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“No License, No Problem” – Is Qualcomm’s Ninth Circuit Antitrust Victory a Patent Exhaustion Defeat?

Patent

Guest post by University of Utah College of Law Professor Jorge L. Contreras. 

The Ninth Circuit’s recent decision in FTC v. Qualcomm (9th Cir., Aug. 11, 2020) is generally viewed as a resounding victory for Qualcomm.  In a strongly worded opinion, the Ninth Circuit reversed the entirety of the district court’s holding, which found that Qualcomm violated Sections 1 and 2 of the Sherman Act.  The Ninth Circuit exonerated Qualcomm with respect to each of its allegedly anticompetitive practices, concluding that these practices merely reflected the flexing of Qualcomm’s “economic muscle” with admirable “vigor, imagination, devotion, and ingenuity” (slip op. at 55).

Among Qualcomm’s challenged practices was its refusal to license rival chip makers under patents that are essential to one or more wireless telecommunications standards (standards-essential patents or SEPs).  While the District Court found that this refusal violated Qualcomm’s antitrust duty to deal under Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585 (1985), the Ninth Circuit disagreed.  It reasoned that Qualcomm did not violate any duty to deal because it uniformly refused to grant patent licenses to chip makers and did not “single[] out any specific chip supplier for anticompetitive treatment” (slip op. at 35).

In praising Qualcomm’s egalitarian approach toward rival chip makers, the Ninth Circuit points out that instead of granting licenses to these rivals, Qualcomm merely “declines to enforce its patents” against them “even though they practice Qualcomm’s patents” (id). As such, the Ninth Circuit quips that Qualcomm’s “policy toward rival chipmakers could be characterized as ‘no license, no problem’” (id., emphasis added).  Yet, as I discuss below, this approach could actually be a very big problem, not only for Qualcomm, but for all patent licensors seeking to extract revenue from the most lucrative point in the supply chain.

The Patent Exhaustion Doctrine and Chip Sales

As the Supreme Court explained in Quanta Computer, Inc. v. LG Elecs., Inc., 553 U.S. 617, 625 (2008), “The longstanding  doctrine of patent exhaustion provides that the initial authorized sale of a patented item terminates all patent rights to that item.”  That is, once the patent holder or its authorized licensee sells a product covered by a patent, that patent can no longer be asserted against a downstream buyer or user of the product. The patent is “exhausted” with respect to that particular product.

In Quanta, LG licensed three patents to Intel.  Intel manufactured chips allegedly covered by the patents, then sold the chips to Quanta for incorporation into Quanta’s PCs. LG then attempted to assert the patents against Quanta.  The court held that so long as the Intel chips “substantially embodied the patent[s]”, they were exhausted upon Intel’s sale of the chips to Quanta (553 U.S. at 633).  LG had no right to assert the patents against Intel’s customer Quanta.

Level Discrimination and SEPs

To grossly oversimplify, the supply chain for standardized wireless telecommunications functionality can be divided into three relevant tiers: (1) standards developers, (2) chip manufacturers, and (3) end user device (e.g., smartphone) manufacturers.  Standards developers like Qualcomm cooperate within standards-development bodies to create telecommunications standards like 4G LTE. Chip manufacturers then implement these standards in chipsets, which they sell to device manufacturers for incorporation into smartphones and other consumer devices.

What happens, however, when a standards developer like Qualcomm holds patents (SEPs) that cover a standard like LTE?  In theory, both the chips embodying the standard and the smartphones incorporating those chips infringe its SEPs.  Thus the SEP holder could choose to license those SEPs at either Tier 2 (chip manufacturers) or Tier 3 (device manufacturers). How to choose?

If a SEP holder licenses a chip manufacturer, then its SEPs covering a particular chip will be exhausted as soon as the manufacturer sell that chip to a device manufacturer, just as LG’s patents were exhausted in Quanta.  This means that if the SEP holder licenses a Tier 2 chip manufacturer, it cannot separately license, or collect royalties from, Tier 3 smartphone manufacturers for the same SEPs.  Qualcomm was keenly aware of the risk of patent exhaustion, which is why it refused to grant “exhaustive” licenses to chip makers like Intel. 411 F.Supp.3d at 748, 761.

If SEP royalties were standardized on a per-unit basis (e.g. $0.50 per product embodying the standard), then it would not matter whether the SEP holder licensed its SEPs at Tier 2 or Tier 3.  In either case it would receive the same payment.  However, due to longstanding industry practice, that is not how SEP royalties are calculated. Instead, they are usually based on some percentage (say 2.5%) of the price of the product embodying the standard.  So for a 4G LTE wireless radio chipset priced at $30, the royalty would be $0.75.  But for a $600 iPhone incorporating that chipset, the royalty would be $15.  For this reason, SEP holders strongly prefer to license their SEPs to end device makers (Tier 3).  As explained by one Ericsson licensing executive, “we choose to license the patents as late in value chain as possible …. One big advantage with this strategy is also that it is likely that the royalty income will be higher since we calculate the royalty on a more expensive product.” Or, as more succinctly expressed by a Qualcomm attorney at trial, licensing SEPs to device makers is “humongously” more lucrative than licensing  them to chip makers. 411 F.Supp.3d at 754, 758, 796.  The practice by which a SEP holder licenses its SEPs at only one tier of the supply chain is sometimes called “level discrimination.” (Courts and commentators disagree whether level discrimination is permitted under the nondiscrimination prong of a FRAND commitment – see this article for a discussion).

Pseudo-Licensing Deals with Chip Makers

If a SEP holder licenses its SEPs at Tier 3, what happens to the Tier 2 chip manufacturer? Does the chip that embodies the standard infringe the SEPs?  Yes, probably. Patent exhaustion only works downstream, not upstream.  That is, a smartphone manufacturer can’t infringe a SEP if it purchases a chipset from a licensed chip maker.  But a chip manufacturer can infringe a SEP even if its customer (the smartphone maker) has a license to use it.  Without a license, the Tier 2 chip maker is exposed to infringement claims by the SEP holder.

So what’s a chip maker to do?  Should it manufacture and sell chipsets that embody a standard even though it knows that it is infringing a host of SEPs?  Wouldn’t this infringement be willful, subjecting the chip maker to a risk of treble damages (see Sec. 5.2.1(1) of this chapter for a discussion of willful infringement of SEPs)?  It seems like an untenable situation for a chip maker.

To address this situation, Qualcomm appears to have developed various strategies.  In the 1990s, it granted chip makers purportedly “non-exhaustive licenses” that permitted them to manufacture chipsets covered by Qualcomm’s SEPs (in exchange for a royalty), but which explicitly excluded any license rights for the purchasers of those chipsets (9th Cir., slip op. at 14 n.7).  In Quanta, the Supreme Court rejected such a “non-exhaustive” arrangement between LG and Intel, holding that LG’s patent rights were exhausted upon Intel’s sale of covered chips to Quanta.  After this, Qualcomm amended its practices and began to enter into “CDMA ASIC Agreements” with chip makers. Under these agreements, “Qualcomm promises not to assert its patents in exchange for the company promising not to sell its chips to unlicensed [smartphone manufacturers]” (9th Cir., slip op. at 14, emphasis added).  According to the Ninth Circuit, these agreements “allow Qualcomm’s competitors to practice Qualcomm’s SEPs royalty-free” (id.).  Or, as the court pithily observed, Qualcomm’s “policy toward rival chipmakers could be characterized as ‘no license, no problem’” (id. at 35).

The Ninth Circuit found that because Qualcomm applied its “no license, no problem” policy uniformly toward all rival chip makers, it did not violate the antitrust laws.  But did Qualcomm, instead, open the door to a finding that its patents are exhausted at the chip maker level?

