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  • Supreme Court Denies Certiorari in Amgen v. Sanofi

    By Kevin E. Noonan —

    Supreme Court Building #2The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a).

    To recap, the Federal Circuit overturned the "newly characterized antigen test" set forth in Noelle v. Lederman and brought treatment of the written description requirement for antibody claims in line with the Court's en banc decision in Ariad v. Eli Lilly.  The case arose when Amgen sued Sanofi and Regeneron for over its Praluent® (alirocumab) product that could compete with Amgen's Repatha™ (evolocumab); Amgen's asserted patents, inter alia, included U.S. Patent Nos. 8,829,165 ("'165 patent") and 8,859,741("'741 patent"), functionally claim a genus of antibodies that encompass Sanofi's Praluent® product.  As background, blood plasma contains low-density lipoproteins that bind cholesterol and are associated with atherosclerotic plaque formation.  Liver cells express receptors for LDL (LDL-R) wherein binding thereto reduces the amount of LDL cholesterol in blood and reduces the risk of plaque formation and cardiovascular disease.  PCSK9 (proprotein convertase subtilisin kexin type 9) is a molecule that binds to and causes liver cell LDL-R to be destroyed, thus reducing the capacity and effectiveness of the liver cell's ability to reduce serum LDL-cholesterol.  The antibodies at issue in this suit bind to PCSK9 and prevent PCSK9 from binding to LDL-R, causing their destruction.

    Claim 2 of the '165 patent (dependent on claim 1, the limitations of which are included in italics) was asserted by Amgen in the litigation:

    An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R, wherein the monoclonal antibody binds to at least S153.

    It is important to note that, while reciting the structure of the residues on PCSK9 that are bound by the claimed antibody, the claim does not recite any structural limitations of the antibody.  The only antibody characteristics recited as limitations are functional, i.e., the ability to bind to at least one of the recited PCSK9 residues and block binding of PCSK9 to LDLR.

    The panel decision, by Chief Judge Prost, joined by Judges Taranto and Hughes, held that an adequate written description of a genus requires the specification to disclose "a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus."  The panel held that the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen, "is not legally sound and [] not based on any binding precedent" and provided its legal analysis of Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002), Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011) in support of its conclusion.  The panel held this instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad."  And the panel found that whether the relationship between the structure of the antigen, no matter how fully characterized, and any of its cognate antibodies is (here and hitherto) "hotly contested" which precluded the Court from making any definitive finding.  The panel recited its abrogation of the "fully characterized antigen" test more directly:

    Further, the "newly characterized antigen" test flouts basic legal principles of the written description requirement.  Section 112 requires a "written description of the invention."  But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen.  The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent."  Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].

    In its certiorari petition, Amgen submitted this Question Presented:

    Whether the standard for determining the adequacy of the "written description of the invention" should be as the statute says—that the description must be "in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same"—or whether court-created standards should control instead.

    Amgen asserted a number of reasons for the Court's review.  Amgen argued that the Federal Circuit's "possession" test for satisfying the written description requirement is contrary to the statutory language, the statute's history, and Supreme Court and lower court precedent.  The petition analyzed the statutory test, finding that the statute's structure mandates that the statute requires a written description of the invention in a manner that discloses how to make and use it.  The brief argued that the Federal Circuit's "'possession' jurisprudence has strayed too far from the statutory standard, imposes extra-statutory barriers to patent protection, and has resulted in a shifting array of uncertain sub-tests and evidentiary considerations that destabilize the incentives and certainty needed to drive the development of breakthrough inventions."  In Amgen's view, the statute contains a single written description requirement that the Federal Circuit has split into two, separating the "written description" requirement from the "enablement" requirement, each having different standards.  This bifurcation "defies the statute and precedent," according to the petition.  Throughout the brief, Amgen contrasted the relatively certain methodology to ascertain whether the enablement requirement has been satisfied with the more "nebulous" requirement for satisfying written description (caused by the factual nature of the written description inquiry).  Using the Federal Circuit's own precedent, the petition called out a number of "subtests" used by the Federal Circuit to address this question, including the "representative-species" test, "structure-function" test, and "common-structural-features" test, none of which, Amgen argued, can be reconciled with the statutory text.  The brief also relied on a number of dissenting opinions by Federal Circuit judges (including in the en banc Ariad decision) and academic criticism to support its allegations that the Federal Circuit erred in its application of the written description requirement of § 112(a).  The brief also pointed to the "ever-shifting" nature of the Court's decisions, culminating in overturning the Noelle v. Lederman test in the case at bar, arguing that:

    The Federal Circuit's departure from § 112(a)'s standard—and the bargain the Patent Act provides—has become intolerable.  It does not promote research and investment required for the breakthrough inventions most deserving of patent protection; instead, incentives are shifted to narrow advances for which narrow patents can be obtained under the Circuit's sub-tests.  The ever-evolving application of the "possession" standard has produced jurisprudential anarchy, leaving inventors uncertain whether disclosures are sufficient.

