by Dennis Crouch

Uniloc 2017 LLC v. Apple, Inc. and the Electronic Frontier Foundation (EFF) (Fed. Cir. 2020)

This is a case about open courts and the public nature of our civil justice system. During litigation, Uniloc designated some amount of material as “highly confidential” as defined by a protective order entered by N.D. Cal. Judge Alsup.  Apple then referenced the material in a motion to dismiss as did Uniloc in its brief-in-opposition. The parties filed motions to seal the material with the district court–with Uniloc indicating that the documents “contain sensitive, confidential and proprietary information related to financial data, licensing terms and business plans with respect to various Uniloc entities … disclosure of this extremely sensitive information would create a substantial risk of serious harm to the Uniloc entities.”

EFF then intervened into the case requesting the documents be unsealed (after first asking the parties to un-seal). The sealed information related to Uniloc’s ownership of its patents.  Because Uniloc was in the process of threatening and suing a dozens of of entities, that information was especially of-interest to the public.

The district court agreed with EFF, concluding that the “generalized assertions” of secrecy and harm were insufficient to “outweigh the public’s right” to know about the patent ownership.  The district court also noted that the sealed portions were “astonishing[ly]” broad – even including quoted portions of Federal Circuit decisions. Uniloc then submitted a revised motion to seal, which the district court rejected — holding that Uniloc should have done it right the first time but instead began its case by “over-classifying and then trying to get away with [it].”

The Federal Circuit has taken-up the interlocutory appeal under the non-statutory Collateral Order Doctrine:

To fall within the collateral order doctrine, “an order must at a minimum satisfy three conditions: It must [1] ‘conclusively determine the disputed question,’ [2] ‘resolve an important issue completely separate from the merits of the action,’ and [3] ‘be effectively unreviewable on appeal from a final judgment.’” Richardson-Merrell, Inc. v. Koller, 472 U.S. 424 (1985). . . . These requirements are met here.

Slip Op.

On the merits the Federal Circuit affirmed the original no-seal order but then vacated to consider interests of third-party licensees who had been promised confidentiality. In its decision, the court contrasted a prior decision in Apple v. Samsung.

Our decision in Apple I [ordering partial sealing] is not to the contrary. There, we concluded that the district court abused its discretion in refusing to redact certain product-specific financial information, such as profit, cost, and margin data, as well as certain proprietary market research reports. Importantly, however, the parties in that case supported the need for such redactions with detailed declarations describing both the competitive injury that would result if such information were disclosed and the significant efforts they had made to keep their product-specific financial information confidential. Furthermore, because the documents in question were not “introduced into evidence . . . the financial information at issue was not considered by the jury and [was] not essential to the public’s understanding of the jury’s damages award.”

Apple Inc. v. Samsung Elecs. Co., 727 F.3d 1214 (Fed. Cir. 2013).

The court went on:

In denying Uniloc’s sweeping motion to seal, the district court sent a strong message that litigants should submit narrow, well-supported sealing requests in the first instance, thereby obviating the need for judicial intervention. Because the court “took seriously the presumption of public access and did so in accord with precedent from the Supreme Court and [the Ninth Circuit],” Kamakana, we conclude that there was no abuse of discretion in its decision to deny Uniloc’s requests to seal its purportedly confidential information and that of its related entities.

Slip Op. With regards to the refusal for reconsideration, the court found that the local rules put the parties sufficiently on notice of what was required and so there was no compelling reason to give Uniloc a re-do.

Regarding third-party licensees, Several licensees submitted declarations to the court indicating that they wanted their material kept secret as was required by contract and separate court order (from prior litigation).  On remand, the district court should consider whether that third-party information includes any information “protectable as a trade secret or otherwise entitled to protection under the law” and thst should be redacted from public view.

= = = =

An important aspect of the decision is that it asks district courts to balance the sealing factors on a case-by-case basis.  For each portion being redacted, the court should consider both any “compelling reasons” for redacting from public view against the public’s interest in viewing the particular material.  In this process, the court should recognize that the party or parties asking for sealing have the burden of persuasion.

