certainly also effectively covered by multiple process, use,
formulation, assay and reference standard patents assigned to or
licensed by Genentech.  For example, ranibizumab was designed using
monoclonal antibody humanization technology licensed from Protein
Design Ltd. (PDL; now PDL Biopharma); Genentech's own Cabilly-Boss
monoclonal antibody design and expression patents also apply; and
Genentech uses Bacterial cell expression technology (BCE) licensed
from Xoma Corp. for E. coli expression of ranibizumab.  So, aside from
Genentech's own mass of relevant patents, you have various process and
other technologies that have been licensed in, perhaps, with
exclusivity.  Combine this with the manufacturing process being
proprietary/secret, there is no way an outsider can ever fully
determine patent coverage for a biopharmaceutical product.   [I
welcome collaborating in trying to figure out what patents cover
Lucentis or any other biopharmaceutical.  Contact me off-list, if
interested].

Further complicating figuring out what patents cover what
biopharmaceuticals, with the weakening of requirements for "best mode"
disclosure (about 12-15 years ago?), there is no obligation to cite
what patent examples, sequences, etc., are considered the "best
mode."  This formerly usually involved citing what actually covered or
was most relevant to commercial products.  Subsequently, patents,
particularly for biopharmaceuticals, are overloaded with examples with
no mention of what is the most useful or actually used in commerce.

BTW:  Transparency, or rather lack of it, is something that has yet to
enter in recent discussions of follow-on biologics legislation.  An
early pro-(bio)generics proposed bill included companies reporting
relevant patents (much like the Orange Book), with sponsors restricted
to only enforcing those they publicly report as covering their
product.  However, this reporting seems to have been abandoned in more
recent proposed bills.  In fact, now most discussion involves FDA
becoming an arbiter of innovation, with a new industry entitlement
program granting "innovator" products proposed 12-14 years of market
exclusivity (protection from approval of follow-on/biosimilar
competition).

Ronald A. Rader
President / Author, Biopharmaceutical Products in the U.S. and
European Markets
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  ron@biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com; www.biomanuf.com;
     www.biopharmacopeia.com; www.followonproteins.com


On Feb 10, 2008, at 3:36 AM, James Love wrote:

> Lucentis (ranibizumab injection) is Genentech's prescription medicine
> for the treatment of patients with wet age-related macular
> degeneration
> (AMD).  We are interested in the patent landscape on this medicine.
> Because the product is a biologic, there is no USFDA orange book entry
> that reports the patents on the product.
>
> We asked Genentech which patents if any they claimed protect Lucentis
> from competition.  Genentech told us that information was proprietary.
>
> There is something very wrong about a system where the patent owner
> does
> not even have to disclose if he is asserting patent protection for a
> prescription medicine.
>
>
> --------------
> Begin forwarded message:
>
> From: Krysta Pellegrino <pellegrino.krysta@gene.com>
> Date: February 7, 2008 6:55:01 PM EST
> To: David Serafino <david.serafino@keionline.org>
> Cc: Krysta Pellegrino <Pellegrino.Krysta@gene.com>
> Subject: Re: Patent question
>
> Hi David,
>
> Genentech considers such patent information proprietary, and as such
> we
> don't disclose it.
>
> Sorry I can't be more helpful on this one.
>
> Krysta
>
>
> On Feb 7, 2008, at 3:11 PM, David Serafino wrote:
>
> Hi Krysta,
>
> Actually, i was hoping to get the patents covering the entire product,
> including manufacturing processes, composition, and the like.  please
> let me know if there is a way i could get that data.
>
> Thanks!
>
> Dave
>
> On Feb 7, 2008, at 5:52 PM, Krysta Pellegrino wrote:
>
> Hi David,
>
> As a follow-up to our conversation this morning, we are not able to
> provide a specific patent number for a specific product as each
> product
> is covered by number of patents, including methods of making,
> composition, et cetera.   Please let me know if I can provide any
> additional information regarding Lucentis for your story.
>
> Thank you.
> Krysta
>
> Krysta Pellegrino
> Genentech, Inc.
> Corporate Relations
> 650-225-8226
> krysta@gene.com
>
>
>
>
> --
> _____________________________
> James Love, Knowledge Ecology International (KEI)
> http://www.keionline.org, mailto:james.love@keionline.org
> voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040,
> Geneva mobile +41.76.413.6584
>
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