Category: Intellectual Property

FDA Issues Final Guidance on Biosimilars

Shortly after approving the first biosimilar under the abbreviated approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the FDA has recently issued 3 final guidances regarding biosimilars. Biological products, or “biologics,” are pharmaceutical products created from biological sources. Unlike chemically synthesized pharmaceuticals, biologics are isolated from natural sources, and are typically more complex than conventional pharmaceutical drugs.

The BPCIA provides abbreviated pathways for the FDA to approve two types of follow-on biologics: biosimilar and interchangeable biological products. Similar to the 1984 Hatch-Waxman Act’s abbreviated pathway for pharmaceuticals, the BPCIA allows a sponsor to seek approval of a “biosimilar” product under section 351(k) of the Public Health Service Act (“PHS Act”) by relying on certain existing scientific knowledge about the safety, purity, and potency of the reference product. The BPCIA defines “biosimilar” as (1) “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and (2) having “no clinically meaningful differences between the biosimilar product and the reference biological product in terms of the safety, purity, and potency of the product.” To meet the higher standard of “interchangeability,” the application must further show (1) the biosimilar is expected to produce the same clinical result as the reference product and (2) a patient can switch back and forth between the biosimilar and the reference product with no adverse effects.

The BPCIA provides abbreviated pathways for the FDA to approve two types of follow-on biologics

The FDA has been slow to accept and approve biosimilar applications, which has left open questions about how to establish biosimilarity and interchangeability under the statutory definitions. On April 28, 2015, the FDA finalized three draft guidances originally published in 2012:

  • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

  • Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product

The new guidances provide insight into the FDA requirements for establishing biosimilarity.

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

This final guidance addresses three categories of commonly asked questions regarding FDA implementation of the BPCIA: (1) biosimilarity or interchangeability; (2) definitions relevant to the BPCIA; and (3) exclusivity. With regard to biosimilarity or interchangeability, the guidance states that a proposed biosimilar may have a different formulation, delivery device, or container closure than the reference product under certain circumstances. Additionally, the guidance discloses conditions permitting an applicant to obtain licensure for fewer than all routes of administration, presentations, and conditions of use for which the reference product is licensed. Further, the guidance describes conditions in which a sponsor may support biosimilarity using comparative data with a non-U.S.-licensed product or extrapolated clinical data designed to support a different condition of use. The guidance additionally instructs applicants how to describe the “strength” of a proposed injectable biosimilar. Finally, the guidance states that a biosimilar product that cites a reference product subject to the Pediatric Research Equity Act must include a pediatric assessment unless the applicant initially seeks approval as an interchangeable biological product.

With regard to the BPCIA’s definition of “biological product,” the guidance discloses the FDA’s regulatory definitions of “protein” and “chemically synthesized polypeptide.” Additionally, it defines when a proposed biological product is considered to be within the same “product class” as previously approved protein products.

With regard to exclusivity, the guidance instructs applicants and sponsor to search an online database to identify whether the reference product is subject to unexpired orphan exclusivity. The FDA will not approve a biosimilar during the 7-year exclusivity period.

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
This final guidance provides an overview of the FDA’s recommendations for establishing biosimilarity and discusses in detail relevant scientific principles for designing data and information to show biosimilarity. The FDA stresses that it will apply a totality-of-the-evidence approach in its assessment of biosimilarity and will use a risk-based approach to evaluate all data and information submitted. The FDA further emphasizes that the information sufficient to demonstrate biosimilarity will be determined on a product-specific basis.

The BPCIA requires an application to include analytical, animal, and clinical studies demonstrating that the biological product is “biosimilar” to a single reference product. As discussed above, the application must establish the product is “highly similar” to the reference product and has “no clinically meaningful differences.” Although the reference product must be U.S.-licensed, the application may rely on data from comparative studies with a non-U.S. licensed comparator product if the data is scientifically relevant. Because the FDA has discretion to determine what data is required to establish biosimilarity in a particular application, it encourages sponsors of the application to meet with the FDA early during product development to discuss adequate scientific justifications.

The FDA encourages sponsors to use a three step approach to develop evidence necessary to establish biosimilarity.

First, the sponsor should characterize the structural and functional aspects of both the proposed product and the reference product to identify potentially clinically relevant safety or efficacy risks. Structural analyses must use “state-of-the-art technology” to analyze multiple representative lots and show the proposed product will encode the same primary amino acid sequence as the reference product. Any minor modifications must be explained by the sponsor. The structural analyses for all relevant characteristics of the protein product (such as primary, secondary, tertiary, and quaternary structure; posttranslational modifications; and biological activities) must also be included. The FDA further recommends structural analysis of the finished dosage form to assess the effect of excipients or any other formulation effects. In vitro and/or in vivo functional assays must also be used to evaluate the pharmacologic activity of protein products.

Second, the sponsor should demonstrate safety and biosimilarity through animal studies. These studies generally do not establish safety, but are relevant to support the demonstration of biosimilarity through evidence of PK and PD measures. Nevertheless, animal toxicity and immunogenicity studies may be useful where uncertainty about safety remains after the initial structural and functional characterization.