Do SEP Makers Inadvertently Grant Exhaustive Licenses to Chip Makers?

As observed by the Ninth Circuit, Qualcomm “promises not to assert” its SEPs against chip makers.  Its CDMA ASIC Agreements allow chip makers “to practice Qualcomm’s SEPs royalty-free”.  Ericsson, which employs a similar form of level discrimination, has referred to the result as “indirect licensing” of chip manufacturers (see Ericsson v. D-Link, 2013 U.S. Dist. LEXIS 110585, *80 (E.D. Tx. 2013)).

In assessing whether a patent has been licensed, courts have generally looked beyond the language used by the parties.  As the Supreme Court reasoned in De Forest Radio Telephone Co. v. United States, 273 U.S. 236, 241 (1927), “No formal granting of a license is necessary in order to give it effect. Any language used by the owner of the patent, or any conduct on his part exhibited to another from which that other may properly infer that the owner consents to his use of the patent in making or using it, or selling it, upon which the other acts, constitutes a license”.

A number of lower court cases have equated a license to a ‘covenant not to sue’.  As the Federal Circuit held in Ortho Pharmaceutical Corp. v. Genetics Institute, Inc., 52 F.3d 1026, 1031 (Fed. Cir. 1995), “A license may amount to no more than a covenant by the patentee not to sue the licensee for making, using or selling the patented invention.”

Given this precedent, SEP holders’ practice of tacitly permitting chip manufacturers to operate under their patents, whether by promising not to assert or “indirectly” licensing, looks suspiciously like licensing.  And, if SEP holders are granting chip manufacturers licenses to make and sell chips under their SEPs, then those SEPs should, by rights, be exhausted upon the sale of those chips to smartphone and other device manufacturers.  And this exhaustion should thereby prevent SEP holders from seeking to license and collect royalties from Tier 3 device manufacturers who incorporate those chips into their smartphones and other products.

This result should come as no surprise to anyone, least of all Qualcomm.  According to the District Court, a Qualcomm executive admitted to the IRS in 2012 that “if Qualcomm licensed a rival [chip manufacturer] … ‘[W]hen [the rival] sell[s] that chip to somebody who’s going to put the chip in a cell phone, okay, the licensee’s sale of that chip will exhaust our rights and then we won’t be able to collect a royalty on a cell phone that’s based on the price of the cellphone’” (411 F.Supp.3d at 796).  When Huawei apparently asserted that Qualcomm’s SEPs were exhausted after selling chips to Huawei, Qualcomm allegedly “threatened to cut off [Huawei’s] chip supply” (id. at 712).

These statements and actions indicate that Qualcomm was well-aware of the threat of patent exhaustion, and actually took measures to avoid the appearance of exhaustion (e.g., by converting its chip maker license agreements into CDMA ASIC Agreements).  Yet in trying to rebut the antitrust allegations made against it, and to overturn the District Court’s antitrust holdings, Qualcomm seems to have persuaded the Ninth Circuit that it effectively grants licenses to rival chip manufacturers. And, in doing so, Qualcomm may have armed its next smartphone licensee with a potent exhaustion defense to any claim of infringement.  Ultimately, “no license, no problem” may cause big problems for Qualcomm and other SEP holders that seek to license only at the most lucrative level of the supply chain.

Where is that Anticipation Rejection? Isn’t it Obvious!

Patent

by Dennis Crouch

The USPTO released a new data set of office action rejections, including an action-by-action breakdown of the basis for each rejection and the prior art relied upon. The first chart below shows the frequency that obviousness and anticipation rejections are found in office actions.  The shift since 2009 is quite interesting — obviousness rejections are up significantly following KSR while anticipation rejections are way down.

NoveltyRejections79% of what: Note here that the data set only includes office actions that contain at least one rejection.  Thus, for 2017 we could say that, 79% of actions with a rejection include an obviousness rejection.  A second big caveat is that the data set only includes applications that have been laid-open; and they had OCR scanning or other data problems with about 10% of the rejections and those have been excluded from the data set.

[Dataset][USPTO Whitepaper]

Intellectual Property Association (AIPLA) calls for the creation of a post-grant opposition procedure

Patent, Patent Legislation

Michael Kirk, Executive Director of the American Intellectual Property Law Association, recently testified before congress and called for the creation of an effective post-grant opposition procedure in the Patent Office.

Appearing at a congressional oversight hearing, Kirk pointed out that issued patents of questionable validity undermine the confidence of business and consumers. While the validity of such patents may be tested through litigation, reexamination, reissue, and interference proceedings, he observed that these options all suffer significant deficiencies. What is needed is a procedure that satisfies a competitor’s need for an adequate opportunity to challenge, the patent owner’s need for a prompt resolution of that challenge, and both parties’ need for an inexpensive proceeding.

Calendar of AIPLA Events:

Aug. 11-13: Practical Patent Prosecution Training for New Lawyers
Hyatt Regency Crystal City, Arlington, VA

Oct. 14-16:2004 Annual Meeting
Grand Hyatt Washington, Washington, DC

Supreme Court Patent Petitions: Seeking Guidance on Eligibility, Inventorship, and Procedure

Patent

by Dennis Crouch

A number of petitions are pending before the Supreme Court raising interesting patent issues, although none have been granted certiorari thus far.

Leading Eligibility Case: In next week’s long conference (Sept 26), the court will consider what I see as the current leading case of CareDx Inc. v. Natera, Inc., No. 22-1066. The case focuses on the question of whether the patent covering a new biologic diagnostic method was properly invalidated as directed to a natural phenomenon.

The CareDx invention relates to early noninvasive detection of organ transplant failure–an important and longstanding issue in the field. The detection method involves identifying DNA fragments from the transplant within the bloodstream, a challenge that had stumped scientists for over a decade.  Although various scientists had proposed mechanisms for using this information, the evidence shows more than a decade of failed ideas, and at least one article reported that the process is “difficult and impractical.”  The breakthrough came when Stanford researchers successfully applied high-throughput multiplex sequencing (“shotgun sequencing”) to detect single nucleotide polymorphisms (SNPs) unique to donor organs.  Of potential importance, the Stanford researchers did not create these new sequencing techniques, but they were the first to take advantage of them in this particular context and identified particular thresholds in crafting a method that works in this situation.  The claims were invalidated by the district court, and that judgment affirmed on appeal.

Another Natural Law Case: A second well written natural phenom petition was recently filed in ChromaDex, Inc. v. Elysium Health, Inc., No. 23-245.  The patent in that case claims a dietary supplement of nicotinamide riboside (“NR”) that increases the production of nicotinamide adenine dinucleotide (“NAD+”) — this one was crated by folks at Dartmouth.  I have written previously that the Supreme Court’s product of nature in Myriad is hard to square with the two-step abstract idea / law of nature cases of Alice & Mayo.  In its decision, the Federal Circuit concluded that the two-step approach is inapplicable in the natural phenomenon case — thus omitting consideration of any inventive concept going beyond the excluded portion.  The Hail Mary case of Killian v. Vidal, No. 22-1220, argues that the judge made eligibility exceptions represent a Fifth Amendment taking, a due process violation, and represent ultra vires actions.

IPR Estoppel: A second important case awaiting the late-September conference is Ingenio, Inc. v. Click-to-Call Technologies LP, No. 22-873, focusing on the scope of IPR estoppel under 35 USC 315(e).  The case asks whether the Federal Circuit erroneously extended IPR estoppel under 35 U.S.C. § 315(e) to all grounds that reasonably could have been raised in the petition. They focus on the the statutory language that, under their reading, applies the reasonably-could-have modifier in a much narrower context. To wit, petitioner argues that estoppel only applies to issues that could have been raised after the petition was granted– that petitioner “reasonably could have raised during that inter partes review.”

