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Seal of Disapproval: TTAB Refuses Registration of County Logos

The Trademark Trial & Appeal Board (Board) issued a precedential decision affirming the US Patent & Trademark Office (PTO) Examining Attorney’s refusal to register two different logo marks filed by southern California’s County of Orange because the marks consisted of and comprised, respectively, an insignia of a municipality. The Board found that a logo adopted by a government entity does not have to be “official” to constitute an insignia for which trademark registration is prohibited under Section 2(b) of the Trademark Act, 15 U.S.C. §1052(b). In re County of Orange, Ser. Nos. 87419378; 87639750 (TTAB, Aug. 4, 2022) (Shaw, Coggins, Allard, Administrative Trademark Judges).

The County applied to register two logo marks. The US trademark applications described one mark as “a circle with the image of three oranges in front of an orange grove and . . . mountains with the words ‘COUNTY OF ORANGE’ . . . and . . . ‘CALIFORNIA’ . . . [around] the circle” (Circle Mark). The second logo mark featured a park ranger badge design that encompassed the Circle Mark in its entirety.

The PTO examining attorney refused registration of both logo marks under Section 2(b), which imposes an absolute bar on registration on either the Principal or Supplemental Register of a mark that “[c]onsists of or comprises the flag or coat of arms or other insignia of the United States, or of any State or municipality, or of any foreign nation, or any simulation thereof.”. This section reflects the sentiment that such symbols are indicia of government authority that ought to be reserved solely for signifying the government, and which should not be registered as symbols of origin for commercial goods and services.

On appeal to the Board, the County argued that the logo marks did not constitute “insignia” because they were not an “official” seal of the County, and, even if they were, registration should not be precluded because the County is not a “municipality.” Considering both of these arguments in turn, the Board provided analysis specific to both the circle and badge iterations of the applied-for logos.

The County argued first that the proposed marks could not constitute an insignia of Orange County, California, because the County created and adopted an official seal (a design of an orange having a stem with three leaves) more than a century ago, in accordance with the applicable state government code requiring a two-step process for adopting an official seal.

The Board found this argument unpersuasive, noting that although the Circle Mark had not undergone the state’s two-step process to become an “official” seal, Section 2(b) does not distinguish between “official” and “unofficial” insignia. Therefore, formal adoption of an “official” seal is not required for an insignia to otherwise fall under the Section 2(b) bar to registration.

The Board explained that the County uses the Circle Mark for a plethora of official government business and [...]

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Patent Venue Statute Doesn’t Apply to Third-Party Counterclaim Defendant; Acts in Furtherance of Partnership May Be Imputed to Partner for Venue Purposes

The US Court of Appeals for the Federal Circuit affirmed a district court’s determination of proper venue, finding that the patent venue statute, 28 U.S.C. § 1400(b), does not apply to a third-party counterclaim defendant and that acts done by separate entities in furtherance of a partnership can be imputed to a partner for purposes of venue determination. The Federal Circuit also affirmed and reversed jury verdicts of adequate written description and patent co-ownership. BASF Plant Sci., LP v. Commonwealth Sci. and Indus. Rsch. Org., Case Nos. 20-1415; -1416; -1919; -1920 (Fed. Cir. Mar. 15, 2022) (Newman, Taranto, Chen, JJ.) (Newman, J., dissenting).

Commonwealth Scientific and Industrial Research Organisation (CSIRO), a research arm of the Australian government, owns six patents directed to the engineering of plants, particularly canola, to produce specified oils not native to the plants. BASF Plant Science is a plant biotechnology company. CSIRO and BASF each explored genetic modification of familiar oilseed crop plants, such as canola, to get them to produce omega-3 long-chain polyunsaturated fatty acids (LCPUFAs), commonly known as “fish oil,” that could be fed to farm-raised fish and are beneficial to human health. In 2007, CSIRO and BASF discussed a focused collaboration and in 2008 entered into a two-year Materials Transfer and Evaluation Agreement (MTEA) to advance that goal. In 2010, following the conclusion of the MTEA, CSIRO partnered with another Australian government entity, Grains Research and Development Corporation, and private company, Nuseed, to commercialize its products. CSIRO granted Nuseed an exclusive license to CSIRO’s LCPUFA technology and patents. In 2011, BASF entered into a commercialization agreement with Cargill. BASF developed a canola seed line that it used to apply for regulatory approvals, which Cargill used in cross-breeding work. As part of the joint project, BASF deposited seeds with the American Type Culture Collection (ATCC) to support BASF’s patent applications.

