Patent Venue Construed Strictly, Even in ANDA Litigation

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In Celgene Corp. v. Mylan Pharmaceutics Inc., [2021-1154] (November 5, 2021) the Federal Circuit affirmed the dismissal of a patent infringement action against defendants, MPI and Mylan Inc. for improper venue, and against defendant Mylan N.V. for failure to state claim upon which relief can be granted.

After an giving an excellent summary of Hatch-Waxman Act litigation, the Federal Circuit recounted the history of the action. Celgene filed its first case in May 2017. The defendants-
appellees moved to dismiss for improper venue and failure to state a claim in August 2017. That motion was denied in March 2018 without prejudice so that the parties could engage in venue-related discovery.

After two years of that discovery, the defendants renewed their motion to dismiss. The district court concluded that venue was improper. Namely, the thin set of facts that Celgene had gathered after those two years—the presence of affiliated entities and employees in New Jersey—failed to show a “regular and established place of business” of the defendants in the district under 28 U.S.C. § 1400(b).

The Federal Circuit found that neither MPI nor Mylan had “committed acts of infringement” in New Jersey. The court noted that in Valeant, it said that “venue in Hatch-Waxman cases must be predicated on past acts of infringement.” For the purposes of the Hatch-Waxman Act, “it is the submission of the ANDA, and only the submission, that constitutes an act of infringement
in this context.” The question, then is where the submission occurred, and what acts it includes.

The Federal Circuit rejected the argument that the submission extends to whereever the generic drug woudl be marketed and sold. The Federal Circuit also rejected the argument that the submission included the act of sending the mandatory ANDA Notice, reiterating that it is the submission of the ANDA, and only the submission, that constitutes an act of infringement in this context.

The Federal Circuit also found that neither MPI nor Mylan had a regular and established place of business in New Jersey. There are three requirements for a regular and established palace of business: (1) there must be a physical place in the district; (2) it must be a regular and established place of business; and (3) it must be the place of the defendant. The third requirement was the relevant one in this case. The place of business must be “of the defendant, not solely . . . of the defendant’s employee.” Accordingly, “the defendant must establish or ratify the place of business,” and it is “not enough that the employee does so on his or her own.”

As to the third requirement, the Federal Circuit noted that it has discussed four non-exhaustive relvant factors:

(1) “whether the defendant owns or leases the place, or exercises other attributes of possession or control over the place”; (2) “whether the defendant conditioned employment on” “an employee’s continued residence in the district” or “the storing of materials at a place in the district so that they can be distributed or sold from that place”; (3) “a defendant’s representations” about that place, including advertisements; and (4) “the nature and activity of
the alleged place of business of the defendant in the district in comparison with that of other places of business of the defendant in other venues.”

17 of MPI’s and Mylan’s tens of thousands of employees live in New Jersey, but MPI and Mylan showed that it did not require or instruct those employees to live in New Jersey, or pay for their homes, or require employees to store materials in their homes, or pay for secretarial or support staff. The Court found that a roster of employees who live in the state, a handful of business cards with employee names and New Jersey home addresses, and two LinkedIn
profiles mentioning New Jersey were all too speculative to show ratification of those addresses by MPI and Mylan.

The Federal Circuit also found that two small storage lockers rented by MPI sales or marketing employees to store product samples are not places “of the defendant.” Nor do they bolster that the employees’ homes were such places. Those lockers are rented in the employees’ own names. They are used to intermittently store and access product samples. There is no evidence, in contrast, that they are used like warehouses—for order fulfillment, wholesaling, retail, or the like.

Overall, the Federal Circuit concluded that the employee-associated locations are not
a regular and established place of business of the defendants under § 1400(b).

The district court also concluded that, for Mylan N.V., Celgene had failed to state a claim upon which relief could be granted. That is, the ANDA that Celgene itself included with its complaint sought approval only on behalf of MPI. And Celgene’s pleadings with respect to the involvement of Mylan N.V. in that submission were simply too speculative and conclusory.