The court also spells out the process: (1) make sure that the party/parties asking for redaction have presented compelling reasons for redaction supported by evidence.  If not, then no redaction.  (2) If compelling reasons have been presented, then also consider the public’s interest in viewing the particular material. One important implicit point here is that even if there are compelling reasons to seal, that may still be outweighed by the public interest.  Here, the district court considered both the compelling reasons and the public’s interest.  On appeal, the Federal Circuit stopped at step-1 and held that Uniloc failed to present a compelling reason to seal.  Thus, the appellate panel did not “address” whether the lower court’s public interest findings were correct. Slip Op. at FN 6.

One note – the Federal Circuit attempted to follow 9th Circuit law in this case and so the approach will be different in different venues.

by Dennis Crouch

Fitbit, Inc. v. Valencell, Inc. (Fed. Cir. 2020)

In this decision, the Federal Circuit makes two important statements going forward relating to inter partes review proceedings:

• A joined party has full rights to appeal a PTAB final decision – even as to claims or grounds not raised by the joined party.
• During an IPR, the PTAB must correct errors in a patent when a certificate of correction would be appropriate and when requested by the parties.  (When you read the case, you’ll note that the court doesn’t quite say this, but almost.)

Valencell’s US8923941 covers methods of generating data relating to blood oxygen level, heart rate, and other physical activity.  The claimed method includes two primary steps: (1) sensing; and (2) processing.  The sensing step requires a single device “attached” to a user that includes a motin sensor (accelerometer) and a pulse-oximeter (photoplethysmography – PPG).  The processing step creates a signal that includes heart rate, respiration rate, and a plurality of physical activity parameters.

This setup is now common with many millions of such devices being sold across the country.  According to its court filings, Valencell repeatedly approached various major players–including Fitbit and Apple–looking for partnership & licensing opportunities. The companies refused and Valencell eventually filed a set of infringement lawsuits back in 2016.  Apple & Fitbit then petitioned for inter partes review.

This case is partically an IPR procedure case and so the following timeline is somewhat important:

• Apple filed its IPR petition on claims 1-13. The Board partially granted the petition in part — only as to claims 1, 2, and 6-13.
• Fitbit then filed its IPR petition on claims 1, 2, and 6-13 and moved for joinder with Apple’s case. The Board granted that motion.
• The Supreme Court then issued SAS — barring the practice of partial institution.  As such, the Board issued a new institution decision adding all of the challenged claims (3-5).
• The Board then found the originally granted claims to be unpatentable, but found no problem with claims 3-5 (“not unpatentable.”)

Apple did not appeal, but Fitbit has appealed — arguing that claims 3-5 are also invalid.

Joinder and Right of Appeal: The first question in the case is whether Fitbit has a right to appeal regarding claims that it did not challenge in the first place.  Here, the Federal Circuit says yes they do get to appeal — holding that a joined party’s rights apply “to the entirety of the proceedings and includes the right of appeal.” The court here was primarily guided by the right-of-appeal statute that states plainly “Any party to the inter partes review shall have the right to be a party to the appeal.” 35 U.S.C. § 319.  And, the joinder provision indicates that the new entity is “join[ed] as a party.” 35 U.S.C. § 315(c).

On the merits of obviousness: I discussed the general scope of claim 1 above.  Claims 3-5 are all dependent and add a few additional limitations:

• Claim 3 – the processed data is usable with an application specific interface (abbreviated API)
• Claim 4 – the “the application” generates statistical relationships between the various parameters. [Note – there is no antecedent basis for “the application”]
• Claim 5 – adds further definition to the stats developed, including “Bland-Altman plots.”

Do the Analysis: As to claim 3, the parties had offered competing constructions of the term application-specific-interface.  The Board chose the patentee’s narrower construction and ruled the claim not-proven-unpatentable. On appeal, the Federal Circuit ruled that the Board should have completed its analysis and walked through whether the claim was obvious under the narrow construction.

