Acknowledging Juneteenth

While there were certainly inventors who were slaves, the patent system was unavailable to them. In an interesting case from 1857, a slave named Ned invented a “double plow and scraper,” which enabled a farmer to plow and scrape both sides of a row of cotton simultaneously. Ned was “owned” by Oscar J.E. Stuart, a lawyer and planter from Mississippi. Stuart tried to patent the invention first in Ned’s name and then in his own, but was denied by the Commissioner of Patents because Ned, as a slave, could not execute the required oath, and neither could Stuart, because he was not the inventor. Stuart, apparently having no sense or irony, complained that it would violate “equal protection” if slave owners could not patent the inventions of their slaves. Read more about this in Frye, Invention of a Slave, 68 Syracuse Law Review 181 (2018)

According to the Report of the Commissioner of Patents for the Year 1857, the invention of a slave could not be patented because a slave inventor could not take the patent oath, and in any event could not receive, own, or transfer a property right. This latter point was actually consistent with the laws in some states (e.g., Louisiana) that prohibited slaves from owner property, even if they could obtain it.

The Confederate States patent laws express permitted the owner to apply to patent the invention of slave, although it is not clear whether any slave owner took advantage of this during the short tenure of the Confederate States Patent Office. This provision may have been initiated by Confederate President’s Jefferson Davis, who, with his older brother Joseph Emory Davis, previously unsuccessfully attempted to get a U.S. patent on an improved propeller invented by Benjamin Thornton Montgomery, then a slave owned by Joseph.

155 years ago today, on June 19th, 1865, Major General Gordon Granger, landed at Galveston, Texas, and with his General Order 3, completed the elimination of slavery in the United States begun by Republican President Abraham Lincoln’s September 22, 1862, Emancipation Proclamation. The inability to get a patent seems trivial in comparison with the injustice of slavery; but this embarrassment of the patent system ended 155 years today.

Wrong or Even Purposefully Evasive Decisions on IPR Time Bar Are Not Reviewable

In Thryv, Inc., v. Click-To-Call Technologies, LP, [18-916] (April 20, 2020), the Supreme Court vacated the Federal Circuit’s decision vacating the PTAB’s Final Written Decision invalidating claims of U.S. Patent No. 5,818,836 relating to a technology for anonymous telephone calls.

Entities associated with Thryv, Inc. sought inter partes review of the ‘836 patent, and patent owner Click-to-Call argued that the petition was untimely under §315(b). The PTAB disagreed and instituted review, eventually issuing a final written decision reiterating its §315(b) decision and finding 13 of the patent’s claims unpatentable. Click-to-Call appealed the Board’s §315(b) determination. Treating the Board’s application of §315(b) as judicially reviewable, the Federal Circuit concluded that the petition was untimely, vacated the Board’s decision, and remanded with instructions to dismiss.

The Supreme Court held that 35 USC §314(d), which precludes judicial review of the USPTO’s institution decision, applies to §315(b)’s time prescription, and vacated the Federal Circuit’s decision and remanded.

The issue was whether a challenge based on §315(b) ranks as an appeal of the agency’s decision “to institute an inter partes review.” §314(d). The Supreme Court found no need to venture beyond Cuozzo’s holding that §314(d) bars review at least of matters “closely tied to the application and interpretation of statutes related to” the institution decision, because a §315(b) challenge easily meets that measurement. Section 315(b), sets forth a circumstance in which “[a]n interpartes review may not be instituted,” expressly governs institution and nothing more.

The Supreme Court said that this conclusion is strongly reinforced by the statute’s purpose and design. Congress designed inter partes review to weed out bad patent claims efficiently. Allowing §315(b) appeals, however, would unwind agency proceedings determining patentability and leave bad patents enforceable.

The Supreme Court rejected Click-to-Call’s argument that §314(d)’s bar on judicial review was limited to the USPTO’s threshold determination under §314(a) of whether the petitioner has a reasonable likelihood of prevailing. Finding Cuozzo is “fatal” to that interpretation.

Justice Gorsuch and Sotomayor dissented, with a persuasive explanation of not just how the majority got it wrong, but also why they are wrong, noting: “No matter how wrong or even purposefully evasive, the Director’s assessment of a petition’s timeliness is always immune from review.” According to Gorsuch and Sotomayor it was only the initial determination of a reasonable likelihood of success that was insulated from review, since this would necessarily be reviewed as part of the review of the Final Written Decision.

There just seems to be something wrong in allowing an administrative agency to determine an issue of law outside of its expertise (the significance of service of a complaint), and then barring the courts from reviewing it. It is bad policy to insulate the patent office from review, and bad precedent to insulate any administrative agency from review.

Similar Compounds at Overlapping pH’s Created Prima Facie Case of Obviousness

In Valeant Pharmaceuticals International, Inc. v. Mylan Phamaceuticals Inc., [2018-2097] (April 8, 2020) the Federal Circuit reversed and remanded that district court’s grant of summary judgment that claim 8 of U.S. 8,552,025 is not invalid.