Favorite Pending Case – Inventorship: My favorite pending case is HIP, Inc. v. Hormel Foods Corporation, No. 23-185. HIP argues that the Federal Circuit’s decision improperly heightens the standard for joint inventorship by focusing on quantity rather than substance of inventive contributions. HIP contends any original contribution included in a claim, even if partial, warrants joint inventor status under 35 U.S.C. § 116.  In the case, a HIP engineer provided suggestions to Hormel on implementing a pre-cooked bacon method. HIP’s suggestion (using an infrared oven for the preheating step) made its way into the claims, the court concluded it was not significant enough to warrant joint inventorship.  For me, the case is largely about the strong presumption that the listed inventors are correct.

Additional Pending Petitions: Two more pending petitions. In Personalized Media Communication, LLC v. Apple Inc., No. 23-230, the patentee PMC argues that the court improperly applied prosecution laches to render its patents entirely unenforceable. PMC argues that under cases such as SCA Hygiene, a patentee’s compliance with statutory deadlines precludes equity from stepping in via laches.  I believe that PMC owns the most pre-GATT patents that are still within their patent term. Yes, even more than Gill Hyatt.   Finally, in Salazar v. AT&T Mobility LLC, No. 23-241, the petitioner argues that the Federal Circuit acted improperly by issuing an unforeseeably narrow claim construction on appeal.  Back in 1995 when these applications were filed, Apple had just released an updated Newton that included Graffiti handwriting recognition software from Palm.

Conclusion: The Supreme Court has not yet granted certiorari on any of these patent law petitions, but their treatment of these issues will provide valuable guidance. Cases like HIP v. Hormel and ChromaDex v. Elysium give the Court opportunities to clarify murky areas of the law around joint inventorship and patent eligibility. Meanwhile, petitions in Ingenio v. Click-To-Call and PMC v. Apple deal with critical procedural issues tied to post-issuance review and prosecution laches. The next few weeks may prove pivotal as the Court considers which of these issues merit its attention.

Peter v. NantKwest: Attorney Fees for Challenging PTO Decisions

Patent

Peter v. NantKwest, Inc., No. 18-801 (Supreme Court 2019)

I believe there are many situations where it makes sense to award reasonable costs and attorney fees to the prevailing party.  It goes further to ensure that the injured party is ‘made whole’ and it also discourages folks to push forward with weak arguments.

That said, I don’t like 35 U.S.C. 145. That provision awards the USPTO “all the expenses of the proceedings” regardless of whether the agency wins or loses.  The provision works to discourage the filing of Civil Actions to obtain a patent.  In NantKwest, the USPTO is asking that “all the expenses” be interpreted to include its personnel expenses, including attorney fees, win-or-lose.  The Federal Circuit ruled against the PTO and denied such fees, but the Supreme Court has agreed to hear the case:

Whether the phrase “[a]ll the expenses of the proceedings” in 35 U.S.C. 145 encompasses the personnel expenses the USPTO incurs when its employees, including attorneys, defend the agency in Section 145 litigation.

USPTO’s opening merits brief is due later this week, with amicus filings shortly thereafter.

Until recently, the case was known as Iancu v. NantKwest.  However, in a recent letter to the Supreme Court, Solicitor Noel Francisco indicated that Iancu “is recused in this matter.” Solicitor Francisco suggested that Laura Peter be substituted as petitioner in her official capacity as the Deputy Director of the United States
Patent and Trademark Office.  Thus, the case has become Peter v. NantKwest.

The letter does not indicate the reason for Iancu’s recusal. However, NantKwest is represented by top advocate Morgan Chu from Irell & Manella.  Iancu was managing partner at Irell when the representation began.

En Banc Federal Circuit: PTO Does Not Automatically Get Attorney Fees in Appeals and Civil Action Claims

Patent

by Dennis Crouch

In its new en banc opinion, the Federal Circuit has confirmed that the Patent Act does not require patent applicants to pay the USPTO’s attorney fees in Section 145 actions.  The USPTO had requested $100,000+ to compensate for the time of its in-house attorneys.

NantKwest, Inc. v. Iancu, 16-1794, 2018 U.S. App. LEXIS 20932 (Fed. Cir. 2018) (en banc).

35 U.S.C. 145 provides an unsuccessful patent applicant with the option of either (a) appealing the PTAB decision to the Federal Circuit or (b) filing a “civil action” in district court.  One kicker though – the statute provides that “All the expenses of the proceedings shall be paid by the applicant.”

Back in 2010, the Federal Circuit ruled that the statute allows the USPTO to collect expenses “regardless of the outcome.” Hyatt v. Kappos, 625 F.3d 1320 (Fed. Cir. 2010) (en banc).

In NantKwest, the original panel split on the meaning of “all the expenses” — with the majority holding that “expenses” include USPTO attorney fees (including in-house salaried attorney fees)..  That panel decision has now been rejected in a 7-4 decision with Judge Stoll penning the majority decision. Chief Judge PROST wrote in dissent and was joined by Judges Dyk, Reyna, and Hughes.

The court’s reasoning here is that the “American rule” on fees (each party pays for its own attorney fees) is a strongly embedded and any statutory rejection of the rule must be “specific and explicit.” The “all the expenses” language here does not meet that requirement — especially since such an interpretation would render this the only federal statute requiring “a private litigant to pay the government’s attorneys’ fees without regard to the party’s success in the litigation.”

The bottom line here is that patent applicants who challenge a PTAB decision will still be forced to pay other expenses such as printing costs and expert fees — but will not be required to pay the PTO attorney fees as a matter of course.

Rarity: Federal Circuit Reverses Jury Verdict of Non-Obviousness

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ABT Systems and University of Central Florida v. Emerson Electric (Fed. Cir. 2015)

The patent at issue here is owned by UCF and covers a circulating fan system. U.S. Patent No. 5,547,017. Co-Plaintiff (licensee) ABT is the company started by Armin Rudd who is the named inventor on the ‘017 patent.

Prior art systems, such as the one in my house allow for the circulation fan to be left-on even when the air conditioning system is off in order to better distribute conditioned air. The improvement offered by Rudd is to turn on the fan only periodically “after a preselected time period.” That intermittent approach would save “energy and power.”

A jury found that Emmerson’s high-end “Big Blue” thermostats infringe and awarded $300,000 in damages based upon a royalty of $2.25 per unit. The jury also held that Emerson had failed to prove the claims invalid as obvious.

On appeal, the Federal Circuit has reversed – finding that the district court should have granted JMOL on obviousness.

Invalidating a Patent on Obviousness: The question of obviousness asks whether the “differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time of the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. 103(a)(pre-AIA). In KSR v. Teleflex, the Supreme Court held that a “combination of familiar elements according to known methods” that “yield[s] predictable results” is likely invalid as obvious.

Here, elements of the patented system were all known in the art as was the motivation of improving circulation at reduced cost. Likewise, one prior art reference disclosed a “single-shot” fan operation that came on one-time after a heating/cooling cycle and another disclosed period fan-only cycles at times when there was no call for heating. The question then is whether it would have been obvious to create the claimed system of periodically activating and deactivating the fan after a predetermined time following a cooling cycle. Applying KSR, the Federal Circuit found that the law requires an obviousness finding.