    The petition also contained a section directed to the purported importance (on policy grounds) of the question presented, putative negative effects on innovation, dissension amongst Federal Circuit judges over the recognition of a separate written description requirement, and the disparate effects on biotechnology inventions.

    Sanofi's responsive brief provided several reasons why the Supreme Court should not grant cert.  First, the brief argued that this case was an "exceptionally poor candidate for certiorari," at least because the issue underlying the Question Presented was not raised by the parties below or addressed by the Federal Circuit (the Supreme Court is "a court of review, not of first view," according to the brief, citing Byrd v. United States, 138 S. Ct. 1518, 1527 (2018)).  This argument was supported by Amgen's positions, in this case and as amicus in, inter alia, the Federal Circuit's Ariad decision, supporting the Federal Circuit's decisions on written description.  Under these circumstances, Sanofi argued that the Court should consider the issue waived by Amgen.  Raising judicial economy principles, the brief also argued that even if the Court granted certiorari and decided the case, its judgment was not dispositive (because the Federal Circuit remanded for the District Court to reconsider Sanofi's enablement challenge based on post-arising evidence the District Court "improperly excluded") and that the case remained ongoing below.  Turning to stare decisis, the brief argued that there was no reason for the Court to "disrupt more than fifty years of settled precedent" by reviewing the Federal Circuit's written description case law.  Sanofi asserted that the Federal Circuit had come to the right conclusions in how its written description jurisprudence had developed, and again asserted to the Court that Amgen had "vastly overstate[d]" the importance of the Question Presented.

    It is impossible to know, of course, why the Supreme Court decides whether or not to grant cert.  Whether this decision signals a lessening of the Supreme Court's interest in deciding patent law cases, what we do know is that the Court will not yet be reviewing how the Federal Circuit applies the written description requirement to antibody claims.

  • USPTO on Patent Eligibility — Examples 38 & 39

    By Michael Borella —

    USPTO SealOn January 7, 2019, the U.S. Patent and Trademark Office published updated examination guidance, instructing the examining corps and the PTAB how they should apply 35 U.S.C. § 101.  On the same day, the USPTO also published the latest in its series of examples of how this application of the § 101 inquiry should be carried out.  This latest set, encompassing Examples 37-42, apply the updated guidance (Examples 1-36 were previously published over the last four years).  Our analysis of Example 37 was recently published.

    The USPTO emphasizes that these examples are "hypothetical and only intended to be illustrative of the claim analysis" under the updated guidance.  Furthermore, the examples "should be interpreted based on the fact patterns set forth below as other fact patterns may have different eligibility outcomes."  In other words, even if an applicant's claim recites similar language and functionality as that of one of the examples, that does not mean the applicant's claim is patent-eligible.  Context matters.

    The updated guidance modified only part of the § 101 analysis (step 2A in the USPTO's parlance).  As set forth in Alice Corp. v. CLS Bank Int'l, this step involves determining whether a claim is directed to a judicial exception, such as an abstract idea.  If not, then no § 101 rejection can be made.

    The updated guidance breaks step 2A into a pair of sub-steps:

    • In sub-step 2A(i), one is to determine whether the claim recites a judicial exception, such as an abstract idea. Abstract ideas are now limited to three categories: mathematical concepts, certain methods of organizing human activity, and mental processes.  If there is no exception recited, the claim is eligible.

    • If the claim recites such an exception, then in sub-step 2A(ii) one is to determine further "whether the recited judicial exception is integrated into a practical application of that exception." If so, the claim is eligible.

    If the claim fails to establish its eligibility in step 2A, the second part of the § 101 analysis (step 2B) is applied to determine whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.  If this is the case, the claim is patent-eligible under § 101.  If not, it can be rejected.

