Wednesday, June 13, 2007

More Voices Speak Out on Patent Reform

As the Patent Reform Act of 2007 makes its way through the Senate, more and more entities are making sure their concerns are being heard by Congress. To be sure, the swell of dissent is increasing, and is expected to further increase over the coming weeks. Some recent letters to Congress include:

Chief Judge Michel: his letter includes a biting criticism over the apportionment of damages:

• "As promised, I have since reviewed some of the Federal Circuit decisions that address aspects of this subject [damages], and I have also identified and attached an article that should help you more than reading individual opinions. Significantly, it was written by a seasoned patent litigator with direct experience in how such damage theories are actually litigated in court. Lawyers employed by particular companies, like most law professors, have little or no experience from that perspective. Mr. Rooklidge, by contrast, has several decades of litigation experience in precisely these types of cases."

• In short, the current provision has the following shortcomings. First, it requires a massive damages trial in every case and does so without an assignment of burden of proof on the proper party and articulation of a clear standard of proof associated with that burden. Second, the analysis required is vastly more complicated than that done under current law. Third, the meaning of various phrases in the bills would be litigated for many years creating an intervening period of great uncertainty that would discourage settlements of disputes without litigation or at least prior to lengthy and expensive trials.

View/download Michel letter here (link).

View Rooklidge article here (link).

Advanced Medical Technology Association (AvaMed): the world's largest association of medical device manufacturers stated the following:

• "We agree with the position taken by many other industry groups, as well as Chief Judge Michel of the Federal Circuit, in opposing any apportionment of damages."

• "AdvaMed’s IP Working Group also opposes the “second window” of post-grant oppositions.Unlike many other industries, the life cycle of medical devices is relatively short—often no longer than seven to ten years. The ability to quickly capture, and then maintain, market share over this short period is critical."

• "Inequitable Conduct Should be Reformed and Substantive Rulemaking Should Not be Delegated to the PTO . . . With respect to the delegation of substantive rulemaking to the PTO, we oppose this provision. Such rulemaking likely would result in litigation challenging the PTO, which would create further uncertainty. In addition, giving the PTO power to make substantive rules, while bypassing legislation that is subject to debate and commentary, would inevitably lead to specialized lobbying groups."

View/download AvaMed letter here (link).

Massachusetts Medical Device Industry Council (MassMEDIC): Massachusetts ranks second among all states in the number of medical device patents filed each year. In a letter to Senator Kennedy, MassMEDIC states:

• "MassMEDIC opposes an open-ended post-grant opposition that allows for a second window of review after the initial post-issuance challenge period. Having a second, open-ended window prevents conveyance of patent certainty, validity, and exclusivity, which are essential to justify the millions of investment dollars needed to bring these types of inventions through to commercialization."

• "MassMEDIC opposes the bill’s limit on patent infringement damages to the economic value attributable to the patent’s “improvement over the prior art.” As Judge Michel of the Court of Appeals for the Federal Circuit (which has exclusive jurisdiction over appeals for patent cases) has recognized, a “prior art subtraction” standard would add complexity and uncertainty to patent litigation and result in more costly and lengthy court proceedings."

MassMEDIC opposes [the] delegation of expansive rulemaking authority [to the USPTO] provided under S1145.

View/download MassMedic letter here (link).

Medical Device Manufacturer's Association (MDMA):
• The Patent Reform Act of 2007 includes provisions that, when combined with the changes that have already taken place, threaten to devastate life sciences investment, and thereby, innovation. MDMA is particularly concerned with the provisions dealing with PTO rule making authority, apportionment of damages, the open-ended nature of the post-grant review window, and the lack of redress for the growing use of the inequitable conduct defense.

View/download MDMA letter here (link).

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