Commercial Success: ABT had also argued that the commercial success and long-felt need of the invention should provide enough weight to prove the invention nonobvious. Objective evidence of nonobviousness, such as commercial success, long-felt need, failure of others, copying, and unexpected results can each provide evidence for the analysis. On appeal, however, the Federal Circuit was not persuaded that ABT had proven its case. In particular, ABT did not present evidence particularly linking product commercial success to the claimed periodic fan operation. Likewise, there was no particular evidence presented that Emerson’s infringing product market was being driven in any way by the recycling feature. ABT does have a number of patent licensees that weigh in favor of nonobviousness. However, the Federal Circuit held that those licenses were insufficient to overcome the convincing case of obviousness coming from the prior art.

Holding: Patent Claims Obvious

Biosig v. Nautilus: Indefiniteness on Remand

Patent,

By Jason Rantanen

Biosig Instruments, Inc. v. Nautilus, Inc. (Fed. Cir. 2015) (on remand from the Supreme Court) [2015 WL 1883265]  Download Opinion
Panel: Newman, Schall, Wallach (author)

About a month ago, I wrote an essay entitled “Teva, Nautilus and Change without Change.”  To the extent that anyone still harbored doubts about that premise in the context of Nautilus, the Federal Circuit’s opinion on remand should dispel them.  (Caveat: As I discussed in the essay, means-plus-function claims, such as the claims in Eon that Dennis will post about shortly, are a whole different ball of wax.  To me one of the most fascinating issues in patent law right now is whether the court will expand that framework to function-claiming more broadly.  The revised Nautilus opinion leaves that door a little more open than the original opinion.)

This dispute is well-known, so I’ll just summarize the procedural posture.  The district court granted summary judgment that the claims were indefinite.  On appeal, the Federal Circuit reversed, holding the claims not indefinite.  The Supreme Court granted certiorari to address the legal standard the Federal Circuit referenced on indefiniteness: that a claim is indefinite “only when it is ‘not amenable to construction’ or ‘insolubly ambiguous.'” 715 F.3d 891, 898 (2013).  In Nautilus, the Supreme Court rejected this standard:

Those formulations can breed lower court confusion, for they lack the precision § 112, ¶ 2 demands. It cannot be sufficient that a court can ascribe some meaning to a patent’s claims; the definiteness inquiry trains on the understanding of a skilled artisan at the time of the patent application, not that of a court viewing matters post hoc. To tolerate imprecision just short of that rendering a claim “insolubly ambiguous” would diminish the definiteness requirement’s public-notice function and foster the innovation-discouraging “zone of uncertainty,” United Carbon, 317 U.S., at 236, 63 S.Ct. 165, against which this Court has warned.

Nautilus, 134 S.Ct. at 2130 (2014).  The Court did not, however, resolve the overall dispute, instead returning the appeal to the Federal Circuit.

On remand the parties disputed “whether the Supreme Court articulated a new, stricter standard or whether, in rejecting the phrases ‘insolubly ambiguous’ and ‘amenable to construction,’ the Court was primarily clarifying that a patent’s claims must inform those skilled in the art with “reasonable certainty” of what is claimed.”  Slip Op. at 7-8.  The Federal Circuit did not directly answer this question, but suggested the latter through a nautical metaphor: “The Court has accordingly modified the standard by which lower courts examine allegedly ambiguous claims; we may now steer by the bright star of ‘reasonable certainty,’ rather than the unreliable compass of ‘insoluble ambiguity.'”  Id. at 9. The implication of this metaphor, combined with the passage preceding it, is that the problem the Court perceived was not that the insolubly ambiguous standard allowed too much imprecision in patent claims; the problem was that the insolubly ambiguous standard itself was too imprecise: “The Court found too imprecise our “insolubly ambiguous” standard,” Id. at 8.  The implication that Nautilus simply clarified, rather than raised, the standard for indefiniteness is further supported by an extensively-footnoted discussion of “reasonably certainty” as a “familiar standard,” one that “In the wake of Nautilus II, judges have had not problem operating under.”  Id. at 12.  The takeaway is that Nautilus offers a more precise standard, but not one that moves the target.

With this clarification in place, the panel concluded that its prior decision was correct: Biosig’s claims inform those skilled in the art with reasonable certainty about the scope of the invention.”  Id. at 14.  The court’s revised analysis turns entirely on the intrinsic evidence (“We revisit the intrinsic evidence here to make clear that a skilled artisan would understand with reasonable certainty the scope of the invention.”)  Notably missing from this discussion is any mention of Halliburton, which the court distinguished at length in the original opinion.  To the contrary: the description of the indefiniteness standard at the beginning of the opinion expressly quotes from that case: “Moreover, when a claim limitation is defined in ‘purely functional terms,’ a determination of whether the limitation is sufficiently definite is ‘highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area).’ Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008).”  Function-claiming remains an area to watch.

H.R. 6621: Proposed Modifications to the America Invents Act of 2011

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On November 30, Rep. Lamar Smith introduced H.R. 6621, a Bill titled "To correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code". Because of its late introduction, the Bill would need to be passed and enacted before the new Congressional session begins in early January. The most likely outcome is that no action will be taken and the Bill will be reintroduced in 2013. A second viable alternative is that the language of the Bill will be included as part of a massive fiscal cliff resolution Bill. The Bill includes a number of interesting elements. In that case, there would be virtually no official debate on the Bill or its contents.

Killing pre-GATT applications: There are currently around 200 applications pending that were filed prior to the 1995 patent term changeover. Once issued, those applications will have a patent term of 17 years from the issuance date. If issued as patents, these applications will likely be disruptive to settled interests in various industries. H.R. 6621 would alter the rules for calculating patent term for any application still pending 1-year from the Bill's implementation date. For those applications, the patent term would be 20 years from filing — meaning that those patents will likely be expired. Because of their pre-URAA filing date, those applications would not be eligible for patent term adjustment. At this point, I am unsure how the change would impact applications whose issuance was delayed due to a US Government secrecy order. On 2012, the USPTO has issued 24 applications with pre-URAA filing dates. Of those, five were delayed due to secrecy orders. One example is Patent No US8,278,099 is interesting in that it claims a monoclonal antibody to human thrombopoietin and is owned by Genentech. Prosecution of that application was delayed for 10 years pending the outcome of an interference in a related case. The application makes clear that the claimed antibody could be either isolated from a human or else prepared by recombinant or synthetic methods. This breadth brings the claimed antibody within the ambit of the Myriad gene patent challenge. If isolated human genes are not patentable what about isolated human antibodies? But I digress.

Post-Grant Dead Zone: Once the AIA is fully implemented, an issued patent will be immediately challengeable through a post-grant review. Then, after a nine-month window, challenges will be available through inter partes review. However, the AIA has bit of an implementation issued because (1) post-grant reviews will only be available for patents issued on applications filed on or after March 16, 2013; (2) inter partes reviews are available for all patents, but only those that have been issued for at least 9-months; and (3) the old inter partes reexaminations are no longer available. This creates something of a dead zone in that for the next couple of years patents will not be challengeable through some inter partes system for the first 9-months. H.R. 6621 would eliminate that 9-month dead zone by allowing inter partes reviews to be filed at any time for applications with an effective filing date before March 16, 2013.

Delaying Inventor's Oath: Section 115(f) of the AIA indicates that an either an oath, substitute statement, or sufficient assignment must be submitted prior to the notice of allowance of a patent application. The amendment would push that deadline back to be "no later than the date on which the issue fee for the patent is paid."

Less Patent Term Adjustment: The current language of Section 154(b) suggests an applicant may begin accumulating PTA as of the filing date of an international PCT application that is later followed by a US national stage application. The proposed amendment would eliminate that option by clarifying that the PTA calculations only begin "commencement of the national stage under section 371 in an international application." The change also provides that the PTO calculate PTA with the issuance rather than at the notice of allowance. The amendment would also clarify that PTA challenges may only be filed in the Eastern District of Virginia.