Lack of Antecedent Basis: The limitations of claims 4 & 5 lack antecedent basis. In particular, the claims appear to add limitations to “the application” but that portion of the invention is not previously claimed.   The Board didn’t get into its obviousness analysis because of this technical issue with the claims:

Although we agree that the recitation of the term “the application” in claim 4 lacks antecedent basis in claim 1, we declined to speculate as to the intended meaning of the term.   Although Petitioner and Patent Owner now seem to agree on the nature of the error in claims 4 and 5 [citing briefs], we find that the nature of the error in claims 4 and 5 is subject to reasonable debate in view of the language of claims 1 and 3–5 and/or that the prosecution history does not demonstrate a single interpretation of the claims.

Board Op.

It turns out that during prosecution, the patent applicant cancelled a dependent claim discussed the Application, and the stray reference was not caught by either the attorney nor the examiner.

On appeal, the Federal Circuit holds that the Board should have fixed the error here.

The preferable agency action is to seek to serve the agency’s assignment under the America Invents Act, and to resolve the merits of patentability. Although the Board does not discuss its authority to correct errors, there is foundation for such authority in the America Invents Act, which assured that the Board has authority to amend claims of issued patents. See 35 U.S.C. § 316(d). . . . The concept of error correction is not new to the Agency, which is authorized to issue Certificates of Correction.

In particular, all the parties agreed that the error was inadvertent and could be corrected by the Board.

Although the Board states that the intended meaning of the claims is “subject to reasonable debate,” we perceive no debate. Rather, the parties to this proceeding agree as to the error and its correction. The Board erred in declining to accept the parties’ uniform position and correct the error that claim 4 depend from claim 3. With this correction, the rejection of claims 4 and 5 for absence of antecedent basis for “the application” disappears.

Slip Op. On remand, the Board will correct the error and actually judge the obviousness of these three remaining claims.

by Dennis Crouch

Regeneron Pharmaceuticals Inc. v Kymab Ltd., [2020] UKSC 27.

This important patent decision comes from the UK Supreme with a holding that Regeneron’s patents are invalid for insufficiency of the disclosure.  The insufficiency doctrine in the UK is parallel to US enablement law.

In the U.S., the courts have limited the enablement doctrine – especially considering McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091 (Fed. Cir. 2020) (claims are valid absent identification of “concrete” and “particular” embodiment covered by the claim but not enabled).  Of course, the US now has a powerful eligibility doctrine that overlaps as well.

The Regeneron patents cover transgenic mice that produce human immunoglobulin used to create drugs.

1. A transgenic mouse that produces hybrid antibodies containing human variable regions and mouse constant regions, wherein said mouse comprises

an in situ replacement of mouse VDJ regions with human VDJ regions at a murine chromosomal immunoglobulin heavy chain locus and

an in situ replacement of mouse VJ regions with human VJ regions at a murine chromosomal immunoglobulin light chain locus.

EP2264163 (EP1360287 also asserted).  If I understand this correctly, mice were first generically modified to contain DNA sequences for creating the human antibody.  However, those mice died easily and so the researchers added back some amount of murine (mice) DNA.  With just the right mix, the mice lived well and also produced antibodies that could be given to humans without triggering a human anti-mouse antibody response (HUMA).

UK statutory law requires:

The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.

14(3) of the UK Patents Act 1977 (Replicating the EPC Article 83). In the UK and Europe, courts have also used the undue-experimentation test and have also considered whether a skilled person would need create a follow-on invention in order to practice the invention.

Typically a claimed “range” in patent law is thought of as a numerical spread with the claim covering all potential embodiments in-between.  The full-scope of a claimed range must be enabled, and this is a common attack-point for defendants.  Here, the claims do not specify such a range, but the defendant was able to characterize the claimed replacement regions as constituting a wide swath of potential transgenic mice — thus a range (“range of products”).  The Supreme Court agreed here that it is the full scope of claimed “range of products” that must be enabled.

In the case, the trial court sided with the defendants — holding that “the teaching in the patent did not enable any type of mouse within the range to be made, let alone mice across the whole of the relevant range.” (quoting here from the Supreme Court opinion).  The appellate court disagreed — finding that the claim did enable something within the claimed scope — and that the disclosure was sufficient because the invention was inventive and groundbreaking.