The ‘025 claims stable methylnaltrexone pharmaceutical preparations. Claim 8 recites “[t]he pharmaceutical preparation of claim 1, wherein the preparation is stable to storage for 24 months at about room temperature.”

Mylan argued that the district court erred in at least two respects: (1) by failing to hold that Mylan established a prima facie case that claim 8 would have been obvious because the pH range in the claim overlaps with pH ranges in the prior art for similar compounds and (2) by resolving disputed fact issues at summary judgment.

The Federal Circuit agreed with Mylan that the record supports a prima facie case of obviousness. Here, the pH range recited in claim 8 clearly overlaps with the pH range in the record art, but none of the references disclose the same drug as the one claimed. The qestion was whether prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range can establish a prima facie case of obviousness. The Federal Circuit conclude that they can and, in this case, do. The Federal Circuit noted that its case law reflects an understanding that skilled artisans can expect structurally similar compounds to have similar properties, and that that an obviousness analysis can rely on prior art compounds with similar pharmacological utility in addition to structural similarity.

Because these three molecules bear significant struc-tural and functionality similarity, and because the prior art of record teaches pH ranges that overlap with the pH range recited in claim 8, Mylan has at least raised a prima facie case of obviousness sufficient to survive summary judgment.

Allegations of Infringement Should not have been Enjoined without Evidence of Bad Faith

In Myco Industries, Inc. v. Blephex. LLC, [2019-2374] (April 3, 2020), the Federal Circuit reversed the district court’s preliminary injunction enjoining BlephEx from making allegations of patent infringement and also from threatening litigation against Myco’s potential customers over U.S. Patent No. 9,039,718, entitled “Method and Device for Treating an Ocular Disorder,”

The Federal Circuit said that when a preliminary injunction prevents a patentee from communicating its patent rights, a court applies federal patent law and precedent relating to the giving of notice of patent rights. In such cases, the grant of a preliminary injunction is reviewed in the context of whether, under applicable federal law, the notice of patent rights was properly given. The Federal Circuit further said that federal law requires a showing of bad faith before a patentee can be enjoined from communicating his patent rights. A showing of “bad faith” must be supported by a finding that the claims asserted were objectively baseless, and an asserted claim is objectively baseless if no reasonable litigant could realistically expect success on the merits.

The Federal Circuit concluded that the district court abused its discretion when it granted a preliminary injunction enjoining patentee speech with-out a finding of bad faith. The Federal Circuit said that although a district court’s discretion to enter a preliminary injunction is entitled to substantial deference, the patent laws permit a patentee to inform a potential infringer of the existence of its patent. The Federal Circuit found that the district court neither made a finding of bad faith nor even adverted to the requirement. The Federal Circuit added that to the extent the district court made any factual findings relevant to bad faith, the court expressly declined to find that any of BlephEx’s statements were either false or misleading.

The Federal Circuit rejected Myco’s argument that it would be bad faith to accuse physicians with infringement in view of 35 U.S.C. § 287(c)(1), but the Federal Circuit said the statute did not make physicians “immune from infringement,” it merely prevents the patent owner from seeking a remedy. Further, the District Court found no evidence that any threats were made.

Finally the Federal Circuit vacated the finding that Myco was likely to succeed on the merits, finding several lapses in the district court’s efforts at claim construction.

The Federal Circuit concluded:

Speech is not to be enjoined lightly. Here, there is not even a finding, let alone a finding supported by evidence and a correct view of the law, that the speech restrained was either false or misleading. The district court abused its discretion when it granted a preliminary injunction en-joining BlephEx from making allegations of patent infringement without a finding of bad faith and with no adequate basis to conclude that allegations of patent infringement would be false or misleading.

Leap Patents

Even though 2020 is a leap year, there will be no leap patents this year because patents only issue on Tuesdays, and February 29 is a Saturday. The last leap patent issued February 29, 2000, and our next opportunity for a leap patent will not occur until February 29, 2028.

U.S. Patent No. 6,029,269, the last leap patent to issue, covered a Ballistic-Resistant Helmet and method for Producing the Same.

Leap patents also issued in 1972, 1944, 1916, and 1876.

You Mess with Me, you Mess with my Whole [Patent] Family

In Cheetah Omni LLC v. AT&T Services, Inc., [2019-1264] (February 6, 2020) the Federal Circuit affirmed the dismissal of claims for infringement of U.S. Patent No. 7,522,836.

AT&T (and its supplier Ciena) moved for summary judgment that Cheetah’s infringement claim was barred by agreements settling previous litigation between Cheetah and Ciena involving U.S. Patent No. 7,339,714 the patent-in-suit’s “Aunt”.

To dispose of the previous litigation, Cheetah granted to Ciena “a perpetual, irrevocable, worldwide, non-exclusive, fully paid-up license under the Licensed Patents to make, have made (directly or indirectly and solely for Ciena or its Affiliates), use, offer to sell, sell, and import and export the Licensed Products.” “Licensed Patents” were defined as:

(i) the Patents-in-Suit, and (ii) all parents, provisionals, substitutes, renewals, continuations, continuations-in-part, divisionals, foreign counterparts, reissues, oppositions, continued examinations, reexaminations, and extensions of the Patents-in-Suit owned by, filed by, assigned to or otherwise controlled by or enforceable by Cheetah or any of its Affiliates or its or their respective successors in interest at any time as of, prior to, on or after the Effective Date, whether filed before, on or after the Effective Date.

