Sunday, March 24, 2019

Thursday, February 21, 2019


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Union ("WCU" or "IUCN") 50-years-without-a-sighting threshold for extinction offer any comfort, for it has been superseded by a new standard whereby a taxon may be considered extinction if "there is no reasonable doubt that the last individual has died."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.

Tuesday, January 22, 2019

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.

Monday, October 1, 2018

Life Is Short, Art Is Long, But IP Is Longer

The full text of the inartfully-named United States-Mexico-Canada Agreement ("USMCA?") on North American trade was released on October 1, 2018.  It betrays considerable tinkering with the intellectual property provisions of the existing North American Free Trade Agreement ("NAFTA"), along with several substantial changes.

Perhaps the two most important of the latter are those extending the minimum terms of data exclusivity for biologics to 10 years (USMCA Article 20.F.14(1)) and increasing minimum copyright term to life of the natural person author plus 70 years (USMCA Article 20.H.7(a)).  While not altering already-lengthy U.S. term-lengths, Canadian ones for will have to be lengthened substantially, by 25% for data exclusivity and 20 years for copyright term.

Intellectual property owners will be happy.  Advocates of free innovation will not be.  However, by lengthening terms, USMCA is merely conforming to a general global pattern of statutory strengthening of intellectual property.

Monday, April 16, 2018

Kiwi Credibility

My colleague and coauthor, Bill Tomlinson, a professor at the Victoria University of Wellington Business School/Orauariki, New Zealand/Aotearoa, alerted me to the fact that our 2009 article, Patents and the Regress of Useful Arts, has been tabled by the Commerce Committee of the New Zealand Parliament/Pāremata Aotearoa (see here) and featured as an informational resource on the "Forum" page of The Pirate Party of New Zealand (see here).

Thursday, January 11, 2018

The Cas Against CRISPR

The realization that some diseases have genetic etiologies long inspired the hope that "correcting" mutant DNA sequences in patients could cure their diseases.  Recent progress in gene therapy has made this tantalizing possibility seem achievable, and precise and efficient gene editing methods using tools like CRISPR-Cas9 have accelerated progress considerably.  However, an important preprint article, entitled "Identification of Pre-Existing Adaptive Immunity to Cas9 Proteins in Humans", published by Charlesworth et al. on bioRχiv, has now cast a shadow on the efficacy of CRISPR-Cas9 in humans.  The Matt Porteus' research team, based at Stanford Medical School, appear to have discovered an immune response to CRISPR-Cas9:
The most widely used homologs of the Cas9 protein are derived from the bacteria Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes). Based on the fact that these two bacterial species cause infections in the human population at high frequencies, we looked for the presence of pre-existing adaptive immune responses to their respective Cas9 homologs, SaCas9 (S. aureus homolog of Cas9) and SpCas9 (S. pyogenes homolog of Cas9)...[Our results] demonstrate[s] that there are pre-existing humoral and cell-mediated adaptive immune responses to Cas9 in humans, a factor which must be taken into account as the CRISPR-Cas9 system moves forward into clinical trials. [Italics added for Linnaean emphasis.]
If humans, and, presumably, other mammals, possess potent immune responses to the Cas protein component of this powerful gene editing system, the therapeutic prospects for CRISPR-Cas9 may dim considerably beyond applications in isolated cells or tissues or patients having immature or suppressed immune responses.  After many more than two steps forward, therapeutic gene editing may be about to take at least one substantial step backward.

Sunday, December 31, 2017

A New Gene Therapy Vision

Vertebrates see by converting photons into electrical signals in the retina, which, in turn are interpreted by the brain into visual depictions of the environment.  Part of this phototransduction system relies on an enzyme called retinoid isomerohydrolase (or retinal pigment epithelium-specific 65 kDa protein ("RPE65")) to convert all-trans-retinyl esters into 11-cis-retinol in the smooth endoplasmic reticulum.  Healthy functioning of retinal pigment epithelium ("RPE"), a thin layer of cells that nurtures the retina, can become impaired when both RPE65 genes contain mutations that prevent normal enzymatic function.  In patients with Confirmed Biallelic RPE65 Mutation-associated Retinal Dystrophy, this can lead to poor vision or even blindness.

The Food and Drug Adminstration ("FDA") announced, on December 19, 2017, its approval of a gene therapy method developed to improve, or even restore, healthy RPE65 enzyme function by introducing wild-type copies of RPE65 genes directly into RPE tissue.  The method involves surgical delivery of RPE65 genes incorporated into adeno-associated viruses.  Spark Therapeutics, the company marketing this gene therapy, calls its "drug" voretigene neparvovec-rzyl (brand-named LUXTURNA).

As the FDA announced, LUXTURNA "is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene."  In the FDA press release, FDA Commissioner, Scott Gottlieb, waxed enthusiastic, suggesting that
this milestone reinforces the potential of this breakthrough approach in treating a wide-range of challenging diseases. The culmination of decades of research has resulted in three gene therapy approvals this year for patients with serious and rare diseases. I believe gene therapy will become a mainstay in treating, and maybe curing, many of our most devastating and intractable illnesses[.]
After previous fatal missteps (e.g., see here), gene therapy is finally seeing the light of day.