US as International PCT Office: H.R. 6621 would eliminate 35 U.S.C. 373. That section currently limits who may file international PCT applications at the USPTO. Under current rules, at least one of the inventors or the assignee must be a resident or national of the United States of America.

Sharing Fees Between the Patent and Trademark Side: The AIA requires that, for the most part, fees collected on patents be used to cover "administrative costs of the Office relating to patents" while fees collected on the trademark side be used to cover "administrative costs of the Office relating to trademarks." H.R. 6621 would eliminate that restriction and thus allow patent fees to pay for trademark operations and vice versa.

Derivation Proceedings: The AIA eliminated the ongoing viability of interference proceedings (although some will be pending for years) but created a new beast known as a derivation proceeding. H.R. 6621 would clean up the language for initiated a derivation proceeding under 35 U.S.C. §135(a). I need to think some about the language to understand the substance. I have created a rough mark-up of this language. (/media/docs/2012/12/CompareNewOldDerivation.docx).

Noticeably absent from this bill are changes to clarify the new section 102 or to modify the estoppel provisions of post-grant oppositions. Still pending is the Patent Law Treaties Implementation Act of 2012 and the Saving High-Tech Innovators from Egregious Legal Disputes Act of 2012. In my estimation, the first still has a good chance of passing this term while the second does not.

Related articles
Draft Bill Proposes Fixes To America Invents Act
America Invents Act Technical Corrections
Lame Duck Patent Reform: AIA Technical Corrections

An Empirical Study of the Role of The Written Description Requirement in Patent Prosecution

Academic Studies, Articles and Publications, En Banc, Enablement, Patent, ,

Table 3[Download the Draft Essay]

Essay Overview: In the pending case of Ariad v. Eli Lilly, an en banc Federal Circuit is considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curiae brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.

This essay presents the results of a retrospective empirical study of the role of the written description requirement in patent office practice. It is narrowly focused on rebutting the USPTO’s claim that the separate written description requirement serves an important role in the patent examination process. To the contrary, my results support the conclusion suggested by Chief Judge Michel during oral arguments that it is indeed “exceedingly rare that the patent office hangs its case on written description.”

For the study, I analyzed 2858 Board of Patent Appeals and Interference (BPAI) patent opinions decided January-June 2009. Written description issues were decided in 123 (4.3%) of the decisions in my sample. Perhaps surprisingly, I found that none of the outcomes of those decisions would have been impacted by a legal change that entirely eliminated the written description requirement of Section 112 so long as the USPTO would still be allowed to reject claims based on the addition of “new matter” (perhaps under 35 U.S.C. Section 132). New-matter style written description requirement rejections were outcome-determinative in 20 of the 2858 cases – about 1.0% of the cases in my sample. (I am very confident that the PTO will retain its ability to make new matter rejections even if the separate written description requirement is eliminated.)

Although there may be valid reasons for retaining a separate written description requirement, this study safely leads to the conclusion that the government’s conclusory statements regarding the doctrine’s critical importance for patent examination lack a factual basis.

Continue reading the essay. [PDF]

These results fit well with those of UMKC professor Christopher Holman that he reported in his 2007 article, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO , 17 ALB. L.J. SCI. & TECH. 1, 62 (2007).

What is a troll patent and why are they bad?

Academic Studies, Articles and Publications, Patent,

By TJ Chiang (Professor at George Mason Law School). Professor Chiang wrote the following squib after reading yet another article complaining about patent trolls.

There is much debate and controversy over the term "patent troll." Let me suggest a fairly narrow definition, but one that identifies a category of patents with distinct problems. Moreover, let me suggest that we should talk about individual patents as "troll patents," rather than entire entities as patent trolls. A troll patent is one that:

  1. Is owned by someone that does not practice the invention.
  2. Is infringed by, and asserted against, non-copiers exclusively or almost exclusively. By copying I mean any kind of derivation, not just slavish replication.
  3. Has no licensees practicing the particular patented invention except for defendants in (2) who took licenses as settlement.
  4. Is asserted against a large industry that is, based on (2), composed of non-copiers.

The problem with a patent troll—or, more accurately, the particular troll patent—that fits all four conditions above is that the troll patent does only two things. First, it gathers dust in the patent office. Second, it inflates prices on products. The patent itself contributes nothing useful to society, in so far as the people who actually make anything useful would have done it equally in the absence of the patent.

These four conditions also rule out a few non-practicing entities; or, rather, many of the patents held by these entities. University-held patents are largely not troll patents, in so far as they are often on substantial advances where the infringers copy. Individual inventors are also not always trolls. An individual inventor that licenses others to commercialize the invention is not a troll; nor where the inventor actually has something significant that gets pirated. But a patent owner who sits in wait to ambush an industry later, with a patent that does nothing otherwise except gather dust, is a troll.

One hypothetical that will surely be thrown at me is the individual inventor who tries to commercialize the invention, but fails, and then sues the industry years later. This inventor is a visionary ahead of his time who was merely unlucky. On the other hand, this inventor still contributed nothing useful to society. It is worth emphasizing the fact that, by my hypothetical, the industry produced the same technology independently, without copying anything from the patent. In the absence of copying by someone else or the commercialization of the product through the patent, I do not see the inventor as having done society much of a favor.

SCOTUS: Three Potential Patent Cases

Patent

At the “long conference” last week, the Supreme Court considered the fate of 13 pending petitions for writ of certiorari.  Three cases have survived. In two, the Court invited the Solicitor General to file an amicus brief “expressing the views of the United States.”

  • Teva v. GSK, 22-37 (Skinny Label)
  • Interactive Wearables v. Polar Electro, 21-1281 (Eligibility)

CVSG.  The SG’s brief typically takes several months to draft and so we’ll likely not see further action in these cases until 2023.

The court took no action in Juno v. Kite, 21-1566 (full scope written description), meaning that the case will be reconsidered at a later conference. The remaining 10 petitions were denied certiorari.

  1. CustomPlay, LLC v. Amazon.com, Inc., No. 21-1527
  2. Gilbert P. Hyatt v. United States Patent and Trademark Office, No. 21-1526
  3. Worlds Inc. v. Activision Blizzard Inc., No. 21-1554
  4. SawStop Holding LLC v. United States Patent and Trademark Office, No. 22-11
  5. Larry G. Junker v. Medical Components, Inc., No. 22-26
  6. CPC Patent Technologies PTY Ltd. v. Apple Inc., No. 22-38
  7. Ampersand Chowchilla Biomass, LLC, et al. v. United States, No. 22-69
  8. Aaron G. Filler, et al. v. United States, No. 22-53
  9. Lakshmi Arunachalam v. Kronos Incorporated, No. 22-133
  10. Biogen International GmbH, et al. v. Mylan Pharmaceuticals Inc., No. 21-1567

Law School Canons: Ford – The New Personal Jurisdiction Quick Reference Guide

Patent

Editor’s Note: Avery Welker is a rising 2L at Mizzou and likely a future patent attorney. He authors a series linking law school canonical cases with intellectual property counterparts. You can email ideas for future posts to avery@patentlyo.com.  – Dennis Crouch

By Avery Welker

This past Spring semester, I had Civil Procedure II on my schedule. As taught this year, Civil Procedure II took us through personal jurisdiction, subject matter jurisdiction, and finished off with the Erie doctrine. Personal jurisdiction was the bulk of our semester, taking us through midterms. I had my midterm on March 19, 2021 – six days before the Ford Motor Co. v. Montana Eighth Judicial Dist. Ct. decision. Ford Motor Co. v. Montana Eighth Judicial Dist. Ct., 141 S.Ct. 1017 (2021). Prof. Crouch[1] diligently placed Ford on our class’s radar as the midterm approached, and I was crossing my fingers every day to hope that my new Civil Procedure book wasn’t going to become outdated less than six months after I bought it.