During this period, BASF and CSIRO entered negotiations for BASF to take a license to CSIRO’s LCPUFA technology, but the negotiations broke down. In 2016, Nuseed sent Cargill a letter identifying multiple CSIRO patents and inviting Cargill to discuss CSIRO’s omega-3 patent portfolio. In April 2017, BASF sued Nuseed in the District of Delaware, seeking a declaratory judgment that BASF did not infringe certain CSIRO patents listed in the 2016 letter. The District of Delaware dismissed the case for lack of jurisdiction.

In 2017, BASF filed a declaratory judgment action in the Eastern District of Virginia against CSIRO, Nuseed and Grains Research (collectively, CSIRO). CSIRO filed an answer and counterclaims asserting infringement of the asserted patents against BASF and Cargill. BASF entered the case as a party and asserted co-ownership of the asserted patents under the MTEA. Cargill moved to dismiss the counterclaims for lack of personal jurisdiction and improper venue. The district court denied the motion, determining that it had personal jurisdiction over Cargill and that venue was proper. Cargill did not dispute that it had a regular and established place of business in the Eastern District of Virginia but argued that it [...]

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Federal Circuit Won’t Rescue Parachute Patent

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that claims to a ballistic parachute were obvious over the prior art based on knowledge attributable to artisans and denying the patentee’s motion to substitute proposed amended claims, finding that they lacked written description. Fleming v. Cirrus Design Corp., Case No. 21-1561 (Fed. Cir. Mar. 10, 2022) (Lourie, Hughes, Stoll, JJ.)

Cirrus Design filed a petition for inter partes review on certain claims of Fleming’s patent related to ballistic parachute systems on an aircraft. The challenged claims relate to an autopilot system that increases the aircraft’s pitch, reduces the aircraft’s roll or changes the aircraft’s altitude when a ballistic parachute deployment request is made. Fleming moved to amend some of the challenged claims, effectively cancelling those claims. In its final written decision, the Board found the remaining original claims obvious over the prior art and found that the amended claims lacked written description and were indefinite. Fleming appealed both the obviousness determination and the denial of the motion to amend.

Fleming argued that the Board’s obviousness determination was incorrect because the prior art did not disclose the commands to the autopilot to alter the aircraft’s pitch, roll or altitude. The Board acknowledged that neither of the primary prior references included the claimed commands upon the receipt of a deployment request, but nevertheless, concluded that a person of ordinary skill in the art would have had the motivation to combine the prior art disclosures to arrive at the claimed invention. The Federal Circuit concluded that the Board’s findings were supported by substantial evidence, citing to the Supreme Court’s 2007 KSR decision for the proposition that it is appropriate to consider a person of ordinary skill in the art’s knowledge, creativity and common sense, so long as they do not replace reasoned analysis and evidentiary support. Here the Court noted with approval the Board’s finding that aircraft autopilots are programmable and can perform flight maneuvers and deploy a parachute. The Court also noted that an artisan would have understood that certain maneuvers, such as stabilizing at an appropriate altitude, should be performed prior to deploying a whole-aircraft parachute. The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute to improve safety outcomes.

Fleming also appealed the Board’s rejection of his argument that the prior art taught away from claimed invention because a person of ordinary skill in the art would deem the combination unsafe. He argued that the prior art taught that autopilot systems should not be used in the sort of emergency situations that would lead to the deployment of a ballistic parachute. The Board rejected that argument, and the Federal Circuit found that the substantial evidence supported the Board’s determination that the prior art did not teach that a person of ordinary skill in the art would never use an autopilot system during [...]