    Example 38

    Example 38 relates to simulating an analog audio mixer.  The background provided by the USPTO is as follows (abbreviated to focus on key aspects):

    [Many audiophiles prefer] listening to music in its analog form, as digital audio files are considered to "lose" much of the sound quality in the conversion from analog to digital.  Prior inventions attempted to create digital simulations of analog audio mixers to simulate the sounds from analog circuits.  However, the prior art audio mixer simulations do not produce the same sound quality as the actual analog circuits.

    Applicant's invention . . . begins with a model of an analog circuit representing an audio mixing console.  The model includes a location of all the circuit elements within the circuit, an initial value for each of the circuit elements, and a manufacturing tolerance range for each of the circuit elements.  A randomized working value of each element is then determined using a normally distributed pseudo random number generator (PRNG) based on the initial value of the circuit element and the manufacturing tolerance range.  The model is then simulated using a bilinear transformation to create a digital representation of the analog circuit.

    The claim of Example 38 recites:

    A method for providing a digital computer simulation of an analog audio mixer comprising:
        initializing a model of an analog circuit in the digital computer, said model including a location, initial value, and a manufacturing tolerance range for each of the circuit elements within the analog circuit;
        generating a normally distributed first random value for each circuit element, using a pseudo random number generator, based on a respective initial value and manufacturing tolerance range; and
        simulating a first digital representation of the analog circuit based on the first random value and the location of each circuit element within the analog circuit.

    Applying the first sub-step of 2A, the USPTO states that this claim does not recite any of the three types of abstract ideas.  Notably, the USPTO concludes that despite explicitly reciting "generating a normally distributed first random value," the claim does not recite a mathematical calculation.  The USPTO's reasoning to support this rather surprising outcome is that "[w]hile some of the limitations may be based on mathematical concepts, the mathematical concepts are not recited in the claims."  The USPTO quickly concludes that the claim also does not recite a mental process ("because the steps are not practically performed in the human mind") or a method of organizing human activity.  Therefore, the claim is eligible and the analysis ends without moving on to the second sub-step.

    Example 39

    Example 39 relates to training a neural network for facial detection.  The background provided by the USPTO is as follows (again abbreviated to focus on key aspects):

    In facial detection, a neural network classifies images as either containing a human face or not, based upon the model being previously trained on a set of facial and non-facial images.  However, these prior methods suffer from the inability to robustly detect human faces in images where there are shifts, distortions, and variations in scale and rotation of the face pattern in the image.

    Applicant's invention addresses this issue by using a combination of features to more robustly detect human faces.  The first feature is the use of an expanded training set of facial images . . . developed by applying mathematical transformation functions on an acquired set of facial images.  Unfortunately, the introduction of an expanded training set increases false positives when classifying non-facial images.  Accordingly, the second feature of applicant's invention is the minimization of these false positives by performing an iterative training algorithm, in which the system is retrained with an updated training set containing the false positives produced after face detection has been performed on a set of non-facial images.

    The claim of Example 39 recites:

    A computer-implemented method of training a neural network for facial detection comprising:
        collecting a set of digital facial images from a database;
        applying one or more transformations to each digital facial image including mirroring, rotating, smoothing, or contrast reduction to create a modified set of digital facial images;
        creating a first training set comprising the collected set of digital facial images, the modified set of digital facial images, and a set of digital non-facial images;
        training the neural network in a first stage using the first training set;
        creating a second training set for a second stage of training comprising the first training set and digital non-facial images that are incorrectly detected as facial images after the first stage of training; and
        training the neural network in a second stage using the second training set.

    Applying the first sub-step of 2A, the USPTO states that this claim does not recite any of the three types of abstract ideas.  It is reasonably well known that neural networks can be considered mathematical structures (albeit very complex ones), and are often modelled using linear algebra and calculus.  But, not unlike the analysis of Example 38's claim, the USPTO finds this claim to not recite any mathematical concepts.  Also like that of Example 38's claim, the USPTO further concludes that the claim does not recite a mental process or a method of organizing human activity.  Even the admittedly mathematical image transformations escape unscathed.  Therefore, the claim is eligible and the analysis ends at the first sub-step.

