Written Description: Four Points Are Not A Range

This is an important written description case involving ranges, and highlights a tension within the court over when special disclosure is required within the specification.

Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2021)

IPR challenges are limited only to obviousness and anticipation arguments, and so a patent cannot be directly challenged via IPR for lack of enablement or written description. However, Section 112(a) issues do arise in situations where the challenged patent purports to claim priority back to a prior filing.  The priority claim fails if the earlier filing fails to support the challenged claims, and this permits  assertion of intervening prior art.

Dr. Reddy challenged Invidior’s U.S. Patent 9,687,454 via IPR. The patent claims priority to a chain of prior applications:

  • The ‘454 patent is a continuation of application No. 14/715,462, filed on
    May 18, 2015, now abandoned;
  • The ‘462 Application is a continuation of application No. 14/478,786, filed on
    Sep. 5, 2014, now abandoned;
  • The ‘786 Application is a continuation of application No. 13/964,975, filed on Aug. 12, 2013, now abandoned;
  • The ‘975 Application is a continuation of application No. 13/923,749, filed on Jun. 21, 2013, now abandoned;
  • The ‘749 Application is a continuation of application No. 12/537,571, filed on Aug. 7, 2009, now Pat. No. 8,475,832.

The challenged patent covers a sublingual film containing some drug treatment.   The claims include several different limitations regarding the amount of polymeric matrix used for the film.

  • Claim 1: “about 40 wt % to about 60 wt % of a watersoluble polymeric matrix”;
  • Claims 7 & 12: “about 48.2 wt % to about 58.6 wt %”; and
  • Claim 8: “about 48.2 wt %”;

The problem though is that the original specification does not recite any of these amounts or ranges directly. The specification does include two tables that collectively include four examples that, when calculated-out, all fall within the range of 48.2-58.6%.  However, that calculation process is not express in the specification and the specification does not note particular reason why the particular endpoints form a “range.”  On appeal, the court agreed with the PTAB that “written  description support of a claimed range” requires “more clarity.”

Here, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the ’571 application to create an otherwise unstated range. That is not a written description of the claimed range.

Slip Op. The court also notes that the specification provided no additional support for particular ranges and instead indicated that “[t]he film may contain any desired level of . . .polymer” and that in one embodiment it is “at least 25%.”

[The patentee] failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %. A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention. “[A] patent is not a hunting license. It is
not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).

Slip Op. Although the ranges were not supported, the court did find sufficient evidence to affirm the PTAB’s determination that the individual point of “about 48.2 wt %” was supported by the original specification: “given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board’s decision concerning claim 8.”  Without that priority, the claims were clearly invalidated by prior art published between 2009 and 2015.

The majority opinion was filed by Judge Lourie and joined by Judge Dyk.

Judge Linn wrote in dissent, arguing that the majority’s approach creates “an overly demanding standard for written description of ranges” and is contrary to cases such as In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976) and Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019).  The majority had recognized the value of those precedents, but argued that written description is an intensely fact intensive question.

 

Recoveries in Patent Suits

A patent right is the only property which can be trespassed upon without the owner’s knowledge, in every part of the country, by an innumerable number of trespassers at the same time. The owner can neither watch it, nor protect it by physical force, nor by the aid of the police or of the criminal law. He thus necessarily requires more efficient civil remedies than those do the protection of whose property does not depend upon civil remedies alone.

James Storrow, Money Recoveries in Patent Suits, 13 American Law Review 1 (1879).

 

Guest Post: Design Protection and Functionality: Does the PTO or the Copyright Office Apply a More Rubbery Stamp?

Guest post by Peter S. Menell, Koret Professor of Law; Director, Berkeley Center for Law & Technology; Faculty Director, Berkeley Judicial Institute; University of California at Berkeley School of Law, and Ella Corren, University of California at Berkeley School of Law, J.S.D. Candidate

In Design Patent Law’s Identity Crisis, presented at the Berkeley Center for Law & Technology’s February 2021 “Design Patents” symposium, we traced the origins of design patent law’s ornamentality/non-functionality doctrine and showed how the Federal Circuit, the nation’s de facto design patent emperor over the past four decades, has turned the doctrine on its head: it has upended the 1902 Act’s intent and reversed three-quarters of a century of regional circuit jurisprudence. So much so that the post-1902 Act regional circuit design patent cases invalidating design patents on functionality grounds would come out oppositely under the Federal Circuit’s lax standards. Those standards led to the absurd result that Apple could disgorge Samsung’s profits on its smartphones because they employed rounded rectangular shapes. We showed that the Patent Act limited design protection to original, ornamental articles of manufacture, and excluded protection for functionality.

BCLT invited practitioners and academics to comment on our analysis. While none of the commentators questioned, no less refuted, our core finding that the Federal Circuit has flipped the ornamentality/non-functionality doctrine, several offered fig leaves to clothe the Federal Circuit’s lax standards for design patent eligibility and infringement. In responding to our article, practitioner Perry Saidman and Professor Mark McKenna suggested that the design patent regime can be justified in part based on the tighter functionality screen that the PTO applies to design patents than the low threshold that the Copyright Office applies to copyright registrations to useful articles.

We found the suggestion that the PTO is more rigorous than the Copyright Office in applying the functionality screen intriguing and decided to test it out: Does the PTO or the Copyright Office apply a more rubbery stamp?. This commentary presents some of our findings.

Before turning to some illustrations, we note that the Compendium of U.S. Copyright Practices, in contrast to the Manual of Patent Examining Procedure, implements limiting doctrines in relatively clear and concise terms. As regards originality, the Compendium states that copyright law does not protect “words and short phrases,” “familiar symbols and designs,” “mere variations of coloring,” spatial format and layout design, blank forms, and common geometric shapes, either in two-dimensional or three-dimensional form.” The Patent Office applies no such limitations, notwithstanding that the design patent statute specifically requires that articles of manufacture be original to obtain design patent protection.

