Happy Thanksgiving!

The patent collection is an underused resource for solutions, and yes, it contains a solution to the biggest problem of the day. Back in 1980, Lucy Barmby invented a solution to overeating on Thanksgiving (and every other day):

Lucy Barmby’s U.S. Patent No. 4,344,424 on an Anti-Eating Face Mask.

Lucy may have solved the problem of turkey and pecan pie, but it looks as if gravy is still a threat. Beware, and have a happy holiday with family and friends.

To Claim a Range, Make it Clear You are a Claiming a Range

In Indivior UK Limited v. Dr. Reddy’s Laboratories S.A., [2020-2073, 2020-2142] (November 24, 2021), the Federal Circuit affirmed the PTAB’s decision in an IPR that claims 1–5, 7, and 9–14 are unpatentable, and that DRL failed to demonstrate unpatentability of claim 8.

The ’454 patent, which generally describes orally dissolvable films containing therapeutic agents. The ’454 patent issued as the fifth continuation of U.S. Patent Application 12/537,571, which was filed on August 7, 2009. This appeal involves the question whether Indivior can get the benefit of that 2009 filing date for the claims of the ‘454 patent, and in particular support for the claimed ranges:

Claim 1about 40 wt % to about 60 wt %
Claim 7about 48.2 wt % to about 58.6 wt %
Claim 8about 48.2 wt %
Claim 12about 48.2 wt % to about 58.6 wt %

Invidior pointed out that Tables 1 and 5 of the ‘571 application disclose formulations with 48.2 wt % and 58.6 wt % polymer, and discloses that “the film composition contains a film forming polymer in an amount of at least 25%
by weight of the composition.” Indivior argued that the combination of these disclosures encompasses the claimed ranges, and therefore provides a written description of them. DRL contended that a skilled artisan would not have discerned the claimed ranges because the ’571 application does not disclose any bounded range, only a lower endpoint and some exemplary formulations. DRL contended that a skilled artisan would not have discerned any upper range endpoint.

Regarding claim 1, the Federal Circuit agreed with the Board that there was no written description support in the ’571 application for the range of “about 40 wt % to about 60 wt %,” noting that the range was not expressly claimed in the ’571 application; and that the values of “40 wt %” and “60 wt %” are not stated in the ’571 application.

Regarding claims 7 and 12, the Federal Circuit also agreed with the Board that there is no written description support for the range of “about 48.2 wt % to about 58.6 wt %” in the ’571 application, noting that this range also does not appear in the ’571 application. While the endpoints of this “range” could be discerned from the Tables, the Federal Circuit said that constructing a range from this data “amounts to cobbling together numbers after the fact.” The Federal Circuit said that Indivior failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %.

Because Indivior did not contest that the claims would be anticipated without the benefit of the 2009 filing date the court affirmed the invaldity of the challenged claims, except claim 8, whose single data point was supported by the disclosure of the ‘571 patent.

This result is of course concerning to chemical practitioners who have or may one day fine the need to construct a range from disclosed datapoints. The Federal Circuit’s assurances that each case is fact specific is of little comfort if one find themselves in this predicament. The bottom line is if ranges are intended, ranges should be mentioned. It is unlikely that Invidior ever contemplated that the invention only worked at selected points, and not in between, Invidior apparently needed to make explicit what it thought was implicit. The issue in Invidior is not a problem in claiming ranges, but a problem in making clear that you are claiming ranges.

Arbitrator Decides Arbitratability

In Rohm Semiconductor USA LLC v. Maxpower Semiconductor, Inc., [2021-1709] (November 12, 2021), the Federal Circuit affirmed the district court’s decision compelling arbitration and dismissing ROHM USA’s declaratory judgment action without prejudice.

In 2007, ROHM Japan and MaxPower entered into a technology license agreement (“TLA”). Under the TLA,
ROHM Japan and its subsidiaries (collectively “ROHM”) were permitted “to use certain power [metal oxide semiconductor field effect transistors (‘MOSFET’)]-related technologies of” MaxPower (“Licensor”) developed under a
Development and Stock Purchase Agreement in exchange for royalties paid to MaxPower. The TLA, as amended in 2011, includes an agreement to arbitrate “[a]ny dispute, controversy, or claim arising out of or in relation to this Agreement or at law, or the breach, termination, or validity thereof.” The arbitration agreement provides that arbitration is to be conducted “in accordance with the provisions of the California Code of Civil Procedure” (“CCCP”).

In 2019, a dispute arose between ROHM Japan and MaxPower concerning whether the TLA covers ROHM’s silicon carbide MOSFET products. In September 2020, MaxPower notified ROHM Japan of its intent to initiate arbitration. Shortly thereafter, on September 23, 2020, ROHM USA, a subsidiary of ROHM Japan, filed suit.

Rohm USA argued that the CCCP is ambiguous, containing two apparently conflicting provisions regarding who determines arbitrability, but the district court found, and the Federal Circuit agreed, that the provisions were not in conflict, and the provision allowing the arbitrator to determine arbitribility controlled.

Rohm USA further argued that even if §1297.161 applies, it states that “[t]he arbitral tribunal may rule on its own jurisdiction,” which Rohm USA says it merely allows the parties to agree to waive a court determination, which ROHM USA does not want to do. The Federal Circuit disagreed, noting that while Rohm USA is correct that
“may” is generally a permissive verb, “may” as used in §1297.161 does not mean “may also,” as ROHM USA
urges. MaxPower’s interpretation of the permissive “may” as “may, if arbitrability is disputed,” makes much more
sense in this context.

Thus the court concluded that the Arbitrator should determine whether the dispute was arbitrable.

Veterans: Thank You for your Service

November 11 is Veteran’s Day, and a chance to thank all veterans for their service. Because of their willingness to defend us, we enjoy the freedom to live largely as we choose to and to pursue our interests. U.S. Patent No. 1,429,506 issued September 19, 1922, is, literally, a salute to veterans:

The invention is a doormat-operated animated figure, which issues a salute to someone who steps on the mat. The patent describes the figure as “an American Veteran of the World War,” not contemplating on December 4, 1919, when the application was filed, and the ink on the November 11, 1918, armistace barely dried, that we would soon again call on our soldiers to defend us in a second world war, and a number of other conflicts since.

To all verterans, thank you for your service and for our freedom.

Patent Venue Construed Strictly, Even in ANDA Litigation

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

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.