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Tax Court Allows Partial Deduction, Requires Partial Capitalization of Generic Drug Approval Legal Expenses

The US Tax Court determined that a pharmaceutical manufacturer’s legal expenses incurred to defend against a patent infringement suit were eligible for an immediate deduction as ordinary and necessary business expenses, while legal expenses incurred as part of an abbreviated new drug application (ANDA) were not eligible for an immediate deduction and thus had to be capitalized and then amortized over 15 years. Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (Apr. 27, 2021) (Urda, J.)

The ANDA process allows for faster approval of a generic drug if the manufacturer can show that the generic drug is sufficiently similar to an approved brand name drug. As part of the ANDA process, the generic manufacturer must file statements certifying that the generic drug does not infringe any brand drug patents, or that such patents are invalid. The generic manufacturer also must send a notification to the holder of any patents covered by the certification statements.

Mylan filed several ANDAs for generic versions of brand name drugs, including Celebrex, Lunesta and Nexium, during the tax years at issue in the case. Considerable legal expenses were incurred as part of filing the ANDAs and making the required certifications and notifications. As a result of those certifications and notifications, patent holders brought approximately 120 patent infringement suits against Mylan. Mylan defended itself against the infringement suits, incurring litigation expenses.

In general, taxpayers may take an immediate deduction for ordinary and necessary business expenses. However, taxpayers must capitalize expenditures that create or enhance a distinct asset or otherwise generate benefits for taxpayers beyond a single tax year. Special rules apply to determine whether expenses related to an intangible asset should be capitalized. The income tax regulations provide that a “taxpayer must capitalize amounts paid to a governmental agency to obtain, renew, renegotiate, or upgrade its rights under a trademark, trade name, copyright, license, permit, franchise, or other similar right granted by that governmental agency.” Taxpayers must also capitalize an amount paid to facilitate an acquisition or creation of an intangible.

Litigation expenses for patent suits may be deducted or must be capitalized depending on the nature of the litigation. Defense of title claims are treated as the acquisition or disposition of a capital asset and must be capitalized. In contrast, patent infringement claims arise in tort and can be deducted in the year the expense is incurred.

Applying these rules to Mylan’s legal expenses, the Tax Court held that expenses related to the preparation of the ANDA, including the certifications and notices, were capital expenses to acquire or create an intangible asset and had to be recovered incrementally over 15 years. However, the Tax Court held that the costs of defending against patent infringement suits is an ordinary and necessary business expense for a generic drug manufacturer and permitted Mylan to deduct its litigation expenses in the year the expense was incurred.




The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., Case no.18-1876 (Fed. Cir. Feb. 9, 2021) PER CURIAM. The case concerns communications regarding generic approvals and “skinny labels,” which permit companies to sell pharmaceutical products that omit certain patented uses.

On Oct. 2, 2020, a panel of the Federal Circuit (PROST, C.J ., NEWMAN and MOORE, JJ.) issued an opinion finding that Teva induced infringement of a patent covering GlaxoSmithKline’s (GSK’s) drug Coreg® (carvedilol). In a per curiam Order, the Court has now vacated that opinion and set a new round of oral arguments that was held on February 23.

Teva had requested an en banc rehearing the case, which was denied in the Order vacating the Oct. 2, 2020 opinion while ordering panel rehearing limited to the following issue:

Whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011.

Background

GSK’s patent covers a method of using carvedilol, the active ingredient in Coreg®, for the treatment of congestive heart failure. In 2007, the FDA approved Teva’s application to market generic carvedilol tablets. To obtain that approval prior to the expiration of the patent (or prevailing on noninfringement, invalidity, or unenforceability of the patent in litigation), Teva had “carved out” certain patent-protected left ventricular dysfunction uses and only included claims to treat hypertension, i.e., claims not covered by the GSK patent. That original patent expired in 2007, but it was reissued in 2008.

Teva had deliberately omitted congestive heart failure in its label until the FDA made it add that indication in 2011. In accordance with the Order, the February 23 oral argument focued on alleged infringement in the period before the label change, i.e., the period 2008 and 2011. The outcome is expected to turn on associated activities and statements made by Teva that went beyond the approval of the generic drug with skinny labeling, where Teva did not explicitly claim that their product was for the patent-protected uses.