The Federal Circuit noted that MPI, not Mylan N.V., was the entity that signed and physically submitted the ANDA. Thus the question was whether Celgene sufficiently plead that (1) Mylan N.V. was actively involved in and directly benefited from the ANDA (including in the agent–principal sense) or (2) MPI acted as Mylan N.V.’s alter ego in derogation of the corporate form.
The Federal Circuit found that Celgene’s pleadings fail under either theory.

As to the denial of leave to amend the Complaint, the Federal Circuit said that Celgene’s allegations in its complaint were conclusory and insufficient. It knew the basis for their deficiency for years, as the district court correctly concluded, yet made no attempt to amend them in a timely manner. Nor has Celgene argued on appeal that it showed good cause. In
our view, then, the district court did not abuse its discretion in denying Celgene’s request for leave to amend its complaint.

Failure in the Art Undermines any Reasonable Expectation of Success

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In University of Strathclyde v. Clear-Vu Lighting LLC, [2020-2243], (November 4, 2021) the Federal Circuit reversed the PTAB’s determination holding unpatentable as obvious claims 1-4 of U.S. Patent No. 9,839,706, directed to photoinactivation of Methicillin-resistant Staphylococcus aureus (MRSA), and other Gram-positive bacteria, without using a photosensitizing agent.

The Board determined that claims 1 and 3 of the ’706 patent would have been obvious over Ashkenazi in view of Nitzan, and that claims 2 and 4 would have been obvious in further view of Jones. The Board found that Ashkenazi and Nitzan teach or suggest all the limitations of claims 1 and 3,” and that a person of ordinary skill in the art would have been motivated to combine these two references and “would have had a reasonable expectation of successfully doing so.

On appeal, Strathclyde challenges the Board’s obviousness determination, arguing that the Board erred in finding that the combination of Ashkenazi and Nitzan teaches inactivating one or more Gram-positive bacteria without using a photosensitizer. It also asserts that the Board’s
finding of a reasonable expectation of success is not supported by substantial evidence. Whether the prior art discloses a claim limitation, whether a skilled artisan would have been motivated to modify or combine teachings in the prior art, and whether she would have had a reasonable expectation of success in doing so are questions of fact.

The Federal Circuit said that both parties agreed that most of the limitations found in claims 1 and 3 are disclosed by Ashkenazi or Nitzan, and that the only dispute is whether these references teach inactivating one of the claimed Gram-positive bacteria without using a photosensitizer. The Federal Circuit found that the Board’s finding that this was taught by the combination of Ashkenazi and Nitzan is not supported by substantial evidence. The Federal Circuit said that all of Ashkenazi’s P. acnes cultures were grown in the presence of a photosensitizer—either riboflavin alone, or riboflavin together with ALA. The Federal Circuti found nothing in Ashkenazi that discloses or suggests inactivating P. acnes, or any other bacteria, without using a photosensitizer.

The Federal Circuit noted that while Nitzan provides an example in which MRSA and other bacteria were exposed to blue light without ALA or any other photosensitizer, there is no evidence that Nitzan successfully achieved inactivation under this condition. The Federaal Circuit noted that in finding that Nitzan did not anticipate claims 1 and 3, the Board found Clear-Vu failed to establish that Nitzan’s non-ALA MRSA demonstrated “inactivation” as required by the claims.

The Federal Circuit said that given neither Ashkenazi nor Nitzan teaches or suggests inactivation of any bacteria without using a photosensitizer, it failed to see why a skilled artisan would opt to entirely omit a photosensitizer when combining these references. The Federal Circuit said that the Board articulated no rational basis—and it could discern none—for combining Ashkenazi’s P. acnes experiments, which at all times used a photosensitizer, with Nitzan’s non-ALA MRSA experiment, which did not achieve inactivation, to arrive at an embodiment in which MRSA is inactivated by exposing it to 407–420 nm blue light without
using a photosensitizer.

