IP
Metalworks!A Cautionary Tale:
Adversarial Submissions in EPO Practice:
Science-based adversarial proceedings
available in Europe. It is in the
client’s best interest to file a definite and fully supported United
States patent application, indeed it is critical for any start-up
business, because the burdens and uncertainties of litigation may not be
sustainable. Many investors insist on seeing a credible patent estate.
A well written patent that spells out “literal infringement” is at
least a little less likely to be challenged when the technology becomes
profitable. There are no shortcuts in patent application
drafting. As in every
activity, there are times when not all goes according to plan. A
weak or flawed patent application can become a keystone of support for
(or an obstacle to) the whole business plan. This raises issues
for both the patentee and the potential infringer that may to litigation
in US Courts. In Europe, the situation is much less damaging. This installment
of IP Metalworks compares US and European Patent Examination procedures
for amending or correcting an application post-filing, and for
challenging defective patents prior to action in the Courts. This
editorial also suggests that until the US system is improved, potential
defendants must carefully weigh their own resources before pursuing a
full course of litigation. Litigation is essentially the only
means available in the US to attack the scientific merits of a patent
application or issued patent. Regrettably, given this limited
recourse, the money can be perhaps better spent in organizing or
supporting a legislative initiative to expand public intervention and
inter partes
re-examination proceedings at the US Patent and Trademark Office (PTO).
For the time being, licensing a bad patent may be a more productive
course of action than risking infringement. As a corollary, no
licensee should agree to take on the costs of defense of any patent.
And all patentees should endeavor to craft each patent application as
carefully as possible, because money spent up front can avoid
irreparable harm later, especially given current US PTO procedures. The patent system is a powerful engine for
technological advance. However, there is increasing skepticism
directed at the ability of the US PTO to root out defective patent
applications. Patent invalidity continues to be the primary
defense elected by all patent infringement defendants, and the courts
have not been unsympathetic to this, suggesting an erosion in the
credibility of the patent examination process. One possible remedy
is found already in use in the European Union, where inter partes
proceedings begin early in the patent application process. American
practitioners are understandably wary of uniquely European practices
that permit inter partes adversarial proceedings during patent
examination and in the 9 month period following grant. However,
insofar as these procedures winnow out weaker patents without the burden
of litigation, this reluctance is perhaps not in the best service of the
client. The procedures are particularly appealing as a means to
settle a brewing patent controversy on the basis of the scientific
merits, instead of in court. The European system of Opposition has
some elements that may seem more familiar from Trademark practice in the
US, but it goes much farther, ... as described below both pre-grant and
post-grant inter partes proceedings may be practiced. In the European
Union, pre-grant proceedings take the form of a petition written to the
EPO attacking the patentability of a pending application, and providing
scientific data and argument in support of the allegations. Thus,
competitors or other interested parties may comment on any pending,
published application by filing an “Observation” which details any
results that were obtained in experimental trials of the teachings of
the patent, and any interpretation of those results in the context of
applicable patent law. The applicant is then given an extensible
period of 6 mo to develop data that controverts the allegations.
The Examiners, all professional scientists, then weigh the scientific
bases of the arguments from both sides and make a decision that the
applicant may either accept or appeal. The pre-grant proceeding is
almost unknown in the United States except to those who have been been
required to respond to it during prosecution of a counterpart
application to a US filing in Europe. A strong patent applicant has
nothing to fear in these proceedings. Interestingly,
during pre-grant Observation proceedings, the new data provided by the
applicant can serve to supplement or flesh out an otherwise weak or
flawed application, and constitutes “acceptable new matter” that is
considered by the EPO in evaluating and amending the application.
Think of this as “filling in the holes” rather than expanding the scope
of the invention. By virtue of a science-based adversarial
process, the outcome is generally a fair and accurate assessment of the
substance and scope of the invention as it was filed and a more precise
delineation of the claims. A strengthened patent usually emerges.