Turning to our findings, we begin with Universal Robots’ “UR5” robot arm. In 2015, it sought copyright registration of this useful article as a sculptural work.

The Copyright Office refused registration on the ground that UR5 “is a ‘useful article’ which does not contain any separable authorship.” Universal Robots appealed the decision to the Copyright Office, arguing that the UR5 contains conceptually separable artistic elements that are not necessary to its performance of its utilitarian function, namely its “raised circular caps containing the stylized ‘UR’ design,” and the ‘“T’ shaped, modular interlocking wrist.” The Copyright Office affirmed its rejection, explaining that the UR5 “does not contain any separable, copyrightable features” because “the caps and wrist of the arm are both integrated parts of the ‘overall shape’ of the arm.” In September 2016, Universal Robots filed a second appeal for reconsideration, in which it contended that since the blue caps are “capable of being physically removed from the robotic arm without altering the useful aspects of the article,” and “are not necessary to the utilitarian functioning of the device,” they are “conceptually separable, artistic and protectable.” Universal Robots also asserted that the T-shaped piece was “designed to achieve a sleek, modem and aesthetically pleasing appearance,” is “not necessary to the utilitarian function of the article,” and could have been designed in many other ways, rendering this part protectable as well. Universal Robots claimed that these elements of the Work “embody more than the mere ‘modicum’ of creativity that is required for copyright registration,” highlighting that the designers are Danish and inspired by the Danish Modem movement.

In rejecting the second appeal, the Copyright Office concluded “that the elements Universal Robots identifies as expressive—namely the plastic caps and the T-shaped piece—could be visualized as works of authorship separate and independent from the Work’s utility.” And that “[e]ven if those features could be deemed separable, however, they simply are not sufficiently original to warrant copyright protection.”

Universal Robots then filed a design application for the UR5 in January 2020. See U.S. Design Patent No. D915,487 (Apr. 6, 2021). The Patent Office granted the design patent in April 2021.

Robotic arms with similar functional configuration have long been the subject of utility patents. See, e.g., U.S. Patent No. 4,273,506 (Jun. 16, 1981) (“Industrial Manipulator for Placing Articles in Close Proximity to Adjacent Articles”).

This pattern of copyright registration refusal/design patent grant is a common occurrence. In another poignant example, the Copyright Office declined registration for the Purple® pillow, concluding that the overall shape of the pillow—featuring an interior grid of hollow triangles—is unprotectable and not capable of conceptual separation from the useful article. The Copyright Office explained that the triangles have an “intrinsic utilitarian function” and thus are useful articles themselves,” noting that Purple’s marketing materials make “clear that these triangles are wholly utilitarian,” including that the Work’s “hundreds of little triangles . . . give the core of the pillow lateral strength so it retains its oh-so supportive, head-cradling comfort all night” and emphasizing the word ‘SCIENCE!’ in all capital letters; and “[e]ven if the grid of triangular prisms was not functional, however, it would not be a basis for copyrightability. The Copyright Office’s refusal to register quoted the Compendium of U.S. Copyright Practices: ‘The Copyright Act does not protect common geometric shapes’ including triangular prisms.”

Nonetheless, the design patent application for the Purple Pillow sailed through the Patent Office. See U.S. Design Patent 909,790 (Feb. 9. 2021) (“Pillow”).

The design patentee continues to emphasize the ergonomic advantages of its pillow design: “Unique to the Purple Harmony Pillow, the Deluxe Hex Grid is specially formulated and engineered for head and neck support. The soft hexagon-shaped air channels optimize the dynamic response and airflow for unbelievable comfort.”).

We explore these and other examples in The Design Patent Emperor Wears No Clothes: Responding to Advocates of Design Patent Protection for Functionality.

These minimalist designs raise serious functionality and originality concerns. They demonstrate the rubber stamp quality of the Patent Office and that the design patent system as currently administered results in significant overprotection of functional features and designs. And even though design patents have “only” 15 years of duration, that length of time can be an eternity in some design markets and substantially diminish competition. The utility patent supremacy/channeling principle is about preserving competition in exactly the same way as trademark’s functionality doctrine—the channeling of functionality protection exclusively to utility patents is meant to subject all other, not sufficiently innovative, functional features to unimpeded market competition.

Mandamus Monday

Four new mandamus orders from the Federal Circuit stemming from Judge Alan Albright’s court in Waco Texas.

  • In re Apple, 21-181 (Fed. Cir. Nov 15, 2021).  Abuse of discretion to deny transfer motion. No significant ties between the action and the W.D.Tex.  Apple does have thousands of employees in the district, but the key employees related to the infringement are not in the district.
  • In re Altassian Corp., 21-177 (Fed. Cir. Nov 15, 2021). Abuse of discretion to deny transfer motion even though defendant is from Australia and has a major Austin Office.  None of its employees who work in Austin, Texas possess unique knowledge about the accused products.
  • In re Google, 21-178 (Fed. Cir. Nov 15, 2021). Abuse of discretion to deny transfer motion even though defendant maintains a major office in Austin.  None of its Austin employees were involved with developing the accused functionalities.
  • In re Merkai Integrated Circuit (21-180).  Mandamus was moot, Judge Hughes wrote separately to chastise Judge Albright’s orders.  This case is interesting — can a defendant request transfer, but reserve the right to argue that the new court lacks personal jurisdiction?

Moot Court: Aka Spinning Class at the Law School

by Dennis Crouch

We do a moot court competition every year in my basic patent law course at the University of Missouri.  The students just submitted opening briefs. Responsive briefs are due over the weekend, and oral arguments will be held next week on the 16th and 17th of November. It is a fun capstone for the course, although it is some amount of work for the students.  Folks at McKool Smith have provided some funding and so the winner receives a nice $1,000 check.

[I could use a few more judges — you can sign-up via doodle; or contact my Teaching Assistant Homayoon Rafatijo]

This year’s case is based directly on Judge Gilstrap’s recent patent eligibility decision in  Mad Dogg Athletics v. Peloton Interactive (E.D. Tex. Sept. 15, 2021).   Mad Dogg was the originator of the indoor Spinning market back in the early 1990s (it owns the registered TM on SPINNING and SPINNER).