On this record, the Federal Circuit concluded that no reasonable fact finder could have found that the combination of Ashkenazi and Nitzan discloses inactivating one or more Gram-positive bacteria without using a photosensitizer.

Regarding whether there was a reasonable expection of success, the Federal Circuit disagreed with the Board’s finding that a skilled artisan would have expected that MRSA could be inactivated by blue light without using a photosensitizer due to the presence of at least some amount of naturally produced porphyrin in the bacteria. The Federal Circuit said that the only suport for the finding was “pure conjecture coupled with hindsight reliance on the teachings in the [challenged patent].”

The Federal Circuit said that the Board, relying on Ashkenazi’s teaching that “blue light may” inactivate “other bacterial cells that produce porphyrins,” reasoned that because light-activated
porphyrin molecules were shown in Ashkenazi to cause inactivation for P. acnes (even though Ashkenazi’s experiments applied a photosensitizer), the fact that MRSA has some level of endogenous porphyrin suggests to a skilled artisan that MRSA, too, would exhibit some amount of inactivation after exposure to 407–420 nm blue light. But, the Federal Circuit said that there is simply no evidence of record at the time of the ’706 patent to support this assumption. The Federal Circuit said that the evidence of record—Nitzan and an earlier publication by Nitzan, showed the opposite. The data Dr. Nitzan reported would have indicated to a person of ordinary skill in the art that those natural levels are insufficient to inactivate MRSA using 407–420 nm blue light without also using a photosensitizer.

Thus, the Federal Citcuit found, not only is there a complete lack of evidence in the record that any bacteria were inactivated after exposure to 407–420 nm blue light without using a photosensitizer, there is also evidence showing that others had failed to inactivate MRSA—one of the claimed Gram-positive bacteria— without using a photosensitizer, despite experimenting with different light doses and different wavelength ranges of blue light.

The Federal Circuit raffirmed that absolute predictability of success is not required, only a reasonable expectation. Howver in the present case, where the prior art evidences only failures to achieve that at which the inventors succeeded, no reasonable fact finder could find an expectation of success based on the teachings of that same prior art.

Happy Halloween

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What’s scarier than a Section 101 rejection? Some of these patents for celebrating the spookiest holiday?

U.S. Patent No. 396252 on a Jack-A-Lantern, patented January 15, 1889
U.S. Patent No. 699,669 on a Toy Jack-O’-Lanntern patented May 13, 1902.
U.S. Patent No. 741,293 on a Jack-O’-Lantern patented October 13, 1903
U.S. Patent No. 2,236,071 on Jack-O’-Lantern Lamp and Bulb Holder, patented March 25, 1941

IPR’s Survive More Constitutional Challenges

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In Mobility Workx, LLC v. Unified Patents, LLC, [2020-1441] (October 13, 2021), the Federal Circuit concluded that Mobility’s constitutional arguments were without merit, and without reaching the merits of the Board’s decision, in light of Arthrex, it remanded to the Acting Director to determine whether to grant rehearing.

Mobility argued that the structure and funding of the Board violates due process.  First, because “the fee-generating structure of AIA review[] creates a temptation” for the Board to institute AIA proceedings in order to collect post institution fees (fees for the merits stage of the AIA proceedings) and fund the agency.  Second, because individual APJs have an unconstitutional interest in instituting AIA proceedings because their own compensation in the form of performance bonuses is favorably affected.  The Federal Circuit found no merit to these defenses.

Mobility raised several additional constitutional challenges not raised before the agency that have been previously rejected by this court in other cases.  Mobility argued that the Director’s delegation of his authority to institute AIA proceedings violates due process and the Administrative Procedure Act because the Director has delegated the initial institution decision to “the exact same panel of Judges that ultimately hears the case.” Mobility additionally argued that subjecting a pre-AIA patent to AIA review proceedings “constitutes an unlawful taking of property.”  The Federal Circuit rejected these challenges.


Finally, Mobility raised an Appointments Clause challenge. The Federal Circuit agreed that a remand is required under the Supreme Court’s decision in Arthrex to allow the Acting Director to review the final written decision of the APJ panel pursuant to newly established USPTO procedures, and remanded the case.

