Patent Docs: Novelty

Novelty

June 13, 2019

U.S. Water Services, Inc. v. Novozymes A/S (Fed. Cir. 2019)

Earlier this year, in U.S. Water Services, Inc. v. Novozymes A/S, the Federal Circuit reversed a decision by the U.S. District Court for the Western District of Wisconsin, partially granting judgment as a matter of law in favor of Defendants-Appellees Novozymes A/S and Novozymes North America, Inc. that claims 1, 6, and 12 of U.S. Patent No. 8,415,137 and claims 1, 2, 5, 7–9, and 18–20 of U.S. Patent No. 8,609,399 were invalid as inherently anticipated. In reversing and remanding the District Court, the Federal Circuit determined that Novozymes did not meet its burden at trial of showing that the prior art inherently anticipates the asserted claims.

The dispute between the parties began when Plaintiffs-Appellants U.S. Water Services, Inc. and Roy Johnson filed suit against Novozymes for infringement of the asserted claims of the '137 and '399 patents. A jury determined that the asserted claims were not inherently anticipated by International Publication No. WO 01/62947 A1 ("Veit"). Novozymes responded by moving for judgment as a matter of law, which the District Court granted, and U.S. Water Services then appealed.

The '137 and '399 patents, which share a common specification as continuations of an earlier-filed application, are directed to methods for reducing the formation of deposits of phytic acid salts and phytates on equipment used during ethanol production. Representative claim 1 of the '137 patent recites:

1. A method of reducing formation of insoluble deposits of phytic acid or salts of phytic acid on surfaces in a fuel ethanol-processing equipment, the method comprising:
adding phytase to an ethanol processing fluid in the equipment containing phytic acid or salts of phytic acid under conditions suitable for converting the insoluble phytic acid or phytic acid salts to soluble products; thereby reducing the formation of deposits of insoluble phytic acid or phytic acid salts on surfaces in the equipment; wherein the equipment in which deposit formation is reduced comprises a beer column, and
wherein the pH of the ethanol processing fluid in the beer column is 4.5 or higher during production of ethanol.

The opinion notes that phytase is an enzyme that is capable of breaking down phytic acid found in plant material.

Veit describes a process for producing ethanol, and in particular, discloses the addition of phytase during the fermentation step (or a combined or simultaneous fermentation and saccharification step) of ethanol production that may result in the increase in the fermentation and ethanol yields. In the lone experiment disclosed in Example 1 of Veit, the addition of phytase is shown to improve the fermentation process; the experiment was conducted in a 500 mL bottle in which phytase was added during the pre-saccharification reaction (i.e., prior to fermentation).

At trial, the jury determined that Novozymes had not proven by clear and convincing evidence that Veit anticipates the asserted claims by inherently disclosing the requirement of reducing the formation of insoluble deposits of phytic acid or salts of phytic acid. The jury also determined that Novozymes infringed the asserted claims, and awarded damages of $7,582,966 to U.S. Water Services. Novozymes moved for judgment as a matter of law, arguing that Veit inherently anticipates the asserted claims because Example 1 shows that in the absence of any phytate, no deposits of phytate can form. The District Court granted Novozymes' motion, finding that Veit inherently disclosed using phytase to reduce phytate deposits because Veit's fermentation test expressly disclosed conditions sufficient to break down all the phytic acid present in the ethanol fluid, which would have prevented phytate deposits from forming on ethanol processing equipment.

On appeal, U.S. Water Services argued that the District Court erred because Novozymes failed to show that a rational jury could have found that Example 1 inherently anticipateds the asserted claims since the asserted claims require a reduction of phytate deposits on surfaces on ethanol processing equipment. The Federal Circuit agreed with U.S. Water Services, finding that:

The District Court erred in ruling as a matter of law that Veit inherently anticipates the Asserted Claims. The Asserted Claims require the reduction of phytic acid deposits in specific locations of an ethanol plant such as on the "heat transfer equipment" or in the "beer column." . . . By contrast, Veit does not disclose any examples using phytase to reduce phytic acid deposits in an ethanol plant, but rather describes in Example 1 an experiment in a laboratory bottle.

In particular, the opinion notes that in Veit, the phytase is not added into fermentation, but rather is added into a saccharification step, which differs from the reaction specified in the asserted claims. The opinion indicates that "[e]nzymes that may be effective at saccharification's temperatures may be ineffective at the lower temperatures required during fermentation," and therefore concludes that "Veit's addition of phytase at the pre-saccharification stage cannot disclose the reduction of phytic acid deposits on ethanol processing plant equipment as required by the Asserted Claims." The Federal Circuit also noted that:

[U]nlike the stated limitations for reducing deposits found in the Asserted Claims, Example 1 [of Veit] does not provide any conditions necessary to determine whether any deposit on equipment is formed during the experiment, nor does it provide any specific variables that impact phytase in a way that will always reduce deposits in the plant equipment.

The Federal Circuit therefore determined that there was "substantial evidence to support the jury finding that Example 1 only discloses the possibility of reducing phytic acid concentration below detection levels, which is not legally sufficient to demonstrate inherent anticipation" (emphasis in opinion). Citing Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939), for the proposition that "[i]nherency . . . may not be established by probabilities or possibilities," the Court explained that:

Because Example 1 is silent as to whether its Protocol would reduce phytate fouling in the "beer column" or "heat transfer equipment" and Novozymes did not provide evidence that Example 1 satisfies all the required constraints in the Asserted Claims, Veit does not disclose whether any deposits would have formed when using Example 1's Protocol in a fuel ethanol plant.

The Federal Circuit therefore found that Novozymes did not meet its burden at trial of showing by clear and convincing evidence that Example 1 would always eliminate phytic acid deposits under the conditions required by the asserted claims, that a jury could have reasonably found that Veit does not inherently anticipate the asserted claims, and that the District Court erred in overturning the jury's verdict. The Federal Circuit thus reversed and remanded the District Court's decision partially granting judgment as a matter of law in favor of Novozymes.

U.S. Water Services, Inc. v. Novozymes A/S (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Circuit Judges Moore, Wallach, and Taranto
Opinion by Circuit Judge Wallach

Posted at 11:59 PM in Federal Circuit, Novelty | Permalink | Comments (1)

June 09, 2019

Intellectual Ventures II, LLC v. Sprint Spectrum, L.P. (E.D. Tex. 2019)

By Donald Zuhn --

In April, in Intellectual Ventures II, LLC v. Sprint Spectrum, L.P., U.S. Magistrate Judge Roy S. Payne of the U.S. District Court for the Eastern District of Texas issued a Report and Recommendation that Defendants' Motion for Partial Summary Judgment that Certain Disputed References are Prior Art should be granted in part and denied in part. In particular, Judge Payne recommended that summary judgment should be denied for four references (i.e., Hwang, Liebetreu, CATT, and LG) and granted for one reference (i.e., Yang).

In arriving at his recommendation, Judge Payne noted that an important fact question in determining whether a reference qualifies as a printed publication under 35 U.S.C. § 102 is the public accessibility of the reference. Citing Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347 (Fed. Cir. 2018), for the proposition that "[a] reference is considered publicly accessible if it was 'disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it,'" Judge Payne pointed out that several factors are used by courts to determine whether a reference was publicly accessible. Such factors include "how widely circulated the reference was, whether the reference was indexed in a manner that would have made it accessible to interested persons with a reasonable degree of effort, and whether the reference was distributed with a pledge or understanding that the contents would remain confidential"; another factor to be considered is the expertise of the target audience.

Judge Payne addressed the Yang reference first, noting that Plaintiff Intellectual Ventures did not contest the public accessibility of this reference. Judge Payne therefore concluded that the Yang reference was publicly accessible before the priority date of the asserted patents, and as a result, recommended that Defendants' Motion be granted with respect to this reference.

Judge Payne next turned to the Hwang and Liebetreu references, which the Defendants (except for Nokia) argued were submissions to the March 2004 IEEE 802.16 Working Group Session #30 meeting, were publicly accessible by at least March 15, 2004, and thus qualified as prior art to U.S. Patent No. 8,953,641. Despite Defendants' argument, however, Judge Payne determined that "fact questions remain as to whether the Hwang and Liebetreu references were publicly accessible before the relevant priority date," since "[b]oth references were filed on a website with somewhere between 4,000 to 10,000 references (by the estimate of the applicable Defendants' own witness) with the references listed primarily in chronological order." Judge Payne also noted that "the Hwang reference was withdrawn, so it likely was not discussed at the meetings, making it even more difficult for this reference to be found." Finding that "a question of fact exists as to whether these references were publicly available as it is unclear whether persons interested and ordinarily skilled in the subject matter would be able to locate these references using reasonable diligence," Judge Payne recommended that Defendants' Motion be denied with respect to the Hwang and Liebetreu references.

Finally, Judge Payne addressed the CATT and LG references, which Defendants argued were publicly accessible by at least March 31, 2006, and thus qualified as prior art to U.S. Patent Nos. 8,682,357 and 9,532,330. Finding that questions of fact remained as to the public accessibility of these references, Judge Payne recommended that Defendants' Motion also be denied with respect to the CATT and LG references. In support of this recommendation, Judge Payne noted that "[w]hile the references were distributed by email to the working group and then placed on the 3GPP server, it remains unclear whether the references were indexed in a way that would allow persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, to locate the two references." In response to Defendants' argument that indexing is not a prerequisite to finding that a reference qualifies as a printed publication, Judge Payne stated that "a failure to appropriately index may still create a question of fact as to whether a reference qualifies as a printed publication." Moreover, Judge Payne noted that Intellectual Ventures' expert asserted that the CATT and LG references were not publicly available, and therefore, he indicated that "this suggests that summary judgment would be inappropriate."

Judge Payne therefore recommended that Defendants' Motion for Partial Summary Judgment that Certain Disputed References are Prior Art should be denied for the Hwang, Liebetreu, CATT, and LG references, and granted for the Yang reference.

Intellectual Ventures II, LLC v. Sprint Spectrum, L.P. (E.D. Tex. 2019)
Report and Recommendation by Magistrate Judge Payne

Posted at 11:44 PM in District Court, Novelty | Permalink | Comments (0)

May 14, 2019

IBM Corp. v. Iancu (Fed. Cir. 2019)

Federal Circuit Reverses Board in Two IPR Decisions

By Joseph Herndon --

In International Business Machines Corp. (IBM) v. Iancu, the Federal Circuit found that the Board's interpretation of key claim limitations was incorrect resulting in the Board's decisions having errors.

IBM owns U.S. Patent No. 7,631,346, entitled "Method and System for a Runtime User Account Creation Operation Within a Single-Sign-On Process in a Federated Computing Environment." At the behest of several private companies (who have settled and are not parties here), the U.S. Patent and Trademark Office, acting as delegee of the USPTO Director, instituted two related inter partes reviews (IPRs) of various claims of the '346 patent. In the first IPR, the Board found that claims 1, 3, 12, 14, 15, and 18 are unpatentable because they are anticipated by Japanese Publication No. Tokkai 2004-302907A (Sunada). In the second IPR, the Board found that claims 1, 3, 12, 13, 15, and 18 are unpatentable because they are anticipated by U.S. Patent No. 7,680,819 (Mellmer).

The Federal Circuit vacated and remanded the Sunada IPR decision as being based on an incorrect claim construction of the "federated computing environment" limitation of all claims at issue. In the Mellmer IPR decision, the same claim construction error was found to be present, but did not affect the Federal Circuit's holding to reverse the Board's decision.

The '346 Patent

The specification explains that enterprises try to give their users the benefit of being able to gain access to multiple applications without regard to authentication barriers that protect each particular system supporting those applications. A user might assume that once he or she has been authenticated by some computer system, the authentication should be valid throughout the user's working session, or at least for a particular period of time, without regard to the various computer architecture boundaries that are almost invisible to the user. Among the techniques used to do so are "single-sign-on" (SSO) processes, which aim to require of a user only one authentication process during a particular user session.

The specification explains that user expectations about ease of access are coming to extend beyond the systems within an enterprise to Internet domains of different enterprises so that users can jump from interacting with an application on one Internet domain to another application on another domain without regard to the authentication barriers that protect each particular domain. Thus, to reduce the costs of user management and to improve interoperability among enterprises, federated computing spaces have been created.

The specification then defines the term "federated" as being based on a cooperative relationship among enterprises that falls short of the unitary control available within an enterprise. As enterprises move to support federated business interactions, these enterprises should provide a user experience that reflects the increased cooperation between two businesses. In particular, a user may authenticate to one party that acts as an identity provider and then single-sign-on to a federated business partner.

Claim 1 of the '346 patent recites:

1. A method for managing user authentication within a distributed data processing system, wherein a first system and a second system interact within a federated computing environment and support single-sign-on operations in order to provide access to protected resources, at least one of the first system and the second system comprising a processor, the method comprising:
    triggering a single-sign-on operation on behalf of the user in order to obtain access to a protected resource that is hosted by the second system, wherein the second system requires a user account for the user to complete the single-sign-on operation prior to providing access to the protected resource;
    receiving from the first system at the second system an identifier associated with the user; and
    creating a user account for the user at the second system based at least in part on the received identifier associated with the user after triggering the single-sign-on operation but before generating at the second system a response for accessing the protected resource, wherein the created user account supports single-sign-on operations between the first system and the second system on behalf of the user.

IPR Claim Construction

The disputes here focuses on the "federated computing environment" and "single-sign-on" claim limitations. The Board and the parties agreed that both phrases are limiting, even though the first appears only in the preamble.