In the 2000s Mad Dogg entered a new marked for video-led home-indoor cycling and also created its new spinning bicycle that incorporated a touch-screen display and controller.  The patents at issue here cover this new development (2005 priority filing date; 9,694,240 and 10,137,328).   In 2014, Peloton released its own competitor product and has built-up a multi-billion-dollar product line.

In December 2020, Mad Dogg sued in E.D. Tex.  Peloton responded with a 12(b)(6) motion to dismiss for failure to state a claim — arguing that the claimed inventions were improperly directed toward an abstract idea.  And, the district court agreed – dismissing the case.  The court particularly concluded that the claims are directed to the abstract idea of “providing instruction for an exercise bike class.” Regarding Alice Step 2, the court did not actually determine whether the claims recite a sufficient inventive concept, but still dismissed the case — holding that the plaintiff did not plead “enough facts … to avoid a Rule 12(b)(6) dismissal.”

In the real case, Judge Gilstrap dismissed without prejudice–providing Mad Dogg with the opportunity to refile a complaint that asserting additional facts regarding Alice Step 2.  However, I modified the order for our moot court so that the dismissal is with prejudice, thus setting up the appeal. [Read the Case File Here].  In order to facilitate our quick timeline within class, I announced the issues by fiat and required both appellants and appellees to file their briefs simultaneously.

The parties have agreed to limit the appeal to two questions:

  1. Whether the district court erred by placing the burden on the patentee to affirmatively show patent eligibility.
  2. Whether the district court erred by finding that the patentee had failed as to patent eligibility under 35 U.S.C. 101.

As you think about this case, consider claim 1 of the ‘240 patent:

1. An exercise bike, comprising:

a frame that is configured to allow a rider to ride in sitting and standing positions;

a direct drive mechanism that couples a pedal assembly and a flywheel and that facilitates a smooth transition between sitting and standing positions;

a set of handlebars that is coupled to the frame and that provides the rider with at least one hand position;

a mechanism that provides resistance to the flywheel and that is manually adjustable by the rider to vary the pedaling resistance;

a computer that is coupled to the stationary bike, that is configured to connect with the internet or other computer network to access a collection of exercise routines, wherein the exercise routines include instructions regarding cadence, pedaling resistance, and riding positions including sitting and standing positions, and that stores power exerted by the rider;

a display that is coupled to the computer, that displays an exercise routine from the collection of exercise routines so that the rider is provided with instructions for the rider to manually adjust pedaling resistance, and instructions for the rider to vary cadence and riding positions including sitting and standing positions, thereby simulating an instructor-led exercise class, and that displays power exerted by the rider; and

an input device that is coupled to the computer and that enables the rider to input data into the computer.

What do you think of this case? Any thoughts on how you might argue the appeal? Thanks!  Crouch.

Venue: Out of Texas

In re Quest Diagnostics (Fed. Cir. 2021)

Ravgen sued Quest in W.D. Texas for infringing two patents covering pre-natal genetic tests. As the map shows below, Quest has dozens of “places of business” open within the Western District (Waco and Austin areas) where Quest was selling the services.  So, venue was proper under the narrow venue statute for patent cases, Section 1400(b).  Likewise, the court has personal jurisdiction over the defendant with Quest’s Texas-based operations allowing for specific jurisdiction under the minimum contacts test of International Shoe.   But, even when jurisdiction and venue are proper, they may still be inconvenient.

Here, the Federal Circuit has again ordered Judge Albright to release this case and transfer it to a more convenient venue of the Central District of California.  The basic issue is that Quest designed and developed the tests in C.D. Cal., and it uses those same labs to actually conduct the genetic test.  Quest’s primary argument for keeping the case in Waco is that there are already three other cases before Judge Albright involving the same two patents (Ravgen vs PerkinsElmer, vs. Natera, and vs. LabCorp).

The parties did not point to any non-party witnesses, but Quest did point to the long travel time from C.D.Cal., to Waco, and the Federal Circuit indicated that the district court should have placed more weight on that factor and also erred by not considering travel convenience in a more wholistic manner.

In his order, Judge Albright had noted that his familiarity with the patents at issue and his push for quick trial weighed heavily in favor of keeping the case in Waco.  However, the appellate panel found that Albright should not account for any of his familiarity learned after Quest filed its motion for transfer.   In addition, the Federal Circuit restated a prior holding that “it is improper to assess the court congestion factor based on the fact that the Western District of Texas has employed an aggressive scheduling order for setting a trial date.”  Quoting Juniper.

Transfer ordered.

H. R. 5874: Restoring America’s Leadership in Innovation Act of 2021

Rep Massie (R-KY) along with three republican co-sponsors has introduced a new pro-patent-holder legislative proposal. [LINK]

Elements of the proposal:

  1. Restore a first-to-invent system and one-year grace period: “a person shall be entitled to a patent where the inventor is first to conceive of the invention and diligently reduces the invention to practice.”  This includes substantial reversion of Section 102 to its pre-AIA status.
  2. Abolish Inter Partes Review and PGR: “Chapters 31 and 32 of title 35, United States Code, are repealed.”
  3. Allow for civil actions to demand patent rights from the USPTO in any district court.
  4. End Fee-Diversion of USPTO Revenue.
  5. Abrogation of Alice, Mayo, Bilski, and Myriad “to ensure that life sciences discoveries, computer software, and similar inventions and discoveries are patentable, and that those patents are enforceable.”  This includes statutory revision of Section 101.
  6. Expressly establishing a patent as a private property right: “A patent right is a private property right secured to an inventor upon issuance of the patent that shall only be revoked by a court ruling in a judicial proceeding, unless the patent owner consents to an administrative or other procedure.”
  7. End Automatic publication of patent applications.
  8. Patent term tolled during any period of patent validity challenge.
  9. Patent infringement judgment presumptively results in an injunction.
  10. Best mode reestablished as an operative condition of patentability.