An Army of Citation Footnotes Crouching in a Field of Jargon is no Substitute Explanation

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In Traxcell Technologies, LLC v. Sprint Communications Company, LP, [2020-1852, 2020-1854] (October 12, 2021), the Federal Circuit agreed with the district court’s claim construction, and further that under that construction Traxcell failed to show a genuine issue of material fact as to infringement, and further that several of Traxcell’s claims were indefinite.

The case involves U.S. Patent Nos. 8,977,284, 9,510,320, 9,642,024, and  9,549,388 related to self-optimizing network technology for making “corrective actions” to improve communications between a wireless device and a network.

At issue was the claim limitation “means for receiving said performance data and corresponding locations from said radio tower and correcting radio frequency signals of said radio tower.” The parties agreed that this was a means-plus-function claim, and the corresponding structure was an algorithm identified in the specification.  Traxcell argued that Sprint’s accused technology included a structural equivalent to the disclosed structure under the function-way-result test.  The district court disagreed, reasoning that Traxcell failed to establish that Sprint’s accused technology operates in substantially the same “way.”

The Federal Circuit agreed, noting that the identified structure from the specification was a “very detailed” algorithm, including numerous steps necessary for its function. However, Traxcell neglected to address a significant fraction of that structure.  Accordingly, Traxcell didn’t provide enough evidence for a reasonable jury to conclude that the accused structure performs the claimed function in “substantially the same way” as the disclosed structure.

Also at issue was the limitation “location.”  The parties agreed, and the district court accepted, that “location” meant “location that is not merely a position in a grid pattern.”  However, under this construction Traxell lost.  On appeal Traxell insisted in retrospect that this construction was wrong. The Federal Circuit said that “having stipulated to it, Traxcell cannot pull an about-face.”

With respect to infringement by Sprint, the independent claims all require sending, receiving, generating, storing, or using the “location” of a wireless device.  The district court concluded that Traxcell simply hadn’t shown that the accused technologies used “location” as construed by the court, and the Federal Circuit agreed.  With respect to infringement by Ericson, the district court rejected Traxcell’s argument that the accused technology uses “location” because it collects “information regarding the distance of devices from a base station.”  The Federal Circuit agreed that this was not location information but information to calculate distance.

Also at issue were the limitations “first computer” and “computer.”  Construing these as referring to a single computer, the district court concluded that Traxell had not shown that these limitations were met, and the Federal Circuit agreed.  The Federal Circuit said that Traxell failed to particularize those conclusory assertions with specific evidence and arguments. Traxell argued it provided substantial evidence that the district court ignored, but the Federal Circuit said it was “an army of citation footnotes crouching in a field of jargon. What they lack is explanation.” The Federal Circuit concluded that Traxell’s showing was “simply too unexplained and conclusory.”  The Federal Circuit said that Traxcell has cited swaths of documents, but it Failed to explain how those documents support its infringement theory. It didn’t do so at the trial court, and it didn’t do so on appeal.

Traxcell’s remaining infringement arguments on appeal relied upon  the doctrine of equivalents. But the Federal Circuit concluded that Traxcell surrendered multiple computer equivalents during prosecution of these patents.

Turning to indefiniteness, Claim 1 of the ‘284 patent was found indefinite on two grounds: (1) lack of reasonable certainty about which “wireless device” the term “at least one said wireless device” referred to, and (2) lack of an adequate supporting structure in the specification for the claim’s means-plus-function limitation.  The Federal Circuit found that the claim was indefinite for lack of adequate supporting structure in the specification.

A means-plus-function claim is indefinite if the specification fails to disclose adequate corresponding structure to perform the claimed function.  While Traxcell cited an algorithm, the district court found that Traxcell’s explanation provided nothing more than a restatement of the function, as recited in the claim.  The Federal Circuit concluded that the claim was indefinite, without the need to reach the issue of “wireless device.”

