Patently-O comments include lots of good information, but any site with over 300,000 comments will have their share of problematic ones. I’d like to refer everyone back toward my 2014 post: Moving Toward a Better Patently-O Ecosphere.
Tech Update: If you want to customize your commenting-photo, the process is to first create an account with WordPress (wordpress.com) and then go to https://wordpress.com/me to manage details.
My Senator (McCaskill) has introduced S. 1948 titled “A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents.” [TribalImmunity]
The Bill provides one simple statement as follows:
Notwithstanding any other provision of law, an Indian tribe may not assert sovereign immunity as a defense in a review that is conducted under chapter 31 of title 35, United States Code.
As discussed previously, Tribal Nation Sovereign Immunity is not Constitutionally protected and may be eliminated by particular acts of Congress. Thus, this Bill would seem to be effective to eliminate the ongoing concern regarding tribal immunity assertions. The proposal does lack an effective date and so the only missing element would be whether the Bill would retroactively veto pre-enactment claims of immunity.
More on Tribal Immunity: Is a Tribal-Owned Patent Immune from IPR Challenge?
Allergan: Creating Sovereign Immunity with Tribal Pass-Through
By Dennis Crouch
Amgen v. Sanofi (Fed. Cir. 2017). The Delaware district court sided with Patentee Amgen and awarded permanent injunctive relief barring Sanofi from selling its injectable drug product Praulent (alirocaumab) – a human monoclonal antibody used to reduce low-density lipoprotein (LDL) cholesterol – covered by U.S. Patent Nos. 8,829,165 and 8,859,741.
On appeal, the Federal Circuit has vacated the injunction – holding that the district court made reversible errors with regard to written description and enablement. Before walking through the decision, I’ll note here that the Federal Circuit panel here – made up of Chief Judge Prost, Judge Taranto and Judge Hughes – would not be identified as overly pro-patentee.
The drug at issue works by inhibiting the protein PCSK9 from binding with LDL Receptor (LDL-R), thus leading to a reduction of blood LDL. Basically, the claimed antibody binds to a particular residue (amino acid) of the PCSK9 molecule in a way that blocks the PCSK9 from then binding and promoting LDL-R. Representative claim 1 of the ‘165 patent is as follows:
An isolated monoclonal antibody,
wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, … or S381 of SEQ ID NO:3, and
wherein the monoclonal antibody blocks binding of PCSK9 to LDL-R.
Looking at the claim – it basically covers all isolated monoclonal antibodies capable of performing the required binding function – and the basic issue in the case is whether that broad claim is sufficiently supported by the specification. On point, the specification describes a number of example antibodies; the screening process that the inventors used to find those examples; and 3D structure of two of the known antibodies, including the antibody that serves as the patentee’s actual drug product (Repatha).
The Written Description and Enablement requirements are both stem from the same sentence in 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.
Written description focuses on whether the original patent disclosure conveyed evidence that the patentee – at the time of filing – had “possession” of the claimed invention. Ariad. Most written description challenges arise from post-filing amendments to the patent claim scope, however in Ariad the Federal Circuit made clear that originally-filed claims may lack sufficient written description if the claim covers a wide genus of embodiments and the specification fails to disclose “a representative number of species.”
Post-Priority Evidence: The extent of required written description disclosure depends upon the number of potential species. However, the district court refused to allow the accused-infringer attempted to introduce such evidence unless it reflected a pre-priority understanding of the science. On appeal, the Federal Circuit rejected that approach – holding that “the use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper.” Note here, the rule here is distinct from the limitation that only pre-priority date evidence is permissible for showing state-of-the-art at filing.
Enablement also focuses on sufficiency of disclosure, but asks the slightly different question of whether, after considering the specification, a skilled practitioner would be enabled to make and use the invention.
Under the enablement requirement, “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997).
As with written description, the focus is on enablement at the time the application was filed, however here the court also allows post-priority-date evidence to show that the accused infringers here “engaged in lengthy and potentially undue experimentation to enable the full scope of the claims.” The court writes:
Such evidence could have been relevant to determining if the claims were enabled as of the priority date and should not have been excluded simply because it post-dated the claims’ priority date.
