[Ip-health] BIO's play for perpetual monopoly [Deciding Newness of Biologics as a Basis for Exclusivity]

Wed Aug 1 14:22:01 2007

With a proposed 12 years of marketing exclusivity to be granted to
each biologic from date of approval for each biologic (simply
stated), everything will be dependent on how a "new" biologic is
defined.  As discussed in my two-part series, "What is a Generic
Biopharmaceutical?" in recent issues of BioProcess International
(full text accessible at www.biopharmacopeia.com), rationally
defining what is a new or unique/different biopharmaceutical product
is a very difficult task.  In many respects, deciding newness,
uniqueness, etc. for biologics is more difficult than deciding on
similarity, comparability, etc. between different products.

One can define what is a "new" biologic basing this is on examining
the active agent and formulation, i.e, a scientific approach, with
the "process=product" paradigm and the traditional approach to
biologics regulation essentially stating that a product, no matter
how similar, originating from a different manufacturing process (or
manufacturer), e.g., using a different process, cell line, reagents,
equipment, etc., is invariably unique, different, new, etc.  This
approach suggests that any substantantive (by what/whose criteria?)
change (usually improvements) in manufacture of a biologic defines or
makes it a new/different product (even to the extent that
comparabilty trials may be needed to approve the changed product).
So, does one give 12 years to each product iteration or to selected
ones, or only to original products (and how does one defines this)?
For example, if a company revamps a product to remove all animal-
derived products, both bioprocessing and formulation (e.g.,
stabilizing the product without the usual use of human albumin or
other proteins), does the company get 12 years of exclusivity?
Established/innovator companies want and expect this (substantive/
major changes and other aspect, e.g., new indications/uses, defining
new products) from any bill they sponsor, with FDA making subjective
judgements about what  changes define a new product (based on what?),
much as they will have to decide on similarity of follow-on/
biogeneric products from different manufacturers.

Another way of defining "new" biologics is to go by the regulations/
laws, particularly regarding approvals, either original or
supplemental.  However, a major problem is that regulations and CBER/
FDA precedents for what changes in a product result in granting of
either a new/original or supplemental BLA are totally inconsistent,
incoherent, etc. (largely as a result of FDA regulating biologics on
a case-by-case basis).  Does one only give 12 years exclusivity to
biologics from their date of original BLA approval?  Or, does one
give 12 years from the date of each major supplemental approval; and
if so, which ones (product/process changes; new indications/uses)
count in this context?  Relying on biologics regulations (vague and
with a history of inconsistent precedents), besides these being
inscrutable, will be prone to considerable gaming of the system.  For
example, even if exclusivity is only given based on original BLA
approvals, what is to stop companies from making changes in their
products every few years, even seemingly major changes (e.g., new
formulation, cell line, delivery system, etc.), such that the "new"
product is truly and clinically different from the original, and then
applying for a new BLA for this product (even if this requires all
new trials)?  Presumably, changes or a new BLA might be obtained
towards the very end of patent protection, allowing an additional ~12
years exclusivity.  Regulatory-based "everygreening" could result
from reliance on biologics regulations and FDA interpretations.  And,
this is not even considering major issues involving follow-on
biologics applications from different manufacturers, e.g., to which
of the innovator's products (the original or his follow-on/new ones)
will these be considered comparable/similar to (and how can one
obtain approval as a follow-on to a product replaced by a "new"
version, e.g., with all supplies of the original/earlier version out-
of-date?).

The third way of defining new biologics is to base this on commercial
aspects, e.g., if the product is renamed, rebranded, etc.  Obviously,
this will not work.

So, whether one decides what is a "new" biologic based on science,
regulation or even common sense, how to actually do this is far from
clear.  This is an issue well beyond Congress' capabilities to deal
with, and has not even been discussed within the (bio)pharmaceutical
industry (e.g., I think my articles are the first on this topic).
So, whatever Congress does will likely be ill-conceived, ill-defined,
etc.  And with FDA having totally avoided even commenting
meaningfully in any way on biogeneric/follow-on biologics issues for
years and with biologics regulations and precedents confounding the
situation, it will take FDA many years to resolve these issues
(further slowing biogenerics, and providing ample opportunities for
vested interests, whether innovator or biogeneric, to influence the
outcome).

