As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology Considerations

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit addresses the proliferation of digital technology and software being used in the medical community, specifically in medical devices. As connected medical technology grows well beyond digital step counters and heart rate monitors, FDA has reacted with greater interest and regulation. The pace of technology in this area has accelerated with the advent of cloud computing and viable artificial intelligence. Companies are now offering highly sophisticated medical devices with technology to promote individualized health outcomes and to aid in self-monitoring. Health care institutions leverage patient data and artificial intelligence to identify new health care risks, make diagnoses and provide better healthcare services. These types of tools are something that FDA has been aware of and has taken an interest in, but it has struggled to keep pace. FDA’s Digital Health Program, “which seeks to better protect and promote public health and provide continued regulatory clarity,”[1] and staffing additions look to change that.     Continue Reading

GOOGLE Mark Is Not a Victim of Genericide

On May 16, 2017, internet search engine and content provider Google Inc. was handed a win by the United States Court of Appeals for the Ninth Circuit in Elliot v. Google Inc. The court ruled that the GOOGLE trademark had not become a victim of genericide, unlike other now generic terms such as ASPIRIN, CELLOPHANE and THERMOS. A copy of the court’s decision can be found here.

The case was filed by David Elliot and Chris Gillespie, who had registered 763 domain names that combined the word “google” with other specific brand, person or product names. After Google successfully challenged those registrations through the National Arbitration Forum for violations of the Uniform Domain Name Dispute Resolution Policy, Elliot and Gillespie filed a lawsuit seeking cancellation of two GOOGLE trademark registrations (U.S. Reg. Nos. 2884502 and 2806075) before the United States District Court for the District of Arizona. The district court refused cancellation and granted summary judgment in Google’s favor. Continue Reading

Registration of “Phantom Marks” Denied

“Phantom marks” are trademarks that contain a variable element, such as the mark T.MARKEY TRADEMARK EXHIBITION 2***, in which the asterisks represent elements that change to indicate different years. Trademark Manual of Examining Procedure (TMEP) § 1214.01 (Apr. 2017). While a phantom mark refusal would not be necessary in this example, the Trademark Office generally refuses the registration of phantom marks because they fail to “give adequate constructive notice to third parties as to the nature of the mark and a thorough and effective search for conflicting marks is not possible.” TMEP § 1214.01. Additionally, phantom marks often result in the registration of more than one mark, violating the requirement that “a trademark application may only seek to register a single mark.” Id. at § 807.01 (emphasis added).  Continue Reading

Impression Products, Inc. v. Lexmark International, Inc. – Setting the Common Law’s Limits on the Rights of Patent and Copyright Owners


Last week, in Impression Products, Inc. v. Lexmark International, Inc., Case No. 15-1189 (May 30, 2017), the Supreme Court ruled that under the “exhaustion doctrine,” patent owners cannot use patent law to impose restrictions on the downstream sales or transfers of lawfully purchased patented goods. The decision took many patent practitioners by surprise. Not only did the Court reverse an en banc decision of the Federal Circuit, but it overturned the widespread view that patentees could enforce post-sale restrictions on the use or resale of patented products through patent infringement lawsuits so long as the post-sale restrictions were “clearly communicated.”

For copyright lawyers, however, the “exhaustion” restrictions the Court imposed on patentees were already familiar: they are the same ones the Court imposed four years ago on copyright owners under the Copyright Act’s first sale doctrine, 17 U.S.C. § 109(a). See Kirtsaeng v. John Wiley & Co., Inc., 568 U.S. 519, 538 (2013) (Court rejects imposition of geographical restrictions on the application of the first sale doctrine on the ground that it contradicts “the very basic concept of copyright law that, once you’ve sold a copy legally, you can’t restrict its resale.”)  Indeed, Chief Justice Roberts’ near-unanimous opinion[1] for the Court in Impression Products emphasized that patent law’s exhaustion doctrine and the Copyright Act’s first sale doctrine derive from a shared lineage, namely, “the ‘common law’s refusal to permit restraints on the alienation of chattels.”  (Opinion at p. 6, quoting Kirtsaeng, 568 U.S. at 538.) As a result, “differentiating the patent exhaustion and copyright first sale doctrines would make little theoretical or practical sense [as] [t]he two share a ‘strong similarity . . . and identity of purpose.” (Id. at p. 14, quoting Bauer & Cie v. O’Donnell, 229 U.S. 1.13 (1913).) In short, the Supreme Court’s Impression Products means that patent and copyright owners will now be subject to the same basic set of “exhaustion” requirements. Continue Reading