Antitrust Liability Risk When Listing Patents in Orange Book

The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser Antitrust Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020) (Kayatta, J).

In applying for FDA approval to market new drugs, drug manufacturers must list all patents that “claim” the drug or the method of using the drug in FDA’s “Orange Book.” Listing a patent in the “Orange Book” allows the drug manufacture to trigger an automatic 30-month stay of FDA approval of any application for a competing drug product.

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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).

The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.

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And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit (characterizing the matter as the “entrepreneurial equivalent of musical chairs”) affirmed a dismissal of a trade secret claim against a foreign defendant but not against the related US entity, and found that the case qualified under Rule 54(b) for the “narrow exception” to the finality rule. Amyndas Pharmaceutical, SA v. Zealand Pharma A/S, Case No. 21-1781 (1st Cir. Sept. 2, 2022) (Barron, Selya, Kayatta, JJ.)

Amyndas is a Greek company with a US affiliate. It is a biotechnology firm that researches and develops therapeutics targeting a part of the immune system known as the complement system. One area of Amyndas’s research deals with “complement inhibitors.”

Amyndas’s research yielded compstatin, a peptide that selectively inhibits the C3 protein (which plays a role in activating the complement system). Amyndas also developed a related peptide (AMY-101) that targets that protein. Amyndas owns trade secrets and confidential information related to this work.

Zealand Pharma, a Danish biotechnology firm, contacted Amyndas about a potential partnership for the development of complement-related therapeutics. The firms entered into a confidential disclosure agreement (CDA) regarding information-sharing “for the purposes of evaluating a possible business/services relationship between the parties and their respective Affiliates.” Amyndas started giving Zealand Pharma access to confidential information (including confidential information about AMY-101). The firms also entered into a second CDA—with added protections—for “the evaluation or formation of a possible business and/or services and/or collaborative relationship.”

Both CDAs included an identical “Governing Law” provision stipulating that the CDAs would “be interpreted and governed by the laws of the country (applicable state) in which the defendant resides” and a forum-selection clause stipulating that “any dispute arising out of th[e CDA] shall be settled in the first instance by the venue of the defendant.”

Zealand Pharma also began its own research program focused on complement therapeutics. It did not inform Amyndas of this initiative. Although negotiations continued, the firms ultimately decided not to collaborate. Amyndas later terminated its information-sharing relationship with Zealand Pharma.

Zealand Pharma later formed Zealand US, a Delaware corporation. Without Amyndas’s knowledge or consent, Zealand Pharma also filed two European patent applications for compstatin analogues and later an international patent application designating the United States and claiming priority to the earlier  EU applications.

After the international applications were published, Amyndas learned that they described “compstatin analogues that are capable of binding to C3 protein and inhibiting complement activation,” which had been the focus of Amyndas’s research and a subject of Amyndas’s confidential information-sharing with Zealand Pharma.

The other defendant, Alexion, is an established player in the complement therapeutics field and a proprietor of Soliris, a complement inhibitor that targets a protein in the complement system. Soliris is approved by the US Food and Drug Administration (FDA) and previously was the only FDA-approved and clinically available [...]

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Nothing Private about Relator’s Qui Tam Action Info

The US Court of Appeals for the Ninth Circuit reversed a district court’s order denying the defendants’ motion to dismiss a qui tam action under the False Claims Act (FCA) and remanded for further proceedings. U.S. ex rel Silbersher v. Allergan, Inc., Case No. 21-15420 (9th Cir. Aug. 25, 2022) (Gould, Bennett, Nelson, JJ)

Relator Silbersher, a patent lawyer, brought his action against the defendants under the FCA. (31 U.S.C. § 3730(b)). Silbersher alleged that the defendants unlawfully obtained several patents related to two drugs used to treat Alzheimer’s disease. He asserted that by fraudulently obtaining these patents, the defendants prevented generic drug competitors from entering the market. As a result, Medicare paid inflated prices for the two drugs in violation of the FCA.