Thus, the district court’s exclusion of such evidence was improper.
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In addition to improperly excluding evidence, the Federal Circuit also ruled that the district court antibody-antigen jury instruction relating to written description was also improper. In particular, the jury instructions included the following explanation of the law:
In the case of a claim to antibodies, the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine.
According to the appellate court, this instruction is wrong because it allows a patentee to satisfy the description-of-use portion of written description by relying upon the level of skill in the art. Rather written description requires an actual written description showing possession of the invention, including express instructions on how to make and use the invention.
The essential problem with the jury instruction given in this case is that it effectively permitted the jury to dispense with the required finding of a written description of the invention. . . . A jury would naturally understand the instruction to permit it to deem any antibody within the claim adequately described merely because the antibody could easily be “produc[ed]” (and, implicitly, used as an antibody).
The decision here repudiates statement to the contrary from Enzo that are here characterized as dicta. On remand, the jury will likely also be asked to consider whether – in this particular case – “the chemical structure of an antigen [provides] structure-identifying information about the corresponding antibodies.
The past week I have included a few design patent law updates on Patently-O. While on the topic, I should mention the new book edited by (and substantially authored by) Christopher Carani titled Design Rights: Functionality and Scope Protection ($200 from WK).
The book walks through design protection available the various global regions – US, Europe, Japan, China, India, S.America, etc – and is designed to help practitioners both understand the law and get started on strategy. From the book-blurb:
This book, while providing a solid foundation of the law regarding the protection and enforcement of design rights, focuses on the ever-present, and always contentious, issue of functionality in the context of design rights. While there is considerable harmonization on the fundamental principle that design rights regard aesthetic appearance and not underlying technical function, courts and legislatures the world over have long struggled with determining whether to permit, and how to interpret the scope of, design rights directed at products whose appearance may, partially or completely, be the result of functional consideration.
At 700 pages, the design-focused tome may also help sculpt your biceps as you read.
I previously wrote about Alfred Pirri’s federal complaint against Lori Cheek and her company Cheek’d. The story looked like an odd-ball law professor exam question: Mild mannered Pirri had a great idea for reverse online dating, he told his personal therapist who told a friend (who happened to be the fabulous entrepreneur Lori Cheek) and the friend stole the idea and patented it for herself.
Lori Cheek has now responded with a basic statement that the story is an entire whole-cloth fabrication. Cheek writes:
Hi Dennis,
I saw your story “Reversing the Patent on Reverse Online Dating.” The allegations contained in Mr. Pirri’s complaint are completely untrue and defamatory. They are terribly upsetting to me personally, but I am assured they will be dealt with quickly and effectively in court.
If you’ve actually read the entire complaint, you can see for yourself that Mr. Pirri’s story is bizarre. Neither I nor either of my co-inventors had ever heard of, much less knew Mr. Pirri’s therapist, Joanne Richards, and Ms. Richards confirms that she had never heard of any of us, prior to this lawsuit.
Neither I nor my co-inventors would ever do – and never did – the things that are alleged by Mr. Pirri. We are a highly regarded, ethical company. If you wish to pass judgment on me or my company, I simply ask that you wait for the outcome of this matter, which we hope will come soon, which will completely exonerate me, my co-inventors, and Cheekd, Inc.
Best,
Lori Cheek, CEO
Cheekd, Inc.
[Reproduced with permission] Pirri’s attorney Oleg Mestechkin has responded that the case “will shed light on the truth.”
by Dennis Crouch
Aqua Products v. Matal (Fed. Cir. 2017) (en banc) [Aqua Products Decision]
In a nuanced set of opinions the Federal Circuit – with no clear majority opinion – holds merely that:
The final written decision of the Board in this case is vacated insofar as it denied the patent owner’s motion to amend the patent. The matter is remanded for the Board to issue a final decision under § 318(a) assessing the patentability of the proposed substitute claims without placing the burden of persuasion on the patent owner.
The ‘leading opinion’ by Judge O’Malley goes on to explain:
Because the participating judges have different views—both as to the judgment we should reach and as to the rationale we should employ in support of that judgment, as explained below, today’s judgment is narrow.