The Board recognized that both IBM and the private companies that requested the IPRs ("Petitioner") agreed about what a "federated computing environment" means: "a 'loosely coupled affiliation of enterprises which adhere to certain standards of interoperability; the federation provides a mechanism for trust among those enterprises with respect to certain computational operations for the users within the federation.'"

But, surprisingly, the Board rejected the parties' agreed-on construction "that the scope of the term is limited to an affiliation of enterprises." The Board did so even while recognizing the specification passage stating that "[a] federation is a loosely coupled affiliation of enterprises . . . ." Despite that passage, the Board concluded that a federated computing environment is not limited to enterprises, such as organizations, institutions, etc.

Alternatively, the Board construed "federated computing environment" to mean an environment having a loosely coupled affiliation of entities that adhere to certain standards of interoperability; the federation provides a mechanism for trust among those entities with respect to certain computational operations for the users within the federation. That construction replaces "enterprises" with "entities."

The Board was then able to find that claim element met in Sunada, and the key significance of that replacement is that, under the Board's construction, "two computer systems (or entities) within a single enterprise could disclose a 'federated computer environment.'"

The Federal Circuit concluded that the Board's construction is not reasonable in light of the specification. In the key specification passage quoted above, which is on its face definitional, the patent states that a "federation" is "a loosely coupled affiliation of enterprises." Nothing in the specification contradicts the passage's plain meaning. In fact, the specification describes that a federation is a set of distinct entities, such as enterprises, organizations, institutions, etc., that cooperate to provide a single-sign-on, ease-of-use experience to a user.

The Federal Circuit found that a "system," referring to just the physical equipment and not who controls it or deals with customers in providing access to it, is not of the same type as "enterprises, organizations, institutions."

IPR Decisions

Thus, the Board's final written decision in the Sunada IPR was vacated and remanded for the Board to determine in the first instance whether, under the correct claim construction, Sunada anticipates the claims at issue in that IPR.

With respect to the Mellmer IPR, the Federal Circuit reversed the finding of anticipation. The relevant claim limitation of the '346 patent requires "triggering a single-sign-on operation on behalf of the user in order to obtain access to a protected resource that is hosted by the second system." The Board construed "single-sign-on operation" to mean "a process by which a user is authenticated at a first entity and subsequently not required to perform another authentication before accessing a protected resource at a second entity."

It is undisputed that, under those definitions, a user performs an authentication when the user takes an action that provides credentials, or that plays a role in launching a provision of credentials on the user's behalf, to obtain access to resources. Thus, a "single-sign-on operation" is one that does not require the user to take such action to gain access to a second entity's resources after the user has been authenticated with a first entity.

The Mellmer patent describes a basic architecture for managing digital identity information in a network, such as the Internet. Mellmer teaches techniques for securely logging in to multiple sites with a single password and doing so from any machine on the network. More particularly, Mellmer describes a "DigitalMe" system that, for a user with a DigitalMe ID, eases access to various independent websites (DigitalMe partners) that participate in the system.

The issue here is whether a particular part of the described system requires a second user authentication action to gain access to a DigitalMe partner's resources.

The Federal Circuit found that the Board unreasonably viewed Mellmer and took a login scenario in isolation and out of context. Once the focus was properly widened to understand the whole set of options and scenarios shown, substantial evidence did not support a finding that there is no user action triggering an authentication at the target site.

The Board did not cite, and the Director has not cited, anything in Mellmer that would support a contrary finding. Nor was there any basis for discrediting the testimony of IBM's expert, which was grounded solidly in consideration of the full passages relevant to understanding the entire scenario. The Federal Circuit therefore found that Mellmer does not teach the single-sign-on limitation of the claims at issue in the IPR. Thus, despite the incorrect claim interpretation, that interpretation did not change the finding that Mellmer does not anticipate the claims. The Board's decision in the Mellmer IPR was therefore reversed.

IBM Corp. v. Iancu (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Circuit Judges Moore, Taranto, and Chen
Opinion by Circuit Judge Taranto

Posted at 10:15 PM in Claim Construction, Federal Circuit, Novelty | Permalink | Comments (0)

March 11, 2019

In re Qapsule Technologies, Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

Patent law is known for its several challenges in sufficiently capturing an invention, tangible in form and substance, in words with all their limitations. Patent law is known for being littered with traps for the unwary. And patent law is replete with instances where claims are found unpatentable because they can fairly be construed to encompass disclosure in the prior art. All these features of patent law are present in one form or another in the Federal Circuit's decision handed down today in In re Qapsule Technologies, Inc.

The claims at issue in this appeal from the Patent Trial and Appeal Board (PTAB) decision affirming rejection are represented by rejected claim 1:

1. A synthetic capsule construct for providing a protected chemical milieu, the construct comprising:
    a shell having a plurality of shell proteins, said plurality of shell proteins being assembled with one another for forming said shell and defining an enclosure therein, each of said shell proteins, when assembled for forming said shell, having an interior surface facing inwardly toward said enclosure and an exterior surface facing outwardly away from said enclosure, said shell serving to restrict permeability to and from said enclosure for providing the protected chemical milieu therein, said shell proteins being recombinant;
    a cargo protein, said cargo protein being recombinant and optionally including a peptide tag; and
    a bifunctional polynucleotide having both a first aptameric activity for binding said cargo protein and a second aptameric activity for retaining said bifunctional polynucleotide within said enclosure by assembly with the interior surface of said shell protein,
    said bifunctional polynucleotide being non-naturally occurring; said bifunctional polynucleotide serving to link said cargo protein within said enclosure for providing the said cargo protein with the protected chemical milieu therein.

(Where the bold, italicized terms are identified in the Court's opinion as being relevant to the issues discussed therein.)

Procedurally before the Board Applicants overcame grounds of rejection under §§ 102 and 103 over references not discussed in the opinion, but (improvidently, as it turned out) when faced with new grounds of rejection from the PTAB decided not to reopen prosecution but to request rehearing under 37 C.F.R. § 41.50(B)(2). When that proved unavailing this appeal followed. The new grounds of rejection disclosed the following:

which the discerning will recognized to be an influenza virus (a recombinant one, as it turns out). The Board was able to map the limitations in the claims to this structure (wherein the M1 protein is a "shell protein," mutated viral protein PB1 satisfied the "cargo protein" limitation, and the interaction between the viral RNA and both the M1 protein and PB1 protein as part of the "mutated" (and thus "non-naturally occurring") viral RNPs constituted the "bifunctional polynucleotide" limitation. Finally, the Board rejected Applicant's argument that the reference did not disclose "recombinant" proteins as an attempt to impose a process limitation (how the proteins were made) on a product claim. Having found all the recited elements disclosed in this recombinant influenza virus, the Board affirmed its own determination that the Perez reference "inherently" anticipated the claimed invention.

The Federal Circuit affirmed, in an opinion by Judge Newman joined by Judges Chen and Stoll. The panel recognized that Applicant had the burden to overcome the deference the Federal Circuit is compelled to give the PTO on fact questions (such as anticipation) and accordingly found that the Board had adduced sufficient evidence to support its rejection of these claims under § 102. Specifically, the Court rejected several distinctions drawn by Applicant because they were not affirmatively recited (despite being negative limitations). For example, to Applicant's argument that viral assembly as disclosed in the cited art requires viral ribonucleoproteins (RNPs), the Court notes that the claims recite that the claimed synthetic capsule construct "comprises" the recited elements (and in other limitations recites the open claim language "having") and thus does not exclude embodiments that include such RNPs. Accordingly, "it does not affect the Board's ground of rejection that Qapsule has purportedly created a capsule that will assemble in the presence of only a shell protein, cargo protein, and bifunctional polynucleotide, . . . for representative claim 1 is not so limited," and the panel held that the Board's conclusion was supported by substantial evidence. Similarly, the Court found unpersuasive other aspects of the recombinant influenza virus disclosed in the Perez reference not recited in the rejected claims (the viral lipid envelope, the other proteins comprising the virus) using the same reasoning, as well as arguments related to the different functions of the claimed construct and the prior art virus. These distinctions did not persuade the panel because "unclaimed functional distinctions or uses are insufficient to overcome anticipation," and, in the only faint glimmer of hope provided to Qapsule in the opinion, "[i]t is not before us to decide whether further specificity in the claims might distinguish these references."

It is not without some irony that the specification recites a great number of sources of shell and capsid proteins and viruses that produce them:

• [0008] Another preferred embodiment selects the shell protein from a group consisting of capsid proteins, coat proteins, and envelope proteins. In particular, the shell protein may be Qβ capsid protein; alternatively, the shell protein may be of a type derived from a single-stranded RNA virus, for example, icosahedral virus, bromovirus, comoviruses, nodavirus, picornavirus, tombusviruses, levivirus, or tymovirus. In another preferred embodiment, the shell protein is of a type derived from a double-stranded RNA virus, for example, birnavirus and reovirus. In another preferred embodiment, the shell protein is of a type derived from a double-stranded DNA virus, for example, parvovirus, microvirus, podovirus, or polyomavirus.

• [0083] However, capsid proteins from other bacteriophages and viruses may be employed assembling synthetic capsule constructs. The bifunctional polynucleotide employed with an alternative capsid protein employs an aptamer obtained from or adapted to assemble with such virus or bacteriophage shell proteins. Bifunctional polynucleotide employable with capsids from single-stranded RNA viruses and bacteriophages are single-stranded RNA. Exemplary single-stranded RNA viruses having assemblable shell proteins employable with the present invention are as follows

• [0084] Non-icosahedral viruses (rod-shaped or other shapes) tobacco mosaic virus.
• [0085] Bromoviruses: alfalfa mosaic virus, brome mosaic virus, cowpea chlorotic mottle virus, cucumber mosaic virus, tomato aspermy virus.

• [0086] Comoviruses: bean pod mottle virus, cowpea mosaic virus, tobacco ringspot virus.
• [0087] Nodaviruses: black beetle virus, pariacoto virus.
• [0088] Picornaviruses: coxsackievirus, echovirus, foot and mouth disease virus, rhinovirus 14, poliovirus.
• [0089] Tombusviruses: artichoke mottled crinkle virus, red clover necrotic mosaic virus, tomato bushy stunt virus.
• [0090] Leviviruses: bacteriophages MS2, FR, GA, PP7.
• [0091] Tymoviruses: physalis mottle virus, desmodium yellow mottle virus, turnip yellow mosaic virus.

• [0092] Shell proteins from virus particles that package double-stranded RNA can also be employed. However, their bifunctional polynucleotides will employ a single-stranded aptamer to bind/assemble with shell proteins. Exemplary double-stranded RNA viruses having assemblable shell proteins employable with the present invention are as follows:

• [0093] Birnaviruses: infectious pancreatic necrosis virus, infectious bursal disease virus.
• [0094] Reoviruses: reovirus, rice dwarf virus.

• [0095] Shell proteins from virus particles that package DNA can also be employed. These are constructed in the same way, by expression in cells using plasmids that drive the synthesis of both the shell protein and pieces of DNA (usually single-stranded) that associate with the protein and get packaged inside. Exemplary DNA viruses having assemblable shell proteins employable with the present invention are as follows:

• [0096] Parvoviruses: adeno-associated virus, canine parvovirus, feline panleukopenia virus, porcine parvovirus.
• [0097] Microviruses: bacteriophages phi-x 174, G4, alpha-3.
• [0098] Podoviruses: bacteriophages P22, T7, epsilon 15.
• [0099]Polyomavirus: SV40, Murine polyomavirus, Merkel cell virus.

And yet influenza virus (indeed, any paramyxovirus) is not disclosed. It is possible that Qapsule will pursue claims having a scope that can better differentiate claimed embodiments supported by its disclosure from prior art recombinant virus, if only for claims withdrawn pursuant to a restriction requirement. But the procedural history of this case and the PTAB's and Federal Circuit's decisions on the merits provide yet another cautionary tale of the difficulties and uncertainties occasioned by the patenting process.

In re Qapsule Technologies, Inc. (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Circuit Judges Newman, Chen, and Stoll
Opinion by Circuit Judge Newman

Posted at 11:43 PM in Federal Circuit, Novelty | Permalink | Comments (0)

January 30, 2019

Barry v. Medtronic, Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

Elevation to Chief Judge in a U.S. Court of Appeals, particularly in the Federal Circuit, is frequently accompanied by an apparent mandate to place an imprimatur on the Court's decisions. This pattern has been shown consistently in this appellate court, from Chief Judge Markey through Chief Judges Michel and Rader. Now it is Chief Judge Prost's turn, as illustrated by her decision in Amgen v. Sanofi, overturning application of the written description precedent of Noelle v. Ledermann as being inconsistent with the Court's en banc opinion in Ariad v. Eli Lilly & Co. This week she did not prevail in convincing her brethren of the correctness of her opinion and thus provided a dissent, in Barry v. Medtronic, Inc., relating to the application of the public use and on-sale bars to patentability and its relationship to the experimental use exception to applying these bars.