Finally, at the Supreme Court, the Lord Justices followed a third path – that ultimately resulted in the claims being invalid. Like the appellate court, the Supreme Court agreed that some embodiments covered by the claim were enabled.  However, the court ruled that “some embodiments ” was not enough.

Patentees are free to choose how widely to frame the range of products for which they claim protection. But they need to ensure that they make no broader claim than is enabled by their disclosure.

A claim which seeks to protect products which cannot be made by the skilled person using the disclosure in the patent will, subject to de minimis or wholly irrelevant exceptions [such as the length of a mouse’s tail], be bound to exceed the contribution to the art made by the patent, measured as it must be at the priority date.

Enablement across the scope of a product claim is not established merely by showing that all products within the relevant range will, if and when they can be made, deliver the same general benefit intended to be generated by the invention, regardless how valuable and ground-breaking that invention may prove to be.

Id. In applying these principles to the Regeneron patents, the court found that the wide-range of potential products claimed were not sufficiently disclosed. In particular, the claimed range of products included transgenic mice with long segments of the human variable region gene locus.  But, the specification only taught how to do this with short-segments.  Invalid.

by Dennis Crouch

I’m sure that there will be a few references to the Aunt Jemima trademarks in upcoming law review articles. Let me direct you to a handful of court decisions regarding the mark. The cases offer an important look at how judges saw race & commerce in the mid-20th century.

The courts here effectively concluded that only one company could sell flour (or syrup) branded with the caricature of a black-skinned person.

(more…)

United States Patent & Trademark Office (USPTO) v. Booking.Com B.V. (Supreme Court 2020) [Full Decision PDF]

In this trademark case, the USPTO asked the court to implement its “nearly per se” rule that a generic term remains generic even if coupled with a generic top level domain (such as “.com”).  The 4th Circuit sided with BOOKING.COM and the Supreme Court has now affirmed: “[W]e discern no support for the PTO’s current view in trademark law or policy.” Id.

According to the majority, the question is not whether some portion of BOOKING.COM is generic but rather whether the term “taken as a whole” is generic.  Then the court queries — what type of generic thing is a “booking.com”

That should resolve this case: Because “Booking.com” is not a generic name to consumers, it is not generic.

In its opinion, the court notes the PTO inconsistency (ART.COM and DATING.COM are both registered).

The following quote from the case is probably the most controversial:

[I]f “Booking.com” were generic, we might expect consumers to understand Travelocity—another such service—to be a “Booking.com.” We might similarly expect that a consumer, searching for a trusted source of online hotel-reservation services, could ask a frequent traveler to name her favorite “Booking.com” provider. Consumers do not in fact perceive the term “Booking.com” that way, the courts below determined.

The majority opinion was written by Justice Ginsburg and joined by six other justices, including all five conservatives. Justice Sotomayor concurred in a very short opinion; and Justice Breyer wrote in dissent and would have applied Goodyear’s India Rubber Glove Mfg. Co. v. Goodyear Rubber Co., 128 U. S. 598, 602 (1888). Justice Breyer writes:

Goodyear recognized that designations such as “Company,” “Corp.,” and “Inc.” merely indicate corporate form and therefore do nothing to distinguish one firm’s goods or services from all others’. . .  .[W]here a compound term consists simply of a generic term plus a corporate designation, the whole is necessarily no greater than the sum of its parts. . . .

Breyer in dissent.

Breyer spends some time focusing on the problems associated with survey evidence.  I suspect that aspect of his dissent will have some impact on how courts conduct trademark cases in the future.

As TM owners willingly give up their racially disparaging and gender stereotyping marks, are there ways to ensure that the marks are not reoccupied by others wanting to free ride on their fame and infamy?

Guest Post by Deborah R. Gerhardt, Reef C. Ivey II Excellence Fund Term Professor of Law at UNC School of Law

Quaker Oats says it plans to phase out its “Aunt Jemima” brand. The character has long been criticized as a stereotypical representation of black women as inferior servants. In recognition of the problem, the Company had been gradually revising the brand’s image and considering when might be the appropriate time to phase it out altogether. Of course, if taking a bold stand against racism had been their true intent, they would have taken much more decisive action to drop the brand long ago.

