MX: Patent Reexaminations: The Crucial First 90 Days

Advanced preparation and urgent action are needed if a patent owner wants to protect the value of claims under attack.

8 Min Read
MX: Patent Reexaminations: The Crucial First 90 Days

Edwards Lifesciences should have known a valuable asset was under attack when it received notice that a reexamination of two of its key patents had been requested. Medtronics had asked the U.S. Patent and Trademark Office to look into patents for Edwards’ Sapien heart replacement valve. Sales of the Sapien valve topped $200 million in 2010, and a related patent was the basis of an award that could exceed $100 million.

Similar alarm bells should have sounded in the executive suite at Abbott Diabetes Care when competitor DexCom, as part of its strategy for dealing with its litigation with Abbott, requested reexamination of a number of Abbott’s patents related to glucose monitoring equipment.

Such requests have more than tripled over the last 10 years. Increasingly, companies are initiating patent reexamination proceedings as part of a strategy to avoid liability for patent infringement. Reexamination is a specialized proceeding in which the USPTO reconsiders an issued patent. The process can result in invalidation of some, or all, of the patent claims. Reexamination may be initiated by the USPTO or by the patent owner, but increasingly third parties start the process as part of an overall strategy to challenge a patent.

If a patent owner receives a notice of a request to reexamine one of its patents, it is likely the requester knows the challenged patent is particularly valuable if it is not invalidated.  Accordingly, even the filing of such a request should alert the patent owner that its valuable asset is under attack. The USPTO grants a reexamination request more than 90% of the time. And if the request is granted, a proceeding begins that may lead to the patent owner’s loss of the patent asset.

This article focuses on the challenges of reexaminations requested by third parties and explores the five critical steps patent owners should take before the USPTO declares a reexamination.

A Closer Look

There are two kinds of reexaminations, ex parte and inter partes. These types differ in the level of participation provided to the requester, but both begin with a request for reexamination and can end with some or all claims invalidated. If the USPTO determines the request raises a substantial new question of patentability, the patent is reexamined.

By Congressional mandate, the USPTO conducts reexaminations with “special dispatch.” This means a patent owner must fight to save its patent under rules that tightly constrain options and timing. Worse, a patent owner may be fighting against a third party that has prepared for months—or even years—before the reexamination.

To maximize the likelihood of retaining the asset’s value, the patent owner should not wait until the USPTO grants the requested reexamination to begin preparing for the likelihood of such a decision. There are steps patent owners can take during the approximately 90 days it takes the USPTO to declare a reexamination—actions that could mean the difference between saving and losing a valuable patent.

Unique Rules for Reexaminations

The reexamination process is governed by specific rules that differ from standard patent prosecution and litigation. As a result, a patent owner will face unique challenges during reexamination, some of which are discussed below.

Challenge 1—Time. The USPTO takes “special dispatch” seriously, conducting these reexamination proceedings with an interest in closing the prosecution as quickly as possible. In fact, by statute, once a reexamination is requested, the USPTO must grant or deny the request within three months. Thereafter, rigid timelines are imposed for responding to USPTO actions and submitting evidence. A request for more time is rarely granted. A patent owner must carefully plan its activities under the tight time constraints to best save the claims or make sure the record is fully developed for appeal.

Challenge 2—Intervening rights. Reexamination allows a patent owner to amend or add new claims to its patent, provided the scope of the original claim is not broadened. If used effectively, this tactic can yield claims that overcome the prior art (while hopefully still capturing infringing acts), which may save the value of the patent. However, a doctrine called “intervening rights” can limit the value of new or amended claims and needs to be considered.

Challenge 3—Differences from litigation. During reexamination, clear and convincing evidence is not required to invalidate claims, as it is in litigation. Claims are also interpreted differently. This means a third-party challenger may find it easier to convince an examiner that a patent’s claims are invalid than to persuade a judge or jury in litigation. Additionally, examiners, who understand patentability—and most likely the technology underlying the invention of the claims—decide the final result of the reexamination, rather than a judge or jury who may not have expertise in the subject matter under consideration. This means that even a well-formulated litigation strategy may not be right for reexamination.