This substantially eliminates the need (and motivation) for litigation
during the post-grant lifetime of the patent. Even after grant,
the European system offers Opposition proceedings that permit third
parties to again challenge a patent by either legal argument or
experimental data, although the grounds for such challenge are more
limited and must be based on either:
·
Non-novelty, lack of
inventive step, or non-statutory subject matter;
·
A non-enabling disclosure;
·
Or, an allegation that
expansion of the claims during prosecution constitutes new subject
matter. The number of
submissions made by advocates for the opposing parties is not fixed or
limited, and the EPO will continue to solicit material until clarity is
reached. Both written and oral arguments are permitted, and the
process is inexpensive. A post-grant Opposition must be filed
within 9 mo of the date of grant. Following this period, granted
patents gain a strong assumption of validity if challenged in court,
although each member country of the European Union forms a separate
juridiction, and the impact of a successful litigation in one country
has no impact on a similar litigation in any other country. The
strong assumption of validity of patents within the European system
should be seen as a plus by innovative technology-based small
businesses, who may not have the resources for the kind of “due process”
that at the outset levels the playing field in the United States courts,
and then tilts it in favor of the party with the deepest pockets. While some US
Patent Attorneys steadfastly refuse to participate in the European
Observation process, arguing that the European Opposition processes give
away ammunition that could better be used in court, the forum
nonetheless has merit. For one, the EPO Observation proceeding
avoids the need for redundant litigation in each national jurisdiction
within the European Union. It also should be noted that technical
experts, not a judge or jury, review the scientific results and that the
applicant has the opportunity to respond with comments or added
experimentation, thus contributing to a strong scientific and legal
record in support of the claims. No similar opportunity for scientists
to weight the scientific data is provided in the US patent examination
system. Indeed, there is
no adversarial balance in the patent examination proceedings of the US
PTO, which is an ex parte proceeding. The PTO does not
itself research and test the technologies that come before it, and no
adversarial scientific testimony or peer review is of record for any
issued patent. Evidence in the circumscribed inter partes
reexamination procedures is limited to prior art from publications or
from patent files, and submissions and oral arguments are grossly
stacked in favor of the patentee, acting unopposed (who may take
advantage of the reexamination process to correct, clarify or expand the
claims), often in concert with the Examiner who originally allowed the
patent. Even very recent legislation to address these concerns[1]
made only token concessions to “third-party requestors” by widening the
scope of prior art that may be brought to bear on any “substantial new
question of patentability” and by legislatively undoing the Portola
Packaging[2]
decision. Estoppel continues to apply: any findings of fact made
in the re-examination process cannot be challenged in a follow-on civil
action. Admittedly, the changes do provide a more seamless
transition from re-examination to patent litigation,
[3] affording for the
first time 3d party access to appellate relief following adverse
re-examination decisions, but empowering neither the PTO nor the courts
to engage a science-based adversarial, peer review of the patent in the
interests of prompt, affordable justice. Thus in the United
States, strangely as it may seem, all scientific questions about a
patent are the responsibility of the District Courts and Court of
Appeals for the Federal Circuit to untangle, however poorly prepared
they are to tackle the explodingly advanced technologies of
nanocomposites, biotechnology, or electron tunnelling and
electrochemi-luminescence, for example. The current US
system relies entirely on the wits of oft overworked Patent Examiners,
most of whom have an entry level scientific background, to ensure that
issued patents meet the requisite standards of validity. Working ex
parte, the Examiner must have prima facie grounds for
questioning the assertions of the patent applicant, or take them as
fact. It is perhaps not surprising that some appellate panels have
demonstrated skepticism that an issued US patent merits the special
status it once commanded. About 7% of
European patents provoke Opposition proceedings after grant. In
contrast only 0.3% of US patents undergo reexamination, most at the
request of the patentee to correct errors, omissions, or to broaden the
claims. At the EPO, about 70% of the 7% of patents that are
challenged undergo amendment, limitation or cancellation of claims (ie.