As Trevor Noah observed on the Daily Show’s June 17, 2020 episode,

It’s also amazing that the brand knew that Aunt Jemima was racist and then instead of just changing it, they chose to instead slowly phase out the racism over time. That is so ridiculous. Can you imagine you caught your partner cheating and instead of stopping, they said, Yeah, yeah. You’re right baby. This is so wrong. I think I’m going to slowly start phasing out all of my affairs. From now on no sex, just hand stuff.

Amidst protests following the wake of George Floyd’s untimely death, Quaker Oats proclaims it truly does plan to take action to recreate the brand, although you would not know that from looking at its website one week after the announcement. As the screenshot below illustrates, no indication of abandonment appears on their pancake mix or syrup web pages.

The current plan is hardly inspiring. It appears to be: “Let’s keep the admittedly racist mark in place until a suitably less racist substitute has been crafted.”

One of the potential ways to challenge a third-party registration of a racist brand was eliminated in 2017. For years Section 2(d) of the Lanham Act blocked registrations that disparaged a group of people. But despite this bar, the “Aunt Jemima” mark (and so many other disparaging marks) registered anyway.  Some however, were blocked or cancelled (including the Washington Redskins mark) on that basis before the Supreme Court held the bar unconstitutional in Matal v. Tam 137 S. Ct. 1744 (2017). Since that decision, the First Amendment right to free expression permits citizens to seek registration of racially offensive trademarks.

After Tam, the Quaker Oats plan to abandon the Aunt Jemima mark raises an interesting question: what if a third party were to seize the opportunity to pick up the well-known mark and double down on the racist stereotype? Are there strategies that Quaker Oats can use to minimize any consequential harm? For a fun take on what such a highjacking looks like, go here https://southpark.cc.com/clips/vlg1j1/from-one-redskin-to-another to see what happens when the Southpark kids adopt “the Washington Redskins” for their start-up after the registration was cancelled. Contrary to the suggestion in that episode, there at least a couple of strategies that may work.

The Southpark spoof appears to be coming true with recent application to register marks on AUNT JEMINA and ESKIMO PIE by notorious “trademark entrepreneur” Leo Stoller. Consider Also Mark Cohen’s discussion of Colgate Palmolive’s Darlie (“Black man toothpaste.”) trademark in China.

The easiest option is to lean on the USPTO’s examiner corps. Even if the company ceases using the mark, the company’s portfolio of registrations will remain on the Principal Register until, one by one, they expire. If a new entrant to the syrup and pancake mix market applies to register “Aunt Jemima,” the Examiner would look at the Principal Register and see if any confusingly similar marks are still live. I predict that as long as Aunt Jemima lives on the Principle register, the marks will block others from registering confusing similar brands. We will not have to wait long to see if my prediction is right because on June 18, 2020, an individual in California applied to register “Aunt Jemima” for “Pancake mixes; Maple syrup; Pre-mixed pancake batter; Table syrup.” Something at the USPTO would have to go terribly against the norm for this application to succeed. Quaker Oats owns five registrations (and one pending application) for the brand, and some will not be up for renewal until 2025. Even if Quaker Oats took no action against the current applicant, the mark’s continued presence in the USPTO’s TESS data will give trademark examiners a clear and easy way to deny registration of the mark to anyone else until the last Quaker Oats “Aunt Jemima” mark expires.

This practice reveals that some trademark owners can succeed in blocking new entrants years after use has stopped. Although the Lanham Act ties trademark rights to use, for the sake of efficiency, USPTO trademark examiners treat third party federal registration as an irrefutable heuristic for use in office actions. When an Examiner blocks an application because the proposed mark is confusingly similar to one already registered, the USPTO treats the facts in the registration as true. Because Quaker Oats would not be a party to the applicant’s registration proceeding, USPTO examiners will not look into allegations of abandonment without Quaker Oats present to defend its brand. The company’s current “Aunt Jemima” registrations will be more than sufficient to deny the new entrant registration. However, if Quaker Oats opposed the registration, the new entrant could raise the defense of abandonment. Therefore, Quaker Oats would be smart to stay quiet and let the USPTO take care of the matter. If the new entrant had the chutzpah to seek cancellation of the Quaker Oats federal registrations, they would have to respond to the applicant’s claim that “Aunt Jemima” was available because Quaker Oats abandoned use of the mark and expressed a clear intent not to resume its use.