Third, the sponsor should conduct comparative human PK and PD studies and a clinical immunogenicity assessment of the two products in an appropriate study population. The sponsor should discuss study proposals and overall clinical development plan with the FDA before initiating such studies. A sponsor should provide adequate scientific justification for choices in study design, population, endpoints, and other parameters. Human PK and PD measures comparing the proposed product to the reference product are typically fundamental to demonstrate biosimilarity. Even where relevant PD measures are not available, sensitive PD endpoints may be assessed. The FDA further expects at least one comparative clinical study regarding immunogenicity in order to assess the safety and effectiveness of the proposed product. The overall immunogenicity assessment should consider the nature of the immune response, the clinical relevance and severity of consequences, the incidence of immune responses, and the population being studied. Generally, the FDA expects studies to present statistical evidence that the proposed product is neither significantly inferior nor superior to the reference product. An applicant may provide sufficient scientific justification to extrapolate clinical data to support a determination of biosimilarity for various indications.

If there is uncertainty at each step, the sponsor should evaluate the uncertainty and consult with the FDA to adequately address it.

Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product

This guideline relates to the biosimilarity of therapeutic protein products and describes nine factors that are relevant in developing analytical studies to show a proposed product is “highly similar” to a reference product.

1. Expression System. The application should seek to minimize differences between the proposed and referenced expression systems. The FDA expects the expression construct for a proposed product encodes the same primary amino acid sequence as its reference product. However, minor modifications (such as N- or C- terminal truncations) that are not expected to change the product performance may be justified.

2. Manufacturing Process. The application should demonstrate its manufacturing process does not result in significant differences between the proposed product and its reference product.

3. Assessment of Physiochemical Properties. Physicochemical assessments are designed to maximize the potential for detecting differences between the proposed and reference products. The sponsor should consider all relevant characteristics of the protein product and design tests to account for the heterogeneity of the proposed product and the reference product as well as the ranges of variability for each.

4. Functional Activities. Functional assays are designed to complement physicochemical analyses and evaluate the function of the protein product. Sponsors should perform appropriate assays to evaluate the range of relevant functional activities for a product.

5. Receptor Binding and Immunochemical Properties. Sponsors should analyze specific binding or immunochemical properties when they are part of the activity attributed to the protein product.

6. Impurities. Sponsors should characterize, identify, and quantify impurities in the proposed product and reference product. Sponsors should further perform a risk-based assessment regarding any differences in process-related impurities between the proposed and reference products.

7. Reference Product and Reference Standards. Sponsors should provide a broad comparison of the proposed product to the reference product that is not strictly limited to analysis of each product in isolation. For example, the biosimilarity analysis may further consider applicable reference standards and relevant publicly available information.

8. Finished Drug Product. Product characterization studies should be performed on the most downstream intermediate best suited for each analytical procedure. Thus, sponsors should analyze the finished drug product if it is best suited for a particular analysis. If the analysis is performed on an earlier intermediate, sponsors should provide additional information. Additionally, sponsors should clearly identify excipients used in the proposed product that differ from those in the reference product.

9. Stability. Sponsors should include comparative studies conducted under multiple stress conditions to establish degradation profiles of the proposed and reference product.

Conclusion

The recently issued final guidances provide insight into how the FDA will evaluate biosimilarity and directions for sponsors throughout product development. However, many additional questions surrounding the BPCIA remain. For example, the currently issued guidances do not address how the FDA will determine “interchangeability.” Interchangeable drugs are likely to be more profitable than mere biosimilars because they can be sold in place of the reference drug without a prescribing doctor’s approval.

Upcoming draft guidances plan to provide additional information regarding the required scientific requirements for establishing biosimilarity and interchangeability as well as naming and labeling requirements for approved biosimilars. In January, the FDA’s Center for Drug Evaluation and Research (CDER) announced plans to publish five draft guidances on biosimilars in 2015:

  • Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

  • Considerations in Demonstrating Interchangeability to a Reference Product

  • Labeling for Biosimilar Biological Products

  • Nonproprietary Naming for Biological Products

  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

ARTICLE BY Imron T. Aly, Sailesh K. Patel, John K. Hsu and Helen H. Ji of  Schiff Hardin LLP
© 2015 Schiff Hardin LLP

First Look At False Marking Under The AIA – America Invents Act

In Sukumar v. Nautilus, Inc., the Federal Circuit took its first look at the standing requirements to bring a false marking case under the American Invents Act (AIA). The court rejected Nautilus’ arguments that only “market participants” could bring suit, but required plaintiffs to at least have taken action to enter the market in order to possibly have suffered a “competitive injury.”

The AIA Changes To Private False Marking Suits

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The AIA amended the false marking statue (35 USC § 292) to limit private actions for false marking:

(b) A person who has suffered a competitive injury as a result of a violation of this section may file a civil action in a district court of the United States for recovery of damages adequate to compensate for the injury.

According to the effective date provisions, these amendments were retroactive, and “shall apply to all cases that are pending on or commenced on or after the date of the enactment of this Act.” The Federal Circuit affirmed their retroactivity in a nonprecedential opinion issued in 2012.