Luckily, that wasn’t the case! Instead of a radical ripple effect on personal jurisdiction, it made a splash in another way: expanding on our understanding of due process and specific jurisdiction. As of May 24, 2021, 63 cases have cited Ford. Upon reading Ford, it’s easy to see why. Ford is a fantastic resource for personal jurisdiction, elaborating on general and specific personal jurisdiction, expanding understanding of minimum contacts, and giving a north star to perform the analyses. Id. at 1024-25.

Ford’s utility as a roadmap is immediately apparent. One example stems from a budding Trademark infringement suit: Galaxy America, Inc. v. EZ Inflatables, Inc., No. 2:19-cv-855-JES-MRM, slip op. at *1 (M.D. Fla. May 12, 2021). Galaxy America, Inc. (Plaintiff / Galaxy) alleged that EZ Inflatables, Inc. and its owner, Edgar Abraamyan (Defendants / EZ Inflatables), designed and sold knock-off products based on Galaxy’s designs. Id. Galaxy designs various commercial amusement inflatables (e.g., slides, obstacle courses, etc.), marketed under their TOXIC® trademark and Galaxy’s trade dress. Id. This decision partly responds to Abraamyan’s Rule 12(b)(2) motion to dismiss all counts against him for lack of personal jurisdiction. Id.

In performing the personal jurisdiction analysis, the Middle District of Florida lays out the roadmap for the examination, indicating that the court will need to go through specific and general jurisdiction analyses. Id. at *2. Here, the court produces a lengthy quote from Ford, setting the scene for the examinations. The gist of Abraamyan’s argument is that he is not a Florida resident and has insufficient contacts with Florida to warrant the exercise of personal jurisdiction. Id. at *3.

Of course, that is the same song and dance as every personal jurisdiction question hypo given in Civil Procedure classes. In Civil Procedure II, the analysis pattern I learned flowed from first looking to a long-arm statute, seeking out any traditional Pennoyer bases of personal jurisdiction (e.g., presence), and performing an International Shoe minimum contacts analysis.

The Middle District of Florida follows the pattern set out by Ford. The court first analyzes whether Florida may exercise general jurisdiction over Abraamyan, which it declines to assert. Id. at *4-5. Next, the court looks to whether Galaxy pled sufficient facts to plausibly demonstrate specific jurisdiction, based on directing tortious activity to Florida, satisfying Florida’s long-arm statute and the court’s exercise of personal jurisdiction. Id. at *6.

At this point in the decision, my understanding of personal jurisdiction expanded. It was often easy to take the statutory authorization for granted or as a given in class. Generally, most of our analysis came from the multitude of court cases involving personal jurisdiction (e.g., International Shoe, Bristol-Myers Squibb, Daimler A.G., etc.). For me, it serves as a reminder that the analysis must cover all the bases in the analysis. In my first reading of this decision, I assumed that what the court was doing in the specific jurisdiction was a pared-down version of a minimum contacts analysis. Instead, it was what we usually readily assumed in a classroom setting.

Upon finding that the tortious activity alleged by Galaxy was plausible, the court continues the personal jurisdiction inquiry into a third prong of due process under the Fourteenth Amendment. Id. Here is where the comfortable terms “purposeful[] avail[ment],” “arise out of or relate to,” and “traditional notions of fair play and substantial justice” come into play. Id. The court finds that personal jurisdiction is authorized and fair. Id. at *7. Soon, I will be taking a look more in-depth at these factors in future posts.

Personally, Civil Procedure was one of the most interesting classes I had in my 1L. The Ford decision handed down a half-semester’s worth of studying in one neatly wrapped decision. While the Galaxy decision didn’t necessarily take advantage of the more heavy-hitting parts of Ford (e.g., expanding on the “arise out of or relate to” from Bristol-Myers Squibb, see footnote 1.), the decision used the succinctly worded descriptions of specific and personal jurisdiction as their targets for analysis.

Ford will be my quick-reference guide for personal jurisdiction for the time being!

[1] See Prof. Crouch’s Patently-O post about Ford here: https://patentlyo.com/patent/2021/03/montana-personal-jurisdiction.html

Supreme Court End of Term Updates

Patent

by Dennis Crouch

The Supreme Court decided only two patent cases this term.  Helsinn is somewhat important for many patentees and certainly the PTO; while Return Mail more narrowly focuses on the role of Federal Government agencies in challenging patents:

  • Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 139 S.Ct. 628 (2019) (non-public sales are still “on sale” under the America Invents Act (AIA) rewriting of 35 U.S.C. 102).
  • Return Mail, Inc. v. United States Postal Service, et al., 139 S.Ct. 397 (2019) (IPR statute does not provide for petitions filed by the Federal Gov’t.).

Certiorari has been granted in only one additional patent case: Peter v. NantKwest. That case asks whether the USPTO is permitted by statute to recover attorney fees associated with § 145 civil actions.

An applicant dissatisfied with the decision of the [PTAB] . . . may . . . have remedy by civil action. . . . The court may adjudge that such applicant is entitled to receive a patent for his invention, as specified in any of his claims. . . . All the expenses of the proceedings shall be paid by the applicant.

35 U.S.C. § 145. In this case Laura Peter, USPTO Deputy Director, is the named petitioner on behalf of the Government, standing in for Dir. Iancu who has a conflict of interest in the case. (Irell & Manella represents NantKwest, and Iancu was managing partner at Irell when the representation began.)

In many other countries, litigation losers commonly pay the attorney fees of the victor.  One argument against that approach is an access-to-justice problem — parties without much money will not be able to find representation if there is a good chance that they’ll have to pay the other-side’s attorney fees upon losing.  In its amicus brief supporting the Government, R Street (Charles Duan) argued that only rich pharmaceutical companies are bringing these cases. “There is thus little reason to believe that those additional expenses will greatly affect the strategic calculus of those patent applicants likely to make legitimate use of § 145.”

As R Street‘s brief outlines, § 145 are used rarely — usually for the most potentially valuable pharmaceutical patents – with top lawyers handling the case (such as Irell & Manella).  The real shift from the outcome may come from the USPTO — if it knows someone else is footing the bill, the USPTO may fight these cases harder.

Upcoming Soon: The Supreme Court has one final conference set this term (June 20) and is slated to rule on a number of pending petitions for certiorari:

  • InvestPic, LLC v. SAP America, Inc., No. 18-1199  (physicality requirement for eligibility);
  • Romag Fasteners, Inc. v. Fossil, Inc., et al., No. 18-1233 (profit disgorgement under the Lanham Act);
  • Ariosa Diagnostics, Inc. v. Illumina, Inc., No. 18-109 (prior art date for unclaimed disclosures in a provisional filing);
  • Texas Advanced Optoelectronic Solutions, Inc. v. Renesas Electronics America, Inc., fka Intersil Corporation, No. 18-600 (infringement associated with and “offer” made in the US to actually “sell” a product in a foreign country);
  • Dex Media, Inc. v. Click-To-Call Technologies, LP, et al., No. 18-916 (Is the 315(d) time-bar triggered by prior lawsuits that were dismissed without prejudice?); Atlanta Gas Light Company v. Bennett Regulator Guards, Inc., No. 18-999 (same); Superior Communications, Inc. v. Voltstar Technologies, Inc., No. 18-1027 (same). .

