The big life sciences IP developments from October 2018
Cannabis patent war looming, claims report - With the rapid trend towards legalisation of recreational uses of cannabis in the United States, Canada and elsewhere, a new potentially-lucrative market is opening up in the food and drink sector. A recent report by patent analytics firm PatSnap, provided new insights into the global patent landscape for cannabis-related food and beverage product. Discussed here in more detail, it reveals a dearth of patent applications in areas of particular interest to food and beverage companies: Cannabinoid and terpene profiles, which provide the smell and taste of cannabis; and the methods of distilling those terpenes and introducing them into a product. As such, there are significant opportunities for innovators to acquire valuable assets in the space. But there are also dangers. The report’s author argues that rapid legalisation may lead to a flurry of applications in the space, resulting in a surge of cannabis-related patent conflicts.
“New NAFTA” stands to benefit pharmaceuticals innovators – IAM reported on the signing of the United States, Mexico and Canada Agreement (USMCA), the result of a tense renegotiation of the 1994 North American Free Trade Agreement (NAFTA) between the three countries. The deal contains a number of new IP provisions, including several which favour life sciences innovators. As reported by IAM, signatories have committed to introducing a minimum of 10 years’ regulatory data exclusivity for biologic drugs, whereas Mexico had previously offered no such protection to biologics and Canada had granted only eight years’ exclusivity. New formulation, indications and methods of administration may also receive enhanced protection under the agreement. Section 2(a) of Article 20.F.13 states that their clinical data is entitled to at least three years’ exclusivity. However, signatories have the option of introducing five years’ data exclusivity for products containing a New Chemical Entity not approved in that country. Furthermore, USMCA commits contracting parties to providing patent term extensions for “unreasonable delays” on the part of granting authorities, and stipulates that inventions derived from plants should be patentable.
Novartis IP policy chief tells IAM new WIPO database can answer patent system criticisms – Corey Salsberg, Novartis’ Head of Global IP Affairs, spoke to IAM about his company’s commitment to Pat-INFORMED, a new open-access patent database hosted by the World Intellectual Property Organisation in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations. Allowing easier access to information about worldwide patents in key treatment areas, the database will aid healthcare procurement decisions and benefit participating pharma innovators, whose rights are less likely to be infringed as a result. “The patent system has proven successful over hundreds of years for protecting, and spreading access to, inventions,” Salsberg explained. “We have spent a lot of time trying to educate consumers and governments about its value. And we believe this initiative is a really good illustration of how public and private sectors can work together to address some core challenges…Whatever we can do to help respond to some of (the) criticism, which in many cases is unwarranted, is something we want to do.”
EU generics criticise US for SPC manufacturing waiver interference – The United States government is seeking to influence European debates over the introduction of a supplementary protection certificate (SPC) manufacturing waiver, according to Medicines for Europe, which represents the continent’s generic drug companies. As IAM reported previously, The EU Commission introduced a legislative proposal in late-May to introduce a waiver allowing generic and biosimilar drug companies to manufacture SPC-protected products for export. This, it is argued by the executive, will allow European generics to create of large numbers of jobs in the development and manufacture of copycat drugs. But it would have adverse implications for branded pharmaceutical companies, including many headquartered in the US. The USPTO, US Department of Commerce and US Trade Representative held a meeting in Brussels on 23rd October as part of an attempt to dissuade EU officials from going forward with the proposed waiver. The generics industry representative said. “This is in line with consistent efforts from US commercial interests to close the US healthcare market to biosimilar medicines. Unfortunately, the organisers have no regard for transparency about the details of the meeting, the participants, nor the agenda.”
Trump signs law requiring FTC scrutiny of all biosimilar patent settlements – New legislation was implemented in the US, requiring otherwise confidential patent dispute settlements involving biologic drugs to be submitted to the Federal Trade Commission (FTC) in order to be reviewed for antitrust “pay-for-delay” infractions. While it has been mandated for settlements of small-molecule patent litigation to be reported to the FTC since 2003, biologics agreements had not been subject to the same requirement until last month. The change has been implemented as part of the Patient Right to Know Drug Prices Act, which also contains provisions banning pharmacy “gag clauses”. It comes in the wake of political controversy surrounding AbbVie’s recent patent settlements with producers of biosimilar versions of its best-selling arthritis treatment, Humira.
Quiet Q3 for biopharma acquisitions – Sluggish pharma M&A in the first half of 2018 has continued into the third quarter of the year, according industry analysts at Evaluate. There were only $6.6 billion worth of biopharma takeovers in July, August and September, the least in any three-month period since 2013, and the second lowest since 2010. Amy Brown and Edwin Elmhirst point out that none of the buyouts exceeded $1 billion in cash committed. As Brown told IAM following disappointing deal-making results in 2018’s first six months, the slow acquisition rate probably reflects the sky-high valuations of small and medium biotechs, which have been attracting record volumes of venture capital in recent months. However, some of the money not otherwise invested in acquisitions seems to be being funnelled into licensing deals, which increased year-on-year in the first half of 2018 from 61 to 72 agreements and from $3.17 billion to $3.42 billion in value.