The False Marking At Issue

Sukumar commenced its false marking case before the AIA was enacted, but the case still was pending when the revised statute took effect. Thus, although the district court already had found that some Nautilus machines were “falsely marked” with patents that did not cover the products, the district court granted summary judgment in Nautilus’ favor because Sukumar had not suffered a “competitive injury.”

Sukumar’s Business Plans

According to the Federal Circuit opinion, Sukumar became interested in the Nautilus machines when he was “caring for his aging father” and found the machines unsuitable for “frail seniors.” He contacted Nautilus, “ordered Nautilus machines and asked for certain modifications to cater to elderly users’ needs.” Eventually he founded Southern California Stroke Rehabilitation Associates (another plaintiff in this case) and seemed to intend to open “senior rehabilitation facilities” that would use “modified Nautilus fitness machines.”

To support his claim of competitive injury,” Sukumar alleged that he developed the intent to compete with Nautilus in the mid- to late-1990s. In response, Nautilus alleged that Sukumar at best “intended to operate senior rehabilitation centers” that “would use modified Nautilus fitness machines, which would make Sukumar a customer of Nautilus’, not a competitor.”

The Federal Circuit Opinion 

The Federal Circuit opinion was authored by Chief Judge Prost and joined by Judges Newman and Reyna. The opinion frames the issue on appeal as “whether (or to what extent) an entity that has not entered the relevant market can suffer ‘competitive injury.’”

The court applied the plain meaning of “competitive injury,” the legislative history of the amendments to § 292, and policy rationales and arrived at the following test:

We hold that a potential competitor may suffer competitive injury if it has attempted to enter the market. An attempt is made up of two components: (1) intent to enter the market with a reasonable possibility of success, and (2) an action to enter the market.

Turning to the record on appeal, the Federal Circuit found that “Sukumar’s evidence of his intent to compete with Nautilus is weak.” Moreoever, the Fedearal Circuit found that “even if Sukumar subjectively intended to enter the market for fitness machines, he took insufficient action to pursue that intent” to satisfy the test for “competitive injury.” For example, the court noted:

[T[he list of basic steps Sukumar did not take is long:
Sukumar did not develop a business plan.
Sukumar did not attempt to design a prototype.
Sukumar did not hire any employees.
Sukumar did not gain engineering knowledge.
Sukumar did not investigate developing manufacturing capacity.

Thus, the Federal Circuit affirmed the district court’s grant of summary judgment in favor of Nautilus “because Sukumar lacks standing to bring a claim for false marking under § 292.”

ARTICLE BY Courtenay C. Brinckerhoff of Foley & Lardner LLP

© 2015 Foley & Lardner LLP

FDA Finalizes Guidance Documents on Biosimilarity

On Tuesday, and over three years after the initial guidance documents were released, the US Food and Drug Administration released final versions of three guidance documents discussing how FDA will evaluate applications for regulatory approval of biosimilar products:

•Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

•Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein

•Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Draft versions of the guidance documents were originally released by FDA for public comment in February 2012. In general, the final versions released Tuesday track the draft versions fairly closely, with a few noteworthy differences.

The guidance documents reiterate that the FDA will use a totality of the evidence approach to review applications for biosimilar products, and encourages a stepwise approach to demonstrating biosimilarity which with rare exceptions will include a comparison of the proposed biosimilar product with the reference product in terms of structure, function, animal toxicity, human pharmacokinetics (PK) and pharmacodynamics (PD), clinical immunogenicity, and clinical safety and effectiveness. This stepwise approach is intended to better address residual uncertainty about biosimilarity that might remain at each step of the approval process.

The final guidance documents contain a few changes from the draft versions that are noteworthy:

•Most of the discussion of issues related to demonstrating the heightened standard for interchangeability was removed from the guidances with a note that it will be the subject of a separate guidance document that is forthcoming.

•The final guidances reiterate that, in most instances, a sponsor will need to provide information to demonstrate biosimilarity based on data directly comparing the proposed biosimilar product to FDA-approved reference product. However, they elaborate on the type of bridging data needed when a biosimilar applicant seeks to use a non-US licensed comparator product to support a demonstration of biosimilarity.

•Specific comments have been provided for biosimilar developers considering manufacturing/process changes after completing the initial analytical similarity assessment including a requirement to demonstrate comparability between the pre- and post-change proposed product.

•More detailed comments regarding animal toxicity studies were added.

•Previous Q and As relating to what constitutes the “publicly-available information” that should be included in a 351(k) application and whether an applicant can include a request for reference product exclusivity in its 351(a) application were deleted – an indication that the FDA is still considering its position on these points.

Authored by: Paul A. Calvo, Ph.D. and Timothy J. Shea, Jr., PhD. by Sterne Kessler

© 2015 Sterne Kessler

Last Week Tonight’ Host John Oliver Ignores the Last Three Years of Patent Reform

Have you seen John Oliver’s piece about abuses in the patent system? The ‘Last Week Tonight’ host has quite a bit of fun at the expense of the patent system.  He tossed out three primary complaints:

(A) patent owners that don’t practice their patents shouldn’t be able to assert them;

(B) patent owners enforcing their patents are extorting parties, including small businesses and end users, that lack the funds or capability to litigate; and

(C) patents, especially software patents, are too vague, resulting in uncertainty as to what products or actions are encompassed.