Rather than guessing at the court’s potential decisions as to whether or not to grant certiorari, I’ll just wait a few days on these to know the outcome.

We also have the beginnings of a heap of new cases for consideration next term:

  • HP Inc., fka Hewlett-Packard Company v. Steven E. Berkheimer, No. 18-415 (fact-law divide in eligibility);
  • Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817 (threshold of a natural phenomenon);
  • Google LLC v. Oracle America, Inc., No. 18-956 (copyright for software interfaces).
  • Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., et al., No. 18-1280 (obviousness and blocking patents)
  • Hyatt v. Iancu, No. 18-1285 (reopening prosecution after successful appeal; “Whether MPEP § 1207.04 violates patent applicants’ statutory right of appeal following a second rejection.”);
  • Senju Pharmaceutical Co., Ltd., et al. v. Akorn, Inc., No. 18-1418  (R.36 judgments; holistic approach to obviousness)
  • Glasswall Solutions Limited, et al. v. Clearswift Ltd., No. 18-1448 (eligibility on the pleadings; Berkheimer question);
  • Enplas Display Device Corporation v. Seoul Semiconductor Company, Ltd., No. 18-1530 (can foreign sales qualify as induced infringement of a U.S. patent — if defendant knew that “the components might be incorporated by third parties into infringing products that might be sold by other third parties in the United States.”)
  • Zimmer, Inc., et al. v. Stryker Corporation, et al., No. 18-1549 (more on treble damages — is negligence enough?)

This last set of cases won’t see any light until at least October 2019 when the Court returns from its summer break.

Although Motivated to Try; No Reasonable Expectation of Success

Patent

by Dennis Crouch

Novartis Pharm. v. West-Ward Pharm. (Fed. Cir. 2019)

West-Ward (now known as Hikma) is seeking to make and sell a generic version of the Novartis chemotherapy drug everolimus (Afinitor).  After filing its Abbreviated New Drug Application (ANDA), Novartis sued, alleging infringement of its U.S. Patent 8,410,131.

Following a bench trial, the district court sided with the patentee – finding the claims enforceable – not obvious. Novartis Pharm. Corp. v. West-Ward Pharm. Int’l Ltd., 287 F. Supp. 3d 505 (D. Del. 2017).  On appeal, the Federal Circuit has affirmed.

The claims at issue are method-of-treatment claims with one step — “administering … a therapeutically effective amount” of everolimus.  The preamble of claim 1 indicates that the treatment is for “inhibiting growth of solid excretory system tumors.”  Dependent claims 2 and 3 add limitations that the treatment is for a kidney tumor or “advanced solid excretory tumor.”

At the time of the patent filing, the compound (everolimus) was already known as an mTOR inhibitor; and mTOR inhibiors were known to inhibit tumor growth. Everolimus a derivative of rapamycin and structurally similar to temsirolimus — both of which were already identified as chemotherapy treatments for similar cancer types.

The district court took this evidence and agreed that a person of skill in the art would have been motivated to pursue everolimus as a potential treatment for advanced solid tumors. However, the court’s opinion then seemed to contradict itself by saying that there was no motivation to combine the prior art.   The district court also found that everolimus was one of many different research paths and that the prior art was not sufficient to create “a reasonable expectation of success in using everolimus” to treat advanced kidney tumors.

On appeal, the Federal Circuit rejected the district court’s confusing motivation-to-combine analysis, but agreed ultimately that the claims were not proven invalid (with clear and convincing evidence).  In particular, the appellate panel agreed with the lack of reasonable expectation of success.

Truthfully, this doctrine confuses me.  The claims simply call for administering an effective amount of everolimus to treat a solid tumor; and the courts held that a person of skill in the art would have been motivated to pursue administration of everolimus as a potential treatment. In addition to this motivation, the courts also require clear and convincing evidence of a “reasonable expectation of success.”  You might divide these into “a reason to try” and “reason to believe that the attempt would be successful.”

A party seeking to invalidate a patent based on obviousness must prove “by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348 (Fed. Cir. 2007)).

Another way to think about the doctrine here is that a creation that is “obvious to try” would still be patentable if the attempt was unlikely to succeed.  This situation comes up most often in situations involving many different potential solutions and it would be “obvious” to try each one until the solution is found.

Motivation to Combine: Regarding motivation to combine, the Federal Circuit particularly held that the district court had improperly required the patentee to prove that PHOSITA “would have selected everolimus over other prior art treatment methods.”  That heightened standard does not comport with the law and thus is not required.

I’ll note here that the district court’s approach was appropriate in the setup involving modification of a lead compound.  Precedent asks for an indication that the lead compound would have been selected over other potential lead compounds.  Here, however, the compound was already known and the only “new” element is giving an effective amount to a patient for the purpose of treating a particular illness.

The district court … appeared to apply or conflate the standard for these types of cases by requiring clear and convincing evidence that a person of ordinary skill “would have been motivated to select everolimus.” To the extent the district court required a showing that a person of ordinary skill would have selected everolimus over other prior art compounds, it erred. The proper inquiry is whether a person of ordinary skill would have been motivated to modify the prior art disclosing use of temsirolimus to treat advanced RCC with the prior art disclosing everolimus. This question was answered affirmatively when the district court found that a person of ordinary skill “would have been motivated to pursue everolimus as one of several potential treatment options for advanced solid tumors, including advanced RCC.”

Reasonable Expectation of Success: Despite a motivation to pursue treatment, the district and appellate court found that the claimed treatment would not have been obvious because the prior art did not show a sufficiently high “expectation of success.”

Note here that the requirement is an “expectation” of success — would PHOSITA have expected that the drug would work?  In this case, at the time of the invention, there was no clinical data on everolimus (as an anti cancer agent) and no completed trials for the other similar compounds (only phase I safety-focused data).  And, the district court noted that there had been many many past attempts to find a compound that works — most of them starting with some promise.   On appeal, the Federal Circuit found that the rebuttal evidence and arguments made by the patentee were sufficient to defeat an obviousness finding — giving deference to the district court factual findings.

The district court reviewed the [presented] evidence, determined that the molecular biology of advanced RCC was not fully understood, recognized the limitations in the temsirolimus phase I data, and found that such data did not provide a person of ordinary skill with a reasonable expectation of success. We hold that the district court did not err in its determination and affirm its conclusion that claims 1–3 of the ’131 patent would not have been obvious in view of the asserted prior art.

Non-Obviousness affirmed.

Athena Diagnostics v. Mayo

Patent

The following are really more notes for myself rather than an article or essay – DC

The pending appeal in ATHENA DIAGNOSTICS, INC. v. MAYO COLLABORATIVE SERVICES, LLC is quite interesting.  As in Mayo v. Prometheus, the district court dismissed Athena’s medical diagnostic methods as directed toward laws of nature.  The case is now on appeal, and Athena’s attorneys have argued that this case is different.  In addition to the party briefs, several amici have also filed.  Oral arguments were held on October 4, 2018 — and involved a thoughtful discussion by Judges Lourie, Newman, and Stoll as well as White & Case Fenwick attorney Adam Gahtan (representing Athena and Oxford) and Fish & Richardson attorney Jonathan E. Singer (representing Mayo). [mp3].   Judge Lourie’s comment about the technology here is that the claims cover “medical research rather than product development.”

Claim 7 is at issue in the case. The claim is directed to a diagnostic method :

1. A method for diagnosing neurotransmission … disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising:

the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of MuSK.

7. A method according to claim 1, comprising:

contacting MuSK . . . having a suitable label thereon, with said bodily fluid,

immunoprecipitating any antibody/MuSK complex . . . from said bodily fluid and

monitoring for said label on any of said antibody/MuSK complex …

wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to MuSK.

