Eli Lilly and Company v. Erfindergemeinschaft UroPep GbR, SCT Docket No. 18-1515 (Supreme Court 2019)
Lilly’s new petition for writ of certiorari asks an easy question:
Whether a single-step patent claim that describes its point of novelty solely in functional terms violates the rule against functional claiming set forth in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946).
The question as posed is easy to answer. Any patent claim that describes its point of novelty solely in functional terms is invalid violates the rule set forth in Halliburton. Of course, Halliburton was abrogated by the 1952 Patent Act with the adoption of what is now known as 35 U.S.C. 112(f):
Element in Claim for a Combination. — An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Note here that the 1952 patent act only discussed the treatment of functionally claimed elements in “a claim for a combination.” The real question here is whether Halliburton is still good law for “single-step patent claims.” I’m betting the Supreme Court would say yes — A claim with a single element would be invalid if that element was claimed solely in functional terms.
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The petition reads a bit like a mystery novel.
A few months [after Lilly obtained FDA approval to market tadalfil for BPH treatment], respondent—a shadowy non-practicing entity based in Germany—filed the patent application that ultimately became the patent at issue here,
claiming priority to an application from 1997.
Here, UroPep’s patent covers a one step method of treatment/prophylaxis claim for BPH. The one step is as follows:
administering to a person in need thereof an effective amount of an inhibitor of phosphodiesterase (PDE) V [excluding eight particular compounds].
Back in 1997, PDE V inhibitors where already known, and tadalafil in particular was known to be a PDE V inhibitor. The 1997 priority document mentions ten different PDE V compounds, but does not mention tadalafil, and the claim excludes eight of those ten.
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Lilly’s question presented includes an important and disputed presumption — that the claim “describes its point of novelty solely in functional terms.” In its decision, the district court held that the claimed step of administering a PDE V inhibitor was not wholly functional.
Even if means-plus-function analysis would apply to a product claim to “an inhibitor of PDE V,” it does not apply to a method claim reciting a method of administering that substance to a patient.
District Court Decision. The jury then awarded $20 million in damages. On appeal, the Federal Circuit affirmed without opinion (R.36) — setting up this current petition.
To be clear, the district court analysis here asks whether this fits under 112(6), not whether it comports with Halliburton. That case states that a claim which “describes [its] most crucial element … in terms of what it will do, rather than in terms of its own physical characteristics … is invalid as a violation of Rev.Stat. § 4888 [indefiniteness].” In General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938), the court similarly wrote invalidated claims where the inventor “uses conveniently functional language at the exact point of novelty.”
There are several ways that these cases could be applied here. Example: (A) Since PDE V inhibitors were already known, their existence was not the point of novelty. Rather, the point of novelty is administering those known drugs in order to treat a particular condition — and that “administering” portion of the claim was not described functionally. (B) Another way of thinking here is that the novelty of the claim is administering a particular drug — but we don’t know the details of that particular drug is because it is described functionally.
The knockout punch for farmer-controlled seed was the utility patent. In a landmark (and utterly bananas) decision in 1980, the Supreme Court ruled in favor of allowing patents on living organisms. It wasn’t long before the same protections were extended to crops. New advances in genetic engineering supported the argument, with companies claiming seeds as propriety inventions rather than part of our shared commons. Utility patents restricted farmers’ freedom to save and exchange seed and breeders’ right to use the germplasm for research. . . .
On his Oregon farm, Frank Morton produces 146 varieties of organic lettuce, 88 of which he created. His lettuces … are coveted by top chefs for their distinct colors, flavors, crispiness and butteriness. In three decades of breeding, he has never filed for a patent on his lettuce varieties, because he wants others to build on his work. “Patents are completely unethical. We all need access to traits. My varieties are probably being used to create new varieties right now. I love that.”
Plant Patents: This week, the USPTO issued a number of plant patents, which cover new varieties of asexually reproduced plants.
Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. 161. Like utility patents, plant patents last for 20 years from the filing date. Plant patents are examined under the same provisions as utility patents: patentable subject matter, utility, novelty, obviousness, and disclosure (35 U.S.C. 101, 102, 103, and 112) with a bit of leeway definiteness (like design patents, the claims are generally directed to the plant as “shown and described”).
It is a bit tricky here to understand how self-injury prior art works with plant patents. Most new varieties take several years to cultivate to ensure that the the variety is distinct through successive generations of asexual propagation. Growing of the crops (and presumably selling the fruit) would have the look of prior art on sale and public use activity (as well as being “otherwise available to the public).
Take PP30,551, covering a new apple variety that issued this past week. The patent states that the new variety was first observed in 2009 as a “spontaneous limb mutation” in an commercial orchard and then cultivated (by grafting) from 2011 until the application Australian priority filing date in 2016.