Supreme Court Announces ‘Uniform and Automatic’ Rule for Patent Exhaustion

The Supreme Court on Tuesday, May 30, issued an opinion in Impression Prods., Inc. v. Lexmark Int’l, Inc., No. 15–1189 (S. Ct. May 30, 2017), [hereafter “Lexmark”], reversing the Federal Circuit on two aspects of the patent exhaustion doctrine and redefining the boundaries of the rights afforded a patentee under the Patent Act. Chief Justice Roberts authored the opinion, from which Justice Ginsburg dissented in part.

Under 35 U.S.C. § 154(a), a patent grants to the patentee “the right to exclude others from making, using, offering for sale, or selling” the patented invention. Infringement of a patent occurs when “whoever without authority makes, uses, offers to sell, or sells” the patented invention in the U.S., or imports the patented invention into the U.S. during the life of the patent. 35 U.S.C. § 271(a). But a patentee’s right to exclude and ability to obtain damages for infringement are not without limit. The doctrine of patent exhaustion holds that when a patentee sells a patented item, that sale removes the item from the reach of the Patent Act. Lexmark, slip op. at 6. The purchaser is then free to use, sell or otherwise dispose of the item as he or she sees fit, without fear of liability for infringement. Continue Reading

The Federal Circuit Invalidates a Patent for Failure to Describe the Accused Product

Isolated Coffee CupsIn Rivera v. International Trade Commission, Appeal No. 2016-1841 (Fed. Cir. May 23, 2017), the Federal Circuit affirmed the ITC’s decision invalidating Rivera’s patent under the written description requirement of 35 U.S.C. § 112. The opinion provides important lessons for those who draft and prosecute patent applications and also those who attempt to enforce them. Indeed, it appears that the prosecuting attorney might have avoided the ruling of invalidity and still have secured claims encompassing the product of the intervenor, Solofill, LLC, and the litigating attorney might have presented a different argument that would have led the Federal Circuit to approach the case differently and possibly to reach a different result.

Rivera’s patent disclosed a reusable K-cup that would work with pods of coffee (or other brewable material) in a standard single-cup brewing machine (such as the Keurig® system). The purpose of the invention was to provide an apparatus that makes it possible to use a single standard machine to brew both cup-shaped cartridges and pods, i.e. sealed, filter-paper packages enclosing brewable material such as coffee. Although the disclosed invention has other bells and whistles, it essentially comprises an empty reusable cup with a removable cap, permitting the user to place a pod in the cup, which is designed to fit into the standard single-cup brewing machine. Continue Reading

The Supreme Court, Reversing the Federal Circuit, Holds that “Residence” in the Patent Venue Statute Refers to Only a Domestic Corporation’s State of Incorporation

Patent147631712In a brief, well-reasoned opinion, a unanimous eight-member Supreme Court held that 28 U.S.C. § 1400(b) is a stand-alone provision governing venue in patent infringement suits, unaffected by the broad definition of “residence” in the general venue statute, 28 U.S.C. § 1391.Rather, a domestic corporation “resides” in only its state of incorporation. TC Heartland LLC v. Kraft Foods Group Brands LLC, No. 16-341 (U.S. May 22, 2017).

The Court based its decision on the history of the general venue statute and the patent venue statute and its own consistent interpretation of the patent venue statute. Reviewing that history, the Court observed that Congress created the patent venue statute as the exclusive provision for patent infringement suits, at least against domestic corporations, with little change from its initial creation as an exception to the more frequently amended general venue statute.