What are your thoughts on these proposals?

 

 

 

Dann v. Johnston, 425 U.S. 219 (1976): Invention as the Absolute Prerequisite to Patentability

In the past 50 years, the Supreme Court has decided about 70 patent cases (depending upon how you count).  One of the least cited is the 1976 case of Dann v. Johnston, 425 U.S. 219, 225 (1976). The case was set-up as a showdown on questions of patent eligibility in the “highly esoteric field of computer technology.”  Id. But, in the end, the court focused on the more mundane question of obviousness — a doctrine it continued to refer to as “invention.”

Johnston was seeking to patent a “record-keeping machine system for financial accounts.”  Basically, this was software installed on a bank-owned IBM 1400 that allowed its customers to categorize their income and expenses for better reporting.

The Patent Office rejected the claims, but the CCPA revived them. That 3-to-2 decision included a narrow interpretation of Gottshalk v. Benson, 409 U.S. 63 (1972), concluding that the case only applied to process or method claims.

The issue considered by the Supreme Court in Benson was a narrow one, namely, is a formula for converting binary coded decimal numerals into pure binary numerals by a series of mathematical calculations a patentable process?

In re Johnston, 502 F.2d 765 (C.C.P.A. 1974). Since Johnston was patenting a system, Benson was deemed irrelevant by the CCPA majority.  Judge Rich wrote in dissent, and argued that the invention was barred under Benson. To be clear, Judge Rich was not a fan of Benson, but he took the Court’s decision as law, albeit warty.  He explained:

As the author of the opinion of this court in Benson, which was wholly reversed, I have not been persuaded by anything the Supreme Court said that we made a “wrong” decision and I therefore do not agree with the Supreme Court’s decision. But that is entirely beside the point. Under our judicial system, it is the duty of a judge of a lower court to try to follow in spirit decisions of the Supreme Court— that is to say, their ‘thrust.’

Id. (Judge Rich in dissent).   Still, the big question was what to take-away from Benson and Judge Rich suggested that the focus should not be limited by the Supreme Court’s wording.

I am probably as much – if not more – confused by the wording of the Benson opinion as many others. What the Court did in its decision … contains a message that is loud and clear. If those claims are not to patentable subject matter, neither, in my view, are the claims here, regardless of difference in form.

Id.  Judge Markey also wrote a dissent that foreshadowed the eventual Supreme Court decision. Markey argued that Johnston’s claims were invalid based upon the prior art and that the eligibility questions should be avoided.

After losing before the CCPA, the government then petitioned for Supreme Court review in the name of Marshall Dann, who was President Nixon’s Commissioner of Patents.  The petition includes three questions:

  1. Whether the Supreme Court’s holding in Benson, that a new idea to be implemented by programming an existing computer is unpatentable when claimed as a new “process,” also applies when the programmed computer is claimed as a new “machine system.”
  2. Whether programs for existing general purpose digital computers, however claimed, are patentable under present law.
  3. Whether respondent’s idea of having banks provide an additional bookkeeping service by programming their computers to sort check and deposit data in accordance with category codes was in any event no more than an obvious improvement over the prior art.

Johnston’s attorney Morton Jacobs drafted the patent application and also argued the case all the way to the Supreme Court (eventually losing).  The responsive brief recategorized the questions in an interesting way:

  1. Whether in the absence of specific congressional exclusion, a special purpose computer machine can be excluded from the general class of machines constituting statutory matters under 35 U.S.C. 101 by reason of its construction with software rather than hardware for its programming elements.
  2. Whether the Patent Office denial of patents for “software” emobidments of special-purpose computers while granting patents to “hardware” embodiments is a denial of equal protection of the patent laws.
  3. Whether an automatic record-keeping machine for all types of small-volume users (e.g., merchants, professionals, farmers) that enables each to use an individualistic record-keeping format and bookkeeping procedure, and that employs, inter alia, a general control for directing the processing operations that are common to most users, which control interacts with and is directed by a master control located in the data files for directing the operations that very with each user, is an unobvious improvement over the prior art.

The unanimous Supreme Court decision was authored by Justice Thurgood Marshall and expressly avoided the questions of patentability of software or computer programs.  Rather, the court found the claims obvious.

The opinion began with a recitation of the doctrine:

As a judicial test, “invention” – i.e., “an exercise of the inventive faculty” – has long been regarded as an absolute prerequisite to patentability. However, it was only in 1952 that Congress, in the interest of “uniformity and definiteness,” articulated the requirement in a statute, framing it as a requirement of “nonobviousness.” . . .

This Court treated the scope of § 103 in detail in Graham v. John Deere Co., 383 U.S. 1 (1966). There, we held that § 103 “was not intended by Congress to change the general level of patentable invention,” but was meant “merely as a codification of judicial precedents… with congressional directions that inquiries into the obviousness of the subject matter sought to be patented are a prerequisite to patentability.” While recognizing the inevitability of difficulty in making the determination in some cases, we also set out in Graham, the central factors relevant to any inquiry into obviousness: “the scope and content of the prior art,” the “differences between the prior art and the claims at issue,” and “the level of ordinary skill in the pertinent art.”

Dann v. Johnston, 425 U.S. 219, 226 (1976). In analyzing the claims, the court concluded that it need not find a prior art equivalent to each and every claim limitation.  Rather, the focus of the test is the significance of the differences to one of skill in the art.

[I]t must be remembered that the “obviousness” test of Section 103 is not one which turns on whether an invention is equivalent to some element in the prior art but rather whether the difference between the prior art and the subject matter in question “is a difference sufficient to render the claimed subject matter unobvious to one skilled in the applicable art. . . .”

Id. (quoting Judge Markey’s dissent in Johnston).  It is not entirely clear what point the court was making in noting that the referenced prior art were “closely analogous” but not “equivalent.”