Beyond the arena of registration, there are alternatives for Quaker Oats to explore if someone were to actually start using the “Aunt Jemima” mark in commerce, whether or not the new entrant sought registration. The Lanham Act is broad enough to assert a claim against a new adopter even if the original trademark owner abandoned the mark as a matter of law as long as consumers still draw a connection between the “Aunt Jemima” mark and Quaker Oats. The language of 15 USC 1125(a) may support a cause of action for false sponsorship, false affiliation or false designation of origin or state unfair competition if a new entrant used the mark in commercial advertising in a way that causes Quaker Oats harm.  Contrary to what the Redskins (the football team not the start-up) owner claimed in the South Park skit, there actually is something a trademark owner can do, and much that the USPTO will do for a trademark owner both before and after the mark has been abandoned.

by Dennis Crouch

B/E Aerospace v C&D Zodiac (Fed. Cir. 2020)

Commercial aircraft lavatories are always oddly shaped in order provide some amount of functionality while minimizing space usage. B/E’s patent here covers the shape of the bathroom that includes the carve-out for a seat just forward — notice the “s” shape of the wall in the image below.  On appeal here the Federal Circuit has affirmed the PTAB obviousness decision.  This outcome was easy to guess once I read the court’s opening discussion line: “The technology involved in this appeal is simple.”  U.S. Patent Nos. 9,073,641 and 9,440,742.

The claims includes two “recesses” in the wall — you can see these in Figure 2 above.

• an upper recess to receive the inclined seat-back; and
• a lower recess for the back legs (“seat support”)

PTAB found the claimed invention obvious based upon the two prior art references shown below (and note the lower bottom recess):

Neither of the prior art references include the lower recess to support the back legs. However, the PTAB concluded that a skilled artisan would have found it obvious to modify these to include the claimed second recess. The Board concluded that this modification is was a “predictable” modification for solving a known problem — especially when “coupled with common sense.”

The Board was helped-along with its prior art analysis looking at several other contemporary references showing a lower recess.  I’ll note here that these contemporary references were not used as “prior art” but rather as information of the level of skill in the art.

On appeal, the Federal Circuit has affirmed finding the second recess “nothing more than the predictable application of known technology . . . because a person of
skill in the art would have applied a variation of the first recess and would have seen the benefit of doing so.”  In addition, the court found that it would have been “common sense” to modify the prior art in order to try to save further space.

Here, the Board’s invocation of common sense was properly accompanied by reasoned analysis and evidentiary support. The Board dedicated more than eight pages of analysis to the “second recess” limitation and relied on
Mr. Anderson’s detailed expert testimony. The Board noted Mr. Anderson’s opinion that a “person of ordinary skill in the art would recognize that as a seat is moved further aft the seat support necessarily is also moved further aft.”

Slip Op. The court particularly noted that the simplicity of the technology aided in the conclusion of obviousness.

Here, just like in Perfect Web, the evidence shows that the technology of the claimed invention is simple. The patents relate to contoured walls that “reduce or eliminate the gaps and volumes of space required between lavatory enclosures and adjacent structures.” The missing claim limitation (the “second recess”) involves repetition of an existing element (the “first recess”) until success is achieved.

Id.

With regard to the design drawings submitted to identify the level of skill in the art.  The Federal Circuit determined that it need not reach the issue of whether they were improperly handled or prohibited by 35 U.S.C. 311(b).  Rather, the court held that the PTAB’s obviousness conclusion stands on its own – based upon the two prior art references coupled with the expert testimony.

The court today denied two en banc petitions:

Biogen International GmbH v. Banner Life Sciences LLC, 20-1373 (Fed. Cir. 2020)

The law allows for a limited extension of patent term based upon regulatory delays – such as FDA delay in approving a drug for sale.  The statute is unfortunately complex and poorly written. 35 U.S.C. 156.