The case arose in patent infringement litigation by Dr. Mark Barry, a sole inventor, for infringement by Medtronic of his invention as claimed in U.S. Patent Nos. 7,760,358 and 8,361,121. The invention was directed to a device and method for correcting spinal column deviation conditions; claims 4 and 5 of the '358 patent asserted in the litigation depend from independent claim 1:

1. A method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions comprising the steps of:
    selecting a first set of pedicle screws, said pedicle screws each having a threaded shank segment and a head segment;
    selecting a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having first handle means and a first group of pedicle screw engagement members which are mechanically linked with said first handle means, each pedicle screw engagement member being configured for engaging with, and transmitting manipulative forces applied to said first handle means to said head segment of each pedicle screw of said first set of pedicle screws,
    implanting each pedicle screw in a pedicle region of each of a first group of multiple vertebrae of a spinal column which exhibits an aberrant spinal column deviation condition;
    engaging each pedicle screw engagement member respectively with said head segment of each pedicle screw of said first set of pedicle screws; and
    applying manipulative force to said first handle means in a manner for simultaneously engaging said first group of pedicle screw engagement members and first set of pedicle screws and thereby in a single motion simultaneously rotating said vertebrae of said first group of multiple vertebrae in which said pedicle screws are implanted to achieve an amelioration of an aberrant spinal column deviation condition;
    selecting a first length of a spinal rod member; wherein one or more of said pedicle screws of said first set of pedicle screws each includes:
        a spinal rod conduit formed substantially transverse of the length of said pedicle screw and sized and shaped for receiving passage of said spinal rod member therethrough; and
        spinal rod engagement means for securing said pedicle screw and said spinal rod member, when extending through said spinal rod conduit, in a substantially fixed relative position and orientation;
    extending said first length of said spinal rod member through said spinal rod conduits of one or more of said pedicle screws of said first set of pedicle screws; and
    after applying said manipulative force to said first handle means, actuating said spinal rod engagement means to secure said vertebrae in their respective and relative positions and orientations as achieved through application of said manipulative force thereto.

Further limitations add a step "requiring a second set of pedicle screws and a second derotation tool with a second group of engagement members and a second 'handle means'" (claim 2); and steps requiring a second handle rod (claim 3): steps for applying a "manipulative force" to the first and second handle means, carried out substantially simultaneously to cooperatively achieve an amelioration of an aberrant spinal column deviation condition" in claim 4, dependent on claim 3); and claim 5 dependent on claim 2. Claims 2-4 of the '121 patent are directed to "systems":

2. A system for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions comprising:
    a first set of pedicle screws, each pedicle screw having a threaded shank segment and a head segment; and
    a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having a first handle means for facilitating simultaneous application of manipulative forces to said first set of pedicle screws and a first group of three or more pedicle screw engagement members which are mechanically linked with said first handle means, said first handle means having a handle linked to each pedicle screw engagement member of the first group of three or more pedicle screw engagement members and a linking member to join together the handles linked to the pedicle screw engagement members, wherein the handle means is configured to move simultaneously each pedicle screw engagement member; wherein each pedicle screw engagement member is configured to en- gage respectively with said head segment of each pedicle screw of said first set of pedicle screws; and wherein each pedicle screw engagement member is configured to transmit manipulative forces applied to said first handle means to said head segment of each pedicle screw of said first set of pedicle screws;
    a second set of pedicle screws, each pedicle screw having a threaded shank segment and a head segment;
    a second pedicle screw cluster derotation tool, said second pedicle screw cluster derotation tool having a second handle means for facilitating simultaneous application of manipulative forces to said second set of pedicle screws and a second group of three or more pedicle screw engagement members which are mechanically linked with said second handle means, said second handle means having a handle linked to each pedicle screw engagement member of the second group of three or more pedicle screw engagement members and a handle linking member to join together the handles linked to the pedicle screw engagement members, wherein the handle means is configured to move simultaneously each pedicle screw engagement member; wherein each pedicle screw engagement member is configured to engage respectively with said head segment of each pedicle screw of said second set of pedicle screws; and wherein each pedicle screw engagement member is configured to transmit manipulative forces applied to said second handle means to said head segment of each pedicle screw of said second set of pedicle screws;
    a cross-linking member that links the first handle means to the second handle means . . . .

The cross-linking member element in the '121 patent was distinguished as an advance to the claims of the '358 patent.

The history of the invention and how it was disclosed and ultimately protected by patent forms the predicate facts for the dispute on appeal. Named inventor Barry, an orthopedic surgeon, began development of his invention while working with a sales representative for DePuy, a medical device company. During this time he also discussed his ideas with a representative from another medical device company, SpineVision. After developing the tool, Dr. Barry used it in three back surgeries performed over a three-month period on patients having "the three most common types of scoliosis-caused spinal deviation conditions that surgeons typically see." After a three-month post-operative convalescence for the last of these patients, Dr. Barry prepared an abstract for presentation at a scientific meeting and within one year filed a patent application that eventually matured into the patents-in-suit. These activities were thus within the one-year grace period applied under 35 U.S.C. § 102(b) prior to amendment of the Patent Act under the Leahy-Smith America Invents Act.

Following introduction of an infringing product by Medtronic, Barry sued and a jury found in his favor and awarded $15,095,970 for infringement of the '358 patent and $2,625,210 for infringement of the '121 patent; each of these amounts was increased by 20% by the trial court. The jury rejected Medtronic's defenses of public use, on-sale, and prior invention. This appeal followed, involving Medtronic's defenses of invalidity under § 102(b) and § 102(g), inequitable conduct, induced infringement, and damages.

The Federal Circuit affirmed, in a decision by Judge Taranto joined by Judge Moore; Chief Judge Prost provided a strong dissent (in part) regarding the public use and on-sale bar defenses. On the public use defense, the majority first recited the standard, that the invention must have been in public use and "ready for patenting" more than one year before a patent's filing date. The Court majority found that the invention was not "ready for patenting" based on Dr. Barry's testimony that he did not know that the claimed method and system had worked for their intended purpose until after the results of the third patient surgery could be evaluated three months after the surgery. The panel majority also found that Dr. Barry's use, while not burdened by explicit confidentiality agreements with the patient or surgical staff and (on facts persuasive to Chief Judge Prost in dissent) fully paid for by the patient at Dr. Barry's "customary rates," was negated by the character of the use as experimental use, which "serve[d] as a negation of the statutory bars," citing Polara Eng'g Inc v. Campbell Co., 894 F.3d 1339, 1348 (Fed. Cir. 2018). The majority affirmed in part based on the standard of review, wherein Judges Taranto and Moore found substantial evidence for the jury's finding that the claimed invention was not "ready for patenting" prior to the critical date. Specifically, "there is substantial evidence that Dr. Barry's invention was not ready for patenting until January 2004 because the final follow-up from the October surgery was reasonably needed for the determination that the invention worked for its intended purpose," according to the panel majority.

The majority held that Medtronic had not satisfied its burden of showing that the claimed invention had been reduced to practice, i.e., that he had "(1) constructed an embodiment or performed a process that met all the limitations and (2) determined that the invention would work for its intended purpose," citing In re Omeprazole Patent Litig., 536 F.3d 1361, 1373 (Fed. Cir. 2008). Prong two of this test made evidence of satisfaction of prong one insufficient (including, inter alia, evidence of prior drawings of the invention disclosed by Dr. Barry to third parties). Here, the panel majority held that the jury was reasonable in concluding that the invention had not been shown to "work for its intended purpose" until after completion and followup of surgeries on three patients "who fairly reflected the real-world range of application of the inventive method" (based on evidence and testimony from both plaintiff and defendant's witnesses). And the panel further rejected any requirements in the claims for reciting the "intended purpose," based on conventional claim drafting standards ("one typical way of claiming is simply to define the physical steps of the process, or the physical elements of a product, without building functional or purpose language into the claim limitations at all," citing In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)), as well as Supreme Court (Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U.S. 358, 383 (1928)) and the Federal Circuit's own precedent (TP Laboratories, Inc. v. Professional Positioners, Inc., 724 F.2d 965 (Fed. Cir. 1984); Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 549 (Fed. Cir. 1990); Honeywell Int'l Inc. v. Universal Avionics Systems Corp., 488 F.3d 982 (Fed. Cir. 2007); Polara Eng'g Inc v. Campbell Co., 894 F.3d 1339, 1348 (Fed. Cir. 2018)).

The panel majority also held that Medtronic had not established that the invention was in public use prior to the critical date, and in any event its use fell within the experimental use exception. This conclusion was based on the following facts: Dr. Barry was the only person to perform the surgeries, and thus had not "relinquished control of his invention" (Egbert v. Lippmann, 104 U.S. 333, 335 (1881)); the evidence showed that the people present in the operating theater did not have a clear view of the operation; and that these people were all bound by at least an implied duty of confidentiality. Regarding commercial exploitation, while the panel majority acknowledged Dr. Barry's compensation, it rejected the conclusion that this amounted to commercial exploitation sufficient to amount to public use. This conclusion was based on Dr. Barry's activities satisfying the standards for experimental use as set forth, inter alia, in Clock Spring, L.P. v. Wrapmaster, Inc., 560 F.3d 1317, 1327 (Fed. Cir. 2009):

(1) the necessity for public testing, (2) the amount of control over the experiment retained by the inventor, (3) the nature of the invention, (4) the length of the test period, (5) whether payment was made, (6) whether there was a secrecy obligation, (7) whether records of the experiment were kept, (8) who conducted the experiment, (9) the degree of commercial exploitation during testing, (10) whether the invention reasonably requires evaluation under actual conditions of use, (11) whether testing was systematically performed, (12) whether the inventor continually monitored the invention during testing, and (13) the nature of contacts made with potential customers.

Finally, the panel majority distinguished two earlier cases where experimental use was not found (Sinskey v. Pharmacia Ophthalmics, Inc., 982 F.2d 494 (Fed. Cir. 1992), and LaBounty Mfg., Inc. v. U.S. Int'l Trade Comm'n, 958 F.2d 1066, 1072 (Fed. Cir. 1992)) on their facts (including non-relinquishment of the invention and that other members of the surgical team were aware that the use was experimental).

Turning to the on-sale bar, the panel majority held that their finding that Dr. Barry's use was an experimental use negated the on-sale bar as it had the public use bar, and applied its reasoning for the public use question to decide that the invention was not "ready for patenting" and thus did not satisfy the second prong of the test enunciated by the Supreme Court in Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998). The panel majority upheld the jury's determination that the '358 and '121 patents were not invalid under § 102(b) on this basis (as well as rejecting Medtronic's' objection to jury instructions regarding what constituted "experimental use").

Finally, the panel majority affirmed the jury's determination that the asserted claims were not invalid under § 102(g) because Medtronic failed to establish earlier invention by another, and affirmed the District Court's decision that Dr. Barry had not engaged in inequitable conduct (based on an erroneous description of a Figure in the common patent specifications) because there was no evidence of an intent to deceive. And the majority found "substantial evidence" that Medtronic induced infringement of the surgeons using its infringing systems and methods.

Chief Judge Prost's dissent was predicated on her view that the panel majority had misapplied the law regarding both the public use and on-sale bars under pre-AIA § 102(b); her disagreement was limited to the panel majority's decision regarding the '358 patent. For Chief Judge Prost "the facts are simple":

More than one year before filing for the '358 patent, Dr. Barry successfully performed his claimed surgical method on three different patients, charging each his normal fee. Dr. Barry's method was thus prima facie "on sale" or in "public use" before the critical date under 35 U.S.C. § 102(b).

And the crux of her argument is that Dr. Barry's self-serving testimony (that he did not appreciate that his claimed method worked as intended until three months after the last of the three surgeries) was inconsistent with his appreciation, as a surgeon, that "his method worked as of a surgery's completion." She focuses her argument (as she understands is the dispositive issue) on the "ready for patenting" prong. (In a footnote she also states that she "see[s] no material difference between the two bars in this case or in the way that evidence of experimental use would affect their application.) For Chief Judge Prost, Dr. Barry's practice of the three surgeries for his usual fee establishes that the invention claimed in the '358 patent was on sale prior to the critical date, and that only evidence of experimental use can negate this conclusion. She is convinced that the invention was reduced to practice by at least the completion date of the second surgery, which was also prior to the critical date. Thus, Chief Judge Prost's view of the evidence is that Medtronic established invalidity as a matter of law under the on-sale bar.

The basis for her disagreement with her brethren ultimately rests on her belief that the claimed method was reduced to practice as soon as Dr. Barry achieved correction of the spinal abnormalities on the surgical table and her rejection of the evidence that he could only appreciate reduction to practice after sufficient patient convalescence had occurred for him to conclude that the surgical adjustment had sufficient permanence to satisfy the criterion of "ameliorating" the abnormality as recited in the asserted claims.

Part of the Chief Judge's disagreement also rests on her determination that Dr. Barry's invention was "ready for patenting" after the second surgery, because he had shown that the spinal deformity could be surgically corrected in two patients (and thus established that the method was of general utility). She writes:

There was at least some amelioration of those conditions by the end of the surgeries. At this point, Dr. Barry could have satisfied the enablement and written-description requirements of § 112 and credibly claimed utility under § 101.

She cites Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1189–90 (Fed. Cir. 2014), for the principles that "a patent does not need to guarantee that the invention works for a claim to be enabled" and that "[t]here is no requirement that the disclosure contain either examples or an actual reduction to practice." Chief Judge Prost finds error in the majority's conclusions because it focused on reduction to practice rather than whether the invention was ready for patenting, a broader palate that she believes was satisfied on the facts below. She identifies the error on the majority's conception of what the "intended purpose" of this invention was and finds prior case law "regrettably, confusing" and that "threatens to render superfluous a substantial body of law starting with the Supreme Court's seminal City of Elizabeth case." As explicated in her dissent, Chief Judge Prost contends that the intended purpose was the narrow one of repositioning the spine to correct a deformity (rather than achieving a result that "cured" the patient of the symptoms of having the deformity). She finds no support for this outcome (cure) in the specification or claims (although it is reasonable to presume that an inventive method that did not achieve this outcome would fail to satisfy at least the utility requirements of § 101). While she acknowledges that the majority identify a "common-sense approach to identifying the intended purpose [that] is rooted in the preamble claim language as well as the specification," she asserts that she is "unpersuaded" because concepts like follow-up time are not found in the claims or specification of the '358 patent.