[T]he mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness. The gap between the prior art and respondent’s system is simply not so great as to render the system nonobvious to one reasonably skilled in the art.

Reversed.

Of note, the court’s statement here of the foundations for obviousness from Graham did not include includes secondary indicia such as commercial success.  Later in the opinion, Justice Marshall added a footnote recognizing that their potential relevance in an obviousness analysis.  However, the opinion also reiterated the statement from the checkout-counter case – Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147 (1950) – that “commercial success without invention will not make patentability.”  Justice Jackson’s concluding statement in that case may be equally applicable to Johnston: [The patentee had] “a good idea, but scores of progressive ideas in business are not patentable, and we conclude on the findings below that this one was not.” Id.

In the end, Dann v. Johnston is something of a dud, a sloppy reverb of Graham. The key takeaways going forward:

  1. Obviousness does not require equivalence in the prior art.
  2. Patentees are charged with awareness of the prior art, even in fast-moving technologies.
  3. “[E]xercise of the inventive faculty [is] an absolute prerequisite to patentability.”
  4. “[C]ommercial success without invention will not make patentability.”

[Read it here]

More Venue and Corporate Games: This time with ANDA filing

Celgene Corp. v. Mylan Pharma (Fed. Cir. 2021)

The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. 28 U.S.C. 1400(b). There are two different ways to show proper venue:

  1. Venue by Residence: Venue is proper if the defendant(s) reside in the district where the case is filed. If a non-human person, this requires being incorporated within the state (or the like).
  2. Venue by Infringement and Place of Business: Alternatively, venue is proper in a district where the defendant has (allegedly) “committed acts of infringement” and also “has a regular and established place of business.”

It is usually fairly straightforward to determine some location for the “acts of infringement” if we’re talking about making, using, selling, etc.

This case focuses on the unique paper-filing infringement of Section 271(e)(2)(A).   That provision defines infringement as seeking approval from the FDA to market a drug that is covered by a patent. Thus, a generic drug distributor infringes by simply submitting its ANDA application with a Paragraph IV certification.

It shall be an act of infringement to submit . . . an [Abbreviated New Drug Application] for a drug claimed in a patent or the use of which is claimed in a patent  . . . if the purpose of such submission is to obtain approval … to engage in the commercial manufacture, use, or sale of a drug … claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

Id. For venue, we need to know the location of that “act of infringement.”

Celgene markets a drug treatment for multiple-myeloma (pomalidomide) covered by several of its patents. Mylan created and submitted an ANDA to the FDA, requesting permission to make a generic version of the drug and arguing that the Celgene’s patents were invalid.

Celgene then sued in D.N.J. and Mylan argued improper venue.  Notably, Mylan argued that it is not incorporated in N.J., it does not have any regular-and-established place of business in N.J., and it did not commit acts of infringement in N.J. The state-of-incorporation was not contested, but the other two factors were hotly debated.

Lets talk first about acts of infringement.  Remember for 271(e), the act of infringement is submitting the ANDA to the FDA.  Here, Mylan created its ANDA documents at its West Virginia office and submitted them electronically from that location.  The FDA is headquartered in Maryland, and that was the office that received the ANDA documents.  Thus, it is clear that Mylan’s acts were in W.V., and probably also in Maryland, but not in N.J.

Celgene had a couple of OK arguments:

(1) The intent and effect of the Hatch-Waxman process is national, and thus the acts of infringement should be deemed to have been committed in all states.  This argument was quickly rejected by the court.

(2) The ANDA process requires mailing of a Paragraph IV notice letter to the patentee listed in the Orange Book. And, that letter is required to trigger the Hatch-Waxman timeline.  Mylan did so — sending the letter from W.V. to N.J.   Although the notice letter is a critical aspect of the Hatch-Waxman process, the Federal Circuit found that the letter was not an “act of infringement” as required by the venue statute.  Rather, Section 271 is clear that the act of infringement is submitting the ANDA to the FDA.

Thus, Mylan did not commit any acts of infringement in N.J., and therefore venue in that state is improper.

With regard to the regular-and-established place of business, the court found that the home-offices of several Mylan employees were not sufficient to satisfy that prong of the venue statute.  “Allowing” employees to work in a particular judicial district is not sufficient to find that their homes were the defendant’s place of business.

Celgene also pointed to a wholly owned Mylan subsidiary that, until 2017, did have a  HQ and regular place of business in N.J. On appeal, the Federal Circuit agreed with the lower court that the venue requirement strictly follows corporate lines absent a successful “alter-ego or veil-piercing theory.”  Here, there was not sufficient evidence to consider the sub as the parent’s alter ego.   Sharing marketing and receiving administrative support is insufficient.  Likewise, two separate companies can share the same directors or executives.

= = = =

In the lawsuit, the patentee sued Mylan Pharmaceuticlas Inc. (MPI), Mylan Inc., and Mylan N.V.   This is just a chain of subsidiaries: Mylan N.V. owns Mylan Inc.; Mylan Inc. owns MPI.   MPI is the company that submitted the ANDA, but the complaint does not explain how Mylan N.V. was involved with the submission.  Thus, the district court properly dismissed the claims against Mylan N.V. for failure to state a claim upon which relief could be granted.

Patently-O Bits and Bytes by Juvan Bonni

Recent Headlines in the IP World:

Commentary and Journal Articles:

New Job Postings on Patently-O:

It Works: The Value of “Effective” Claim Limitations

by Dennis Crouch

University of Strathclyde v. Clear-Vu Lighting LLC (Fed. Cir. 2021)

The Federal Circuit’s recent Strathclyde decision focuses on claim limitations that require the invention to be effective.  One oddity of the decision is that the court (and the PTAB below) treat the limitation with full respect just like any other structural limitation.

Researchers at Strathclyde conducted a set of experiments and found that certain blue light (~405 nm wavelength) was effective at inactivating methicillin-resistant Staphylococcus aureus (MRSA) even at low intensity and without first applying a photosensitizing agent.  The resulting method claim focuses on this discovery and includes one simple step — inactivating MRSA bacteria by exposing it to blue (400-420 nm) light and without using a photosensitizer. U.S. Patent No. 9,839,706.