As to infringement of the ‘388 patent, the claims required that the device’s location is (1) determined on the network, (2) communicated to the device, and (3) used to display navigation information.  The district court determined that Traxcell failed to show that the device location was determined by the network, and the Federal Circuit agreed.  Traxcell argued that the network provided data to the devices, but the court observed that it is not data from the network that the claims require. It is that the network itself determines location and transmits the location to the device. The Federal Circuit said that Traxcell has not shown that the network does so with anything but broad and conclusory scattershot assertions.

Revised Judgment is Less Judgmental

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In Hyatt v. Hirshfeld, [2020-2321, 2020-2323, 2020-2324, 2020-2325] (October 12, 2021), the Federal Circuit reissued its August 18, 2021, opinion, at Hyatt’s request, striking the language “in an efforts to submarines his patent applications and receive lengthy patent terms,”  leaving the much less judgmental observation that Hyatt “adopted an approach to prosecution that all but guaranteed indefinite prosecution delay.”

A Little Background on Columbus

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First, a little background on Backgrounds. 37 CFR 1.77(b)(7) suggests that an application should contain a “background of the invention.” However the MPEP is ambiguous as to its content:

Experienced practitioners know that the Background is just another opportunity to make a mistake. From calling it a “BACKGROUND OF THE INVENTION” rather than simply “BACKGROUND,” to admitting admitting prior art that is not prior art, or otherwise limiting the scope of the claims, ther seems little to be gained and much to be lost with a carelessly drafted background. While patent applications continue to include Backgrounds, they are getting shorter and less detailed.

An interesting example of an old-school background, particularly apropos on Columbus Day, is the Background in U.S. Patent No. 5,802,513:

The drafter probably should have stopped right here, and today probably would have stopped right here. A hint about the subject matter of the invention, and the problems it addresses, without admitting anything in particulary is prior are, and without saying anything that might otherwise limit the scope of the claims.

THIS forum selection clause in THIS NDA agreement did not bar the IPRs

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In Kannuu Pty Ltd. v. Samsung Electronics Co., [2021-1638] (October 7, 2021) the Federal Circuit affirmed the district court denial of Samsung’s motion for a preliminary injunction compelling Samsung to seek dismissal of Samsung’s petitions for inter partes review at the Patent Trial and Appeal Board (Board).

In 2012, Samsung contacted Kannuu, an Australian start-up company that develops various media-related products (including Smart TVs and Blu-ray players), inquiring about Kannuu’s
remote control search-and-navigation technology. Kannuu and Samsung entered into a non-disclosure agreement (NDA), to protect confidential business information while engaging in business discussions and the like. Among other things, the agreement provided:

Any legal action, suit, or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby must be instituted exclusively in a court of competent jurisdiction, federal or state, located within the Borough of Manhattan, City of New
York, State of New York and in no other jurisdiction.

Following over a year of discussions, the parties ceased communications. No deal (i.e., intellectual property license, purchase, or similar agreement) over Kannuu’s technology was made. Six years later, Kannuu sued Samsung for patent infringement and breach of the NDA.
Samsung then filed petitions for inter partes review of the patents. Kannuu argued that the that review should not be instituted because Samsung violated the NDA’s forum selection
clause in filing for such review. When the Board institued proceedings as to some of the petitions, Kannuu sought rehearing, which was denied. Kannuu then sought a preliminary injunction to compel Samsung to seek dismissal of the instituted inter partes reviews. The
motion was denied, and Kannuu appealed.

The issue before the district court, and before the Federal Circuit on appeal, was whether the forum selection in the non-disclosure agreement prohibited Samsung from petitioning for inter partes review of Kannuu’s patents at the Board. The District Court found it did not, and the Federal Circuit found no abuse of discretion.