    Analysis

    If the goal of Example 38 is to draw a clearer line around the nebulous notion of abstract ideas, it has failed spectacularly.  Randomly generating a variable according to proscribed distribution is almost always a mathematical calculation.  And if the USPTO is giving patentable weight to the notion of pseudorandom generation being the differentiator, that would be a mistake.  Under a broadest reasonable interpretation, pseudorandom number generators include linear congruential generators, which are simple recursive mathematical functions.

    Of course, even if one were to conclude that the claim of Example 38 does recite the abstract idea of a mathematical calculation, it could be argued that the additional elements of the claim integrate this abstract idea into a practical application thereof — notably, a circuit simulation that can be used to general audible analog impurities.  Still, it remains difficult to rectify the USPTO's reasoning with the scientific and technical reality underlying its example.

    Example 39 on the other hand, provides some relief to patentees who are attempting to protect advances in machine learning.  This example does not describe the structure of the neural network being trained, and essentially treats it like a black box.  But the claim is eligible because of the two-phase training technique in combination with the transforming of the facial images.  In this example, the USPTO is signaling that it will not treat a reasonably-claimed machine learning invention as "just a bunch of math."

  • USPTO on Patent Eligibility — Example 37

    By Michael Borella —

    USPTO SealOn January 7, 2019, the U.S. Patent and Trademark Office published updated examination guidance, instructing the examining corps and the PTAB how they should apply 35 U.S.C. § 101.  On the same day, the USPTO also published the latest in its series of examples of how this application of the § 101 inquiry should be carried out.  This latest set, encompassing examples 37-42, apply the updated guidance (examples 1-36 were previously published over the last four years).

    The USPTO emphasizes that these examples are "hypothetical and only intended to be illustrative of the claim analysis" under the updated guidance.  Furthermore, the examples "should be interpreted based on the fact patterns set forth below as other fact patterns may have different eligibility outcomes."  In other words, even if an applicant's claim recites similar language and functionality as that of one of the examples, that does not mean the applicant's claim is patent-eligible.  Context matters.

    The updated guidance modified only part of the § 101 analysis (step 2A in the USPTO's parlance).  As set forth in Alice Corp. v. CLS Bank Int'l, this step involves determining whether a claim is directed to a judicial exception, such as an abstract idea.  If not, then no § 101 rejection can be made.

    The updated guidance breaks step 2A into a pair of sub-steps:

    • In sub-step 2A(i), one is to determine whether the claim recites a judicial exception, such as an abstract idea.  Abstract ideas are now limited to three categories:  mathematical concepts, certain methods of organizing human activity, and mental processes.

    • If so, then in sub-step 2A(ii), one is to determine further "whether the recited judicial exception is integrated into a practical application of that exception."

    If the claim involves such an exception, the second part of the § 101 analysis (step 2B) is applied to determine whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.  If this is the case, the claim is patent-eligible under § 101.  If not, it can be rejected.

    Hypothetical Background

    Example 37 relates to relocation of icons on a graphical user interface (GUI).  The background provided by the USPTO is as follows (abbreviated to focus on key aspects):

    [C]omputer users may have a large number of icons on their display, making it difficult to find the icons most used.  The typically available ways to organize icons are alphabetically, by file size, and by file type.  If a computer user wants a non-typical arrangement of icons, the user would need to manually manipulate the icons on their display.

    Accordingly, applicant's invention addresses this issue by providing a method for rearranging icons on a [GUI], wherein the method moves the most used icons to a position on the GUI, specifically, closest to the "start" icon of the computer system, based on a determined amount of use.

    Claim 1

    Claim 1 of Example 37 recites:

    A method of rearranging icons on a graphical user interface (GUI) of a computer system, the method comprising:
        receiving, via the GUI, a user selection to organize each icon based on a specific criteria, wherein the specific criteria is an amount of use of each icon;
        determining, by a processor, the amount of use of each icon over a predetermined period of time; and
        automatically moving the most used icons to a position on the GUI closest to the start icon of the computer system based on the determined amount of use.

    Applying the first sub-step of 2A, the USPTO states that claim 1, under its broadest reasonable interpretation, "covers performance of the limitation in the mind but for the recitation of generic computer components."  In other words, "nothing in the claim element precludes the step from practically being performed in the mind," and "[t]he mere nominal recitation of a generic processor does not take the claim limitation out of the mental processes grouping."  Thus, the claim recites an abstract idea.