John Oliver is witty, dry, and often downright silly – and it is for those reasons that millions of people are drawn to his humor and his show.  For those of us inclined to think that America’s tradition of strong patent protection has led us to be the most innovative country in the world, this particular story drew our attention for different reasons. His reporting posited the idea that the Innovation Act, H.R. 9, working its way through the House of Representatives, would solve most of the problems he identified in our patent system.  Far from providing the solutions its proponents claim, that legislation would do little or nothing to limit the sending of bogus demand letters to unsophisticated targets in hopes of extracting nuisance value settlements – a practice that many decry as the most egregious example of patent abuse.  Further, Mr. Oliver seems unaware that the last several years have seen judicial action and legislation that address the costs of patent litigation and the vagueness of software patents.  Whether these measures are sufficient without additional legislation is up for debate, but John Oliver’s hypothesis is weakened by his reliance on outdated and largely irrelevant facts and data.

In the interest of making sure truth isn’t sacrificed for the sake of a few good laughs, there are several points we would like to raise.

  • Not every patent owner that licenses its patents rather than practicing them is a “patent troll” deserving of punishment or deterrence.

  • Patent litigation is decreasing, and its costs are overstated.

  • With the America Invents Act of 2011, Congress has already taken steps to reduce the cost of patent litigation.

  • The Supreme Court has also recently addressed the costs of litigation.

  • The Supreme Court addressed vague software patents as well.

Authored by: Michael T. Renaud, Robert J. Moore and Jack C. Schecter of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

©1994-2015 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Amicus Briefs On Biosimilar Patent Litigation

Foley and Lardner LLP

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal Circuit, and three amicus briefs have been filed. All of the amicus briefs argue for reversal of at least some of the district court’s decision regarding the biosimilar patent litigation framework of the BPCIA.

The Biotechnology Industry Organization

The Biotechnology Industry Organization filed an amicus brief arguing that the BPCIA should be interpreted as requiring “notice to the reference product sponsor of the initial submission of the biosimilar application” and “notice of potential commercial marketing upon approval.” BIO argues that these procedures must be mandatory in order for the patent dispute resolution provisions of the law to achieve their purpose of “provid[ing] a significant and real opportunity to resolve patent issues prior to the launch of the biosimilar.”

Abbvie Inc.

AbbVie Inc. filed an amicus brief arguing that “the notice-and-exchange provisions are mandatory” and that a biosimilar applicant’s “failure to comply with the statute is unlawful.” According to AbbVie, if the district court decision is upheld “the entire biosimilar litigation process would become a free-for-all, where biosimilar companies would utilize the data and work of innovator companies but refuse to provide basic information about their products … leaving innovators to blindly guess as to which patents they should sue on and when.”

AbbVie also argues that the BPCIA does not preempt Amgen’s state law claims of unfair competition.

Janssen Biotech, Inc.

Janssen Biotech, Inc. filed an amicus brief asking the Federal Circuit to “clarify that the statutory patent dispute resolution procedures are intended to be followed as written, and are not merely optional choices or empty formalities.” Janssen criticizes the district court decision for “transforming [the BPCIA’s patent provisions] from a carefully orchestrated dispute resolution process into a series of strategic options existing for the sole benefit of the biosimilar applicant.”

Janssen also urges the Federal Circuit to decide that the notice of commercial marketing required by the BPCIA may not be provided before a biosimilar product is licensed by the FDA. One argument Janssen makes on this point is that the notice of commercial marketing gives the reference product sponsor the right to seek a preliminary injunction based on alleged patent infringement, but a preliminary injunction cannot be granted unless commercial launch is imminent, and commercial launch is not possible until the biosimilar has been licensed by the FDA.

The Expedited Appeal Schedule 

Amgen filed its opening brief on April 3. Sandoz filed its brief on April 21. Oral arguments are scheduled for June 3.

ARTICLE BY

Courtenay C. Brinckerhoff
Foley & Lardner LLP

.CASINO gTLD Launches Sunrise

Lewis Roca Rothgerber LLP

The new gTLD .casino opens to the public on June 3. Trademark owners may be able to register their trademark as a .casino domain name ahead of the public launch. The “sunrise” early registration period for trademark owners opened March 24 and ends May 23. .casino domain name registrations are available now for trademark owners that have already recorded their marks with the trademark clearinghouse (TMCH). As explained below, there is still time for mark owners that have not yet recorded marks with the TMCH to participate in the sunrise registration period.

Gaming enterprises should do what they can to protect their trademarks in the .casino gTLD prior to June 3. Given the proliferation of online gaming, the new gTLD .casino poses a particularly high risk to trademark owners in the gaming industry. The .casino gTLD is a regulated gTLD, meaning registrants must represent that they have the appropriate licenses and credentials and must report any material changes to the registry. However, in many jurisdictions, the licensing process is far less strict than it is in the U.S. and it is not clear how the registry plans to verify such representations.