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 include  www.biopharma.com; www.biopharmacopeia.com;
www.followonproteins.com

On Jul 20, 2007, at 2:03 PM, robert weissman wrote:

> Proposed legislation in the US Congress to create a process for
> approval
> of generic versions of biologic drugs would give the brand name
> company
> 12 years of data exclusivity.
>
> http://lists.essential.org/pipermail/ip-health/2007-July/011476.html
>
> Readers of this list know how problematic this provision is. It's also
> easy to imagine that if this provision becomes law, Pharma will soon
> demand extension of data exclusivity for traditional pharmaceuticals.
>
> BIO, the trade association for the biologics makers, is apparently not
> satisfied with 12 years of exclusivity. It is refusing to permit an
> alteration to the Senate's biogenerics legislation which, as currently
> drafted, would give a new 12 years exclusivity for reformulations
> of the
> initial product.
>
> The logic of the 12 years exclusivity on new biologics -- as
> compared to
> the 5 years exclusivity for traditional drugs -- is that biologics are
> not receiving patent protection. I don't know of any evidence for this
> claim.
>
> In any case, it cannot be jibed with BIO's strident opposition (see
> below) to the patent reform bill now moving through Congress. The
> patent
> reform bill aims to stem the widespread grant of poor quality patents.
>
> Robert Weissman
> Essential Action
>
> ---
>
> "The Biotech Industry Organization, whose members include Amgen
> Inc. and
> Genentech Inc., said Thursday it opposed to the House bill, which
> "threatens continued biotech innovation.""
>
> http://biz.yahoo.com/ap/070719/patent_reform_senate.html?.v=1
>
>
> AP
> Senate Panel Approves Patent Reform Bill
> Thursday July 19, 7:49 pm ET
> By Christopher S. Rugaber, AP Business Writer
> Senate Judiciary Committee Approves Landmark Patent Reform Bill
>
> WASHINGTON (AP) -- The Senate Judiciary Committee approved a sweeping
> patent reform bill Thursday that seeks to improve patent quality and
> reduce the number of costly infringement lawsuits.
>
> The committee's move comes after the House Judiciary panel cleared a
> similar bill Wednesday. The bills will now need to be considered by
> the
> full House and Senate.
>
> Members of Congress and industry groups say the legislation makes the
> most extensive changes to patent law in more than 50 years.
>
> The Senate panel also approved several amendments to the bill,
> including
> one sought by the financial services industry. That amendment would
> protect banks from damage awards in patent infringement cases
> involving
> electronic check-clearing technologies, such as check-imaging systems.
>
> More than 60 banks have been hit with lawsuits alleging the
> infringement
> of such technologies, the American Bankers Association said in a
> letter
> last week to the House and Senate Judiciary Committees. Banks have
> paid
> millions of dollars to settle the suits, the association said.
>
> Both the House and Senate proposals would increase the information
> available to patent examiners and set up a process to re-evaluate
> patents after they are granted. Supporters argue such post-grant
> reviews
> would help weed out patents for minor innovations and overly broad
> patents by allowing companies to challenge them without having to go
> through lengthy litigation.
>
> The bills also seek to reduce the incentives for litigation by
> making it
> harder for a patent holder to show that another company has willfully
> infringed its patents, which can entitle the patent holder to triple
> damages.
>
> The bills are sponsored by Sens. Patrick Leahy, D-Vt., chairman of the
> Senate Judiciary Committee, and Orrin Hatch, R-Utah, and Reps. Howard
> Berman, D-Calif., and Lamar Smith, R-Texas.
>
> The Senate committee began its consideration of the bill last week,
> when
> it accepted an amendment offered by Sen. Arlen Specter, R-Pa., that
> would limit the jurisdictions where patent holders can file lawsuits.
> The suits would have to be filed where the plaintiffs or defendants
> are
> located, or where the alleged infringement took place.
>
> The House approved a similar measure Wednesday. The provisions are
> intended to limit "forum shopping," where patent owners seek out
> fast-moving court dockets and sympathetic juries.
>
> The changes made by the two committees, so far, haven't satisfied many
> of the bill's opponents, which include pharmaceutical, biotech and
> manufacturing companies, as well as technology companies that rely on
> licensing patents, such as Qualcomm Inc.
>
> Those companies argue that the bill will weaken patent protection by
> reducing the penalties for infringement and subjecting patents to
> additional challenges under the post-grant review process.
>
> The Biotech Industry Organization, whose members include Amgen Inc.
> and
> Genentech Inc., said Thursday it opposed to the House bill, which
> "threatens continued biotech innovation."
>
> The legislation is strongly supported by software and technology
> companies, such as Microsoft Corp. and Cisco Systems, which argue that
> their complex products with hundreds of patents makes them easy
> targets
> for patent infringement suits based on inadvertent or minor
> violations.
>
> For instance, a $1.5 billion award was levied against Microsoft
> earlier
> this year on a patent infringement suit brought by Alcatel-Lucent.
>
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