The question of whether an invention is reduced to practice would appear to be one fraught with an understanding of how that phrase would be interpreted by one having ordinary skill in the art. And while the ultimate question of reduction to practice is a legal one, it is based on such significant underlying factual determinations that the substantial evidence standard would in most cases make it difficult for a court (on post-trial motions) or reviewing court on appeal to overturn a jury's fact findings. But this is the root of what Chief Judge Prost seems to be arguing in setting out her position. Her doctrinal analysis is focused on these differences between being "ready for patenting" and "reduced to practice."

For the experimental use exception she recites ancient decisions, notably Smith & Griggs Manufacturing Co. v. Sprague, 123 U.S. 249, 264 (1887), for the principle that the patentee, once either bar has been established, has the burden of establishing experimental use by clear and convincing evidence. Having found on the facts below that Medtronic established both prongs of the on-sale bar had been satisfied, it is unsurprising that she also considers inadequate Dr. Barry's evidence supporting experimental use. More importantly, Chief Judge Prost identifies copious Federal Circuit precedent she believes improperly fails to recognize the heightened burden her understanding of precedent imposes on a patentee wanting to establish the experimental use exception. And the evidence adduced and credited by the District Court and panel majority in her view lacks objectivity, being limited to the inventor's "after-the-fact, litigation-inspired testimony." At least some of her criticism of this testimony and evidence has a "damned if you do damned if you don't" flavor:

I cannot see how charging one's normal fee makes the sale look like anything other than a normal sale. Had Dr. Barry charged a premium, a claim of experimental purpose would be difficult to maintain. Had he charged less, it might suggest experimental purpose—or it might not [citations omitted].

The case has the usual amount of sniping, in footnotes, between the majority and the dissent. One such statement, however, encapsulates the basic grounds for disagreement between the two opinions (or at least the reasoning underlying them):

The dissent proposes several changes to the legal standards stated in governing case law, such as a change to impose a (high) burden of persuasion on the patent owner to establish experimental use. Medtronic has not argued for such changes. We follow existing case law.

Unrecorded but not out of the question would be a simple repost from the Chief Judge: "For now." Having already revised how the written description requirement is applied to antibodies in Amgen v. Sanofi, the only question seems to be whether Chief Judge Prost will have a case that gives her an opportunity to revise the on-sale and public use bars in accordance with the principles and reasoning set out in her dissent.

Barry v. Medtronic, Inc. (Fed. Cir. 2019)
Panel: Chief Judge Prost and Circuit JudgesMoore and Taranto
Opinion by Circuit Judge Taranto; dissenting in part opinion by Chief Judge Prost

Posted at 11:19 PM in Federal Circuit, Novelty | Permalink | Comments (10)

January 22, 2019

Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc. (2019)

By Kevin E. Noonan --

"Pigs fly!" "Hell has frozen over!" Or less dramatically, "Supreme Court affirms Federal Circuit decision!" all would be apt subtitles for any article discussing the Supreme Court's decision today in Helsinn v. Teva. The question before the Court was whether Congress intended by passing the Smith-Leahy America Invents Act (AIA) to change the status of "secret" sales so as not to trigger the on-sale bar of revised Section 102 by adding the phrase "or otherwise known to the public" (the Federal Circuit held it had not done so, at least not effectively). The Supreme Court agreed.

The decision is short (9 pages, with the legal basis of the Court's opinion starting at page 5), unanimous (9-0), handed down less than seven weeks after oral argument, and authored by Justice Thomas, who often writes patent law decisions that are not particularly contentious or for which one Justice does not have a particular interest. By way of reminder regarding the factual predicate of the case, it arose over ANDA litigation regarding Teva's intention to market a generic version of Helsinn's intravenous formulations of palonosetron used to reduce chemotherapy-induced nausea and vomiting ("CINV"). There were four patents-in-suit: U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, and 8,598,219; only the '219 patent was allowed and granted under the AIA changes in U.S. patent law.

A prior art patent (U.S. Patent No. 5,202,333) taught that palonosetron was useful for treating CINV; the patents-in-suit were directed to novel formulations comprising "unexpectedly low concentrations of palonosetron." Claim 2 of the '725 patent is representative of the pre-AIA patents-in-suit:

2. A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising:
    a) 0.05 mg/mL palonosetron hydrochloride, based on the weight of the free base, in a sterile injectable aqueous carrier at a pH of from 4.5 to 5.5;
    b) from 0.005 mg/mL to 1.0 mg/mL EDTA; and
    c) mannitol in an amount sufficient to tonicify said solution, in a concentration of from about 10 mg/ml to about 80 mg/ml.

Claim 1 is representative of the '219 patent (post-AIA):

1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy- induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:
    palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;
    from 0.005 mg/mL to 1.0 mg/mL EDTA; and
    from 10 mg/mL to about 80 mg/mL mannitol,
    wherein said formulation is stable at 24 months when stored at room temperature.

It is undisputed that each asserted claim covers the 0.25 mg dose of palonosetron. Helsinn entered into a contract for supplying the claimed formulation prior to critical date, but contingent on FDA approval (which was not obtained until after the critical date).

The District Court found a sale or offer for sale prior to the critical date, but that the invention was not ready for patenting with regard to the pre-AIA patents, and that the AIA had changed the on-sale bar to require a public sale or offer for sale. Although the existence of the agreement and its terms were publicly known, the parties had not disclosed the 0.25 mg palonosetron dose before the critical date. The District Court thus rejected Teva's invalidity contentions based on the § 102(b) on-sale bar.

The Federal Circuit reversed, in an opinion by Judge Dyk joined by Judges Mayer and Moore. Using the framework set forth by the Court in Medicines Co. v. Hospira, the panel found that the invention was "on sale" prior to the critical date by applying "the law of contracts as generally understood" and "those activities that would be understood to be commercial sales and offers for sale 'in the commercial community.'" Under this analysis, the Court had little difficulty deciding that there had been a sale before the critical date. The contingent nature of FDA approval did not refute this conclusion, the Court saying that commercial practice, exemplified by provisions of the Uniform Commercial Code, contemplate "purported present sale of future goods . . . [which] operates as a contract to sell," UCC § 2– 105(2), and that "[a] contract for sale that includes a condition precedent is a valid and enforceable contract," citing BG Grp., PLC v. Republic of Argentina, 134 S. Ct. 1198, 1207 (2014). The opinion also cited the Court's own precedent regarding the existence of a sale despite the presence of conditions precedent to commercial transfer of goods, such as Enzo Biochem, Inc. v. Gen-Probe, Inc., 424 F.3d 1276 (Fed. Cir. 2005), and C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340 (Fed. Cir. 1998).

The Court also rejected Helsinn's contention that the AIA changed the on-sale bar calculus to limit its application to public sales. Noting that confidential sales did not per se prevent application of the on-sale bar prior to enactment of the AIA (citing, inter alia, In re Caveney, 761 F.2d 671, 673–74 (Fed. Cir. 1985)), the opinion rejected arguments by Helsinn and amici (including the U.S. government) that the AIA changed the law, which were based almost exclusively on statements from the Congressional record (which were directed not to on-sale activities but to public use). It did not help Helsinn's argument in this regard that the panel identified Supreme Court precedent directly contrary to their position, i.e., Pennock v. Dialogue, 27 U.S. (2 Pet.) 1, 19 (1829). Accordingly, the opinion states that "[w]e conclude that, after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale" and thus invalidity of the '219 patent was not properly determined by the District Court.

With regard to the question of whether the invention claimed in the patents in suit was "ready for patenting" prior to the critical date, the panel decided that it was, based on the invention having been reduced to practice before the critical date. This decision depended, in part, on the parties' stipulation that "they would contest ready for patenting 'only with respect to the limitations and intended uses of "reducing emesis or reducing the likelihood of emesis" and '"to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting" of the asserted claims' and not "'for any other reason.'" The panel noted that its case law distinguished the standard needed to show reduction to practice with regard to whether a pharmaceutical invention would work for its intended purpose and the standard for FDA approval of a new drug, citing Scott v. Finney, 34 F.3d 1058, 1063–64 (Fed. Cir. 1994). Specifically, the standard is that the invention "works for its intended purpose 'beyond a probability of failure' but not 'beyond a possibility of failure.'" The Federal Circuit found the District Court erred by applying the FDA standard rather than the proper patent standard in making its (erroneous) determination that the invention was not "ready for patenting" before the critical date. This conclusion was supported by Helsinn's own documents (including portions of the patents' prosecution histories), pre-litigation statements and testimony. And the opinion noted that, if the standard applied by the District Court was correct, Helsinn could not have filed a valid application prior to the critical date, and "[s]uch a standard would preclude the filing of meritorious patent applications in a wide variety of circumstances."

The Supreme Court granted certiorari to consider the following Question Presented:

Whether, under the Leahy-Smith America Invents Act, an inventor's sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.

The Court recognized that it had "never addressed the precise question presented in this case," but voiced its opinion that "our precedents suggest that a sale or offer of sale need not make an invention available to the public." The Court based its decision on the well-established principle that, under prior versions of Section 102, held that "secret sales" could trigger the on-sale bar. These cases were as recent as Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67 (1998) and as ancient as a trio of 19th Century cases (Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92, 94 (1877); Smith & Griggs Mfg. Co. v. Sprague, 123 U.S. 249, 257 (1887); Elizabeth v. Pavement Co., 97 U.S. 126, 136 (1878)) (although to be honest these cases stand for the proposition that a sale triggers the bar and not the issue of whether the sale was secret or public). The opinion credits the Federal Circuit (saying without apparent irony that that Court has 'exclusive jurisdiction' over patent appeals, 28 U.S.C. §1295(a)") with making "explicit what was implicit in our precedent" with regard to the on-sale bar, citing Special Devices, Inc. v. OEA, Inc., 270 F. 3d 1353, 1357 (2001), and Woodland Trust v. Flowertree Nursery, Inc., 148 F. 3d 1368, 1370 (1998), in support of its conclusion.

Based on this various precedent, the Court was able to reach the conclusion that Congress did not change what activities raised the on-sale bar which includes secret sales, because there was insufficient evident of that intent, citing Shapiro v. United States, 335 U.S. 1, 16 (1948). The Court relied expressly on the Solicitor General's argument that "if 'on sale' had a settled meaning before the AIA was adopted, then adding the phrase 'or otherwise available to the public' to the statute 'would be a fairly oblique way of attempting to overturn' that 'settled body of law.'" In reaching this conclusion the Court rejected Helsinn's argument, based on the "associated-words canon" of legislative intent and Federal Maritime Comm'n v. Seatrain Lines, Inc., 411 U.S. 726 (1973), and Paroline v. United States, 572 U.S. 434 (2014), that the effect of construing the statute as Teva advanced (and the Court accepted) would read the amended words out of the statute. The opinion points out that the catch-all phrase "otherwise available to the public" is better interpreted to capture "material that does not fit neatly into the statute's enumerated categories but is nevertheless meant to be covered"; "on-sale" having a defined meaning the Court declines to encompass its proscriptions into what constitutes being on-sale.

The Court also, as is its wont, waxed somewhat philosophical regarding the limitations on Congressional authority for patenting (reproduced here as a sage reminder of the underpinnings of much of the Court's patent jurisprudence):

The United States Constitution authorizes Congress "[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." Art. 1, §8, cl. 8. Under this grant of authority, Congress has crafted a federal patent system that encourages "the creation and disclosure of new, useful, and nonobvious advances in technology and design" by granting inventors "the exclusive right to practice the invention for a period of years." Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151 (1989).

To further the goal of "motivating innovation and enlightenment" while also "avoiding monopolies that unnecessarily stifle competition," Pfaff, 525 U.S., at 63, Congress has imposed several conditions on the "limited opportunity to obtain a property right in an idea," Bonito Boats, supra, at 149. One such condition is the on-sale bar, which reflects Congress' "reluctance to allow an inventor to remove existing knowledge from public use" by obtaining a patent covering that knowledge. Pfaff, supra, at 64; see also Pennock v. Dialogue, 2 Pet. 1, 19 (1829) (explaining that "it would materially retard the progress of science and the useful arts" to allow an inventor to "sell his invention publicly" and later "take out a patent" and "exclude the public from any farther use than what should be derived under it").

Congressman Lamar Smith, the Chairman of the Committee on the Judiciary of the U.S. House of Representatives during the pendency of the AIA, and the lead sponsor of the bill in the House, filed an amicus brief to the Court explaining Congressional intent, which was unpersuasive to the Court.

The Court's language left the door slightly ajar for a future litigant to distinguish this decision on different facts (for example, where there was no disclosure that the agreement existed, for example); the Court was uncharacteristically cautious in its language ("a commercial sale to a third party who is required to keep the invention confidential may place the invention 'on sale' under the AIA" (emphasis added)). Congress, if sufficiently aggrieved by the Court's dismissal of Congressman Smith's amicus brief explaining Congressional intent, could decide to include an express provision into the statute overturning this decision. But it is clear that only something that express will be enough to convince the Court that their own and the Federal Circuit's extensive jurisprudence has in fact been discarded by the changes to U.S. patent law occasioned by passage of the AIA.

Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc. (2019)
Opinion by Justice Thomas

Posted at 11:50 PM in Novelty, Supreme Court | Permalink | Comments (12)

January 02, 2019

December 06, 2018

Supreme Court Hears Oral Argument in Helsinn v. Teva

By Kevin E. Noonan --

The Supreme Court's recent forays into patent law cases have evinced a tendency towards statutory construction analysis, whether regarding substantive law (see, e.g., WesternGeco LLC v. ION Geophysical Corp. (2018); Sandoz Inc. v. Amgen Inc. (2017); Impression Products, Inc. v. Lexmark International, Inc. (2017); TC Heartland LLC v. Kraft Foods Group Brands LLC (2017); SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC (2017); Life Technologies Corp. v. Promega Corp. (2017); Halo Electronics, Inc. v. Pulse Electronics, Inc. and Stryker Corp. v. Zimmer, Inc. (2016); Kimble v. Marvel Entertainment, LLC (2015); and Commil USA, LLC v. Cisco Systems, Inc. (2015)) or the procedural niceties of Federal Circuit review and U.S. Patent and Trademark Office procedures (see Oil States Energy Services, LLC. v. Greene's Energy Group, LLC (2018); SAS Institute Inc. v. Iancu (2018); Cuozzo Speed Technologies LLC v. Lee (2016); Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. (2015)). This trend could be considered a marked improvement over the Court's penchant for imposing their views on patent eligibility displayed earlier in this decade (see "Supreme Court Issues Decision in Alice Corp. v. CLS Bank"; Association for Molecular Pathology v. Myriad Genetics, Inc. (2013); and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)). Consistent with this latest inclination, the Court will decide the extent to which Congress changed what is novelty-destroying under U.S. patent law when it revised 35 U.S.C. § 102 under the Leahy-Smith America Invents Act (AIA) in 2012 in Helsinn Healthcare S.A. v. Teva Pharmaceuticals Inc.

The Court heard oral argument in this case on Tuesday. It is impossible to know, and even more foolhardy to guess, what the members of the Court are thinking from their questions during oral argument, but that cannot stop an attempted analysis of the aspects of the issues before them that naturally arises when reviewing an oral argument transcript.

Kannon K. Shanmugam argued for Petitioner Helsinn; William M. Jay argued for Respondent Teva; and Malcolm L. Stewart, Deputy Solicitor General, argued for the Government. The Chief Justice posed the first question to Mr. Shanmugam, noting that Helsinn's interpretation of the word "sale" in the statute (to mean sales to the general public) is not necessarily consistent with the plain meaning of the word (Mr. Shanmugam attempted to distinguish on the basis of their being a linguistic difference between "sale" and the statutory language "on sale"). New Justice Kavanaugh jumped on Mr. Shanmugam's hypothetical (regarding a purported private sale of Mr. Shanmugam's overcoat to Mr. Jay), disputing why that wouldn't be a sale ("it's pretty hard to say something that has been sold was not on sale"). Justice Breyer, referring to Helsinn's argument in the brief, questioned whether Helsinn's contentions that its position was supported by the Court's precedents ("we only have Justice Story, Learned Hand, and I guess various others, maybe John Marshall for all I know", which in vacuo seem pretty solid), and opined that "the purpose of this on-sale rule including private sales is to prevent people from benefiting from their invention prior to and beyond the 20 years that they're allowed." Mr. Shanmugam countered that "the predominant purpose of the on-sale bar was preserving the public's access to inventions that have entered the public domain." Justice Kavanaugh mentioned "commercial exploitation" as another aspect of the bar, and Justice Breyer interjected that such sales (like the one here) can be secret sales. Mr. Shanmugam, attempting to provide clarification to Justice Ginsberg, said that Congress intended to "clarify" the scope of what would be considered to be "on sale" with, inter alia, the catchall phrase "or otherwise available to the public," which Justice Kavanaugh opined was "a terrible clarification," stating that there were many efforts during debate over the AIA to "actually change the 'on sale language, and all those failed." Mr. Shanmugam countered by suggesting that the way Congress had revised the statute was appropriate to its purpose, which included "abrogating some of the outlying lower court decisions that had extended both the on-sale bar and the public use bar to cases where there was not public availability." Mr. Shanmugam responded directly to Justice Kavanaugh's citation of an amicus brief by Mark Lemley (and other legal academics) that the on-sale bar always included secret sales, a statement challenged by Justice Breyer based on the Court's citation in its Bonito Boats case of Learned Hand's dichotomy that a patentee "has to go ahead and patent [her invention] or keep it a secret forever." To Justice Breyer's accompanying hypothetical of an inventor selling her invention to multiple parties under confidentiality agreements, Mr. Shanmugam says his "submission is a much more modest one," to "correct the Federal Circuit's error, which is to say that public availability is not required."

The Government argued next. Justice Sotomayor responded negatively to Mr. Stewart's hypothetical, regarding sales of iPhones to distributors wherein being "on sale" should be considered to arise upon sales to consumers, saying that this might be true if you asked a consumer, but if you asked the industry they would say the phones were on sale when they were purchased by the distributor. The Justice further said she has found no support for the Government's argument ("I've looked at the history cited in the briefs, I looked at the cases, I don't find it anywhere") and further said that the Government's assertion of the meaning of the statute was not the words Congress used. Indeed, the words Congress did use, "on sale," were fraught with their historical meaning that did not support the Government's position. Justice Kagan followed by asking whether the changes to the statute under the AIA were "capable of flipping [] settled law." After further colloquy, Mr. Stewart conceded that the change in language would not be so capable, but only if he accepted Justice Kagan's assumption (and it's "a big assumption," the Justice herself conceded) that the law was indeed settled on the question of what activities fell under the on sale bar under prior law. Justice Kavanaugh returned to the questioning, asking whether this wasn't "a classic example of trying to snatch victory from defeat in some of the legislative statements?" in view of Congress's failure to affirmatively revise the statute to exclude secret sales. Mr. Stewart aptly (but not necessarily persuasively) responded, referring to how those failed proposals would have otherwise modified the statute to require that the invention be disclosed, even under circumstances where it would not upon sale.

Mr. Jay argued last, leading with the simple proposition that "[a] product that is sold or offered for commercial sale is on sale." Justice Alito questioned whether Respondent's position, if stated in statutory language not used by Congress ("on sale publicly or on sale privately"), "would be nonsense," because this phrase would be followed by "or otherwise available to the public" and "otherwise" should indicate that "all of the things that went before are public." Mr. Jay responded by saying:

So we think that the function of "otherwise" in the statute as amended [] is to acknowledge that there is overlap between the previous four categories and the new category of invalidating prior art that's being added, so as to make sure that the new category doesn't swallow or change the meaning of a prior one.

This "new category" would include "An oral presentation at a conference without slides" and "a collaboration among many people on an app." In Respondent's view, by including the phrase "or otherwise available to the public," Congress intended "to create new invalidating prior art disclosures that weren't invalidating before the AIA." Mr. Jay clarified for Justice Sotomayor that the U.S. is the only country where "secret" prior art could be novelty destroying, and that "otherwise" is intended to "make clear that that new category was a residual category intended to catch things not already caught." Various members of the Court (as is their wont) engaged counsel with an extended exercise in analogy-making, involving collections of sports ("football, baseball, swimming," Justices Alito and Breyer), coupled with a hypothetical catch-all of "amended to add 'or any other activity that involves the use of a ball,'" and a proscription against "peanut butter cookies, pecan pie[, and] brownies" (Justice Kagan), coupled with the question of whether the proscription would be violated by "nutless brownies." Despite yeoman effort to address these analogies, Mr. Jay was able to forthrightly respond to Justice Kagan's question asking whether it was Respondent's position that "it's not even like a little bit doubtful what 'on sale' means?" by saying "[c]ertainly not by the time the AIA was enacted." After additional colloquy with Justice Kavanaugh regarding whether the term "on sale" is ambiguous, Justice Gorsuch asked whether the Court should consider how the Patent Office has interpreted the statute regarding the on-sale bar. Mr. Jay reminded the Justice that "[t]his Court has never given deference to the Patent Office on substantive questions of patentability, on what it takes to overcome the bars put in the statute by Congress where Congress has said you may not have a patent if X, Y, or Z" and that "this Court has any number of decisions in which it has held that a patent issued by the Patent Office in conformance with the -- with the office's then examination guidelines were invalid." Justice Kagan completed the Court's questioning of Mr. Jay by asking "would the prior secret sale of an invention by somebody other than the patentholder invalidate the patentholder's patent?", to which Mr. Jay answered "yes" (while acknowledging that "I've not seen cases like that because I think it would be exceptionally difficult to").

Petitioner's rebuttal drew questioning only from Justice Breyer, regarding the meaning of the term "otherwise." Argument concluded with rather jocular reference to the excellence of the briefs (Justice Breyer having earlier noted "I thought the bar really earned its pay on both sides") with the Chief Justice saying "I am sure we'll come up with an excellent opinion."

Posted at 11:41 PM in Novelty, Supreme Court | Permalink | Comments (2)

November 21, 2018

Acceleration Bay, LLC v. Activision Blizzard Inc. (Fed. Cir. 2018)

What is a Printed Publication for Prior Art Purposes?

By Joseph Herndon --

Patent owner Acceleration Bay, LLC ("Acceleration") appealed the final written decisions of the Patent Trial and Appeal Board holding unpatentable claims of U.S. Patent Nos. 6,829,634; 6,701,344; and 6,714,966. Activision Blizzard, Inc., Electronic Arts Inc., Take-Two Interactive Software, Inc., 2k Sports, Inc., and Rockstar Games, Inc. (collectively, "Blizzard") cross-appealed portions of the Board's decisions holding that the Lin article is not a printed publication under 35 U.S.C. § 102(a), among other issues.

Here, we look at the determination of features in a "preamble" as being limitations of the claim, as well as, requirements of an article being considered a printed publication for prior art purposes.

The patents at issue are directed to a broadcast technique in which a broadcast channel overlays a point-to-point communications network. The communications network consists of a graph of point-to-point connections between host computers or "nodes," through which the broadcast channel is implemented.

Blizzard filed six inter partes review ("IPR") petitions—two for each of the '344, '966, and '634 patents—based principally on two different prior art references: one set of IPRs challenged claims based on the Shoubridge article alone or combined with a prior art book Direct-Play ("Shoubridge IPRs"), and another set of IPRs challenged claims based on the Lin article alone or combined with DirectPlay ("Lin IPRs").

The Board instituted an IPR on each petition, on many of the grounds and claims raised, and rendered six final decisions. In the Shoubridge IPRs, the Board determined many claims to be unpatentable, and in the Lin IPRs, the Board concluded that Lin is not a printed publication under 35 U.S.C. § 102(a) and thus determined Blizzard failed to show the challenged claims are unpatentable over Lin.

Shoubridge IPRs

Acceleration appealed portions of the Board's decisions in the Shoubridge IPRs. Claim 1 of the '966 patent is representative of the claim construction disputes in Acceleration's appeal (emphases added):

1. A computer network for providing an information delivery service for a plurality of participants, each participant having connections to at least three neighbor participants, wherein an originating participant sends data to the other participants by sending the data through each of its connections to its neighbor participants and wherein each participant sends data that it receives from a neighbor participant to its other neighbor participants, further wherein the network is m-regular, where m is the exact number of neighbor participants of each participant and further wherein the number of participants is at least two greater than m thus resulting in a non-complete graph.

Claim 1 of the '344 patent is very similar and begins "1. A computer network for providing a game environment for a plurality of participants, ...".

Acceleration argued that the terms "game environment" and "information delivery service," appearing in the '344 and '966 patents, respectively, should have been given patentable weight despite appearing in the preambles because they provide structure for the remainder of the claims. Acceleration alternatively argues that these terms appear in the body of the claims because there is no transition phrase denoting a preamble.

Regarding the latter argument, the Federal Circuit responded that Acceleration's poor claim drafting will not be an excuse for it to infuse confusion into its claim scope, and simply concluded that "game environment" and "information delivery service" are part of the preamble of the claims.

The Federal Circuit noted that there is no beneficial purpose to be served by failing to include a transition word in a claim to clearly delineate the claim's preamble from the body, and it "caution[ed] patentees against doing so."

Then, because the terms at issue appear in preambles, it must be determined whether the terms are limitations. General case law indicates that a preamble limits the invention if it recites essential structure or steps, or is necessary to give life, meaning, and vitality to the claim.

The Federal Circuit agreed with the Board that the claim terms "game environment" and "information delivery service" are non-limiting because they merely describe intended uses for what is otherwise a structurally complete invention. They do not impart any structure into or serve as antecedents for the claims at issue. Instead, they simply provide an intended use for what is otherwise a claim for a network.

Lin IPRs

Blizzard cross-appealed many portions of the Board's decisions in the Lin IPRs, and here we only discuss the issue of whether Lin is a printed publication under § 102(a).

Whether a reference qualifies as a printed publication under § 102 is a legal conclusion based on underlying fact findings. One such fact question is public accessibility. Because there are many ways in which a reference may be disseminated to the interested public, public accessibility has been called the touchstone in determining whether a reference constitutes a printed publication.

Case law has indicated that a reference is considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

The Board found that Lin was not publicly accessible before the critical date.

