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Supplemental examinations offer patent owners a new way of strengthening their IP portfolio. Kalimah Sims looks at what the proceedings cover and when to consider applying.

It’s harsh, but a successful inequitable conduct challenge invalids a patent. There is no middle ground for cases of inadequate disclosure or inadvertent omission. If used strategically, the supplemental examination however can reduce the risk of invalidity challenges for the entire patent enforceability period. This means a patent owner can sanitizes patent portfolio of prior missteps or omissions and get a do-over. Due to expense and large payoffs, IP portfolio managers are well advised to establish a robust systematic evaluation process to identify vulnerable patents in their portfolios for supplemental examination. To inform an effective strategy to mitigate risk employing the supplemental examination, this article examines the proceeding in light of its history and its limitations.

History

Back during the first patent reform movement in the US in 2007, there was a sizable push to curtail the power of the court to invalidate a patent under inequitable conduct doctrine. Proponents for inequitable conduct reform maintained that patent challengers abused the doctrine in civil litigation. It was asserted that the relatively low standard to prove an inequitable conduct as material meant patent owners are subject to abusive tactics that dragged out litigation and confuse the issues at trial. In prior revisions of the patent reform, proponents advocated for a higher materiality standard for courts hearing inequitable conduct allegations. It was argued that the court’s power to render a patent unenforceable or invalid under inequitable conduct doctrine should be restricted to actual or constructive bad faith cases. This proposition later became the principle built into the supplement examination provision in the America Invents Act in 2011. Reformers reasoned that discouraging non-material attacks is key to protecting patent owners given the known potential for abuse, the expanded arsenal available to challengers under the Post Review provisions, and the expanded definition of prior art. It is formulated to strengthen the validity of a patent that has been reviewed in light of new information submitted by the patent owner in a supplemental examination proceeding. It does not mean a challenger cannot argue inequitable conduct in civil litigation, rather it is a disincentive to do so unless there is strong evidence of actual or constructive bad faith and misconduct. By design, it is most effective against inequitable conduct allegations.

Supplemental examination proceedings

Under the new supplement examination provision, a patent owner may request a post-grant examination of their patent at any time during the period of enforceability. The examination is not limited to patents and printed publications, but can be any information that raises a substantial question of patentability. For example, a patent owner may submit a video recording of a conference presentation regarding the invention or previously undiscovered ‘on-sale’ activity like an unexecuted contract with a supplier. The case law is plenteous with examples where a patent was invalidated based on evidence that likely would not been submitted during the initial patent application and was not the result of inequitable conduct. It was a matter of plain inadequate disclosure not inequitable conduct. The supplemental examination provision also allows a patent owner to correct 101 patentable subject matter or 112 written description issues. This is helpful because court decisions typically expose weaknesses in written specifications over time. To illustrate this, you can look to the case of Decisioning.com v Federated Department Stores. In an infringement suit, a patent for a system for automatically processing loans and credit cards without human intervention was invalidated due to written description error during prosecution. The lower court granted a summary judgment of non-infringement for the defendant because the written description described a remote interface not home computers. On appeal, the Federal court affirmed based on the fact that the abstract stated a kiosk was an important feature and the common definition of a kiosk does not include a personal home computer (See 527 F.3D 1300 (Fed Cir.2008)). With a supplemental examination, a patent owner armed with knowledge of how similar cases have played out in court can correct such written description weaknesses before suing for infringement.

To get this do-over, it is expensive. A patent owner (not licensee) must file a request for supplemental examination along with the information to be reviewed and fee of $5140 plus $16,120 for the reexamination. Both must be paid at the time of initial request, and the $16,120 will be refunded if no re-examination is ordered. Another requirement is all inventors must request the supplemental examination and the only exception is if a joint inventor has died or is incapacitated.

The US Patent and Trademark Office (USPTO) gets three months to review the information and make a determination whether a full ex parte reexamination is needed. If it is determined that the information does not raise a question about patentability, a challenger cannot use the reviewed information in an inequitable conduct claim. If theUSPTO finds there is a question of patentability, the patent owner gets an ex parte reexamination. Again, a challenger can still argue in court that the USPTO is wrong and that the reviewed information does invalidate the patent. But it is a harder fight to wage, thus strengthening the presumption of validity and enforceability.

Limitations and other considerations

The supplemental examination provision does however have two enumerated prior allegation exceptions. Important for pioneering pharmaceutics, a supplemental examination cannot be used to remove invalidating information from a drug patent challenge if the invalidity allegation was made in a prior application to the Food and Drug Administration (FDA) to market and sale the generic version.

So in the generic pharmaceutical industry, there is an extra incentive to identify any errors/omissions and initiate an abbreviated application with the FDA before a patent owner request a supplemental examination.

Likewise, a patent owner cannot use the supplemental examination to foreclose an inequitable challenge if prior litigation is pending. This exception should be closely examined because it makes the decision on whether to request a supplemental examination more complicated. If it can be reasonably forecasted that a patent is open to challenge then it is prudent to initiate the supplemental examination before a viable complaint is filed in court.

When faced with a viable challenge, patent owners must also consider the fact that concurrent proceedings in the courts and the USPTO are common. It is worth noting, if the supplemental examination request results in an order for reexamination, that the pendency for a reexamination is over 36 months. A challenger can haul the patent dispute into court or initiate other Post-Grant proceedings in that time. In fact, over 30% of patents in reexamination before the USPTO are embattled in patent litigation at the same time. The courts are also not obliged to stay civil litigation until the USPTO completes its reexamination. This issue is on its way to the Supreme Court in the case Frensenius USA Inc. v Baxter. More than the pendency issue, the single major drawback for supplemental examination is that most re-exams lead to invalidating or amending claims. According to the USPTO’s statistics, almost 80% of reexaminations result in invalidating or amending one or more independent claim. Therefore, a strong reexamination strategy must be developed to adequately analyze whether the supplemental examination is the best tool to correct patenting errors.

In the absence of a viable challenge, an informed strategist should also consider whether the request for a supplemental examination places a target on the patent and heightens the risk of concurrent litigation for high-stakes patents or invalidation due to ill-advised reexamination strategy.

The new supplemental examination provision came in effect on September 16, 2012 and as of May 31, 2013 twenty-three requests have been filed under it so far. This will likely increase as IP portfolio managers and patent practitioners learn more about the supplemental examination provision.

Résumé

Kalimah Sims, Senior Patent Attorney, Sims IP PLLC

Mrs Sims has over 12 years’ experience in intellectual property. She is primarily responsible for patent prosecution and IP strategy. With broad technical competency and managerial experience, she has held various positions in corporate roles and government position including in-house Technology counsel to Director of Technology Development.