Risks Associated with .CASINO

The gTLD .casino is one of hundreds of new gTLDs launched as part of the first phase of the Internet Corporation for Assigned Names and Numbers (ICANN’s) new gTLD program. The new gTLDs offer more registration options to the public than existing “traditional” gTLDs such as .com, .net, .org, .biz and .info. But with hundreds of new gTLDs comes an increase in risk for trademark owners. For gaming enterprises, the highest risk posed by the new gTLDs is the new gTLD .casino. Third party registration of your mark or brand as a .casino domain name could cause immense damage to your brand and company. Imagine third party operation of the domainwww.YOURBRAND.casino for an offshore gaming site, a site that redirects consumers to your legitimate or illegitimate competitors, or a site that otherwise tarnishes your brand.

Mark owners can prevent this scenario by recording their marks with the TMCH and participating in the .casino sunrise and/or landrush domain registration periods. Although there are options for enforcement “after the fact” of a third party registration for your brand, these may face difficult proof problems (especially as to the necessary showing of “bad faith”) and can be expensive.

The Trademark Clearinghouse (TMCH)

Generally, only trademarks registered with a national trademark office, such as the U.S. Patent and Trademark Office (USPTO), are eligible for registration with the TMCH. Recordation with the TMCH offers several benefits, but the critical benefit of TMCH recordation is eligibility to register the recorded mark as a domain name during the sunrise registration period for any new gTLD, including .casino. Trademark owners may not participate in the sunrise registration period for .casino without first recording their trademark(s) with the TMCH.

In our experience, it takes up to three weeks for the TMCH to complete the recordal process. Accordingly, for companies planning on participating in the .casino sunrise period, we recommend filing TMCH recordal(s) by no later than April 30. Please contact us to discuss the recordal of marks with the TMCH.

Sunrise Registration

Mark owners who have recorded trademark(s) with the TMCH are eligible to participate in the sunrise registration period for .casino. We expect the sunrise registration fees for a .casino domain name to fall between $200 and $300. The sunrise period is open until May 23 but validation of your trademark registration and specimen of use may take two to three weeks. During the sunrise period, mark owners may only register a domain name consisting of the identical mark recorded with the TMCH. For example, the owner of the TMCH recorded mark MYMARK is eligible to register the domain www.mymark.casino during the sunrise period, but is not eligible to register the domain www.mymarkslots.casino absent a separate TMCH recordation for the mark MYMARK SLOTS. In the latter case, we would recommend that the owner of the HOUSE mark consider the landrush registration period if it believes there is a high risk associated with the domain www.mymarkslots.casino. Further, please note that USPTO Supplemental Register registrations are not eligible for recording in the TMCH.

Landrush Period

Another advance registration period, known as the “landrush period” or “early access phase,” opens May 27. The landrush period is open to anyone willing to pay the fees associated with obtaining a landrush registration. Trademark registrations and TMCH recordation are not required for eligibility to participate in the landrush period.

Landrush registration fees depend on the date of registration. The registration fees start at $12,500 per domain on the first day of landrush, when demand for .casino domain names is presumably highest. The fees decrease to $4,500 on the second day, $1,500 on day three, $950 on day four, and $250.00 on days five through seven. These fees are in addition to the general registration fees for a .casino domain name.

The landrush period may be a good option for mark owners seeking to register domain strings that are not eligible for recordal with the TMCH. Such strings may consist of common law marks, or of a registered mark plus a generic term such as “slots.” The decision of whether and when to register domains during the landrush period is a business decision, weighing the potential risk of third party ownership of a given domain against the registration fees for a given day of the period.

Summary of .CASINO Deadlines

The .casino sunrise registration period is open now and closes May 23. TMCH recordals for marks intended for .casino sunrise registration should be filed by no later than April 30. The landrush period opens May 7 and closes June 2, with landrush fees decreasing daily over the period. .casino opens for general registration on June 3.

ARTICLE BY

Nathaniel W. Edwards
Lewis Roca Rothgerber LLP

B&B Hardware, Inc. v. Hargis Industries, Inc.: Trademark Litigation Might Get Simpler

Vedder Price

Trademark litigation includes two similar types of proceedings. First, and most common, issues of trademark infringement and cancellation of a mark may be raised in a trial (i.e., a traditional fight in either State Court or Federal District Court before a judge or jury involving oral testimony). Second, and less common, issues of trademark registration may be raised in a trademark opposition or cancellation proceeding before the Trademark Office. These proceedings are primarily conducted in writing and are governed by administrative rules published in the Federal Register based on the Federal Rules of Civil Procedure. While a trial may result in monetary damages or an injunction preventing a party from using a mark, the Trademark Office merely has the authority to grant or cancel federal trademark registrations.

Since the Trademark Office’s process does not allow for litigants to receive monetary awards, injunctions, or even a determination of infringement, entering the Trademark Office for a cancellation or opposition simplifies the proceedings to focus on a limited number of key issues, such as whether a likelihood of confusion exists between a registered mark and another mark. Along with their limited focus and less formal nature, litigants often found comfort in a the lower costs involved in proceedings before the Trademark Office. Generally, once a trademark registration was cancelled, the owner of the mark that was cancelled would understand that a claim for infringement in court was not likely to succeed and would stop using the mark.