It turns out that the prior art (Nitzan) discloses a series of experiments using the same blue light and testing its effectiveness at inactivating MRSA bacteria. The tests compared the response of untreated bacteria as compared with bacteria treated with a photosensitizing agent.

Nitzan’s prior art procedure was identical to that claimed by Strathclyde with only one key difference.  Nitzan found that none of the MRSA bacteria were killed by the blue light without first applying a photosensitizing agent.  The patentee  (Strathclyde) later used the same frequency of blue light without a photosensitizing agent, and this time it worked to inactivate MRSA.

Thus, the only difference between Strathclyde’s claimed invention and the prior art is the requirement that the invention actually work to “inactivate” the bacteria.

1. A method for disinfecting … by inactivating … pathogenic Gram-positive bacteria … comprising exposing the … bacteria to visible light without using a photosensitizer … and wherein a portion of the visible light that inactivates the … bacteria consists of wavelengths in the range 400-420 nm. . .

Claim 1 of the ‘706 patent.  Traditionally, a functional “resulting” or “whereby” clause is only given patentable weight if it provides some structure or acts that are used to define the invention itself.  For instance, in drug treatment cases, “effective amount” limitations can be used to define the amount of drug given to the patient. Here, however, the “inactivating” limitation does not appear to change any particular structure or acts and so, in my view, does not add patentable weight.

The invention here seems quite important–treating MRSA using otherwise harmless light and without potentially toxic chemical pre-treatment.  And, Strathclyde should be able to patent the  advances that it introduced that actually contributed to the success. I suspect that Strathclyde did do something different than Nitzan in terms of light intensity or frequency of treatment, or some other conditions.  But, the claims here do not require a person of skill in the art to do anything different than Nitzan except achieve a different outcome. Clear-Vu did not make these patentable weight arguments to the Federal Circuit and the Federal Circuit did not raise them sua sponte.

This case was before the PTAB via IPR. The PTAB originally sided with the patent challenge Clear-Vu.  The PTAB concluded that Nitzan taught all of the elements of the invention except for actual success at killing MRSA.  However, another reference Ashkenazi suggested ways that someone of skill in the art would find obvious in terms of increasing light intensity to kill some of the bacteria.  Thus, the PTAB found the claims obvious.

On appeal, the Federal Circuit has reversed and reinstated the patent.  The court noted the complete absence of any prior art indicating that blue light alone would kill MRSA without a chemical pre-treatment to sensitize the bacteria.  Further, there was evidence that such an approach would fail.  Still Strathclyde succeeded and, according to the Federal Circuit, deserve its patent.

On this record, we conclude that no reasonable fact finder could have found that the combination of Ashkenazi and Nitzan discloses inactivating one or more Gram-positive bacteria without using a photosensitizer. The Board’s finding to the contrary is not supported by substantial evidence.

Slip Op.

Guest Post: Patents in Islamic Law

Professor Tabrez Y. Ebrahim is visiting at Iowa Law this semester, where he’s teaching Cybercrime & Security and Entrepreneurship Law & Ethics.  His research interests are broad, and he recently completed a comparative work examining patents in Islamic law.  Below he offers a synopsis of his work.

Companies and law firms with a transnational presence in Islamic countries should recognize that patents may present different considerations in countries with less secular legal systems. Islamic law has primacy in Islamic countries that comprise nearly one-fifth of the world’s population. Many of these countries are members of Trade-Related Aspects of Intellectual Property Rights (TRIPS), which excludes from patentability certain inventions that offend morality in that society. As Islamic countries have begun to embrace patents in recent decades, theories of patents have presented conceptual and theological debates under classical Islamic law, including for construing patentable subject matter and assessing patent infringement.

Patents in Islamic Law present religious considerations that are unique compared to U.S. patent law. First, there are tensions between intellectual property and Islamic law, which is silent on the permissibility of intangibles yet allows for their interpretation. Second, justifications for patents within Islamic law present ethical and morality considerations based on religious limitations that present public policy choices of patentable subject matter and the ordre public meaning of TRIPS Article 27.2 . Third, public interest should be a consideration not only in terms of a potential harm to plaintiff (who is seeking injunctive relief or preventing importation of an infringing article) in the patent infringement context, but also in terms of justification of patents in an Islamic legal system.

In my recent article, Intellectual Property Through a Non-Western Lens: Patents in Islamic Law, I explain these considerations, analyze why and how patents uncomfortably fit within a religious body of law, and provide a new perspective to the patent law community. The tensions of patents within Islamic law arise since Islamic legal systems are based on Shariah, which considers divine law as encompassing and guiding all aspects of human life, yet allowing for interpretation through fiqh, or human understanding of the divine law.  Below, I briefly summarize my observations and conclusions.

First, Islamic law does not explicitly recognize patents. In addition, there are complexities within Islamic law that impose a prohibition or limitations on patents: (1) one school of Islamic jurisprudence has traditionally required physical possession of a property right; and (2) some scholars have argued patents create monopolistic effects contrary to an Islamic vision of patents. In the article, I provide justifications and reasoning as to how patents can be implicitly derived within Islamic law by drawing upon its secondary sources of law, provide a framework and justifications for their recognition within Islamic law, and describe the gradual change in interpretation of property to include intellectual property within Islamic law.

Second, while recognizing that patentable subject matter is rife with indeterminacy in the U.S, I suggest that it is a social policy choice that that has yet to be molded in Islamic countries. In particular, ethically and morally controversial inventions should be excluded from patentability in Islamic legal systems, which I argue should have initial flagging of such inventions in the patent examination process and should be assessed by my proposed Patent Shariah Board (an independent board of specialized jurists that direct, review, and supervise Islamic jurisprudence pertaining to patents). As such, patent offices in Islamic legal systems should have a diminished role for assessment of patentable subject matter, which would require flagging (but not thorough evaluation) by patent examiners in such countries. Moreover, the interpretation of ordre public meaning of TRIPS Article 27.2 should have differential treatment among Islamic countries based on the underlying Islamic school of jurisprudence and by the degree of primary of religious law.

