Tag: patent litigation

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

East Coast Spotlight on Design Patents: Spanx v. Yummie Tummie

The National Law Review recently featured an article, East Coast Spotlight on Design Patents: Spanx v. Yummie Tummie, written by Michael A. Cicero with Womble Carlyle Sandridge & Rice, PLLC:

Womble Carlyle

 

Certainly the recent design patent litigation between Apple and Samsung in the Northern District of California garnered significant media attention.  Design patents now reside in the media spotlight once again, but this time through East Coast litigants.  The president of a New York-based maker of women’s control tops that is a named owner of several design patents openly declared that she hopes her Georgia-based competitor “is ready for war because [she] will not lie down.”  The accused infringer actually started the litigation following its receipt of a cease-and-desist letter from the New York company’s legal counsel.

On March 5, 2013, Spanx, Inc. (“Spanx”) filed a declaratory judgment complaint in the Northern District of Georgia against Times Three Clothier, LLC d/b/a Yummie Tummie (“Yummie Tummie”), requesting the court to declare that three Spanx products do not infringe seven design patentsclaimed to be owned by Yummie Tummie.  The lawsuit has already generated a considerable amount of media coverage, including sources cited below and NBC’s Today Show.

The lawsuit pits two prominent entrepreneurs against one another.  Heather Thomson, the president of Yummie Tummie, is not only the sole inventor named in each of the patents-in-suit (as Heather Thomson Schindler), but was also one of the “Real Housewives of New York.”[1]  Sara Blakely, according to ABC News, “founded Spanx in 2000, introducing what Spanx calls a shaping camisole in 2005,” and is “the youngest woman on Forbes’ billionaires list.”

Referring to an interview Thomson gave to the publication WWD (Women’s Wear Daily),lifeinc.today.com reports:

Thomson told WWD that she first learned of the product this past November when she received an anonymous package containing the Spanx Total Taming Tank and a note saying it was on sale at QVC.  “I immediately recognized it as my original Yummie Tummie tank,” Thomson told WWD.  The unsigned note said Spanx was selling it at QVC.  A spokeswoman for Thomson declined to comment further.

“The Patents-in-Suit are related to one another,” states Spanx’s complaint, “in that [six of the patents] all claim priority to the [oldest] Patent.”  Excerpts from two of these patents appear in Figure 1, below, for purposes of illustration.

The complaint alleges that Yummie Tummie’s counsel sent Spanx a cease-and-desist letter on or around January 18, 2013, identifying the accused products as Spanx’s “Total Taming Tank,” the “Top This Tank Style 1847,” and the “Top This Cami Style 1846.”  (See Figure 2 below, depicting two of those products.)  Spanx responded to that letter on or around February 14, 2013, according to the complaint, “describing in detail significant differences between the Accused Products and the Patents-in-Suit and stating, among other things, that it does not believe the Accused Products infringe the Patents-in-Suit.”

Figure 1: Depictions of Fig. 1 from Yummie Tummie’s U.S. Patents Nos. D606,285S (left) and D632,052S (right)
Figure 2: Two accused Spanx products as shown in its website: Styles Nos. 1846 (left) and 1847 (right)

Counsel for each party then communicated with one another several times but, states the complaint, Yummie Tummie “continued to maintain that the Accused Products infringe the Patents-in-Suit and expressed a willingness to enforce its patents against Spanx.”  Thus, Spanx alleges, it has grounds for seeking a declaratory judgment of noninfringement of the Patents-in-Suit.  The complaint requests such declaratory relief plus “costs, expenses, and reasonable attorneys’ fees as provided by law.”

As of the time of this writing, Yummie Tummie has not yet filed a formal answer to the complaint (its allotted time for doing so under procedural rules has not yet expired).  Yummie Tummie has, though, already  issued a public statement regarding the lawsuit.  In a March 14, 2013 letter addressed directly to Blakely and published on Yummie Tummie’s website, Thomson states, among other things: “We brought this to your attention expecting you to stop.  Instead you’ve chosen to sue us, no doubt thinking that your massive company could intimidate ours.  We have successfully enforced our design patents in the past and will continue to do so.”

The case is Spanx, Inc. v. Times Three Clothier, LLC d/b/a Yummie Tummie, No. 1:13-cv-0710-WSD,filed 03/05/13 in the U.S. District Court for the Northern District of Georgia, Atlanta Division, assigned to U.S. District Judge William S. Duffey, Jr.

[1] Coincidentally, the Northern District of Georgia is also the site of a legal battle between two “Real Housewives of Atlanta,” filed just one week after the Spanx lawsuit.  See prior post.

Copyright © 2013 Womble Carlyle Sandridge & Rice, PLLC