Relying on General Protecht Group Inc. v. Leviton Manufacturing Co., 651 F.3d 1355, 1361 (Fed. Cir. 2011), the district court determined that the ’836 patent was impliedly licensed as the grandchild of the expressly licensed ’925 patent of the ‘714 patent. The Federal Circuit agreed, noting that the presumption established in General Protecht provided a simple and clear resolution in the case. Because the ’925 patent was expressly licensed, the license also included an implied license to a continuation of its continuation, the ’836 patent-in-suit.

Because the licenses extend to both the ’836 patent and the accused AT&T products the district court properly granted summary judgment for AT&T and Ciena and dismissed the infringement suit.

It is Importation that Infringes under 35 USC § 271(g), Not Manufacture

In Syngenta Crop Protection, LLC v. Willowood, LLC, [2018-1614, 2018-2044](December 18, 2019) affirmed-in-part, reversed-in-part, vacated-in-part, and remanded the district court’s judgment in favor of all defendants on infringement of one patent at issue; and against Willowood, LLC, and Willowood USA, LLC, on infringement of the remaining three patents.

The Federal Circuit remanded the dismissal of Syngenta’s copyright claim for a more detailed determination whether FIFRA required defendants to copy the copied portions of Syngenta’s labels.

In a case of first impression reversed the district court’s requirement that that all steps of a patented process be performed by or at the direction or control of a single entity before infringement liability under 35 USC 271(g) can attach.

Section 271(g) provides that “[w]hoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer.” The Federal Circuit said that this language makes clear that the acts that give rise to liability under § 271(g) are the importation, offer for sale, sale, or use within this country of a product that was made by a process patented in the United States. The Federal Circuit said that nothing in the statutory language suggests that liability arises from practicing the patented process abroad. Rather, the focus is only on acts with respect to products resulting from the patented process. The Federal Circuit concluded that because the statutory language as a whole is clear that practicing a patented process abroad cannot create liability under § 271(g), whether that process is practiced by a single entity is immaterial to the infringement analysis under that section.

The Federal Circuit otherwise affirmed the infringement determinations.

Substantial Evidence Supported Jury Verdict that not all Infringing Uses were Reasonably Telated to Developing and Submitting Information to the FDA

In Amgen Inc. v. Hospira, Inc., [2019-1067, 2019-1102](December 16, 2019), the Federal Circuit affirmed the district court’s determination that Amgen’s U.S. Patent No. 5,856,298 was infringed and not invalid; fourteen batches of Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(1); Amgen had proven it was entitled to $70 million in damages; denying Amgen motion for judgment as a matter of law that Amgen’s U.S. Patent No. 5,756,349 was infringed.

After substantial evidence supporting the validity and infringement of the ‘298 patent, the Federal Circuit turned to the safe harbor provisions of 35 U.S.C. § 271(e)(1). The instruction to the jury said that “If Hospira has proved that the manufacture of a particular batch was reasonably related to developing and submitting information to the FDA in order to obtain FDA approval, Hospira’s additional underlying purposes for the manufacture and use of that batch do not remove that batch from the Safe Harbor defense.” Hospira complained that this improperly focused on Hospira’s intent for manufacturing batches of EPO.

The Federal Circuit disagreed, finding that the jury instructions properly articulated the legal principles underlying the Safe Harbor inquiry. Section 271(e)(1)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA. The Federal Circuit said that relevant inquiry, therefore, is not how Hospira used each batch it manufactured, but whether each act of manufacture was for uses reasonably related to submitting information to the FDA.2 The jury instructions properly asked whether each act of manufacture, that is, each accused activity, was for uses reasonably related to submitting information to the FDA. The Federal Circuit added that contrary to Hospira’s contentions, the instructions struck the appropriate balance by telling the jury that Hospira’s additional underlying purposes do not matter as long as Hospira proved that the manufacture of any given batch of drug substance was reasonably related to developing information for FDA submission.

Hospira argued that no reasonable jury could find that some of the batches it made were protected by the safe harbor, while some were not. However the Federal Circuit found that substantial evidence supported the jury’s finding that the batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA. There was testimony that Hospira was not required to manufacture additional batches after it made its initial batches. There was also testimony that stability testing was not required but would be part of a “continuing program for stability that is a postapproval commitment.

On the issue of damages, Hospira argued that its Daubert motion to disqualify Amgen’s damages expert should have been granted. However, the Federal Circuit found no reversible error, noting that the district court permitted Hospira to cross-examine Amgen’s expert and to present the testimony of its own damages expert, and make the very arguments it was now raising on appeal. The Federal Circuit said it was not unreasonable for the jury to choose a damages award within the amounts proposed by each expert, and affirm the district court’s denial of Hospira’s JMOL motion.

Lastly, the Federal Circuit agreed that the finding of non infringement of ‘349 patent was supported by substantial evidence.