Though the district court held the forum selection clause was valid and enforceable, it concluded that the plain meaning of the forum selection clause in the NDA did not encompass the inter partes review proceedings. Specifically, the district court found that the inter partes review proceedings did not “relate” to the Agreement or transactions contemplated under it. The Federal Circuit said that the district court correctly concluded that the inter partes review proceedings “do not relate to the Agreement itself.” The connection between the two—the inter partes review proceedings and the NDA—is too tenuous for the inter partes review proceedings to be precluded by the forum selection clause in the NDA, which is a contract
directed to maintaining the confidentiality of certain disclosed information, and not related to patent rights.

Neither the district court nor the Federal Circuit said that a forum selection clause in an NDA could not bar an IPR, rather they both held that this forum selection clause in this NDA agreement did not bar the IPRs. Under appropriate circumstances, a properly drafted forum selection cause in an NDA could bar an IPR between the parties, just as such clauses in a license agreement can bar challenges to the licensed patents before the PTAB.

What’s in a Name? Patentability.

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In re SurgiSil LLP, [2020-1940] (October 4, 2021), the Federal Circuit reversed the Patent Trial and Appeal Board’s decision affirming an examiner’s rejection of SurgiSil’s design patent application, No. 29/491,550 an “ornamental design for a lip implant as shown and described.”

Applicant’s stunning new design for a lip implant.

The examiner rejected the sole claim of the application as anticipated by an art tool called a stump, shown in a Dick Blick catalog (Blick):

The “stump” from the Dick Blick Catalog.

.

The Board rejected SurgiSil’s argument that Blick could not anticipate because it disclosed a “very different” article of manufacture than a lip implant, reasoning that it is appropriate to ignore the identification of the article of manufacture in the claim language, because whether a reference is analogous art is irrelevant to whether that reference anticipates.

The Federal Circuit said that a design claim is limited to the article of manufacture
identified in the claim; it does not broadly cover a design in the abstract. The Federal Circuit noted that in Curver Luxembourg, SARL v. Home Expressions Inc., 938 F.3d 1334, 1336 (Fed. Cir. 2019), it held that the design patent was limited to the particular article of manufacture
identified in the claim, i.e., a chair, and not other furniture.

The Federal Circuit noted that the claim identified a lip implant, and the Board found
that the application’s figure depicts a lip implant. As such, the claim is limited to lip implants and does not cover other articles of manufacture. There is no dispute that Blick discloses an art tool rather than a lip implant, so the Board’s anticipation finding therefore rested on an erroneous interpretation of the claim’s scope. Thus the Federal Circuit reversed the rejection of the claim.

As a result, a carefully selected title may allow a designer to get a patent where the design is similar to the designs for other types of protects. What’s in a name? Patentability.

Providing Software Does Not Make the Provider the “Final Assembler”

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In Acceleration Bay LLC v. 2K Sports, Inc., [2020-1700] (October 4, 2021), the Federal Circuit affirmed the district court’s claim construction of U.S. Patent No. 6,910,069 and its grant of summary judgment of non-infringement as to the ’069 and U.S. Patent No. 6,920,497, and dismissed the appeal of non-infringement U.S. Patent Nos. 6,701,344 , 6,714,966

With respect to the ‘069 patent, Acceleration Bay argued that the district court erroneously interpreted the claim term “fully connected portal computer” to include a “m-regular” limitation, i.e., a requirement that each participant in the network is connected to exactly m neighbor participants. Take Two argued that pointed out that the district court did not only construe the term “fully connected portal computer” to include the M-regular limitation, but it also construed the term “each participant being connected to three or more other participants” to include it. Since Acceleration Bay did not challenge the construction of each participant being connected to three or more other participants, Take Two argued that the appeal should fail, and the Federal Circuit agreed.

With respect to the ‘497 patent, the Federal Circuit said that Acceleration Bay proffered a “novel theory, without case law support,” that the defendants are liable for “making” the
claimed hardware components, even though they are in fact made by third parties, because defendant’s accused software runs on them, the customer, not Take Two, completes the system by providing the hardware component and installing Take Two’s software. Thus the “final assembler” doctrine of Centrak (where the accused infringer made hardware products and installed them by connecting them to an existing network to create an infringing system) did not apply.