In this case, Biogen received a patent term extension for its Patent US7619001 associated with using the drug Tecfidera (MS treatment). By the time of the litigation, the patent would have expired, but for the term extension.

Banner’s proposed version of the drug is a bit different than Biogen’s Tecfidera — although apparently bioequivalent. The court included the following diagram showing the differences with the Biogen’s version is DMF and Banner’s is MMF (both versions were covered by the asserted claim):

In the case, the Federal Circuit held that the term extension did not apply in this situation.  The court limited limiting PTE to only situations where the same drug (active ingredient) is being accused of infringement, even if the alternative is covered by the patent claims and includes the same active portion.  The court wrote:

Because the scope of a patent term extension under 35 U.S.C. § 156 only includes the active ingredient of an approved product, or an ester or salt of that active ingredient, and the product at issue does not fall within one of those categories, we affirm the judgment of the district court.

In its petition for rehearing, Biogen asked two questions:

1. Whether the panel’s decision allows an infringer to avoid an innovator’s patent term extension by using the claimed and bioequivalent active moiety of the compound in the patentee’s approved drug product.
2. Whether patent term extension under 35 U.S.C. § 156(b)(2) for method claims is limited to the “approved product” only, where the only limit that Congress imposed on patent term extension for method claims is “any use claimed by the patent and approved for the product,” and Congress further provided that “[a]s used in this subsection, the term ‘product’ includes an approved product” (i.e., is not “limited” to an approved product). 35 U.S.C. § 156(b) (emphases added).

PhRMA also filed an en banc petition in support. The PhRMA brief argues that this decision will allow generic companies skirt the Hatch-Waxman generic-innovator compromise. In particular, generic companies will be able to rely upon innovator data to gain market entry since the active portion of the drug product is the same, while not being subject to the term extension.

The Federal Circuit has denied the en banc petition without further opinion.

[BiogenCAFCDecision] [Discussion by Kevin Noonan]
[Biogen en banc petition] [Biogen PhRMA Amicus]

= = = = =

Dragon Intellectual Property v. DISH Network LLC, 19-1283 (Fed. Cir. 2020).

This is a common setup: Patentee sues for infringement; Defendant collaterally attacks patent via IPR and claims are cancelled; District court then dismisses case as moot – void ab initio. The petition questions whether the defendant can be considered a “prevailing party” for attorney fees in such a situation. “When, if ever, can a litigant be deemed the ‘prevailing party’ in a case terminated as a result of mootness?”

In the case, the district court found no prevailing party in this situation. On appeal, the Federal Circuit rejected that approach – holding that the defendant could be considered a prevailing party because it rebuffed the claims.  The Federal Circuit has now denied the en banc petition — meaning that its rule sticks.

DragonIP en banc petition

BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc., fka MonoSol RX, LLC, No. 19-1381 (Supreme Court 2020)

This case is procedural and it focuses – once again – on the unique two-step, two-decision-maker divide by Congress for inter partes review (IPR) proceeding.

1. Step 1 – Institution: The USPTO Director decides whether to grant an IPR petition and “institute” proceedings.  This decision is “final and nonappealable.”
2. Step 2 – Trial: Once the IPR is instituted, the PTAB takes-charge and moves the case to a final decision.

As the USPTO planned-out how to actually implement the proceedings, the Director at the time (Kappos) recognized that he didn’t want to personally decide all of the IPR decisions and also recognized that the USPTO petitions office was (is) not operating at peak efficiency (except for the automatically granted petitions). So, the the rules delegated the Director’s authority for instituting IPRs to the PTAB judges.  This effectively rewrote the proceedings as follows:

1. Step 1: The USPTO Director PTAB decides whether to grant an IPR petition and “institute” proceedings.  This decision is “final and nonappealable.”
2. Step 2: Once the IPR is instituted the PTAB then takes-charge and moves the case to a final decision.

Delegation of institution authority results in some amount of confusion about whether a given decision by the PTAB is associated with a non-appealable institutional decision or instead an appealable final judgment in the case.