During examination, the examiner did require the applicant to provide any evidence that regarding the public nature of the invention from 2009-2011.
Going back up to the NYTimes article and the Lettuce farmer. There are no plant patents on lettuce because lettuce is sexually propagated. Lettuce can still be protected under the USDA administered Plant Variety Protection Act (PVPA) — also for 20 years. So far in 2019, the USDA has issued 222 PVPA certificates — 5 of which cover new varieties of lettuce. (Most of the new certificates have been issued to Monsanto).
The pending petition in Ariosa v. Illumina focuses on a narrow but important issue of prior-art status of a provisional patent application. Really, the question is: what is the “prior art date” of a provisional patent application?
Whether disclosures in a published application that refers back to an earlier filed provisional application are prior art as of the filing date of the provisional application.
The basic answer that we received from the Federal Circuit is “sometimes.” A provisional application will only count as “prior art” as of its filing date if the later published application (or issued patent) sufficiently supports all of the claims in the resulting non-provisional application as published (or issued patent).
This impacts a large number of US patents: Although I have not recently measured, I my expectation is that most non-provisional patent applications add some amount of new matter beyond their provisional priority documents. If that new information makes it into some of the claims — the result is that the provisional filing date will be immaterial with regard to prior art (under current Federal Circuit precedent).
CVSG: The petition for certiorari is well written, and the Supreme Court called for the views of the Solicitor General. The SG has now submitted his brief — joined by the USPTO — suggesting denial of cert.
In its brief, the US Gov’t argues that the Federal Circuit is totally wrong in its analysis, but that this case is not a good vehicle for reviewing its approach because petitioner’s argument is also mistaken.
The government brief follows my approach outlined in my 2015 Dynamic Drinkware post:
Anyone who works with prior art knows that this [priority requirement] setup is an oddball way to address the situation. A patent’s disclosure for prior art purposes should not depend upon what was claimed or not but instead should focus on what was disclosed. My belief is that, once publicly available, all provisional applications should be considered prior art as of their filing dates.
The government brief agrees that interpretation of proper priority claim under “119(e) has no bearing on the date on which a patent application qualifies as prior art under Section 102(e). There is no textual basis for using that provision’s priority rules to backdate patent applications sought to be relied on as prior art.”
Rather, the Government argues that, under the statute, all provisional applications count as prior art as of their filing dates once relied upon for priority by a published non-provisional application. According to the government brief, publication of the underlying application also lays-upon the file history and effectively publishes the provisional as well. Thus, at that point, the provisional counts as “‘an application * * * published under section 122(b)’ and therefore constitutes prior art as of its own filing date.”
The Government brief acknowledges that Section 122(b) states flatly that a provisional application “shall not be published.” Although this appears to contradict their statement that the PTO is publishing those applications, the Government brief argues that the statement only refers to provisional applications abandoned without being relied upon for priority.
Where, as here, a provisional application has been incorporated by reference into a later non-provisional application, the referenced provisional application effectively becomes part of the non-provisional application. Under those circumstances, the USPTO’s obligation to publish the non-provisional application encompasses the contents of the provisional application.
In its Brief, the Government explains that “the Federal Circuit has not directly addressed the question whether a provisional application may itself qualify as prior art under Section 102(e)(1), without recourse to Section 119(e).”
The brief here suggests a GVR (Grant-Vacate-Remand) order from the Supreme Court to address this particular issue on remand.
Interesting to read this particular brief for style. Although this is certainly a complicated area, the SG brief did not really attempt to simplify it in any way — perhaps to further discourage the Supreme Court from taking up the issue.
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Note here that this particular case focuses on “old” pre-AIA Section 102(e). Although the AIA substantially altered Section 102, I don’t believe that the alterations will change the outcome in this case. As such, the case is important.
The Senate today continues Day II of its hearings on Patent Eligibility. In all, the Senate is planning to hear from 45 witnesses — most of whom are arguing in favor of statutory reform that would tighten-up the law of eligibility.
Editor’s Note – Grant Harrison is a new Bits-and-Bytes author for Patently-O focusing on rising software law issues. Welcome Grant! – DC
by Grant Harrison
GNU Licensing: GNU licensing serves to keep software developed and maintained by open source developers free and open to the public. If an entity takes software that is licensed with a GNU and then they modify it, they must re-release the modified software back to the public.
MIT Licensing: MIT licensing for software is perhaps the most common permissive license due to the fact that it has very few restrictions on reuse as long as developers include the MIT license terms and copyright notice. If an entity takes open source software and then adds to it, they do not need to re-release their version of the software back to the public. The extreme permissiveness of MIT licensing means that we rarely see lawsuits arise.