Based on the testimony of Glenn Little, a Systems Administrator at the Computer Science and Engineering ("CSE") department of the University of California, San Diego ("UCSD"), the Board found that Lin had been uploaded to the CSE Technical Reports Library's website as of November 23, 1999, which is not challenged on appeal. As the Board explained, according to Mr. Little, "the CSE department regularly maintains electronic technical reports and records concerning those reports, and a staff member assigns a unique identifier to each report based on the year it was uploaded and the relative order it was uploaded in comparison to other papers."

The Board then noted that public accessibility requires more than technical accessibility. Because there was no evidence that Lin was disseminated to the public, the Board focused on whether an interested skilled artisan, using reasonable diligence, would have found Lin on the CSE Technical Reports Library website. The Board found that despite some indexing and search functionality on the website, Lin was not publicly accessible. It found the website allowed a user to view a list of technical reports indexed only by author or year and that there was no evidence as to how many reports were in the Library's database in 1999. The Board determined that at best, Blizzard's evidence suggests that an artisan might have located Lin by skimming through potentially hundreds of titles in the same year, with most containing unrelated subject matter, or by viewing all titles in the database listed by author, when the authors were not particularly well known. The Board also found the website's advanced search form to be deficient. It found that while the advanced search form appeared to allow a user to search keywords for author, title, and abstract fields, evidence demonstrated that functionality was not reliable. In sum, the Board determined that Blizzard had not shown sufficiently that the UCSD CSE Technical Reports Library was searchable or indexed in a meaningful way so that a person of ordinary skill in the art would have located Lin. The Board, therefore, concluded Lin is not a printed publication under § 102(a).

The Federal Circuit found no error in the Board's reasoning. Namely, the Federal Circuit found that substantial evidence supports the Board's findings that Lin was not publicly accessible, including that Lin was not indexed in a meaningful way and that the website's advanced search form was deficient. Mr. Little testified he does not know how the search works or how keywords are generated, that he never searched for Lin using the advanced search form, and that it was not the CSE department's practice to verify the advanced search capability for title and abstract when a new article was uploaded. Mr. Little also admitted it was possible the search function did not work.

Acceleration also presented evidence that a recent advanced search for keywords in the title and abstract of Lin failed to produce any results.

Blizzard argued these results are unauthenticated hearsay and are based on searches conducted years after the critical date, but Mr. Little testified that as to the website, "[i]t's pretty much the same, actually, between [1999] and now. We're running the same software." The Federal Circuit found no reason to discount the Board's weighing of the evidence. Substantial evidence was thus found to support the Board's finding that there was insufficient evidence of record to support a finding that a person of ordinary skill in the art in 1999 could have located Lin using the CSE Library website's search function.

The Federal Circuit thus distinguished a similar case: In re Lister, 583 F.3d 1307 (Fed. Cir. 2009). In Lister, a reasonably diligent researcher with access to a database that permits the searching of titles by keyword would be able to attempt several searches using a variety of keyword combinations, and thus, the manuscript at issue was publicly accessible as of the date it was included in databases that permitted keyword searching of titles.

The Federal Circuit noted that unlike in Lister, here the record supports the Board's finding that the CSE Library website's advanced search function did not successfully permit keyword searching of titles, a key feature in Lister. The Board's fact finding that, with available reports indexed only by author or year, Lin was not meaningfully indexed, was found to be supported by substantial evidence.

Blizzard argued that because Lin was indexed by title for a given year, author name, and unique sequence number, that was sufficient for public accessibility. But, the Federal Circuit stated that the test for public accessibility is not "has the reference been indexed?" Where indexing is concerned, whether online or in tangible media, the ultimate question has been whether the reference was available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

Here, the Board found that although Lin was indexed by author and year, it was not meaningfully indexed such that an interested artisan exercising reasonable diligence would have found it, which is a proper consideration under the Federal Circuit precedent. As such, the Federal Circuit found that Lin was not a printed publication under § 102.

Acceleration Bay, LLC v. Activision Blizzard Inc. (Fed. Cir. 2018)
Panel: Chief Judge Prost and Circuit Judges Moore and Reyna
Opinion by Circuit Judge Moore

Posted at 11:32 PM in Claim Construction, Federal Circuit, Novelty | Permalink | Comments (0)

October 24, 2018

Nobel Biocare Services AG v. Instradent USA, Inc. (Fed. Cir. 2018)

By Joseph Herndon --

Nobel Biocare Services AG appealed from the decision of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board in an inter partes review (IPR) holding claims 1–5 and 19 of U.S. Patent No. 8,714,977 invalid based on an ABT Catalog. Many issues were presented, and here, we review the opinion with respect to whether the ABT Catalog qualifies as a prior art printed publication under pre-AIA 35 U.S.C. § 102(b).

This case started on October 27, 2014, by Nobel filing a complaint with the U.S. International Trade Commission (ITC) for investigation of Instradent USA, Inc.'s Drive CM dental implants as allegedly violating 19 U.S.C. § 1337 by reason of importation of an implant product that infringes the '977 patent and U.S. Patent No. 8,764,443. The ITC found claims of the '977 patent anticipated by an ABT "Product Catalog" with the date "March 2003" on the cover. However, later, the ITC issued a Commission Opinion which determined that Instradent had failed to show by clear and convincing evidence that the ABT Catalog is prior art under § 102(b).

In the interim, on August 20, 2015, Instradent petitioned for IPR of claims 1–7, 9, and 13–20 of the '977 patent with invalidity challenges based on the ABT Catalog. The Board determined that a preponderance of the evidence establishes that the ABT Catalog qualifies as a prior art printed publication under pre-AIA 35 U.S.C. § 102(b), and ultimately found the claims invalid.

Thus, the appeal largely turns on whether the ABT Catalog is prior art under § 102(b).

The ABT Catalog

In or about the early 1990s, named inventor Fromovich founded Alpha-Bio Tech Ltd. ("ABT"), which sold dental implants and related goods. He also served as ABT's CEO. In his capacity at ABT, Fromovich conducted dentist trainings and attended industry trade shows and conferences, including the International Dental Show (IDS) Conference held in Cologne, Germany. At the IDS Conference, dental manufacturers would showcase their products and distribute written materials describing their products. Nobel acquired ABT and its intellectual property rights in 2008.

The ABT Catalog included a data of March 2003 on its cover and discloses dental implant screws and other details of implants as claimed in the '977 patent. The ABT Catalog was produced by Instradent and alleged to be prior art to the '977 patent.

Fromovich testified about the ABT Catalog during the ITC proceedings. When asked why the catalog says "March 2003" on the cover, Fromovich indicated that he "estimated" it was because it was created in the end of March 2003 for the IDS in Cologne, Germany. Fromovich testified that ABT had a small booth and he attended the March 2003 IDS Conference. According to Fromovich, the IDS Conference is "one of the biggest for distribution in Europe" with possibly a thousand attendees. He further testified that he did not recall if he brought the ABT Catalog to the conference, but that it was "unlikely." He explained that if he brought the ABT Catalog, it would have been a "small amount" of catalogs because it would have been a first version of a 62-page document, and ABT did not send a shipment so it would have had to fit in his luggage.

Fromovich also testified that the ABT Catalog was used in connection with training courses and provided to attendees without requiring them to sign a confidentiality agreement.

The parties dispute whether the ABT Catalog qualifies as a "printed publication" under pre-AIA § 102(b). Whether a reference qualifies as a "printed publication" is a legal conclusion based on underlying factual findings, and the underlying factual findings include whether a reference was publicly accessible. The case law indicates that a reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it.

In addressing public accessibility of the ABT Catalog, the Board considered evidence that had been presented to the ITC, including Fromovich's testimony, and new evidence not considered by the ITC, including the declarations and deposition testimony of Yechiam Hantman and Zvi Chakir. In March 2003, Hantman and Chakir coowned Chakir Implants, Ltd., a dental supply distributor located in Israel. Hantman was unable to attend the conference, and he requested that Chakir collect catalogs from competitors at the 2003 IDS Conference and give them to him upon his return. Hantman's declaration stated: "Based upon my review of the attached materials and my specific recollections of conversations with customer [sic] in later 2002 and early 2003, and examination of the 2003 [ABT] Catalog after receiving it after the IDS trade show, I am certain that the 2003 [ABT] Catalog was publically accessible to the dental industry, including competitors, in March 2003, after the IDS show that year."

Chakir's declaration stated that he collected catalogs and other materials from competitors, including ABT at the 2003 IDS Conference and gave the materials relating to dental implants to Mr. Hantman.

The Federal Circuit found that substantial evidence supported the Board's finding that the ABT Catalog was publicly accessible prior to the critical date. The Federal Circuit credited Chakir and Hantman's testimony that Chakir obtained a copy of the ABT Catalog at the March 2003 IDS Conference and that Hantman retained that copy in his records thereafter. Hantman's declaration included excerpts of his copy of the ABT Catalog taken from his files. The Board found that Hantman's copy of the ABT Catalog and the copy offered as prior art by Instradent in the IPR had identical pages except for some handwriting on the cover of Hantman's copy. Nobel did not dispute this finding.

Additionally, the ABT Catalog has the date "March 2003" on its cover. Although the ABT Catalog's date is not dispositive of the date of public accessibility, its date is relevant evidence that supports the Board's finding of public accessibility at the March 2003 IDS Conference.

Moreover, the Board found, and Nobel did not dispute on appeal, that the ABT Catalog is the type of document normally intended for public dissemination. It is undisputed on appeal that the ABT Catalog is the type of document intended for public dissemination, and it bears no designations, such as "draft" or "confidential," that might suggest that it was not intended for public distribution.

The Federal Circuit gave much weight to Chakir's testimony regarding his habitual practice in obtaining product literature, including brochures, at the IDS Conference. Nobel's suggestion that Chakir could have obtained the ABT Catalog confidentially or under other circumstances that would not legally constitute public accessibility lacked any evidentiary basis.

Additionally, Nobel pointed to no evidence that ABT ever distributed the ABT Catalog with an expectation that it would be kept confidential or not disseminated.

The Federal Circuit addressed the sufficiency of the corroboration of the testimony and found the testimony of Messrs. Hantman and Chakir not only to be corroborated by each other, but also by a) the actual copy of the ABT Catalog, dated March 2003, submitted as evidence and b) Dr. Fromovich's testimony that ABT operated a booth at the March 2003 IDS conference.

The fact that Hantman had a copy of the ABT Catalog in his files further corroborates his testimony that he obtained a copy of the same document asserted to be prior art in the IPR.

Thus, although much of the evidence relied upon was based on testimony of biased witnesses regarding events that took place over 10-15 years ago, the Federal Circuit found no reason that the testimony was problematic. As a result, the ABT Catalog was found to be prior art.

Nobel Biocare Services AG v. Instradent USA, Inc. (Fed. Cir. 2018)
Panel: Chief Judge Prost and Circuit Judges Lourie and Chen
Opinion by Circuit Judge Lourie

Posted at 11:55 PM in Federal Circuit, Novelty | Permalink | Comments (1)

September 18, 2018

Patenting Repurposed Drugs

By John E. Conour --

Even with billions of dollars of funding and the cumulative knowledge and experience of over a hundred years of experimental pharmacology, de novo discovery of effective and safe therapeutics remains a costly and risky endeavor. The number of unsuccessful attempts to obtain Food and Drug Administration (FDA) approval of drugs for specific indications is far greater than the number of successes. As a result, there is an extensive and ever growing list of "failed" drugs, most of which are ultimately abandoned by pharmaceutical companies.

More recently, failed drugs previously considered to be lost causes are being reconsidered as possible therapies for different indications than those for which they had originally been considered. Such drug "repurposing" provides researchers and clinicians with a cost-effective way to identify potential new therapies without needing to start from scratch. Many failed drugs have already established their relative safety in Phase I clinical trials, which can simplify and reduce the cost of obtaining FDA approval should a new indication be found. Drug repurposing is not limited to failed drugs but is also being considered for currently marketed drugs as well as "off patent" generic compounds to expand and extend their usefulness.

But because drug repurposing primarily concerns previously-known drugs, obtaining patent protection can be challenging. In some cases, a drug to be repurposed is still protected by a patent that can be acquired and/or in-licensed, but often the drug itself is not protected by patent. Without patent protection, commercialization of a repurposed drug (i.e., maximizing the potential beneficial impact of the drug) is not realistic. This article discusses certain issues to be considered when trying to obtain new patent protection for repurposed drugs. It should be expected that each attempt to patent a repurposed drug will have its own factspecific challenges. Accordingly, the concepts discussed here are generalized and nonexhaustive.

The foundational inquiry for determining whether a repurposed drug can be patented in the United States is to consider whether, under 35 U.S.C. § 101, the drug constitutes patentable subject matter. Section 101, in relevant part, provides: "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . ."[1] Repurposed drugs are often non-nature-based compositions of matter (i.e., synthetic compounds that are not naturally occurring) that can be used in useful processes (e.g., methods of treating a disease by administering to a patient in need thereof a therapeutically effective dose of a drug). Therefore, claims directed to repurposed drugs and methods of their use should not typically run afoul of § 101. Even repurposed drugs that are nature-based compositions of matter may still be patentable, for example, if recited in a method of treatment claim. Indeed, method of treatment claims reciting nature-based compositions of matter seem to be on more secure footing under § 101 in light of the recent decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals,[2] at least because the United States Patent and Trademark Office has issued a recent memorandum to the Patent Examining Corps advising that the Patent Office intends to follow the legal reasoning in this case.[3] Nevertheless, care must be taken when drafting claims to avoid § 101 issues.