The US Department of Justice, all of the states that have analogues to the federal qui tam provision and the District of Columbia declined to intervene in Silbersher’s action. Additionally, the key factual information in Silbersher’s complaint was all disclosed publicly and much of it could be found on the US Patent & Trademark Office’s (PTO) website as well as on other government websites. The district court denied the defendants’ motion to dismiss, holding that the public disclosure bar did not apply to Silbersher’s claims. The defendants appealed.

The Ninth Circuit reversed and remanded, noting that the “FCA creates civil liability for ‘any person who (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.’ 31 U.S.C. § 3729(a)(1).” The FCA limits who can bring a qui tam action and the sources of information upon which they can base their suit. The public disclosure bar seeks to strike a balance between encouraging suits by whistleblowers with genuinely valuable information and discouraging plaintiffs who have no significant information of their own to contribute. The Court, citing its 2018 case United States ex rel. Solis v. Millennium Pharms., reaffirmed the elements of the test for triggering the bar:

“(1) the disclosure at issue occurred through one of the channels specified in the statute;

 

(2) the disclosure was public; and

 

(3) the relator’s action is substantially the same as the allegation or transaction publicly disclosed.”

The Ninth Circuit determined that only the first element was at issue in this case and that “[i]t is salient and potentially controlling that the key factual information underlying Silbersher’s complaint was all publicly disclosed, and much could be found in websites maintained by the PTO and other government agencies.” Under the public disclosure bar, a court shall dismiss an action or claim if substantially the same allegations or transactions as alleged were publicly disclosed (1) in a federal criminal, civil or administrative hearing in which the government was a party; (2) in a congressional, Government Accountability Office, or other federal report, hearing, audit or investigation or (3) from the news [...]

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File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s abbreviated new drug application (ANDA) specification controlled the § 271(e)(2) infringement inquiry, and that there were no clear errors by the district court that would warrant reconsideration of the § 271(a)-(b) ruling. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc., Case No. 21-2342 (Fed. Cir. Aug. 18, 2022) (Moore, Prost, Hughes, JJ.)

Par is the maker of Vasostrict®, a vasopressin injection product used to treat patients with critically low blood pressure. Par sued Eagle, an ANDA filer seeking to market a generic version of Vasostrict®, asserting infringement of two Orange Book-listed patents. The claims of both asserted patents required a vasopressin composition with a rounded pH between 3.7 and 3.9 (i.e., a pH between 3.65 and 3.94 before rounding). Par argued that Eagle infringed because Eagle’s ANDA sought approval for a product with a pH of 3.64, just 0.01 beneath the claimed range, and because “real-world” evidence purportedly showed that the pH of Eagle’s product drifts up over time. Accordingly, Par asserted infringement under § 271(e)(2), based on the filing of Eagle’s ANDA, and also sought a declaratory judgment that Eagle’s planned generic product would infringe under § 271(a)-(b). The district court disagreed. Par appealed.

Turning first to the issue of infringement under § 271(e)(2), the Federal Circuit explained that because drug manufacturers are bound by strict statutory provisions to sell only those products that comport with their ANDAs, if an ANDA defines a proposed generic drug in a manner that directly addresses the issue of infringement, the ANDA controls the infringement inquiry. The Court stated, however, that if an ANDA specification does not speak clearly and directly to the question of infringement, courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the US Food & Drug Administration (FDA), to assess whether a proposed product will infringe.

The Federal Circuit found that in Eagle’s case, “the inquiry begins and ends with Eagle’s ANDA specification.” Eagle’s ANDA contained both a release specification, requiring the generic product to have a pH range of 3.4–3.6 (i.e., up to 3.64 before rounding) at the time of distribution, and a stability specification, requiring that same pH range throughout the entirety of the product’s shelf life. Par argued that the stability specification was irrelevant to the infringement inquiry because the FDA cannot ensure that every product Eagle sells complies with the stability specification. The Court disagreed, finding that the district court did not clearly err in ruling that Eagle’s ANDA defined a product outside the scope of Par’s claims.

As to Par’s declaratory judgment claim under § 271(a)-(b), the Federal Circuit found that the district court did not commit clear error in its consideration of Par’s infringement arguments. The district court considered but did not find compelling Par’s evidence of an upward pH drift in Eagle’s post-release pH data [...]

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