This result was supported by a 7-member panel.
The opinion package, is 148 pages in length and includes five separate opinions walking the question of deference to PTO Decisionmaking.
The setup and context here is ripe for Supreme Court review. More to come later.
by Dennis Crouch
Don’t stare too deeply into the pattern above – it embodies Columbia Sportswear’s U.S. Design Patent No. D657093 – covering “the ornamental design of a heat reflective material, as shown and described.” The recent $3 million jury verdict in Columbia Sportsware v. Seirus Innovative Accessories appears to be the first post-Samsung verdict on design patent damages.
The design patent damages verdict here is important for Columbia because the jury found the parallel asserted utility patent claims invalid as both obvious and anticipated. [ColumbiaSportsVerdict]
If you remember, the Patent Act includes a special profit-disgorgement provision for design infringement damages requiring that “Whoever during the term of a patent for a design … sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit.” 35 U.S.C. 289.
In the case, the district court had already ruled on summary judgment that Seirus infringed and so the only question for the jury was damages. [Columbia Infringement Decision, holding that as a matter of law “an ordinary observer familiar with the prior art would be likely to confuse Seirus’s design with Columbia’s patented design.”]
In Samsung, the Supreme Court held that, the relevant article of manufacture used as the profit-disgorgement baseline need not be the end product sold to the consumer but might be only a component of that product. As the patent images show below, the case here involves multi-component parts (clothing) and the patented inner-layer can be seen as one of the components.
Here, in Columbia Sportswear, the court instructed the jury to “First, identify the article of manufacture’ to which the infringed design has been applied. The article of manufacture may be the product as a whole or a component of that product. Second, calculate the infringer’s total profit made on that article of manufacture.” The jury instructions then explain this process as (1) first identifying whether the accused-product being sold is multi-component and then, if so, (2) considering a set of factors to determine whether the “article of manufacture” is the whole product or some sub-component. These factors include: the scope of the design as patented; the relative prominence of the design within the product as a whole; whether the design is conceptually distinct from the product as a whole; and the physical relationship between the patented design and the rest of the product. These factors match the test called-for in the Government brief in Samsung v. Apple, but that the Supreme Court declined to expressly articulate.
The jury instructions also explain the burdens:
Columbia [the patentee] bears the initial burden of producing evidence identifying the article of manufacture for which it seeks profits. Columbia may meet that burden by showing that Seirus applied the patented design to a product that was sold and further proving Seirus’s total profit from the sale. Seirus bears the burden of proving that the article of manufacture is something less than the entire product.
A snippet from the jury award is included above. You’ll note that the jury was not asked to actually define the article of manufacture, but the $3 million figure appears to be Seirus’s profits on all of its infringing sales.
At this point, it looks like both parties will appeal various aspects of the decision (after first filing post-verdict motions with the district court). Going back to Apple v. Samsung the case has been remanded back to Judge Koh who is considering party briefs on the article-of-manufacture issue and consequently. [AppleBrief][SamsungBrief]
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In a bit of wild civil procedure, the lawsuit here was originally filed in Oregon but jumped down to Southern California on September 1, 2017 — less than three weeks before the trial. The transfer was deemed appropriate under the TC Heartland case. The trick is that Oregon Judge Hernandez also had himself temporarily transferred to the S.D. Cal. so that he could continue hearing the case.
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Suppes v. Katti and Fender (Fed. Cir. 2017) (non-precedential)
I should probably be a bit careful writing about this case because of its closeness to home. Galen Suppes is a recently fired engineering professor from University of Missouri (my employer); Chris Fender is the director of our University Technology Transfer office, known here as the Office of Technology Management & Industry Relations and Katti is a professor of radiology and physics.
When it hired Suppes, the University (a wing of the State of Missouri) bound Suppes to an agreement that, inter alia, gave the University ownership and control over the filing of patents stemming from Suppes future inventions.
The University “shall have ownership and control of any Invention or Plant Variety developed in the course of the Employee’s service to the University.” University of Missouri Collected Rules and Regulations § 100.D.1.a.