In B&B Hardware, Inc. v. Hargis Industries, Inc., the United States Supreme Court was faced with the question of “[w]hether the Trademark Trial and Appeal Board’s (the “TTAB” or the “Board”) finding of a likelihood of confusion precludes Hargis from relitigating that issue in infringement litigation, in which likelihood of confusion is an element.” The long-standing dispute (almost 20 years) between the parties involved in the decision regarded the trademarks SEALTIGHT and SEALTITE. In 1996, Hargis applied for registration of its mark, SEALTITE. B&B opposed the registration based on an alleged likelihood of confusion of Hargis’s trademark with B&B’s own federally registered mark, SEALTIGHT. After applying the standard multi-factor likelihood of confusion test, the TTAB decided in favor of B&B and held that a likelihood of confusion existed between the marks.

At the same time as the proceedings before the TTAB, B&B sued Hargis for trademark infringement in Federal District Court. After receiving a favorable outcome in the proceeding before the TTAB, B&B argued in District Court that Hargis could not contest the TTAB’s determination that a likelihood of confusion existed due to the preclusive effect of the TTAB’s decision. The District Court disagreed with B&B and allowed the jury to hear the evidence and decide on the issue of confusion. The jury returned a verdict for Hargis, finding that there was no likelihood of confusion between the marks. The parties appealed the verdict, including the issue of the preclusive effect of the TTAB decision. The Eighth Circuit affirmed the decision of the District Court. The parties then petitioned for, and were granted, certiorari on the issue by the U.S. Supreme Court.

The Supreme Court reversed the decision of the Eighth Circuit and remanded the case for further proceedings, holding that as long as the ordinary elements of issue preclusion are met and the usages of the marks are materially the same, a finding that a likelihood of confusion exists by the TTAB should have preclusive effect in District Court proceedings.

The doctrine of “res judicata” or “issue preclusion” states that litigants should not get two bites at the same apple, or two chances to argue over the same issue. Thus, if the Trademark Trial and Appeal Board found overlap (i.e., likelihood of confusion) between two marks (despite using the simplified tools involved in proceedings before the Trademark Office), then a District Court should honor the TTAB’s determination and not force the parties to relitigate the issue.

Prior to this decision, if a case was simultaneously pending in District Court and before the TTAB, the TTAB would readily stay its determination until the litigation in District Court was resolved. Because of this, any time one of the parties to an opposition or cancellation proceeding became agitated, they would file a concurrent action before a District Court. Following the Supreme Court’s decision, it is unclear if the TTAB will continue to grant this courtesy.

Trademark oppositions and cancellations must now be taken very seriously. While the TTAB cannot award damages or find infringement, its decisions could now be used as grounds for finding infringement in District Court. For example, a party who defaults in a cancellation proceeding may well lose the right to defend itself properly in District Court if a subsequent action is filed. Going forward, mark owners with proceedings before the TTAB must consider whether to intentionally abandon a trademark application or registration in order to avoid an adverse decision that could have far-reaching effects.

ARTICLE BY

John E. Munro
Alain Villeneuve
Vedder Price

B&B Hardware, Inc. v. Hargis Industries, Inc.: Trademark Litigation Might Get Simpler

Vedder Price

Trademark litigation includes two similar types of proceedings. First, and most common, issues of trademark infringement and cancellation of a mark may be raised in a trial (i.e., a traditional fight in either State Court or Federal District Court before a judge or jury involving oral testimony). Second, and less common, issues of trademark registration may be raised in a trademark opposition or cancellation proceeding before the Trademark Office. These proceedings are primarily conducted in writing and are governed by administrative rules published in the Federal Register based on the Federal Rules of Civil Procedure. While a trial may result in monetary damages or an injunction preventing a party from using a mark, the Trademark Office merely has the authority to grant or cancel federal trademark registrations.

Since the Trademark Office’s process does not allow for litigants to receive monetary awards, injunctions, or even a determination of infringement, entering the Trademark Office for a cancellation or opposition simplifies the proceedings to focus on a limited number of key issues, such as whether a likelihood of confusion exists between a registered mark and another mark. Along with their limited focus and less formal nature, litigants often found comfort in a the lower costs involved in proceedings before the Trademark Office. Generally, once a trademark registration was cancelled, the owner of the mark that was cancelled would understand that a claim for infringement in court was not likely to succeed and would stop using the mark.

In B&B Hardware, Inc. v. Hargis Industries, Inc., the United States Supreme Court was faced with the question of “[w]hether the Trademark Trial and Appeal Board’s (the “TTAB” or the “Board”) finding of a likelihood of confusion precludes Hargis from relitigating that issue in infringement litigation, in which likelihood of confusion is an element.” The long-standing dispute (almost 20 years) between the parties involved in the decision regarded the trademarks SEALTIGHT and SEALTITE. In 1996, Hargis applied for registration of its mark, SEALTITE. B&B opposed the registration based on an alleged likelihood of confusion of Hargis’s trademark with B&B’s own federally registered mark, SEALTIGHT. After applying the standard multi-factor likelihood of confusion test, the TTAB decided in favor of B&B and held that a likelihood of confusion existed between the marks.