Challenge 4—Strict page limits. The reexamination rules impose strict page limits for submissions during the proceedings. These page limits compound the difficulties a patent owner already faces. The patent owner must also strategize how best to succinctly argue for the patentability of the claims under reexamination while positioning for possible appeal.

Five Critical Steps

As soon as a reexamination is requested, a patent owner should determine the strategy for the process, preferably before the reexamination is declared by the USPTO. A patent owner must actively maximize its chances of preserving valuable claims. To help combat the challenges of reexamination, here are five steps to take as soon as possible after learning of a request for reexamination:

Engage appropriate counsel. A patent owner may already have counsel—either an attorney involved in prosecution of the patent or counsel engaged to enforce the patent. However, the strategy and procedure in reexamination will be unlike either prosecution or litigation, particularly if a valuable patent is at stake.

Accordingly, a first step is to ensure that counsel is able to guide the patent holder through the unique challenges of reexamination. This should be done early. It is possible to petition against a reexamination declared for impermissible reasons. However, chances of blocking a reexamination before it starts are slim. And, again, a more important reason for engaging counsel early is to take advantage of the first 90 days—before the reexamination is declared. 

Assess the strategic importance of each claim. It is critical for a patent owner to evaluate the reasons for invalidation asserted in the request. The patent holder needs to determine which claims to defend and which claims to amend—or even which claims to add. There is a risk of losing value through intervening rights. Therefore, this evaluation must be done in light of how each claim covers current infringers or infringers that may arise before the reexamination certificate is issued. There can be tough choices, and the sooner the consideration is started, the better.

Understand what evidence may be needed. There are strict timeframes for submissions, so it is important to contemplate what evidence will be needed in order to overcome the prior art and then plan accordingly. Such evidence may include materials that show the disqualification of any of the references, input from technical experts explaining or interpreting the prior art, and evidence of secondary considerations to overcome any rejections based on the obviousness of the claim or claims.

Consider the duty of disclosure. The duty of disclosure, as existed in the initial prosecution before the USPTO, reattaches during reexamination. Failure to comply renders a patent unenforceable. Therefore, a patent owner should identify disclosable material discovered since the patent issued, such as discoveries made during licensing discussions or litigation over the patent.

Satisfying the duty of disclosure in reexamination can be complicated because of other concurrent proceedings, particularly in light of the competing duty of confidentiality or a protective order in place during litigation. It is important, therefore, to begin planning to comply with the duty of disclosure as early as possible in the reexamination process. Preferably, a patent owner should be ready to submit an Information Disclosure Statement (IDS) within two months of the declaration of the reexamination to best avoid completely missing the opportunity.

Consider other strategies. A patent owner should also consider whether there are other proceedings to pursue in addition to reexamination. For example, if there is current infringement, a patent owner may wish to consider litigation. A patent owner may also consider filing a reissue application to correct defects in the patent that cannot be corrected in the reexamination. For instance, if a broadening reissue is possible, then the owner may consider the assertion of broader claims. Additionally, a patent owner may consider whether a continuing application is possible as a vehicle to pursue claims instead of, or in addition to, the claims under reexamination. Strategically pursuing coordinated claims in a continuing application may strengthen a patent owner’s position.

Take Immediate Action

As noted above, reexaminations have increased exponentially in the past decade. That trend is likely to continue, and there is every reason to believe the medical device industry will witness a corresponding rise in reexaminations.

Advanced preparation is the best way for a patent owner to protect as much as possible of the value of a patent under attack. The reexamination process poses many challenges for a patent owner if a reexamination request is granted, which happens most of the time. By taking action upon receiving a reexamination request—before a reexamination is declared—a patent owner can increase the likelihood of retaining valuable patent rights.

Edmund J. Walsh is a shareholder and cochairman of the reexamination practice group at Wolf, Greenfield (Boston). Walsh can be reached at [email protected].

Janice A. Vatland is an associate and member of the same practice group. Vatland can be reached at [email protected].

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