Third, I suggest that patent infringement, which is in a nascent and unclear state in Islamic legal systems, presents unique considerations in comparison to the U.S. patent system. I argue that public interest, which is a key consideration in Islamic law, is of greater importance in determining sufficient harm in patent infringement than in U.S. patent law (while also serves to provide a justification for patents within Islamic law).

In sum, while justifying patents within Islamic law, I provide theoretically and theologically sound justifications for patents in an Islamic legal system, while I reason that the reach of patents is narrower than in western legal systems due to more prominent morality, ethics, and public interest considerations. In developing the fiqh (or human interpretation of divine law) of patents, I develop a conceptual framework for patents in Islamic law, while recognizing limitations and institutional design for their administration. This project is part of a longer-term research project that seeks to compare the existing U.S. patent system with patents in Islamic law (including similarities between the systems and unique aspects of each system), and provide insights into how companies and law firms seeking to have a transnational patent presence can operate within nations that follow Islamic law.

Read the full article here on SSRN or the Georgia State University Law Review website.

Tabrez Y. Ebrahim is a law professor and a registered U.S. patent attorney. He is an Associate Professor of Law at California Western School of Law, a Scholar at George Mason University’s Center for Intellectual Property x Innovation Policy, a Senior Cyber Law Researcher at William & Mary Law School’s Center for Legal & Court Technology, an Ostrom Visiting Scholar at Indiana University, and a Visiting Fellow at the University of Nebraska.

Letter to the Chief Justice about Judge Albright. 

For anyone looking for legislative action supporting patent holders.  Let me tell you, not this year.

Rather, in a bipartisan letter Senators Tillis and Leahy have asked Chief Justice Roberts to provide a report on the “extreme” and “problematic” situation in the Western District of Texas where pro-patentee Judge Albright is hosting about 25% of all pending district court patent litigation.

Letter to the Chief Justice about Judge Albright.

Hon. Judge Stark to be Appointed to the Federal Circuit

by Dennis Crouch

Delaware was already a popular venue for patent cases before the Supreme Court’s 2017 venue decision in TC Heartland. Since 2017, it has moved from popular to hot since so many companies are formally incorporated in the state.  (State of incorporation => proper venue in patent cases).  Delaware particularly been seen as a fair jurisdiction where both plaintiffs and defendants receive a full and fair hearing.  Thus, it is a popular spot for operating companies to sue as plaintiffs, knowing that they may face affirmative counterclaims in the same lawsuit.

The Federal Court in Delaware has four judges, all of whom now have a substantial patent litigation caseload. This includes the most senior, Hon. Leonard P. Stark who was appointed by President Obama back in 2010.  At the time, Joe Biden was Vice President of the United States and I am confident that he had a hand in selecting Judge Stark for that position.   Judge Stark was previously a magistrate judge and an assistant US attorney, all in Federal Court in Delaware.

The White House has announced that it intends to elevate Judge Stark–nominating him to serve as a Circuit Judge on the Court of Appeals for the Federal Circuit.  He will replace Judge Kathleen O’Malley who has indicated her intent to retire in March 2022.  Judge O’Malley is the only current Federal Circuit judge with extensive experience at the trial court level, and Judge Stark brings that same type of background.

The following comes from the White House press release:

Judge Leonard Stark: Nominee for the United States Court of Appeals for the Federal Circuit

Judge Leonard Stark has served as a United States District Court Judge for the District of Delaware since 2010. Judge Stark served as Chief Judge for the District of Delaware from July 2014 to June 2021. Previously, he served as a United States Magistrate Judge for the District of Delaware from 2007 to 2010. From 2002 to 2007, Judge Stark served as an Assistant United States Attorney in the United States Attorney’s Office for the District of Delaware, where he worked in both the criminal and civil divisions. From 1997 to 2001, Judge Stark was an associate in the Wilmington, Delaware office of the law firm Skadden, Arps, Slate, Meagher & Flom LLP. He served as a law clerk for Judge Walter Stapleton on the United States Court of Appeals for the Third Circuit from 1996 to 1997.

Judge Stark received his J.D. from Yale Law School in 1996., a D. Phil. from the University of Oxford as a Rhodes Scholar in 1993, and a B.A., B.S., and M.A., summa cum laude and Phi Beta Kappa, from the University of Delaware in 1991.

Congratulations Judge Stark.

Venue Mandamus Petitions Continue to Flow to the Federal Circuit

by Dennis Crouch

We’ve been writing a lot about venue and mandamus petitions at the Federal Circuit.  The cases continue to flow to the court, and will continue so long as appellate panels continue to entertain them.

In October 2021, 10 new mandamus petitions were filed to the Federal Circuit in patent cases.

  • 22-100 In re: Overhead Door Corporation (E.D. Tex.) (proper but inconvenient forum);
  • 22-101 In re: Advanced Micro Devices, Inc. (W.D. Tex.) (proper but inconvenient forum);
  • 22-103 In re: Arista Networks, Inc. (W.D. Tex.) (proper but inconvenient forum);
  • 22-104 In re: Google LLC (W.D. Tex.)  (proper but inconvenient forum);
  • 22-105 In re: Amperex Technology Limited (D.N.J.) (proper but inconvenient forum);
  • 22-106 In re: Juniper Networks, Inc. (E.D. Tex.) (proper but inconvenient forum);
  • 22-107 In re: Medtronic, Inc. (W.D. Tex.) (arguing both improper venue and also inconvenient forum);
  • 22-108 In re: Volkswagen Group of America, Inc. (W.D. Tex.) (improper venue; are dealerships a place of business for VW);
  • 22-109 In re: Hyundai Motor America (W.D. Tex.) (improper venue; are dealerships a place of business for Hyundai); and
  • 22-110 In re: Netflix, Inc. (E.D. Tex.) (arguing both improper venue and also inconvenient forum).