~5% of all EPO patents). In contrast, patented claims are reduced
in only about 12% of the 0.3% of US patents that are reexamined (ie.
less than 0.03% overall). Similar figures were generated when
sibling US and EPO applications were compared, demonstrating that it is
not a difference in the quality of the patents themselves that underlies
the statistical outcomes.[4]
Doing the math, defective US patents are as many as 5% of all issued US
patents. These must be either stared down (made unenforceable by
word of mouth) or invalidated by the courts, a horrendously expensive
process by comparison. No readily
comparable statistics for patent litigation are available for Europe
versus the United States, so we can’t draw a final conclusion as to the
ultimate efficacy of the pre- and post-grant Opposition processes in
avoiding litigation of weak or defective patents. [This author
would like to believe that the procedures provide some effective relief
to the courts and welcomes any comments on the question.] Given the issues
that impact the credibility of the current system, all participants view
the US system with a certain level of dissatisfaction and suspicion, and
businesses not infrequently elect to go ahead with putatively infringing
products after receiving from counsel a favorable formal or informal
infringement analysis. There are many cautionary tales derived
from the disasters that have followed from this risky strategy.[5],[6]
Simply put, the courts are rarely in a position to equitably judge
intellectual property issues involving complex and advanced science, and
no one should go to court on the belief that the justice of their cause
will prevail. The best possible outcome is a summary judgement
sustained on appeal. As the level of ambiguity in the litigant’s
positions increases, litigation becomes increasingly a measure of
resources, not right or wrong. While care can be
taken in the drafting of patents to avoid the kind of ambiguities that
fuel litigation, perhaps only yet more legislative patches will fix the
greater imperfection in American IP practice; policy debate and lobbying
interests are already fully engaged.2,[7]
Rather than cast about for imaginative reform, we can look to the
institutions of the EPO for practical ways to stimulate inter partes
review and to thereby better protect the public interest in and
credibility of this valuable engine for technological advance. As long
as litigation is the only option, the aggregate costs to both patentees
and potential infringers run in hundreds of millions of dollars
annually, a cost that is borne at the expense of technological progress.
Of course, as this
website will never tire in pointing out, individual patentees have the
option to retain the highest quality patent counsel to draft their
patent applications. A few thousand dollars spent to thoroughly
vet the application and search the prior art can save millions over the
life of a patented product. Well written applications that force
literal infringement form an eloquent warning to the potential
infringer, placing at risk not only the infringing company, but also the
personal fortune of its officers.
[1]
Patent and Trademark Office Authorization Act of 2002.
[2]
In re Portola Packaging Inc 110 F3d 786, 790 (Fed Circ
1997).
[3]
Intellectual Property and High Technology Technical Amendment Act
of 2002. For a more enthusiastic view, see JD Bodner. 2003.
New Patent Legislation Impacts Practitioners. Intellectual
Property Today 10(3):8-10.
[4]
Graham SJH et al. 2002. Post-issue patent “quality control”: a
comparative study of US patent re-examinations and European patent
oppositions. Formerly available at
http://www7.nationalacademies. org/step/Hall_et_al_paper.pdf but
archived here in its entirety (see
link
to this site).
[5]
American Medical Systems Inv v Medical Engineering Corp, 794 F
Supp 1370 (1370 E.D. Wisc 1992); 6 F3d 1523 (Fed Circ 1993).
[6]
Bar-Shalom A and R Cook-Deegan. 2002. Patents and innovation
in cancer therapeutics: lessons from CellPro. The Milbank
Quarterly 80(4):637-676.
[7]
Hall, BH. 2001. The global nature of intellectual property:
discussion. Available at
http://emlab.berkeley.edu/users/bhhall/bhhdisc_toronto501.pdf
and archived here in its entirety (see
link).
Ó Copyright K K Lambert 2001-2005. All rights reserved. For permissions, contact the author.