The basis of Suppes lawsuit was that the University took control, but then failed to actually file patent applications on his inventions.
In the appeal, Suppes (acting pro se) presented some interesting arguments:
These were all rejected by the the district court, and that decision is affirmed on appeal (nonprecedential opinion).
One way to think about Suppes argument here is to consider the employment contract as a state law that applies to anyone who works for the state (at least this branch of the state). And, the state law says that the University (rather than the inventor) owns the inventions.
In discussing inventorship rights pre-patent-application, the Federal Circuit makes an interesting set of holdings. First, the court holds that the Constitution does not directly set any limit on inventorship rights. Rather, the Article I provision is simply an authorization to Congress to act:
The Constitution, standing alone, grants the power to Congress to “secur[e] for limited times to . . . inventors the exclusive right to their . . . discoveries.” Any rights Mr. Suppes has in his inventions are thus subject to Congress’s implementation of the Constitution by statute. 35 U.S.C. § 261 provides that “[a]pplications for patent, patents, or any interest therein, shall be assignable in law by an instrument in writing.”
Of course, Section 261 only directly applies to “applications,” “patents,” and “interest[s] therein.” A straightforward interpretation of the provision is that Section 261 says nothing about pre-application assignments. As such, pre-application assignment of rights falls back to state law. “The allocation of interests prior to the filing of a patent application is thus a matter of state contract law and is not preempted by the Patent Act.” Later, the court reiterates that no Federal public policy (such as preemption) would void the state contract:
The determination of whether a statute prohibiting the assignment of “inventive thoughts” would promote the Progress of Science is therefore, at least initially, allocated to Congress by the Constitution. To the extent that Mr. Suppes is arguing that the contract is void as a matter of public policy, that is once again a matter of state contract law.
In the end, Suppes easily loses this case, but it raises some interesting issues in my mind, including: (1) a tacit recognition that states could enact a set of pre-filing quasi-patent rights without those being preempted by Federal Law – perhaps as an expansion of state trade secrecy law; and (2) an implicit call for uniform law associated with ownership and transfer of pre-filing invention rights.
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Follow-up reading: Regents of University of New Mexico v. Knight, 321 F.3d 1111 (Fed. Cir. 2003).
Senator Orrin Hatch has been a deep participant in all major legislative patent reform initiatives for the past 35 years. In a recent update, Sen. Hatch lists upcoming issues for legislative patent reform:
Read more here: https://medium.com/@SenOrrinHatch/a-look-forward-on-patent-reform-288942e634f1
In its first action for the October 2017 term, the Supreme Court has (inter alia) denied Certiorari in three pending Patent Cases:
Of these, only Synposis was truly interesting. That case asked for a review of the law and procedure of the Abstract Idea inquiry under Section 101:
In Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014), the Court reaffirmed the two-part test for determining whether an invention is patent-eligible under 35 U.S.C. § 101: (1) whether the patent claims are directed to a patent ineligible concept, such as laws of nature, natural phenomena, or abstract ideas, and (2), if so, whether the elements of the claim contain an “inventive concept” that transforms the ineligible concept into an invention that is patent-eligible. Here, a panel of the Federal Circuit held that in determining whether a patent is directed to an abstract idea, a court must ignore the specification and evaluate only the express limitations in the claims. The panel further held that the accused patents failed the second step of Alice because the claims do not explicitly call for involvement of a computer and therefore could not be characterized as an improvement to computers. The questions presented are:
1. Whether the § 101 inquiry requires courts to ignore the specification, as the Federal Circuit held, or whether courts should ascertain the true scope of the claims in light of the specification and intrinsic record in determining whether they are drawn to a patent-ineligible concept.
2. Whether an otherwise revolutionary technological breakthrough is not an “inventive concept” under the second step of Alice merely because the court believed the breakthrough could theoretically be implemented without a computer.
In his case, Oleksy faced an uphill battle against an affirmance-without-opinion.
As with Utility Patents, Design Patents are also on the rise with a new fiscal year record for FY2017.
Shown below is an example patent issued last week to QUantcast covering their display screen icon. 