    Moving on to the second sub-step, the USPTO notes that the claim "recites the combination of additional elements of receiving, via a GUI, a user selection to organize each icon based on the amount of use of each icon, a processor for performing the determining step, and automatically moving the most used icons to a position on the GUI closest to the start icon of the computer system based on the determined amount of use."  Thus, the claim integrates the mental process into a practical application by reciting "a specific manner of automatically displaying icons to the user based on usage which provides a specific improvement over prior systems."  As a result, the claim is eligible under step 2A because it is not directed to a judicial exception, and step 2B need not be applied.

    Claim 2

    Claim 2 of Example 37 recites:

    A method of rearranging icons on a graphical user interface (GUI) of a computer system, the method comprising:
        receiving, via the GUI, a user selection to organize each icon based on a specific criteria, wherein the specific criteria is an amount of use of each icon;
        determining the amount of use of each icon using a processor that tracks how much memory has been allocated to each application associated with each icon over a predetermined period of time; and
        automatically moving the most used icons to a position on the GUI closest to the start icon of the computer system based on the determined amount of use.

    Key differences between claim 2 and claim 1 are highlighted.

    Applying the first sub-step of 2A, the USPTO states that claim 2 does not recite any of the three types of abstract ideas.  According to the USPTO, the determining step now "requires action by a processor that cannot be practically applied in the mind" because it involves "a processor accessing computer memory indicative of application usage."  The USPTO further states that the claim does not recite either of the other two types of abstract ideas (mathematical relationships and methods of organizing human activity) either.  Like claim 1, claim 2 is eligible under step 2A because it is not directed to a judicial exception, and step 2B need not be applied.

    Claim 3

    Claim 3 of Example 37 recites:

    A method of ranking icons of a computer system, the method comprising:
        determining, by a processor, the amount of use of each icon over a predetermined period of time; and
        ranking the icons, by the processor, based on the determined amount of use.

    Applying the first sub-step of 2A, the USPTO states that claim 3, like claim 1, "covers performance of the [determining] limitation in the mind but for the recitation of generic computer components."  Therefore, claim 3 recites a mental process.  The USPTO notes that the ranking limitation also recites a mental process because "the claim encompasses the user thinking that the most-used icons should be ranked higher than the least-used icons."

    Under the second sub-step of 2A, the USPTO finds that the only additional element is the processor, and that "[t]his generic processor limitation is no more than mere instructions to apply the exception using a generic computer component."  Thus, the claim does not integrate the abstract idea of the recited mental process into a practical application thereof, and the claim is therefore directed to an abstract idea.

    Invoking step 2B, the USPTO similarly concludes that "the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component."  Thus, the 2B analysis follows that of the second sub-step of 2A, resulting in the claim not containing significantly more than the abstract idea.  Accordingly, the claim is patent-ineligible.

    Analysis

    The USPTO makes it clear in this example that the mental process category of abstract ideas is not meant to be taken literally.  It is not limited to steps that are carried out wholly in the human mind.  Instead, a step that (in theory) could be performed in the mind but is recited as being performed by a processor is still considered a mental step.  This is a bit of legal fiction to note well.

    The distinction between claims 1 and 2 is also quite fine.  Claim 1 recites "determining the amount of use of each icon over a predetermined period of time" while claim 2 recites "the amount of use of each icon using a processor that tracks how much memory has been allocated to each application associated with each icon over a predetermined period of time.  While claim 2 is narrower than claim 1, it is not 100% clear why claim 2 is not also reciting a mental process.

    The USPTO's justification for concluding that it does not is that claim 2 involves "a processor accessing computer memory indicative of application usage."  But if we are allowed to ignore the literal meaning of the term "processor" in these claims, why is the processor's use of memory not ignored as well?  Why isn't the "computer" qualifier disregarded to find the term "memory" broad enough to encompass human memory?

    Perhaps the answer is that the combination of a processor and the specific use of the memory is enough to find the claim not directed to a mental process.  But the USPTO is silent in this regard, and it remains difficult to know where to draw the line.

    Further, the determination of whether a recited abstract idea is integrated into a practical application is similarly vague.  In claim 1, such an integration is found because the claim recites specific requirements that leads to an improvement over the prior art.  In claim 3, however, the apparent lack of recited detail was enough to conclude that any such integration was de minimis at best.  Perhaps the absence of any movement of the icons damned claim 3 to abstractness hell.