Thus, in 1789, Congress in all cases permitted suit in a district if the defendant was “an inhabitant” of the district or could be “found” there. Slip op. at 3 (citing Act of Sept. 24, 1789, § 11, 1 Stat. 79). Congress amended that statute in 1887 to restrict venue to a district where the defendant was an inhabitant or, in diversity cases, where either party was an inhabitant. Slip op. at 3-4 (citing Act of Mar. 3, 1887, § 1, 24 Stat. 552). But a Supreme Court decision in 1893 created confusion about whether the 1887 Act, rather than the 1789 Act, applied to patent cases. Congress enacted the first patent venue statute in 1897 to eliminate the confusion. Slip op. at 4 (citing Act of Mar. 3, 1897, ch. 395, 29 Stat. 695).  Continue Reading

Living it up at the HOTEL CALIFORNIA

Legendary rock band Eagles, Ltd. (The Eagles), filed suit on May 1 against the owners of the Hotel California Baja LLC in the U.S. District Court for the Central District of California. The suit alleges trademark infringement and common law unfair competition by the owners, Debbie and John Stewart (owners).

The hotel originally opened in the 1950s under the name Hotel California, decades before the rock band released its hit song by the same name. However, since opening, the hotel has gone through multiple name and ownership changes, most recently as the Todos Santos Hotel. On Nov. 16, 2015, the defendants filed a trademark application at the U.S. Patent and Trademark Office to register use of the name HOTEL CALIFORNIA on goods, such as T-shirts and other clothing.  Continue Reading

In Case of First Impression, Federal Circuit Rules that a Patent Owner’s Statements in an IPR Proceeding Can Create Prosecution Disclaimer


In Aylus Networks, Inc. v. Apple Inc., Appeal No. 2016-1599 (Fed. Cir. May 11, 2017), the Federal Circuit ruled that a patent owner’s statements during an inter partes review (IPR), even if before an institution decision, can create prosecution disclaimer.

After the patent owner filed suit, the defendant filed two petitions for IPR. In the patent owner’s preliminary responses to the petitions, it argued, for the purpose of distinguishing the asserted claims over the prior art, that the claim limitation—“wherein the CPP logic is invoked to negotiate media content delivery between the MS and the MR”—requires that only the CPP logic be invoked, even though the asserted claims were open (“comprising”) claims. The district court, applying prosecution disclaimer, therefore granted the defendant’s motion for summary judgment of noninfringement, since the patent owner conceded that the defendant did not infringe the asserted claims under that construction. The patent owner appealed the noninfringement determination to the Federal Circuit. Continue Reading

Court Finds Infringement of THE KRUSTY KRAB Mark

early winter, snow, lobster traps, dock, fishing village, harborIn Viacom International Inc. v. IJR Capital Investments, LLC, 2017 WL 1037294 (S.D. Tex. Mar. 17, 2017), Viacom successfully asserted common-law rights in the trademark THE KRUSTY KRAB for a fictional restaurant, which appears in the cartoon SpongeBob SquarePants. The defendant, IJR, had filed an intent-to-use trademark application for the mark THE KRUSTY KRAB for restaurant services. After a Notice of Allowance had been issued, Viacom sent a cease-and-desist letter asserting that registration of the mark would cause a likelihood of confusion with the “iconic” fictional restaurant that had been featured in 166 out of 203 SpongeBob episodes over its seventeen-year run. IJR declined to withdraw its plan to use the mark for a restaurant. Viacom filed suit, alleging trademark infringement, unfair competition and dilution, and ultimately moved for summary judgment.

As to trademark infringement, IJR argued that Viacom never registered the mark THE KRUSTY KRAB and that it could not have a trademark right in a fictional restaurant. The court squarely rejected these arguments. Because trademark rights flow from use, not registration, and Viacom had demonstrated that it used the mark in commerce by featuring it in SpongeBob episodes and two commercially successful movies and by licensing the mark for use on merchandise, Viacom established that it had ownership of the mark. The court also rejected the notion that the fictional nature of the mark undermined its protectability, observing that “specific ingredients of a successful T.V. series, including symbols, design elements, and characters which the public directly associates with the plaintiff or its product,” are entitled to trademark protection, listing “kryptonite” and “The Daily Planet” from Superman as examples. Continue Reading