Another significant hurdle to overcome with respect to patenting repurposed drugs is 35 U.S.C. § 102. Section 102, as applied to a repurposed drug, requires that it was not previously patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before a patent application is filed to cover the repurposed drug. In other words, a claim to the repurposed drug itself must be novel, in that it must recite something not previously publicly known. Practically speaking, most composition of matter claims reciting only the repurposed drug will be excluded from patentability under § 102, because (almost by definition for a "repurposed" drug) the drug was previously known and thus its earlier public disclosure would be prior art to any subsequent patent filing. Accordingly, composition claims directed to the repurposed drug itself will likely be anticipated because they are not reciting anything new. Yet there are ways to overcome § 102 to obtain composition claims on repurposed drugs.

One useful approach for overcoming a § 102 rejection is to incorporate the repurposed drug into a composition that includes one or more other compounds to form a novel combination not previously known. Importantly, the claimed combination can be any practical combination that is novel for purposes of overcoming § 102. However, as discussed below, claims to pharmaceutical compositions that recite combinations with more than one key constituent (e.g., a therapeutically effective amount of a repurposed drug and a therapeutically effective amount of a second drug) are more likely to be patentable. Additional details regarding specific amounts of drugs included in combinations or ratios between the drugs in the combination can add further grounds for finding such claims patentable over what was previously known in the prior art.

A further approach to obtaining claims directed to previously known drugs that are patentable in a § 102 context is to draft claims to novel pharmaceutical dosage forms. Pharmaceutical dosage forms can be, for example, solids, liquids, delayed or extended release forms, and/or for a specific type of administration (e.g., oral, parenteral, intramuscular, etc.). Many types of variations are possible with pharmaceutical dosage forms, which lend themselves to drafting novel claims. For example, desired release characteristics and/or routes of administration may differ for the new use of the repurposed drug compared to its previous use, which would provide the basis of a novel claim.

As a final and particularly important example, a method claim reciting a repurposed drug may more easily overcome § 102 rejections. Repurposing a drug for a new indication is typically a novel use of the drug. Therefore, a method-of-use claim that recites a repurposed drug for treating a subject with the new indication should also be novel. Such method claims are particularly useful because they are difficult for competitors to design around, and they are also available in many foreign jurisdictions (though with potentially different formats).

What is often more challenging for patenting a repurposed drug is overcoming an obviousness rejection. Obviousness (or lack of inventive step) falls under 35 U.S.C. § 103, which states, in relevant part, that:

A patent for a claimed invention may not be obtained . . . , if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.[4]

Here, the basic calculus is that if a skilled artisan (e.g., a clinician or researcher in the same field of practice or study as the person seeking to repurpose a drug and with the average skill level of such clinicians or researchers) who understands the prior art would have reasonably expected the drug to be useful for the new indication, then a claim to a repurposed drug for the new indication may be obvious. Obviousness rejections of claims to repurposed drugs can be very complex and can be based on a combination of several prior art references, each teaching one or more aspects of the rejected claims.

Unfortunately, the relatively straightforward strategies for overcoming a § 102 rejection are mostly ineffective for overcoming obviousness rejections. Simple chemical combinations of repurposed drugs with other drugs that may make a novel composition are arguably obvious if they are nothing more than a routine exercise for a skilled pharmacologist. Fortunately, there are ways to overcome obviousness rejections, but they can require planning well before filing a patent application, and indeed, experiments to investigate the usefulness of a repurposed drug should be designed with obviousness rejections in mind. This is because one of the most powerful arguments against an obviousness rejection of claims directed to a repurposed drug is a showing of unexpected results.[5] In this context, a showing of unexpected results can be a presentation of scientific data (often in the patent application, but data can also be presented after filing) that, for example, show a surprising effect of a drug that would not have been expected based on what was known at the time. Examples of unexpected results can include that a drug surprisingly works as intended for a new indication, or that a drug works at the dose used (e.g., a surprisingly low dose), or that a combination of drugs demonstrates synergy when used together (their combined effect being greater than each drug acting alone), among others.[6] Another powerful example of unexpected results is the discovery that the drug acts via a different target or has a different mechanism of action for the new use than for its previous use. Such examples of unexpected results can overcome obviousness rejections for claims directed to method of use, or pharmaceutical dosage forms, or pharmaceutical compositions comprising a combination of drugs, respectively. Therefore, care should be given to experimental design and the types of data that are collected in support of such evidence of non-obviousness.

Finally, a patent for a repurposed drug must satisfy 35 U.S.C. § 112, which requires that a patent application include:

[A] written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.[7]

Section 112 also requires an application to have one or more claims "particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention."[8] Basically, § 112 requires that, at the time of filing, the written description must enable a skilled artisan to replicate the invention (much like a scientific paper should enable a researcher to replicate the experiments and data presented in the paper) and that the claims must be fully supported by the written description.

Careful patent application planning and drafting can avoid or overcome § 112 rejections. At a minimum, literal support for each claim should be provided, examples of various embodiments of the invention described (e.g., the repurposed drugs and indication, possible drug substitutions and/or derivatives, dosing amounts, dosage forms, excipients, dosing regimens, methods of treatment, etc.), and experimental data establishing drug effectiveness included. The written description should also be drafted with sufficient detail and distinct variations of the invention to permit claim amendments that can dispose of a prior art rejection (under either § 102 or 103). Indeed, all important details and variations of the invention envisioned must be included before filing because § 112 prohibits addition of "new matter" after filing.

In conclusion, patent protection is possible for previously known drugs being repurposed for new indications. The best chances for patenting repurposed drugs occur when care is given to initial experimentation to establish the usefulness of the drugs and for identifying any unexpected properties of the drugs. By combining robust invention disclosures with thoughtful and detailed application preparation, patent applications directed to repurposed drugs will be better prepared to successfully navigate the rigors of the Patent Office.

[1] 35 U.S.C. § 101.

[2] 887 F.3d 1117 (Fed. Cir. 2018).

[3] See Memorandum from Robert W. Bahr, Deputy Comm'r for Patent Examination Policy, to Patent Examining Corps (Jun. 7, 2018), available at https://www.uspto.gov/sites/default/files /documents/memo-vanda-20180607.PDF.

[4] 35 U.S.C. § 103.

[5] Other important objective evidence of non-obviousness, also known as "secondary considerations," includes evidence of commercial success, long-felt but unsolved needs, and failure of others. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17 (1966).

[6] See Manual of Patent Examining Procedure §§ 716.02, 2145.

[7] 35 U.S.C. § 112(a).

[8] Id. § 112(b).

Posted at 11:59 PM in Enablement, Novelty, Obviousness, Patentable Subject Matter, Written Description | Permalink | Comments (4)

July 30, 2018

GoPro, Inc. v. Contour IP Holding LLC (Fed. Cir. 2018)

Catalog Distributed at Conference (Not "Open to the Public") Is Publicly Accessible

By Joseph Herndon --

GoPro, Inc. appealed from final written decisions of the Patent Trial and Appeal Board in two inter partes review (IPR) proceedings. In the proceedings, the Board found that the petitioner, GoPro, did not demonstrate that the challenged claims were unpatentable as obvious, and based this decision on its finding that a certain GoPro catalog was not a prior art printed publication. The sole issue on appeal is whether the GoPro catalog is prior art.

Contour IP Holding LLC owns U.S. Patent Nos. 8,890,954 and 8,896,694. The patents share a common specification that generally relates to and describes action sport video cameras or camcorders that are configured for remote image acquisition control and viewing. According to the patents, the claimed device uses global positioning system (GPS) technology to track its location during recording and a wireless connection protocol, such as Bluetooth, to provide control signals or stream data to the wearable video camera and to access image content stored on or streaming from the wearable video camera.

The patents further describe that when recording video or taking photographs in a sports application, a digital video camera is often mounted in a location that does not permit the user to easily see the camera. The digital camera includes wireless communication capability to allow another device, such as a smartphone or tablet, to control camera settings in real time, access video stored on the camera, and act as a "viewfinder" to preview what the camera sees.

Both the '954 and '694 patents claim priority to a provisional application filed on September 13, 2010. Thus, the one-year critical date is September 13, 2009.

GoPro petitioned for inter partes review of the '954 and '694 patents and challenged the patentability of the claims on obviousness grounds, relying on a 2009 GoPro sales catalog as prior art in each petition. The GoPro Catalog discloses a digital camera linked to a wireless viewfinder/controller that allows for a user to preview before recording.

The Board instituted both IPRs, and in its decisions to institute, the Board found that GoPro made a threshold showing that the GoPro Catalog is prior art. After the hearing, however, the Board found that the GoPro Catalog did not qualify as a prior art printed publication under 35 U.S.C. § 102(b), and because all the instituted grounds were based on the GoPro Catalog, the Board found that GoPro had not demonstrated that the challenged claims of the '954 and '694 patents were unpatentable under 35 U.S.C. § 103. GoPro appealed from these final written decisions to the Federal Circuit.

On appeal, neither the claim terms nor the claimed inventions are at issue in this appeal. The only issue is whether the GoPro Catalog is prior art. The '954 and '694 patents each have an effective filing date before the effective date of the Leahy-Smith America Invents Act ("AIA"). Thus, the pre-AIA version of 35 U.S.C. § 102 was applied.

Section 102(b) provides that a person shall be entitled to a patent unless the invention was described in a printed publication more than one year prior to the date of application for patent in the United States. The printed publication rule is based on the principle that once an invention is in the public domain, it can no longer be patented by anyone. Even relatively obscure documents qualify as prior art so long as the relevant public has a means of accessing them.

The most commonly referenced example is that even a single cataloged thesis in a university library was found to be sufficiently accessible to those interested in the art exercising reasonable diligence. Accessibility goes to the issue of whether interested members of the relevant public could obtain the information if they wanted to and if accessibility is proved, there is no requirement to show that particular members of the public actually received the information. Accordingly, a reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.

Critical to its decision, the Board credited a declaration from GoPro employee, Damon Jones, relating to the distribution of the GoPro Catalog. Mr. Jones worked at GoPro from 2008 to 2016 and participated in various trade organizations relevant to GoPro's business. This included Tucker Rocky Distributing ("Tucker Rocky"), a trade organization focused on action sports. In his declaration, Mr. Jones testified that Tucker Rocky holds an annual dealer trade show, which he attended in Fort Worth, Texas, from July 23 through July 27, 2009, on GoPro's behalf. Mr. Jones also testified that at the 2009 show, there were approximately 150 vendors and more than 1,000 attendees, including actual and potential dealers, retailers, and customers of portable POV video cameras. Mr. Jones stated that he manned the GoPro booth at the show, where the GoPro Catalog was displayed, and that he personally distributed the GoPro Catalog to attendees. Attached to Mr. Jones's declaration, GoPro provided the catalog, a vendor list and map of the Tucker Rocky 2009 show, and email records supporting Mr. Jones's statements. The declaration from Mr. Jones also included testimony that GoPro continued to make the GoPro Catalog available to GoPro's actual and potential customers, dealers, and retailers through its website, direct mail, and other means of distribution.

In its Patent Owner Responses, Contour argued that GoPro had not demonstrated that the GoPro Catalog was a prior art printed publication. To support its argument, Contour submitted two pieces of evidence—a screenshot from Tucker Rocky's website from 2009 and a Facebook webpage for the 2013 Tucker Rocky Dealer Show. The 2009 website screenshot explained that Tucker Rocky is a wholesale distributor that does not sell to the public. The 2013 Facebook page stated that the 2013 Tucker Rocky Dealer Show was open to dealers but not the public. In its final written decisions, the Board concluded that GoPro had not met its burden to show that the GoPro Catalog was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art and exercising reasonable diligence could have located it.

On Appeal, the parties did not dispute any of the facts or evidence presented by GoPro regarding the distribution of its catalog. In addition, there is no dispute that the Tucker Rocky Dealer Show occurred before the critical date of the '954 and '694 patents. The only issue on appeal is whether the GoPro Catalog was sufficiently accessible as contemplated under § 102(b).

The Federal Circuit reversed the Board's decision, and agreed with GoPro in that Mr. Jones's declarations and corroborating evidence were sufficient to meet its burden of establishing that the GoPro Catalog was publicly accessible. The Federal Circuit noted that the case law regarding accessibility is not as narrow as the Board interpreted it. The Board focused on only one of several factors that are relevant to determining public accessibility in the context of materials distributed at conferences or meetings—i.e., that the conference was open to the public.

However, the nature of the conference or meeting must be considered. The Federal Circuit found that if one desires to examine certain new products on the market, attending a trade show involving identical or similar products is a good option. Mr. Jones testified that Tucker Rocky holds an annual trade show that draws thousands of attendees. In 2009, GoPro participated in the Tucker Rocky Dealer Show as a vendor and had a demonstration booth at the show. Mr. Jones testified that there were over 150 vendors, 1,000 attendees, and that GoPro displayed and distributed hundreds of copies of the GoPro Catalog to attendees at the show without restriction.

The Patent Owner did not cross-examine Mr. Jones, and does not point to any reason to doubt the veracity of his testimony.