    From the outset, the Alice test has required a certain suspension of logic in order to follow the Supreme Court's reasoning.  By expanding the test with two additional sub-steps, the USPTO is attempting to provide clarity.  Unfortunately, the USPTO appears to be adopting the same legal fictions that have made the post-Alice § 101 inquiry so subjective in the first place.

  • OPM Announces Federal Office Closure for Monday

    By Donald Zuhn –-

    Washington - Monument & Snow SnowWith reports of between 6 and 11 inches of snow having fallen in parts of Maryland and Northern Virginia, the U.S. Office of Personnel Management (OPM) announced a closure for Monday, January 14, 2019, of Federal offices in the Washington, DC area.  The OPM also announced that emergency employees and telework employees, however, would continue to work on Monday.  The OPM noted that the announcement also did not apply to furloughed employees impacted by the lapse in appropriations, as they are already in a non-work status.  The USPTO has not yet posted a notice on the Office's Operational Status webpage regarding the impact of the closure of Federal offices.  Patent Docs will provide an update as soon as the USPTO does post a notice.

  • PTAB Issues Final Written Decision in Cannabis Patent IPR

    By Nicole Grimm, George "Trey" Lyons, III, and Brett Scott —

    USPTO SealOn January 3, 2019, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) issued a Final Written Decision in Insys Development Co., Inc. v. GW Pharma Ltd. (IPR2017-00503), a landmark inter partes review (IPR) decision involving a cannabis patent.  Although the PTAB found claims 1 and 2 to be unpatentable as obvious, the remaining 11 claims that were challenged survived and remain valid (and potentially enforceable).

    At issue in this IPR was U.S. Patent No. 9,066,920 ("the '920 Patent," entitled "Use of one or a combination of phyto-cannabinoids in the treatment of epilepsy"), which was originally assigned to GW Pharma Ltd. and Otsuka Pharmaceuticals Co., Ltd.

    GW Pharma owns an extensive patent portfolio with many patents directed to treating diseases using cannabis-based formulations.  Notably, GW Pharma, along with its U.S. subsidiary, Greenwich Biosciences, made history in the cannabis industry by becoming the first entity to receive FDA approval of a drug (Epidiolex) that contains an active ingredient (cannabidiol or CBD) derived from a cannabis plant.  CBD is a non-psychoactive cannabinoid that can be naturally produced and derived from portions of cannabis plants, typically hemp.

    Insys Development Company, Inc., a pharmaceutical company that focuses on cannabinoids and drug delivery systems, petitioned to cancel all thirteen claims of the '920 Patent as obvious based on three different combinations of references that included scientific articles as well as one of GW Pharma's own published PCT applications.

    Independent claim 1 of the '920 Patent (which the other 12 claims directly or indirectly depend from) recites:

    1.  A method of treating partial seizure comprising administering cannabidiol (CBD), to a patient wherein the CBD is present in an amount which provides a daily dose of at least 400 mg.

    Dependent claim 2 of the '920 Patent recites:

    2.  The method of claim 1, wherein CBD is present in an amount which provides a daily dose of from 400 to 800 mg.

    Before conducting the obviousness analysis, the PTAB considered whether the term "partial seizure" in claim 1 needed to be construed.  Insys argued that "partial seizures" meant seizures that can include secondary generalized seizures.  However, GW Pharma argued that the term did not need to be construed because, even under Insys's construction, Insys had failed to show that a person of ordinary skill in the art (POSA) would have been motivated to increase the dosage of CBD described by one of the primary references and would have had a reasonable expectation of success that the higher dosage could treat partial seizures.  Ultimately, because GW Pharma did not dispute that the asserted references applied to the treatment of partial seizures, the PTAB did not find it necessary to construe the term in order to determine the patentability of the challenged claims.