Note – Gahtan has jumped from White & Case to Fenwick.

Attorney Fees: What is the meaning of “all expenses?”

Patent

In a sua sponte en banc order, the Federal Circuit has announced its intent to reevaluate the NantKwest decision permitting the PTO to recoup its attorney fees in defending a Section 145 civil action.

Issue: Did the panel in NantKwest, Inc. v. Matal, 860 F.3d 1352 (Fed. Cir. 2017) correctly determine that 35 U.S.C. § 145’s “[a]ll the expenses of the proceedings” provision authorizes an award of the United States Patent and Trademark Office’s attorneys’ fees?

After being finally rejected by both the examiner and the PTAB, a patent applicant can then take its case to court.  The Statute provides two options – either (1) a direct appeal to the Federal Circuit or (2) filing a civil action in district court to pursue a trial on the merits under 35 U.S.C. 145.

An oddity of Section 145 civil action is the last line which states: “All the expenses of the proceedings shall be paid by the applicant.”  In 2010, the en banc Federal Circuit ruled that the statute means what it says – expenses are to be paid by the applicant “regardless of the outcome.” Hyatt v. Kappos, 625 F.3d 1320 (Fed. Cir. 2010) (en banc).  In NantKwest, the panel ruled that the “expenses” include attorney fees.

[Panel Decision][Patently-O Write-up]

The panel decision was split – with Judges Prost and Dyk in majority and Judge Stoll in dissent and arguing that the term “expenses” is not sufficient to overcome the traditional american rule regarding attorney fees.

Oil States: Trump Admin Supports AIA Trial Proceedings

Patent, , , ,

Oil States v. Greene’s Energy (Supreme Court 2017).

After receiving party briefs in this case, the Supreme Court requested a responsive brief from the Michelle Lee in her role as PTO Director on the constitutionality of the AIA trial system.  That brief has now been filed by the new acting Solicitor General Jeff Wall who handled a number of patent cases in private practice.  Despite the regime change, the SG’s office continues to strongly support the AIA Trial system and the brief argues strongly that patents are public rights that may be subject to administrativ review:

Patents are quintessential public rights. Pursuant to its constitutional authority to “promote the Progress of Science and useful Arts” by establishing a patent system, U.S. Const. Art. I, § 8, Cl. 8, Congress created the USPTO, an agency with “special expertise in evaluating patent applications.” Kappos v. Hyatt, 566 U.S. 431, 445 (2012). Congress directed that agency to issue a patent if “it appears that the applicant is entitled to a patent” under standards set by federal law, 35 U.S.C. 131. Patents accordingly confer rights that “exist only by virtue of statute.” Sears, Roebuck & Co. v. Stiffel Co., 376 U.S. 225, 229 n.5 (1964). . . . Petitioner’s constitutional arguments do not warrant this Court’s review.

[Read the Brief: 16-712_oil_states_energy_servs._llc_opp]  The Supreme Court has already denied certiorari in three prior constitutional challenges to the AIA trial mechanisms. MCM Portfolio v. Hewlett-Packard; Cooper v. Lee; and Cooper v. Square.  If Oil States is denied here, there are also several more cases waiting in the wings to raise the challenge again.

Oil States Energy Services v. Greene’s Energy Group

Cancellation of Progressive’s Business Method Patents Confirmed on Appeal

Patent, , , , ,

Progressive Insurance v. Liberty Mutual Insurance (Fed. Cir. 2015)

This case stems from a set of seven overlapping post-grant-review proceedings (CBM PGR) before the Patent Trial and Appeal Board (PTAB) that Liberty Mutual filed against Progressive’s “business method” patents. The patents relate to auto-insurance pricing based upon customer vehicle use patterns – such as the number of sudden stops over a given period of time – as well as online insurance policy adjustments. See U.S. Patent No. 8,140,358 as an example.

In the Covered-Business-Method Review, the PTAB found a number of Progressive’s claims invalid as either anticipated or obvious. On appeal, the Federal Circuit affirms in all respects.

Two different proceedings for the same patent: Liberty Mutual filed two different CBM proceedings against the ‘358 patent. In one, the Board invalidated all claims except for 1, 19, and 20 while in the other the second the Board invalidated all claims of the patent. These two decisions were released about 1-hour apart.

The first challenge on appeal was that the second judgment was improper because – according to Progressive’s theory – the Board lost jurisdiction once it issued the first decision. That theory stems from Section 325(e)(1) that prohibits a petitioner from “maintain[ing] a proceeding before the Office” on issues that “reasonably could have” been raised during a post-grant review that has already reached a final written decision. The argument here is that, once the PTO reached the first final judgment that the second case should immediately disappear. On appeal, the Federal Circuit rejected that approach finding (1) that the statute does not prevent the PTO from maintaining the proceeding and in any event (2) the PTAB indicated that the two decisions were “concurrent” even though actually made public about 1-hour apart. Finally, the Court noted that the PTO has statutory authority to decide how to deal with multiple related proceedings.

Written Description and Claiming Priority: On the merits, a substantial amount of the problem here dealt with patent families and the difficulty in understanding whether a later claim can properly claim priority to an earlier filed application. The PTO typically (except in Hyatt’s case) does not require a patentee to expressly connect each patent claim with its effective priority date. As a result, those arguments are typically saved until later in litigation (thus, the benefit of filing a CIP . . . )

Here, the claims in question included an interface module that produce a “driver safety score” – construed by the PTAB to mean a “calculated insurance risk value associated with driver safety.” The priority application disclosed “rating factors” that might include safety factors, but did not expressly disclose a risk value associated only with driver safety. (Note the seeming subtle shift in construction by the Federal Circuit). In any event, the ruling is that the priority application disclosed the genus but not the later claimed species – as such it does not meet the written description requirement. In this situation, the result is that the priority filing date for the particular patent at issue here is pushed back to the later filing and that date was predated by the intervening prior art disclosures.

= = = =

It does not appear that Section 101 was raised as a challenge:

1. A system that monitors and facilitates a review of data collected from a vehicle that is used to determine a level of safety or cost of insurance comprising:

a processor that collects vehicle data from a vehicle bus that represents aspects of operating the vehicle;

a memory that stores selected vehicle data related to a level of safety or an insurable risk in operating a vehicle;

a wireless transmitter configured to transfer the selected vehicle data retained within the memory to a distributed network and a server;

a database operatively linked to the server to store the selected vehicle data transmitted by the wireless transmitter, the database comprising a storage system remote from the wireless transmitter and the memory comprising records with operations for searching the records and other functions;

where the server is configured to process selected vehicle data that represents one or more aspects of operating the vehicle with data that reflects how the selected vehicle data affects a premium of an insurance policy, safety or level of risk; and

where the server is further configured to generate a rating factor based on the selected vehicle data stored in the database.

 

Functional Claims: Morse, Halliburton & Amgen

Patent

by Dennis Crouch

In the patent context, functional limitations describe inventions in terms of their function or intended use, rather than their specific structure or components. Such claims have been subject to much debate and litigation throughout the history of the US patent system. Notable Supreme Court cases like O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854) and Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946) significantly impacted patent practice and the balance between functional and structural claim drafting.

The pending Supreme Court case of Amgen Inc. v. Sanofi, No. 21-757 (2023) is another example, with the potential to further shift the landscape regarding functional claim limitations. The title of my essay on the case following oral arguments, “Bye Bye Functional Claims,” hints at my outlook. Although the patentee focused on other issues in its briefing, the Justices repeatedly questioned the permissibility of broad functional claim limitations.

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