Although the trade show was only open to dealers, there is no evidence or indication that any of the material disseminated or the products at the show excluded POV action cameras, or information related to such cameras. Contrary to the Board's conclusion, the attendees attracted to the show were likely more sophisticated and involved in the extreme action vehicle space than an average consumer. Thus, it is more likely than not that persons ordinarily skilled and interested in POV action cameras were in attendance or at least knew about the trade show and expected to find action sports cameras at the show.

The Board concluded that the GoPro Catalog was not a printed publication because the Tucker Rocky Dealer Show was not open to the general public and GoPro failed to provide evidence that someone ordinarily skilled in the art actually attended the dealer show. But the Federal Circuit found that the standard for public accessibility is one of reasonable diligence to locate the information by interested members of the relevant public. A dealer show focused on extreme sports vehicles is an obvious forum for POV action sports cameras. And although the general public at large may not have been aware of the trade show, dealers of POV cameras would encompass the relevant audience such that a person ordinarily skilled and interested in POV action cameras, exercising reasonable diligence, should have been aware of the show.

Additionally, the GoPro Catalog was disseminated with no restrictions and was intended to reach the general public. Because the Board refused to accept the GoPro Catalog as a printed publication, it did not consider the merits of GoPro's obviousness claims. The Federal Circuit thus remanded the case for consideration of the catalog as prior art.

GoPro, Inc. v. Contour IP Holding LLC (Fed. Cir. 2018)
Panel: Circuit Judges Reyna, Wallach, and Hughes
Opinion by Circuit Judge Reyna

Posted at 10:00 PM in Federal Circuit, Novelty | Permalink | Comments (1)

June 26, 2018

Supreme Court Grants Certiorari in Helsinn Healthcare v. Teva Pharmaceuticals

By Kevin E. Noonan --

Yesterday, the Supreme Court granted certiorari on Helsinn Healthcare's petition to overturn the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals that its patents were invalid by application of the on-sale bar under 35 U.S.C. 102(b). The Question Presented in the petition was as follows:

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., Docket No. 17-1229.

The issue is specifically related to the question of whether the AIA changed the application of the on-sale bar. By granting cert., the Court opens up the possibility for a decision that extends further than that (see, for example, AMP v. Myriad Genetics).

To recap, the case arose over ANDA litigation regarding Teva's intention to market a generic version of Helsinn's intravenous formulations of palonosetron used to reduce chemotherapy-induced nausea and vomiting ("CINV"). There were four patents-in-suit: U.S. Patent Nos. 7,947,724, 7,947,725, 7,960,424, and 8,598,219; only the '219 patent was allowed and granted under the AIA changes in U.S. patent law.

Claim 1 is representative of the '219 patent (post-AIA):

It is undisputed that each asserted claim covers the 0.25 mg dose of palonosetron. Helsinn entered into contract for supplying the claimed formulation prior to critical date, but contingent on FDA approval (which was not obtained until after the critical date).

With regard to the question of whether the invention claimed in the patents in suit was "ready for patenting" prior to the critical date, the panel decided that it was, based on the invention having been reduced to practice before the critical date. This decision depended, in part, on the parties' stipulation that "they would contest ready for patenting 'only with respect to the limitations and intended uses of "reducing emesis or reducing the likelihood of emesis" and '"to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting" of the asserted claims' and not "'for any other reason.'" The panel noted that its case law distinguished the standard needed to show reduction to practice with regard to whether a pharmaceutical invention would work for its intended purpose and the standard for FDA approval of a new drug, citing Scott v. Finney, 34 F.3d 1058, 1063–64 (Fed. Cir. 1994). Specifically, the standard is that the invention "works for its intended purpose 'beyond a probability of failure' but not 'beyond a possibility of failure.'" The Federal Circuit found the District Court erred by applying the FDA standard rather than the proper patent standard in making its (erroneous) determination that the invention was not "ready for patenting" before the critical date. This conclusion was supported by Helsinn's own documents (including portions of the patents' prosecution histories), pre-litigation statements and testimony. And the opinion notes that, if the standard applied by the District Court was correct, Helsinn could not have filed a valid application prior to the critical date, and "[s]uch a standard would preclude the filing of meritorious patent applications in a wide variety of circumstances."

(It is important to note that this case is another example of patentees making statements before the Patent Office aimed at validating priority claims and overcoming prior art that are at odds with positions they need to take in litigation, here to overcome invalidation under the § 102(b) on-sale bar.)

The Court is expected to hear the case during its October 2018 term, with a decision prior to this time next year.

Posted at 10:51 PM in Novelty, Supreme Court | Permalink | Comments (29)

July 31, 2017

Berkeley Files Opening Brief in CRISPR Appeal

By Kevin E. Noonan --

The University of California/Berkeley filed its opening brief to the Federal Circuit last week, asking that Court to overturn the Patent Trial and Appeal Board's decision that there was no interference-in-fact between Berkeley's application and several U.S. patents and applications assigned to The Broad Institute. That decision is entitled to review under the substantial evidence standard for the Board's factual determinations, but de novo review for the PTAB's legal determination that Broad's claims-in-interference would not have been obvious in view of the claimed invention in Berkeley's earlier-filed patent application.

To recap, the Board found that there was no interference-in-fact based on these requirements:

In this proceeding, to prevail on its argument that there is no interference, Broad must show that the parties' claims do not meet at least one of the following two conditions:

1) that, if considered to be prior art to UC's claims, Broad's involved claims would not anticipate or render obvious UC's involved claims, or

2) that, if considered to be prior art to Broad's claims, UC's involved claims would not anticipate or render obvious Broad's claims.

Broad will prevail and a determination of no interference-in-fact will be made if a preponderance of the evidence indicates one of these conditions is not met.

In considering the evidence before it, the PTAB gave great weight to contemporaneous, cautious statements in the art in view of Professor Doudna's disclosure of in vitro CRISPR activity regarding whether the system would work in eukaryotic cells. Specifically, these statements convinced the Board that while the results "suggested the 'exciting possibility'" that CRISPR-Cas9 could be operative in eukaryotic cells, "it was not known whether such a bacterial system would function in eukaryotic cells." And, "[i]n another report, Doudna was quoted as stating that she had experienced 'many frustrations' getting CRISPR to work in human cells and that she knew that if she succeeded, CRISPR would be 'a profound discovery.'" UC's assertion of other statements by their inventors that could be interpreted more positively did not convince the Board that there was a reasonable expectation of success in the art for getting the CRISPR-Cas9 system to work in eukaryotic cells, the Board stating that:

Although the statements express an eagerness to learn the results of experiments in eukaryotic cells and the importance of such results, none of them express an expectation that such results would be successful.

The Board swept aside Berkeley's arguments that this reasoning was flawed because the standard is not the inventor's expectations but those of the worker of ordinary skill by stating that "if the inventors themselves were uncertain, it seems that ordinarily skilled artisans would have been even more uncertain." The Board also quoted Berkeley's expert as having said (contemporaneously with Professor Doudna's report of in vitro CRISPR activity):

There is no guarantee that Cas9 will work effectively on a chromatin target or that the required DNA-RNA hybrid can be stabilized in that context.

The Board concluded that "[w]e fail to see how 'no guarantee' indicates an expectation of success."

Nor was the Board convinced based on the history of the development of CRISPR technology, which showed that many laboratories independent of the Doudna group quickly applied the new technology to manipulate eukaryotic cell genomic DNA:

Regardless of how many groups achieved success in eukaryotic cells, we are not persuaded that such success indicates there was an expectation of success before the results from these experiments were known. The unpublished results of research groups are not necessarily an indication of whether ordinarily skilled artisans would have expected the results achieved. Instead of viewing such work as evidence of an expectation of success, we consider the number of groups who attempted to use CRISPR-Cas9 in eukaryotic cells to be evidence of the motivation to do so, an issue that is not in dispute. We agree with Broad's argument that a large reward might motivate persons to try an experiment even if the likelihood of success is very low.

On balance, the Board found that this evidence further supported their decision that there was insufficient evidence of a reasonable expectation of success to support Berkeley's allegation that their earlier work and publications would have rendered Broad's invention obvious. This evidence was that "differences in gene expression, protein folding, cellular compartmentalization, chromatin structure, cellular nucleases, intracellular temperature, intracellular ion concentrations, intracellular pH, and the types of molecules in prokaryotic versus eukaryotic cells, would contribute to this unpredictability [regarding whether the CRISPR-Cas9 system would be operative in eukaryotic cells]." In response to Berkeley's allegations that these considerations turned out not to be an impediment to CRISPR's activity in eukaryotic cells, the Board said "[t]he relevant question before us is whether those of skill in the art would have expected there to be problems before the experiments were done," not whether it turned out that the experiments were successful once they were tried.

Finally, the Board rejected Berkeley's citation of other prokaryotic genetic modification systems found to work in eukaryotes, generally on the grounds that there was no "commonality" in these methods that would have refuted Broad's evidence that the skilled worker would not have had any reasonable expectation of success.

In its brief, Berkeley found fault with both the Board's factual determinations and its legal conclusions (although wisely focusing the majority of their 64-page brief on their legal arguments). These arguments begin with Berkeley's allegation that the PTAB applied an incorrect legal standard for obviousness that cannot be reconciled with the Supreme Court's KSR v. Teleflex Int'l precedent as has been further explicated by the Federal Circuit (most notably in In re Kubin). Specifically, Berkeley's brief characterizes the Board's analysis as requiring "specific instructions" in the prior art regarding adapting CRIPSR as demonstrated in bacterial systems to use in eukaryotic cells. This application of the obviousness analysis constitutes a standard "even more rigid" than the Federal Circuit's "teaching-suggestion-motivation test" that the Court "rejected" (albeit not entirely) in KSR. Citing Kubin and In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988), Berkeley contends that:

This Court has explained how KSR applies in the context of an "unpredictable art" such as biotechnology. Kubin, 561 F.3d at 1359-60. In such fields, the obviousness inquiry should not focus exclusively on the degree of ex ante predictive confidence that a potential solution will succeed, because "for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice" through experimentation. In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Rather, the focus should be on the extent of the guidance provided by the prior art—and therefore the extent to which a skilled artisan must innovate beyond that guidance to achieve the solution. Kubin, 561 F.3d at 1359-60 (the question is whether the claimed advance reflects innovation beyond "the predictable use of prior art elements according to their established functions") (quoting KSR, 550 U.S. at 417).

The "key insight" provided by KSR, according to the brief, is that "when the prior art contains sufficient guidance to enable one skilled in the art to draw on well-known conventional techniques to achieve an advance without any genuine innovation, mere ex ante uncertainty about whether such routine efforts will succeed does not elevate a 'product . . . of ordinary skill and common sense' to the status of a patentable invention," citing KSR. This is a theme that runs throughout the body of the arguments in the brief. And, according to Berkeley, applying this "more rigid" standard was legal error by the PTAB.

The brief also asserts as another major theme that the Board erred for not considering contemporaneous evidence of "simultaneous invention," providing a tabulation of the scientific publications that appeared in the art just before and just after Broad's first-filed provisional application:

The presence of this art "can be compelling evidence" of obviousness (the inverse of long-felt need and failure of others) as a secondary consideration, and Berkeley argues that the Board committed legal error in failing to properly consider this evidence. The Board did consider this evidence, of course, but only to support its appreciation that there was express motivation in the art to apply CRISPR to eukaryotic systems, not to support Berkeley's contention that the skilled worker would have had a reasonable expectation of success.

With regard to the question of expectation of success, the brief argues that this evidence of contemporaneous "invention" by several other groups, and the conventionality of the methods used by these groups (and Broad) in using CRISPR in eukaryotes is strong evidence that this accomplishment required no "innovation" and no "invention" independent of Professors Doudna and Charpentier's disclosure of CRISPR in prokaryotes (in the Jinek 2012 paper published prior to Broad's earliest provisional filing date).

The brief asserts that the Board misinterpreted the scientifically cautious statements by Professor Doudna and other Berkeley experts regarding whether CRISPR was "expected" to be operative in eukaryotic cells. The "fundamental error" in the Board's consideration of these statements was that they were "imbue[d] . . . with significance divorced from the context in which they were made," which was not as an opinion regarding whether there was a reasonable expectation of success that CRISPR would be operative in eukaryotic cells according to the brief. Taken as a whole, according to the brief, the prior art establishes that the skilled worker would have had a reasonable expectation of success in using CRISPR in eukaryotes.

The brief also faults the Board for not considering a provisional application by Kim (U.S. Provisional Application No. 61/717,324, filed October 23, 2012, and later published as U.S. Application No. 14/685,568) as prior art under 35 U.S.C. §102(e). (In many ways this is the brief's strongest argument, because this reference is clearly prior art to the earliest-filed Broad provisional, and Berkeley has a strong argument that the Board not considering it was legal error.)

Finally, Berkeley argues that Broad had not shown that it was entitled to the December 12, 2012 filing date of its earlier provisional. According to the brief, the Board should have considered October 15, 2013 as the relevant "end date" for considering prior art; if it had done so, many of the references not considered by the Board (set forth in the table above) would have made it impossible for Broad to satisfy its burden of proof that its claims were not obvious. Instead, the brief contends that the Board "assume without analysis" that Broad was entitled to its December 12, 2012 first provisional filing date for its "hundreds of involved claims," a conclusion Berkeley contends was error.

Broad will have the opportunity to make its arguments in favor of the Board's decision in the coming months; oral argument should be scheduled for some time before the end of the year.

Posted at 11:52 PM in Federal Circuit, Miscellaneous, Novelty, Obviousness, Patent Trial and Appeal Board | Permalink | Comments (4)

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