[Ip-health] BIO's play for perpetual monopoly

[robert weissman]

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.