At the same time as the proceedings before the TTAB, B&B sued Hargis for trademark infringement in Federal District Court. After receiving a favorable outcome in the proceeding before the TTAB, B&B argued in District Court that Hargis could not contest the TTAB’s determination that a likelihood of confusion existed due to the preclusive effect of the TTAB’s decision. The District Court disagreed with B&B and allowed the jury to hear the evidence and decide on the issue of confusion. The jury returned a verdict for Hargis, finding that there was no likelihood of confusion between the marks. The parties appealed the verdict, including the issue of the preclusive effect of the TTAB decision. The Eighth Circuit affirmed the decision of the District Court. The parties then petitioned for, and were granted, certiorari on the issue by the U.S. Supreme Court.

The Supreme Court reversed the decision of the Eighth Circuit and remanded the case for further proceedings, holding that as long as the ordinary elements of issue preclusion are met and the usages of the marks are materially the same, a finding that a likelihood of confusion exists by the TTAB should have preclusive effect in District Court proceedings.

The doctrine of “res judicata” or “issue preclusion” states that litigants should not get two bites at the same apple, or two chances to argue over the same issue. Thus, if the Trademark Trial and Appeal Board found overlap (i.e., likelihood of confusion) between two marks (despite using the simplified tools involved in proceedings before the Trademark Office), then a District Court should honor the TTAB’s determination and not force the parties to relitigate the issue.

Prior to this decision, if a case was simultaneously pending in District Court and before the TTAB, the TTAB would readily stay its determination until the litigation in District Court was resolved. Because of this, any time one of the parties to an opposition or cancellation proceeding became agitated, they would file a concurrent action before a District Court. Following the Supreme Court’s decision, it is unclear if the TTAB will continue to grant this courtesy.

Trademark oppositions and cancellations must now be taken very seriously. While the TTAB cannot award damages or find infringement, its decisions could now be used as grounds for finding infringement in District Court. For example, a party who defaults in a cancellation proceeding may well lose the right to defend itself properly in District Court if a subsequent action is filed. Going forward, mark owners with proceedings before the TTAB must consider whether to intentionally abandon a trademark application or registration in order to avoid an adverse decision that could have far-reaching effects.

ARTICLE BY

John E. Munro
Alain Villeneuve
Vedder Price

Supreme Court Holds That TTAB Decisions on Likelihood of Confusion May Bind Courts in Infringement Litigation

Foley and Lardner LLP

In a 7 – 2 decision issued March 24, 2015, the U.S. Supreme Court held that decisions of the Trademark Trial and Appeal Board (TTAB) on the issue of likelihood of confusion, made in registration cases, can be binding on courts in deciding the same issue in subsequent infringement cases. Such “issue preclusion” will likely arise if the uses of the marks before the court are materially the same as the uses considered by the TTAB. The decision in B&B Hardware, Inc. v. Hargis Industries, Inc. is likely trigger more hotly contested — and more expensive — TTAB litigation.

In this case, B&B owned a registration for “Sealtight” for metal fasteners used in the aerospace industry. Hargis sought to register “Sealtite” for metal screws used in the manufacture of buildings. B&B opposed registration, claiming that use of the marks on the respective goods would create a likelihood of confusion. The TTAB agreed and sustained the opposition. In a parallel infringement action, the district court refused to be bound by the TTAB decision, reasoning that the TTAB is not an Article III court. The jury went on to find that confusion was not likely.

The Eighth Circuit affirmed. It held that while an administrative agency’s decision can be a basis for applying collateral estoppel, the doctrine was not appropriate in this context, primarily because the TTAB and the Eighth Circuit use different factors to evaluate likelihood of confusion.

In an opinion by Judge Alito, the U.S. Supreme Court reversed. It held first that “issue preclusion is not limited to those situations in which the same issue is between two courts” (emphasis in original). Rather, under Astoria Fed. Sav. & Loan Assn. v. Solomino, 501 U.S. 104 (1991), “courts may take it as a given” that Congress intends issue preclusion to apply to administrative proceedings where appropriate, except when a statutory purpose to the contrary is evident. The court held that no such purpose was evident in the Lanham Act of 1946.

The court acknowledged that the TTAB considers different factors than do courts in determining likelihood of confusion. In particular, the TTAB compares marks and goods as they are set forth in prior registrations and pending applications, whereas a court will consider all elements of the parties’ uses, including the context in which the marks appear on packaging. But the court held that the same legal standard of “likelihood of confusion” always applies, even if different usages are considered. Therefore, the possibility of applying collateral estoppel cannot be categorically ruled out.

Importantly, however, the court did not hold that issue preclusion always applies. The question depends primarily on whether the actual usages of the respective marks are “materially different” from the usages specified in the applications or registrations at issue. “If the TTAB does not consider the marketplace usage of the parties’ marks, the TTAB’s decision should have no later preclusive effect in a suit where actual usage in the marketplace is the paramount issue,” it said.