I’m quite skeptical of parties use of Section 1404 in patent litigation. All of the parties listed above are major nationwide companies that have successfully litigated in courts across the country.  The motivation behind “convenient forum” litigation is all about judge shopping.  Patentees want certain judges; defendants want different judges.  But, that motivation does not provide any legal basis for transfer of venue.  So, instead parties argue that the file server location in California and the lack of non-stop flights makes it too hard to litigate in Texas.  Truthfully, it is hard for me to believe that the Federal Circuit is so engaged with rescuing these folks from burdensome file transfers.

Patent Law Textbooks: A Micro-Symposium

By Jason Rantanen

This Friday, November 5, the Iowa Innovation, Business & Law Center will be hosting a first-of-its-kind event (to the best of my knowledge at least): a panel discussion by patent law casebook authors about what makes their textbooks tick.  There are at least eight different patent law textbooks with editions published in the last few years, and we’ve brought their authors together to talk.  The program, entitled Patent Law Textbooks: A Micro Symposium, will be live-streamed via Zoom webinar on from 1:30-4 pm Central.  You can preregister or join here: https://tinyurl.com/PatentCasebookPanel.

The symposium will consist of two panels:

  • Panel 1: Exploring Patent Law Textbooks (1:30 – 2:45 p.m. CT): This panel will feature authors talking about the distinguishing features of their textbooks, the design decisions that they made in creating them, and the pros and cons of self-published and open-access casebooks versus traditional publishers.
  • Panel 2: Publishing Your Own Textbook.  (3:00 – 4:00 p.m. CT) This panel will feature authors talking about their experiences creating an open-access or self-published textbook and tips for others who are thinking about creating their own open-access or self-published textbook, including why they made the copyright license choices that they did.

These panels will feature authors of the following casebooks:

  • Martin J. Adelman, Randall R. Rader, & John R. Thomas, Cases and Materials on Patent Law (West Academic 2019)
  • Daniel H. Brean & Ned Snow, Patent Law: Fundamentals of Doctrine & Policy (Carolina Academic Press 2020)
  • Sarah Burstein, Sarah R. Wasserman Rajec, & Andres Sawicki, Patent Law: An Open Access Casebook (2021)
  • John F. Duffy & Robert P. Merges, Patent Law and Policy: Cases and Materials (Carolina Academic Press 2021)
  • John M. Golden, F. Scott Kieff, Pauline Newman, & Henry E. Smith, Principles of Patent Law: Cases and Materials  (West Academic 2018)
  • Mark D. Janis, Ted M. Sichelman, et. al., Patent Law: An Open-Source Casebook (Law Carta 2021)
  • Jonathan S. Masur & Lisa Larrimore Ouellette, Patent Law: Cases, Problems and Materials (2021)
  • Craig A. Nard, The Law of Patents (Wolters Kluwer 2020)

Hope you can join us!

CardioNet’s Signal Transform Invention is Ineligible

by Dennis Crouch

CardioNet v. InfoBionic (Fed. Cir. 2021)

CardioNet lost at the district court with a summary judgment of non-infringement. On appeal, the Federal Circuit has shifted its judgment–now finding the heart monitor claims ineligible under Section 101.  U.S. Patent Number 7,941,207.

The patent covers a heart monitor that includes a “T wave filter” that helps make sure the signal processor does not confuse the T-wave with the R-wave.

Asserted claim 20 is directed to a “cardiac monitoring apparatus” with the T wave filter.   In particular, the claim requires four elements:

  • a communications interface;
  • a real-time heart beat detector;
  • a frequency domain T wave filter; and
  • a selector that activates the T wave filter.

The claim also has a resulting wherein clause: “wherein the activated frequency domain T wave filter preprocesses a cardiac signal provided to the real-time heart beat detector.”

The district court found an abstract idea of “filtering raw cardiogram data to optimize its output;” but concluded that the claim also included a curative “something more” and so survived under Alice step two. In particular, the district court found that the claim was “tied to a machine” and therefore satisfied “the machine-or-transformation test.” On appeal, the Federal Circuit found this to be the wrong test.

The Federal Circuit agreed that the claims are directed to an abstract idea.  In particular, the court effectively held that any computational signal transformation is an abstract idea:

At bottom, filtering the data requires only basic mathematical calculations, such as “decompos[ing] a T wave into its constituent frequencies and multipl[ying] them by a filter frequency response.” And such calculations, even if “[g]roundbreaking,” are still directed to an abstract idea.

Slip Op.   At step two, the Federal Circuit disagreed with the lower court and found that the claimed invention lacked any inventive concept beyond the excluded abstract idea.  On this point, the court noted the existence of prior art for attenuating the T-wave.  In other cases, the court has held that such a comparison with prior art is not relevant to the eligibility inquiry.

Machine or Transformation: In Bilski, the Supreme Court explained that the machine-or-transformation test was an important “clue” to patent eligibility.  However, the court there was clear that machine-or-transformation was not the test.

This Court’s precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under §101. The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible “process.”

Bilski v. Kappos (2010).   In this case, the court found that the claim is “technically tied to a machine” but its focus is actually the abstract signal transformation. The court explained that merely “formulating a claim in the form of an apparatus” does not protect it from eligibility challenge.

To the extent that formulating a claim in the form of an apparatus insulates it from an ineligibility attack if it only recites conventional components for performing an abstract idea, the Supreme Court has closed that door, at least for now.

Slip Op.

This is the third CardioNet case before the Federal Circuit and so the trio offers a good set of comparisons.  Although all three relate to heart monitor patents, the patents and claims differ from one another.

CardioNet v. InfoBionic: Patenting a Diagnostic Tool

Patent Patent Patent

For these numbers, I aggregated all opinions filed with each decision.  The leading decision appears to be Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) with several hundred “patent” repeats across the four opinions in that en banc decision.