CJEU ruling on SPCs is a blow for medical device innovators –Reviewing Boston Scientific’s attempts to register an SPC for its device-drug combination product Taxus, the Court of Justice of the European Union (CJEU) ruled that no products approved under the Medical Devices Directive qualify for a patent extension under the EU’s SPC regulation, even if they contain a medicinal substance that was required to undergo extensive safety and utility testing. Discussed in more detail in this IAM blog, the decision has strategic implications for inventors of future device-drug combinations whose R&D and regulatory decisions may determine whether their products qualify for lucrative IP term extensions in the future. It may also lead to calls for SPC regulation reforms, or the introduction of a new sui generis right, to compensate medical device inventors which are currently uncompensated for the often burdensome regulatory approval processes they must undergo.
SCOTUS invites Solicitor General’s input on Ariosa petition – It looks as though the US Supreme Court is taking a close look at a petition for a writ of certiorari made by Ariosa Diagnostics in its dispute with Illumina. Late last month, it invited the Solicitor General to file a brief expressing the country’s views on the matter. The case arises from a 2014 attempt by Ariosa to invalidate an Illumina gene-editing patent before the US patent office’s Patent Trail and Appeal Board (PTAB) on the grounds the patent’s claims are anticipated by those in a published application which contained in a provisional registration filed before Illumina’s patent. The board ruled that this published application did not constitute prior art – a finding upheld by the Federal Circuit in 2017 – because its claims were not supported by the earlier provisional filing. Ariosa is now asking the court to consider whether “unclaimed disclosures in a published patent application and an earlier application it relies on for priority enter the public domain and thus become prior art as of the earlier application’s filing date, or, as the Federal Circuit held, does the prior art date of the disclosures depend on whether the published application also claims subject matter from the earlier application?” It states that the Federal Circuit’s ruling conflicts with the Supreme Court’s 1926 Milburn decision, which held that “if a person files a patent application and does not abandon it, the disclosure in any patent that issues from that application qualifies as prior art as of the application’s filing date”. Supporting Ariosa’s petition, a group of IP law professors have claimed that the Federal Circuit’s decision develops patent law in a way that prevents public knowledge from qualifying as prior art and is less favourable to innovation.
Federal Circuit denies Saint Regis Mohawks a rehearing – The Saint Regis Mohawks have suffered another blow in their attempts to claim tribal immunity for their Restasis patents from administrative inter partes review validity challenges. The tribe acquired the patents in a deal with Allergan, under which the pharma company receives an exclusive licence for the assets in return for an upfront payment and ongoing royalty fees. The controversial agreement was aimed at exempting the patents from administrative validity challenges launched by Mylan by asserting the Mohawks’ sovereign immunity. However, the plan seems to have failed, with the PTAB rejecting the tribe’s claimed exemption, and the Federal Circuit ruling that tribal immunity protects tribes from lawsuits but “does not apply where the federal government acting through an agency engages in an investigative action or pursues an adjudicatory action”. On 22nd October, the Federal Circuit denied petitions for panel rehearing of the case and rehearing en banc.
Teva fails in efforts to restore Copaxone patents - The Federal Circuit upheld a district court decision to invalidate four of Teva’s patents relating to its best-selling multiple sclerosis treatment Copaxone. The appellate court found that the patent claims asserted in litigation against Sandoz, Amneal and Dr Reddy’s Laboratories had been correctly deemed obvious and therefore invalid. It agreed with the lower court that the use of 40mg 3x/week (rather than 20mg per day) doses of Copaxone – claimed by the patents in question – would have been obvious given that that dose was one of the two tested in the prior art and that researchers were pursuing less frequent dosing at the time of filing. The Federal Circuit rejected several Teva arguments, including that the district court had “narrow(ed) the universe” of possible GA regimens and relied on hindsight and one of Teva’s own studies to reach its obviousness conclusion; there was “ample evidence besides hindsight and the disclosures in GALA on which to find a thrice-weekly dosing regimen of 40mg GA obvious to try”, it ruled.
Federal Circuit upholds USPTO rejection of Forward Pharma challenge – The CAFC upheld a March 2017 ruling by the PTAB that Biogen’s patent claiming a treatment method relating to Tecfidera is valid. The patent had been challenged administratively by Forward Pharma, which claimed the asset interfered with its own patent application for the drug. It agreed with the PTAB’s finding that, while Forward Pharma’s application was filed earlier than Biogen’s, the former’s application does not adequately disclose the method in question. The decisions follow a February 2017 licensing agreement in which Biogen paid an upfront fee of $1.25 billion – with the return of €917 million to shareholders through a capital reduction in September 2017 – in return for the right to all of Forward Pharma’s relevant IP. However, success in interference proceedings would have entitled the Danish company to royalty payments under the terms of the deal. The dispute continues to be fought before the European Patent Office.
Supreme Court denies cert in Regeneron counsel misconduct dispute – The highest court in the US passed on the chance to review the cancellation of a Regeneron patent on the grounds of inequitable conduct. The patent, which pertained to a genetically modified mouse, was extinguished in 2014 litigation with Merus when a district court ruled that Regeneron’s trial lawyers had committed litigation misconduct by failing to produce certain non-privileged documents during discovery. This was later affirmed by majority decision by the CAFC. Appealing to the Supreme Court, Regeneron argued that the patent cancellation based on litigation misconduct of a rights holder’s trial counsel was contrary to Supreme Court and Federal Circuit precedent and raised constitutional concerns. Also, the precedent “threatens to place enormous burdens on nearly every major player in the patent system, and its effects could be felt in nearly every patent infringement suit across the country,” it stated.