Justice Ginsburg separately concurred to emphasize this point. Quoting the authoritative McCarthy on Trademarks and Unfair Competition treatise, she noted that contested registrations are often decided upon “a comparison of the marks in the abstract and apart from their marketplace usage.” When the registration proceeding is of that character, she said, there will be no preclusion in a later infringement suit.

As a result, the preclusive effect of a prior TTAB decision will be a point of contention in a subsequent infringement action. The court will have to look closely at what the TTAB decided, and the evidence it relied upon. For example, in some cases the opposer relies on a registration which is unrestricted as to trade channels or likely purchasers, even though the opposer’s actual business may be restricted to a narrow area. This can sometimes lead to anomalous results, if the applicant seeks to register the same or similar mark for the same or similar goods, but uses its mark in entirely different fields of endeavor, such that the prospects for confusion in the “real world” are remote. Nevertheless, the TTAB will likely refuse registration in that scenario. It would appear that the B&B decision would permit the court, in a subsequent infringement case, to disregard the TTAB decision and decide “likelihood of confusion” based on the parties’ actual use.

In many cases, however, the question of preclusive effect will not be so clear cut. For this reason, parties litigating in the TTAB must consider that the TTAB decision will compel an identical result if infringement litigation ensues later. Typically, TTAB cases have been litigated in a more leisurely and less expensive manner than a court case. After B&B, some may choose to develop a fuller record to help assure preclusion in the event of a future infringement action against the applicant. This would lead to TTAB cases being litigated even more aggressively (and expensively) than they are now.

The decision may also encourage opposers, who fail to prevent registration at the TTAB, to seek review not by appeal to the federal circuit, but by the alternative means of filing a civil action in U.S. District Court under Section 21 of the Lanham Act. In such a case, the opposer would be entitled to de novo review of the TTAB decision and would be able to include infringement claims. The TTAB decision would have no preclusive effect in that case.

The B&B decision finally answers the question of which different circuits have taken different approaches. It does not, however, provide an answer to the question of whether a TTAB decision on likelihood of confusion will or will not have a preclusive effect on a court in a particular infringement litigation. That question will be determined on a case-by-case basis, under normal principles of issue preclusion.

ARTICLE BY

Andrew Baum
Foley & Lardner LLP

Understanding Post-AIA Power of Attorney Procedures –America Invents Act

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Applicants identified upon a U.S. patent application’s filing can impact the ownership rights to the patent application throughout prosecution.  Prior to implementation of relevant aspects of the America Invents Act (AIA) on September 16, 2012, patent application Applicants could only be Inventors.  Conversely, applications filed on or after September 16, 2012 can have Inventors or Assignees as Applicants.  The choice of Applicant – Inventors or Assignees – upon filing in post-AIA applications affects how Power of Attorney can be properly established before the U.S. Patent and Trademark Office (USPTO).

Pre-AIA patent applications filed before September 16, 2012 can have Power of Attorney granted by Inventors or Assignees under Rule 32, provided that the requirements of Rule 3.73 are satisfied.  In contrast, post-AIA applications filed on or after September 16, 2012 can be filed with Inventors or Assignees as the Applicant, with Rule 32 requiring a Power of Attorney to be signed by either the “Applicant” or “Patent Owner.”  However, an Assignee only becomes the patent owner after the application issues as a patent.  Thus, in order to take over prosecution in a post-AIA application, the Assignee must either initially be listed as or later formally established to be the Applicant for Power of Attorney to be granted on behalf of the Assignee.

In circumstances where a post-AIA application’s Applicant is identified upon filing as the Assignee, the Assignee may execute a Power of Attorney, and it can be filed without the need to file any separate papers to satisfy Rule 3.71 or Rule 3.73.

When a post-AIA patent application is filed without listing the Assignee as the Applicant (i.e., because the Inventors are listed as the Applicant) or when the Assignee changes during the course of prosecution, Rule 3.71 or Rule 3.73 must be satisfied for the Assignee to establish a Power of Attorney before the USPTO.  Namely, a statement under Rule 3.73(c) and a Power of Attorney must be filed.  However, the Assignee must first be identified as an Applicant.  Currently there are two ways for an Assignee to become an Applicant when not so listed upon initial application filing.  First, an Applicant can be added to the existing list of Applicants.  Alternately, all Inventors can be removed as the Applicant and be replaced with the Assignee as the Applicant.

A change in an Applicant can be accomplished by filing a supplemental Application Data Sheet (ADS), fulfilling the Rule 3.73(c) requirements including a showing of ownership.  A chain of title can be demonstrated through executed assignment(s) and a statement specifying where documents verifying the chain of title from the original owner to the assignee are recorded in the assignment records of the USPTO by reel and frame number.  After adding the Applicant, Rule 3.71 or Rule 3.73 can be satisfied by filing a statement under Rule 3.73(c) and filing a properly executed Power of Attorney, thereby appointing the designated patent practitioner.

Accordingly, administrative burdens on the USPTO, on Assignees, and on Assignee representatives can generally be reduced by filing post-AIA applications listing the Assignee as the Applicant, should the Assignee be known at the time of filing.

Colleen Witherell also contributed content for this article.

ARTICLE BY

Christina Sperry
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.