Avoiding Conflict Between IP and Regulation


I: Introduction

Many products require both patent protection and FDA (or other) regulatory clearance. These two
can be in conflict unless care is taken both in securing the regulatory approval and in securing
the IP protection. The core conflict is easily stated. In preparing and prosecuting a patent
application an important objective is to show substantive differences between the prior art and the
device being patented. In securing quick regulatory approval it can be extremely helpful to show
that the device for which approval is sought is substantially equivalent to a prior “predicate”
device. This conflict can manifest itself in three major ways.

II: Patentability Issues

The first of these are issues that may be raised is statements in the regulatory filings (not just
FDA filings) which contradict the positions typically taken vis-à-vis the patent office by
minimizing novelty and/or suggesting the obviousness of the patent claims. Statements that are
generally most problematic are those which identify a predicate device as being substantially
equivalent and the subsequent comparison of the operation of the new device such that the
differences are minimized. This is in contrast to the way the same differences may be presented in
the patent application or in subsequent prosecution. Another way in which patentability may be
called into question is when the FDA filing is available to the public prior to filing of the
patent application. The disclosure of the FDA filing may, in fact, be a disclosure of the
invention. For devices which require a PMA, the parts of the PMA that are public are also

publications which may destroy novelty, suggest obviousness
or obviousness to try. This kind of publication is especially damaging to patent applications
outside the US where there is no grace period for self-publications.

III: Infringement Issues

A second issue is that statements made by a party (for example, but not limited to) when filing
for regulatory approval may set that party up for a claim of patent infringement. We have had a
case in which a patent holder presented a local manufacturer with “proof” of infringement based
on statements made in a 510(k) filing. While for infringement purposes the alleged infringing
device should be compared to the patent and not to the patentee’s product, statements made in
regulatory filings can be very harmful to the defendant’s position.

III: Information Disclosure Issues

A third area of concern is the duty of disclosure to the US (and Israel) patent office. Failure to
properly carry out this duty can result in the entire patent being unenforceable, even if otherwise
valid and infringed. In the US, the applicant has to bring any information that a US Examiner
may consider to be material to patentability to the examiner’s attention. Especially relevant are
statements made elsewhere that may contradict statements made to the patent office. One result of
this obligation
is the necessity to report all comparisons made to predicate devices to the US patent office.
Additionally, one should report any patents which the manufacturer may have on the predicate
device of which you are aware. The comparison made between the predicate device and the device for
which approval is sought should also be disclosed as well as any explanation of the new device
made to the regulatory authorities. For devices which
require a PMA, the public parts of the PMA are prior art from the time they appear on the web site
of the FDA. However, even the confidential parts can be considered material and need to be
reported, for example if they conflict with statements made to the USPTO or in the patent
application. One can expect that during litigation even the confidential parts will be disclosed to
the attorneys for the patentee.

IV: Conclusion and Recommendations

It is possible, in great measure, to mitigate the problems inherent in the contradictory aims of
the regulatory and patenting processes. A complete discussion of the ways to avoid problems is
beyond the scope of this short paper. However, an important first step is to have an integrated
approach between the regulatory side and the patent side. While patent attorneys are not qualified
to judge the adequacy of regulatory filings, regulatory advisors are seldom experienced enough to
determine the effects of such statements on patentability or liability for infringement. It is
strongly recommended that any regulatory filings (original or responsive) be vetted by the patent
attorney before it is filed and that all filings are brought to the attention of the patent
attorney so that an informed decision as to what should be disclosed to the patent office can be
made. Better yet, there should be a joint strategy developed, at the outset, by the various people
involved (company, regulatory advisor and patent attorney) as to how best to secure a both high
speed of approval and quality of protection of IP, while minimizing the need to trade one off
against the other.

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