Broad Wins, Sovereignty Loses, and Patents Dance

My brilliant colleague, Dr. Kevin E. Noonan, partner at the law firm of McDonnell Boehnen Hulbert & Berghoff LLP, and a creator and author of the leading biotechnology patent law blog, Patent Docs, and I are happy to announce the publication of our summary of important 2018 patent law decisions.  Many thanks to the staff and faculty supervisors of the Akron Law Review for shepherding our article, entitled Biotechnology Patent Law Top Ten of 2018 - Broad Wins, Sovereignty Loses, and Patents Dance, into print.  A free PDF of our article is available for download here.

Awarding Scholarly Laurels

Here is a video of the 2019 University Scholarly Achievement Award ceremony.

Seven Words You Can Trademark

In Class Clown, his 1972 comedy album, George Carlin pilloried governmental restrictions that led to "Seven Words You Can Never Say On Television."  On June 24, 2019, the United States Supreme Court ("Supremes") joined Carlin's critical chorus, holding that

The Lanham Act’s prohibition on registration of “immoral[ ] or scandalous” trademarks violates the First Amendment.

Although the Supremes are often unanimous in their decisions concerning intellectual property law, in this case only five justices unequivocally supported the decision, with the rest filing concurrences or dissents.  The decision, Iancu v. Brunetti, suggests that 15 U.S.C. §1052(a) of the Lanham Act, engages in viewpoint discrimination by allowing registration of words other than those the statute proscribes as "immoral" or "scandalous".  In doing so, it violates the First Amendment of the United States Constitution.  This may be enough to make those who oppose registration of rude words by an official government agency -  the United States Patent & Trademark Office - swear out loud.

Sum Law And Math

Rhys Dipshan published a good article on legaltech and quantitative legal analysis in Legaltech news on May 6, 2019.  I was delighted to speak to him for his article.

Bye, Bye, Biodiversity

The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services ("IPBES") "is an independent intergovernmental body, established by member States in 2012 [whose purpose is] to strengthen the science-policy interface for biodiversity and ecosystem services for the conservation and sustainable use of biodiversity, long-term human well-being and sustainable development."  The IPBES released several documents on May 6, 2019, in advance of its ~1500-page Global Assessment report, anticipated to be published later in 2019.

Here are the top-level "Key messages" reproduced from the IPBES' Summary for Policymakers:

A. Nature and its vital contributions to people, which together embody biodiversity and ecosystem functions and services, are deteriorating worldwide (page 2)

B. Direct and indirect drivers of change have accelerated during the past 50 years (page 3) 

C. Goals for conserving and sustainably using nature and achieving sustainability cannot be met by current trajectories, and goals for 2030 and beyond may only be achieved through transformative changes across economic, social, political and technological factors (page 5)

D. Nature can be conserved, restored and used sustainably while simultaneously meeting other global societal goals through urgent and concerted efforts fostering transformative change (page 7)

A striking, but unsurprising, statement in the Summary for Policymakers is that "Biodiversity – the diversity within species, between species and of ecosystems – is declining faster than at any time in human history" (page 2).  The IPBES estimates that, based on this "most comprehensive assessment of its kind", it has concluded that "Nature is declining at rates unprecedented in human history", with approximately "1,000,000 species threatened with extinction".

Although the IPBES suggests it is not too late for humanity to "make a difference", precise details about how to make a difference, and what exactly the difference might be, will not be available until the full report is released later this year.

Rick Steves - Copyleftist

The Sunday, March 24, 2019, New York Times Magazine had a fascinating article, entitled "Rick Steves Wants to Save the World, One Vacation at a Time", about the travel writer's business empire as well as his philosophy of life, the universe, and everything.  Especially fun was a passage in the article describing a copyleftish provision in his first travel book, Europe Through the Back Door: "Anyone caught reprinting any material herein for any purpose whatsoever will be thanked profusely".  At quick check of my bookshelf confirms that his current books (sample size n=1) assert more traditional copyright protections, complete with "All Rights Reserved."

When Patients Become Innovators

My dear colleagues, Harry DeMonaco (MIT Sloan School of Management), Pedro Oliveira (Copenhagen Business School), Christiana von Hippel (UC Berkeley School of Public Health), and Eric von Hippel (MIT Sloan School of Management), and I published an article entitled "When Patients Become Innovators" in the Spring 2019 issue of the MIT Sloan Management Review.  The article is available for free download here.