BioDelivery began at the PTAB with three IPR petitions against Aquestive’s US8765167. This was pre-SAS, and the USPTO partially instituted the proceedings.  On appeal, the Federal Circuit vacated the final written decision on SAS grounds — holding that the USPTO cannot partially institute an IPR.  The partial-institution clearly falls on the side of step-1 nonappealable institution decision, but the Supreme Court created a limited exception in this situation.  See SAS Institute v. Iancu, 138 S. Ct. 1348 (2018) as limited by Thryv, Inc. v. Click-to-Call Techns., LP, 140 S. Ct. 1367 (2020).  You can read that original 2018 BioDelivery opinion here BioDelivery Scis. Intl., Inc. v. Aquestive Therapeutics, Inc., 898 F.3d 1205 (Fed. Cir. 2018).

In SAS, the Supreme Court held that at institution stage the Director must either (1) institute the proceeding as to all challenged claims or (2) deny the petition all together. Federal Circuit then extended SAS to also require that any final written decision address every ground for challenge (not just every claim). PGS Geophysical AS v. Iancu, 891 F.3d 1354 (Fed. Cir. 2018).

On remand, the PTAB decided it was faced with the question of whether to (1) proceed with a final decision on all grounds raised or (2) drop the whole case. It chose the latter–terminating all three IPR petitions.

The patent challenger then appealed again and the Federal Circuit had to figure out whether the termination of proceedings was more like an institution decision or a final written decision.  The court decided the former and held that the termination was final and nonappealable.  BioDelivery Scis. Intl., Inc. v. Aquestive Therapeutics, Inc., 935 F.3d 1362 (Fed. Cir. 2019) (opinion by Judge Reyna, dissent by Judge Newman); en banc petition denied at BioDelivery Scis. Intl., Inc. v. Aquestive Therapeutics, Inc., 946 F.3d 1382 (Fed. Cir. 2020) (dissent by Judge Newman).

Now comes the petition for writ of certiorari — arguing that “termination” should not be considered an institution decision. Questions presented:

1. Does the Judiciary have authority to review a Patent Office decision refusing to implement its mandate and this Court’s precedent?

2. May a petitioner appeal a decision terminating an instituted IPR, despite the decision being mislabeled as a nonappealable decision?

[BioDelivery Petition]

Although the situation is muddled by the PTAB/Director delegation, the basic question is whether ‘termination’ of an [improperly] instituted IPR is a furtherance of the institution process given to the discretion of the Director or is it instead a role given by statute directly to the PTAB.  The statute does discuss termination following settlement, but not in the particular context of this case.

The situation also reminds me of the recent essay by Brian Fry and Maybell Romero, The Right to Unmarry: A Proposal,  https://ssrn.com/abstract=3566944.

= = = =

I have included Fig. 1 from the challenged patent above. The claims are directed to an “oral film” that melts-in-your-mouth for drug delivery.  The film includes an “anti-tacking agent” such as vegetable oil or wax.

By Jason Rantanen

The Surpeme Court seems to have ended its term for patent cases today – although the court has at least one more week of business before the summer break.

Petitions denied:

• Collabo (retroactive IPR violates due process & takings); Celgene (same); Enzo (Same)
• Hospira (limits on DOE); CJ CheilJedang (same)
• Comcast (mootness of ITC decision for expired patent)

Federal Circuit decision Vacated & Remanded: 

• Emerson Electric Co. (Thryv follow-on case)

Consideration of one fully briefed petition was postponed. Chrimar Systems. Chrimar has to do with the timing of judgment finality and issue preclusion. Particularly: How does claim cancellation via inter partes review impact prior court judgments upholding the the patent? (In this case, an appeal in the infringement litigation was still pending on other grounds).  A petition on related issues was recently filed in PhaZZer, and the court may be considering the issues together.

The last direct IP case for the court to decide this term is USPTO v. Booking.com. In that case, the USPTO wants to apply a bright-line-rule that adding “.com” to a generic word does not create a protect-able mark.  One reason I’m rooting for Booking.com is that they label me a Level 2 Genius! (Image below as proof).