    Regarding the obviousness challenge, Insys argued that all claims of the '920 Patent were obvious because the primary reference taught treatment of epilepsy with CBD, and a POSA "would have concluded that the claimed daily dosage of at least 400 mg of CBD is predictable, safe, and expected" in view of the combination of asserted references.[1] GW Pharma countered that, at the time of invention, CBD was "at best, a promising candidate for further study" and that a POSA would have "no reasonable expectation that CBD would treat partial seizures at all, let alone at doses of 400 mg or higher," as claimed by the patent.[2]

    The PTAB found that Insys demonstrated by a preponderance of the evidence that claim 1 (the broadest claim of the patent) and dependent claim 2 were obvious over two of the three asserted combinations of references.  Both combinations relied on the same primary reference, which described clinical studies involving administering CBD to epileptic patients.  Although the primary reference described a daily dose of CBD that was less than 400 mg, the PTAB found that the combination of asserted references, when read together, would have led a POSA to reasonably believe that the amount of CBD could be safely increased to the claimed dosage of at least 400 mg/day because, as of the time of invention, "CBD had been shown to be well tolerated in humans without any serious side effects or toxicities at doses up to 600 mg."[3]

    Regarding claims 3-13, Insys argued that those claims were obvious over the asserted combinations of references for the same reasons that claims 1 and 2 were obvious.  GW Pharma argued that Insys failed to identify where most of the limitations of claims 3-13 were disclosed in the prior art, and also did not present expert testimony as to why those dependent claims would be obvious.  The PTAB agreed with GW Pharma on this point, and found that Insys failed to meet its burden to show that claims 3-13 were obvious over any of the asserted combinations of references.

    Although claims 1 and 2 were deemed unpatentable, the '920 Patent remains largely intact following the PTAB's decision with claims that are still fairly broad relative to claim 1.  In particular, dependent claims 6 and 9 only further require that "the CBD is present as a plant extract" and "the CBD is present as a pure or isolated cannabinoid," respectively.

    Whether Insys or GW Pharma will appeal the Final Written Decision remains to be seen.  If they do, there are essentially two routes:  (1) panel rehearing, then potentially the Federal Circuit (and maybe even the Supreme Court); or (2) straight to the Federal Circuit.  Either way, the industry will be watching closely over the next two months to see where the parties go next before the deadline to challenge this opinion passes.

    And, as we have previously noted, this IPR raises some important implications for challenging and enforcing patents in the cannabis space.  One key takeaway from this decision is that the PTAB seemed to treat this cannabis patent just like any other patent subject to an IPR challenge (the fact that cannabis remains a Schedule I drug was not an issue).  Therefore, this decision may provide some clarity (or at least hope) to canna-patent owners and third-party challengers that IPR proceedings (and likely other USPTO post-grant proceedings) are at least one option for challenging cannabis patents.

    Additionally, as canna-patents continue to make their way through the federal courts (including, e.g., one of the first cannabis patent infringement lawsuit underway in the U.S. District Court for the District of Colorado—United Cannabis Corp. v. Pure Hemp Collective Inc. (1:18-cv-01922)), the industry may expect to see even more IPR challenges of cannabis patents, as well as more frequent patent application filings, following the legitimization of canna-patent infringement cases in district courts.

    At bottom, in light of these decisions and others, the message to canna-patent owners and applicants seeking to protect their innovations is what it has always been—obtaining canna-patents is highly valuable for companies in this industry, as these canna-patents will serve as irreplaceable stakeholders as the market continues to normalize and expand.  And the stakes will continue to increase as courts and federal agencies take note.

    [1] Final Written Decision, p. 15.

    [2] Id.

    [3] Final Written Decision, p. 27.

  • Conference & CLE Calendar

    CalendarJanuary 15, 2019 – "Patent Eligibility and Engineered Natural Products — Overcoming 101 Challenges, Leveraging Options to Obtain IP Protection" (Strafford) – 1:00 to 2:30 pm (EST)

    January 16, 2019 – "Top Patent Law Stories of 2018" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 17, 2019 – "Patent Application Preparation in View of Recent Court Decisions: Updates and Strategies" (Practising Law Institute) – 3:00 pm (Eastern)

    January 17, 2019 – "Preparing for and Navigating PTAB Appeals Before the Federal Circuit — Conducting PTAB Trials With Eye to Appeal, Determining Errors for Appeal, Understanding PTO Practice and Federal Circuit Law" (Strafford) – 1:00 to 2:30 pm (EST)

    January 17, 2019 – "Extraterritoriality: Spotlight After WesternGeco" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    January 17, 2019 – "MyUSPTO and USPTO.gov accounts" (U.S. Patent and Trademark Office) – 11:00 am to 12:00 pm (ET)

    January 22, 2019 – "Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation" (Strafford) – 1:00 to 2:30 pm (EST)

    January 22, 2019 – European patent prosecution & litigation webinars with focus on UK, Germany, and EPO & CJEU (D Young & Co) – 1:00 pm, 2:30 pm, and 3:30 pm (GMT)