DODOcase recently petitioned the Federal Circuit for en banc rehearing on patent licensing law. The petition raises two questions – paraphrased below:
Should a general forum selection clause (“disputes shall be litigated before . . . California [Courts]”) be interpreted to exclude AIA trials brought by the licensee?
What is the enforceability of a license term that prevents a licensee from filing an AIA trial petition (inter partes review of post grant review).
For its part, the Federal Circuit opinion held that the generic forum selection clause did indeed prevent an AIA petition brought by the licensee and assumed that the clause was enforceable – not even considering the impact of Lear.
Two groups have now filed amicus briefs supporting the petition.
Law Professors: A group of 21 law professors signed-on to a brief drafted by Stanford’s IP Clinic run by Phillip Mallone. The brief explains that Lear, Inc. v. Adkins, 395 U.S. 653 (1969), should apply with equal strength (if not more) to contracts barring AIA Trial Challenges by the licensee.
The panel’s sweeping elevation of boilerplate forum selection clause language is contrary to Congress’s clear intent to allow and even facilitate licensee validity challenges before the PTAB. Lear requires courts to consider the exceptionally important patent policy interests in validity challenges. Because the panel failed to engage in any such consideration and ignored binding precedent, this Court should grant rehearing to correct the error.
An industry brief was also filed by a group of companies, including SAS, Vizio, Zilinix, and Garmin as well as the Consumer Electronics Ass’n and Engine. This brief argues that the federal circuit misinterpreted the contract — arguing that boilerplate forum selection clauses pre-AIA licenses should not be interpreted to limit AIA trials. The Brief also explains that the licensing parties already knew and understood at the time of drafting that the terms restricting validity challenges by the licensee were not enforceable.
Allen v. Cooper representing North Carolina (Supreme Court 2019)
The Supreme Court has granted certiorari in a sovereign immunity copyright case.
Issue Presented: Whether Congress validly abrogated state sovereign immunity via the Copyright Remedy Clarification Act in providing remedies for authors of original expression whose federal copyrights are infringed by states.
Issue Restated in Opposition: The Copyright Remedy Clarification Act purports to abrogate the states’ sovereign immunity for alleged violations of federal copyright law. Did the Court of Appeals correctly hold that the Copyright Remedy Act’s abrogation of state sovereign immunity was invalid?
The case has a few interesting parts. First off, the underlying issue stems from the discovery of the Blackbeard’s Pirate Ship Queen Anne’s Revenge off the North Carolina Shore where it sank in 1718. Intersal found the wreckage and hired Allen to document the salvage operation. Allen registered the copyrighted works. Later, the State of North Carolina uploaded the videos online without Allen’s permission. In order to insulate itself from infringement liability, the state passed Blackbeard’s Law,” which purported to place the uploaded videos in the public domain. (It’s not piracy if legal).
Allen then sued the State for copyright infringement — naming various individuals in their official elected capacity, including ROY A. COOPER, III, as Governor of North Carolina. The question in the case – is whether the State can be sued for copyright infringement.
On one hand is the U.S. Constitution — 11th Amendment to the U.S. Constitution seems quite clear – the Federal Courts have no power over “any suit … against one of the United States” brought by “citizens of another State.”
The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.
At the same time, Congress attempted to expressly “abrogate” this immunity in the Copyright Remedy Clarification Act with the following language:
Any State, any instrumentality of a State, and any officer or employee of a State or instrumentality of a State acting in his or her official capacity, shall not be immune, under the Eleventh Amendment of the Constitution of the United States or under any other doctrine of sovereign immunity, from suit in Federal court by any person . . . for a violation of any of the exclusive rights of a copyright owner provided by [federal copyright law].
Here the statute is clear in its attempt to contravene the 11th Amendment. The only problem through is that statutes are ordinarily subject to the U.S. Constitution, not vice-versa. The reality though is more complicated – at times the courts have permitted suits against states and have allowed Congress to abrogate state sovereign immunity by statute.
The basic test was spelled out in Seminole Tribe v. Fla., 517 U.S. 44 (1996):
Was the Act in question passed pursuant to a constitutional provision granting Congress the power to abrogate?
In its decision here, the 4th Circuit held that, although Congress does have power to create a copyright regime, it does not have power to abrogate state sovereign immunity for copyright infringement. I’ll say that there is a good chance that the court will side with Allen against the State — holding that Congress has power to abrogate here because of the need for a “carefully crafted copyright regime.”
Trademark regulations require that the lawyer sign — even type in the electronic signature — all documents. A lawyer had been letting non-practitioner legal assistants sign various documents. She realized that this was improper, but waited several months before doing anything. As a result, she was publicly reprimanded and placed on a year’s probation. The decision in In re Sapp is here.
In addition to being a reminder about signature requirements, I wonder if this is the way the Office will get at the various TM filings that have made the news lately…