Melomysing

Australian mice are dear to my heart.  My doctoral dissertation described a molecular phylogeny of murids (that is, mice and rats) native to Australasia, and offered evidence for several scenarios about how these cute, charismatic, carving-knife-toothed critters might have spread throughout the region and its diverse ecological niches.

So, it was sad to read that the Australian Minister for the Environment, the Honourable Melissa Price, had changed the conservation status of the Bramble Cay Melomys (Melomys rubicula) "from the Endangered Category to Extinct Category".  A 2016 report had already declared this murid extinct on its tiny four-hectare island in the Torres Strait.  But, its official downgrading in governmental status likely ends further conservation efforts.

Nor can the World Conservation Union ("WCU" or "IUCN") 50-years-without-a-sighting threshold for extinction offer any comfort, for it has been superseded by a new standard whereby a taxon may be considered extinction if "there is no reasonable doubt that the last individual has died."

So, barring rediscovery or deextinction, Bramble Cay will be mouseless.

Highway To Helsinn

Today (January 22, 2019), the United States Supreme Court published its decision in the patent law case Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al. ("Helsinn v. Teva"). At issue was whether, under the Leahy-Smith America Invents Act of 2011, a commercial sale of an invention to a third party legally bound to keep the invention confidential triggers the on sale bar of 35 U.S.C. §102(a).  The Supremes unanimously held it could in an opinion written by Justice Clarence Thomas.
Justice Thomas summarized the case as follows:

Petitioner Helsinn Healthcare S. A. makes a treatment for chemotherapy-induced nausea and vomiting using the chemical palonosetron.  While Helsinn was developing its palonosetron product, it entered into two agreements with another company granting that company the right to distribute, promote, market, and sell a 0.25 mg dose of palonosetron in the United States.  The agreements required that the company keep confidential any proprietary information received under the agreements.  Nearly two years later, in January 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron.  Over the next 10 years, Helsinn filed four patent applications that claimed priority to the January 2003 date.  Relevant here, Helsinn filed its fourth patent application in 2013.  That patent (the ’219 patent) covers a fixed dose of 0.25 mg of palonosetron in a 5 ml solution and is covered by the Leahy-Smith America Invents Act (AIA). 

In 2011, respondents Teva Pharmaceutical Industries, Ltd., and Teva Pharmaceuticals USA, Inc. (collectively Teva), sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued Teva for infringing its patents, including the ’219 patent.  Teva countered that the ’219 patent was invalid under the “on sale” provision of the AIA—which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U. S. C. §102(a)(1)—because the 0.25 mg dose was “on sale” more than one year before Helsinn filed the provisional patent application in 2003.  The District Court held that the AIA’s “on sale” provision did not apply because the public disclosure of the agreements did not disclose the 0.25 mg dose.  The Federal Circuit reversed, holding that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the terms of the sale agreements.

Here is Justice Thomas' summary of the Supremes' decision:

Held: A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under §102(a).  The patent statute in force immediately before the AIA included an on-sale bar.  This Court’s precedent interpreting that provision supports the view that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art.  See, e.g., Pfaff v. Wells Electronics, Inc., 525 U. S. 55, 67.  The Federal Circuit had made explicit what was implicit in this Court’s pre-AIA precedent, holding that “secret sales” could invalidate a patent. Special Devices, Inc. v. OEA, Inc., 270 F. 3d 1353, 1357.  Given this settled pre-AIA precedent, the Court applies the presumption that when Congress reenacted the same “on sale” language in the AIA, it adopted the earlier judicial construction of that phrase.  The addition of the catchall phrase “or otherwise available to the public” is not enough of a change for the Court to conclude that Congress intended to alter the meaning of “on sale.” Paroline v. United States, 572 U. S. 434, and Federal Maritime Comm’n v. Seatrain Lines, Inc., 411 U. S. 726, distinguished. Pp. 5–9. 855 F. 3d 1356, affirmed.

A lingering question is how the Court of Appeals for the Federal Circuit's Special Devices, Inc. v. OEA, Inc. (Federal Circuit 2001) ("Special Devices v. OEA") decision is now to be interpreted in light of both The Medicines Co. v. Hospira Inc. (Federal Circuit en banc 2016), which addressed stockpiling by a manufacturer, on behalf of a patent owner, of the claimed invention, and Helsinn v. Teva, which appears to have cited Special Devices v. OEA with approval.  Since the Supremes are unlikely to dive this deeply into the details of §102(a), it will be interesting to see how the Federal Circuit unravels this doctrinal knot.