    January 24, 2019 – "Drafting and Defending Software Patents: Meeting Sections 102, 103 and 112 Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

  • IPO Webinar on Extraterritoriality After WesternGeco

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Extraterritoriality: Spotlight After WesternGeco" on January 17, 2019 from 2:00 to 3:00 pm (ET).  Danielle Joy Healey of Fish & Richardson, PC; Prof. Timothy Holbrook of Emory University School of Law; and Thomas Saunders of Wilmer Cutler Pickering Hale and Dorr, LLP will discuss how district courts have applied the Supreme Court's decision in WesternGeco v. ION to date (including in Power Integrations v. Fairchild in the District of Delaware) and the open questions that remain, will analyze relevant case law at both the Supreme Court and the Federal Circuit, and will address the challenges in litigating these issues.  The panel will discuss the following cases:

    Halo v. Pulse (Fed. Circ. 2014)
    NTP v. Rim (Fed. Circ. 2005)
    Microsoft v. AT&T (S. Ct. 2007)
    Cardiac Pacemakers v. St. Jude Medical (Fed. Circ. 2009)
    Life Technologies v. Promega (S. Ct. 2017)

    The registration fee for the webinar is $135 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • USPTO Inventor Info Chat Webinar on MyUSPTO and USPTO.gov Accounts

    USPTO SealThe U.S. Patent and Trademark Office will be offering an Inventor Info Chat webinar on January 17, 2019, from 11:00 am to 12:00 pm (ET) to provide a demonstration and discussion of "MyUSPTO and USPTO.gov accounts."  The presentation will demonstrate the customizable homepage that serves as the launch pad into all of USPTO-related activities.  Attendees will see a demo of the docket, news, and other widgets designed to help with daily job activities.

    Additional information regarding this webinar, including instructions for viewing the webinar and registering for the webinar, can be found here.

  • Webinar on Biologics and Biosimilars

    Strafford #1Strafford will be offering a webinar entitled "Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation" on January 22, 2019 from 1:00 to 2:30 pm (EST).  Shana K. Cyr and Mark J. Feldstein of Finnegan Henderson Farabow Garrett & Dunner and Kurt R. Karst of Hyman Phelps & McNamara will provide essential updates on FDA practice and patent law relating to biologics and biosimilars, and will discuss the current state of and recent changes to FDA initiatives, approvals and exclusivities, as well as patent prosecution, post-grant proceedings and litigation.  The webinar will review the following issues:

    • What can we learn from FDA's recent guidance on biologics and biosimilars?
    • How does FDA's recent guidance impact patent strategy?
    • Should your patent strategy for biologics differ from your approach for small molecule drugs?

    The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

  • Webinar on European Patent Prosecution & Litigation

    D Young & CoD Young & Co will be offering three European patent prosecution & litigation webinars on January 22, 2019.  The three webinars, which will be presented by Antony Craggs (Solicitor Advocate), Garreth Duncan (European Patent Attorney), and Uli Foerstl (Rechtsanwalt), will be offered at the following times (and then will be available on-demand):

    1:00 pm GMT — European patent prosecution & litigation with focus on the UK:

    • Practical application of the new doctrine of equivalents (UK decisions Generics v Yeda, L'Oreal v RN Ventures and Fisher & Paykel v Resmed).
    • Availability and nature of FRAND declarations (UK decisions Unwired Planet v Huawei, Conversant Wireless v Huawei & ZTE, Apple v Qualcomm).
    • Guidance on plausibility and sufficiency (UK decisions Warner-Lambert v Generics).

    2:30 pm GMT — European patent prosecution & litigation with focus on Germany:

    • Indirect infringement and exhaustion of patent rights (German Supreme Court decisions Trommeleinheit and Digitales Buch).
    • Pharmaceutical product compulsory license sought and granted in preliminary injunction proceedings (Federal Patent Court decision Raltegravir).

    3:30 pm GMT — European patent prosecution & litigation with focus on EPO & CJEU:

    • EPO significant cases (T 2026/15, T 2374/16, T 384/15 and T 1280/14).
    • Supplementary protection certificates (CJEU decisions Teva v Gilead, Boston Scientific v Deutsches Patent- und Markenamt).

    While there is no charge to attend the webinar, attendees must register in advance.  Those wishing to register can do so here.