Next week, the House of Representatives plans to vote on a bill that would effectively decriminalize and deschedule cannabis, marking only the second time in over 50 years that a chamber of Congress has voted to reclassify cannabis from its existing status as a federally prohibited substance. What can we expect as far as timetables and anticipated […]
Alt Finance: Sex for loans. Not really Fintech is it? The UK’s Centre for Social Justice a centre-right think tank has published a paper suggesting that approximately 2.4% of the population or 1.08 million people had admitted to borrowing money from “ someone locally who charged interest” outside of the regulated finance sector and nearly […]
Mysteries and action will turn your world upside down this weekend in Free Play Days. Lost Judgment, Before We Leave, and Far Cry 6 are all available this weekend for Xbox Live Gold and Xbox Game Pass Ultimate members to play from Thursday, March 24 at 12:01 a.m. PST until Sunday, March 27 at 11:59 […]
Federal Reserve Chairman Jerome Powell emphasized on Wednesday that technology transformation is here to stay in the financial sector and that new regulations will be required. Powell revealed some insight into how the United States would govern the market during a presentation at the Bank of International Settlements Innovation Summit on central bank digital currencies. The digital age was not taken into consideration when establishing our current regulatory structures, the Fed official said. “There will be revisions to current laws and regulations, as well as the creation of wholly new rules and structure, if central banks, stablecoins, and digital currencies are to be implemented,” he said during a roundtable discussion on CBDCs at the BISI Summit. Is There A Threat? Powell noted that emerging forms of digital money, like cryptocurrencies and stablecoins, pose threats to the US financial system and will necessitate the adoption of additional consumer protection measures. Powell reaffirmed his position that cryptocurrency should adhere to the “same activity, same regulation” premise. He proposed regulating stablecoin issuers, such as banks, in October 2021. “Stablecoins function similarly to money market funds. They’re similar to bank deposits… and it is reasonable for them to be controlled similarly, same activity, same regulation,” he concluded. Powell Says DeFi Can Improve Finance Sector Despite this, the Fed chairman acknowledged that distributed technology and DeFi have the potential to improve the payment system’s efficiency and foster a more competitive financial sector. This is an impressive recognition from the director of one of the country’s premier financial institutions. Other agencies and their personnel have embraced crypto and blockchain technology as well, albeit they all appear to advocate for some level of regulation. Crypto total market cap at $1.94 trillion on the daily chart | Source: TradingView.com Suggested Reading | Fiat – Not Crypto – Still The Top Choice For Financial Crimes, US Treasury Says Stablecoins are a type of cryptocurrency that are typically backed by the dollar or a commodity such as precious metal. CBDCs are digital representations of dollars or other fiat currencies that governments issue. The Fed is exdigital currencies but has not yet decided whether to issue them. In January, it published a study on stablecoins. Biden’s Executive Order US President Joe Biden signed an executive order earlier this month directing the Treasury Department and other federal agencies to conduct a study on the impact of cryptocurrency on economic stability and national security. Biden’s directive comes as many Democratic legislators, notably Massachusetts’ Elizabeth Warren, have expressed worry that cryptocurrency could be used to circumvent US sanctions against Russia. As part of the executive mandate, the Treasury is leading a report on a CBDC in consultation with the Departments of Justice, Commerce, and State, as well as the Office of Management and Budget, Homeland Security, and the Director of National Intelligence, to determine whether the US should pursue a digital dollar. Suggested Reading | Bitcoin Breaks Past The $40,000 Barrier Again – Can It Sustain The Momentum? Featured image from CryptoSlate, chart from TradingView.com
On 18 March 2022, the Full Court of the Federal Court of Australia issued decisions relating to term extensions of patents covering pharmaceutical products: Commissioner of Patents v Ono Pharmaceutical Co. Ltd FCAFC 39 (‘Ono’); and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd FCAFC 40 (‘MSD’). The two decisions have (at least) three things in common. First, both were decided unanimously by a panel comprising Chief Justice Alsop and Justices Yates and Burley. Second, both found against the patentee, with the court reversing the primary judge’s decision in Ono granting an extension of term, and confirming the primary judge’s decision in MSD nullifying a previously granted extension of term. And, third, both referred to the principle set out in the objects clause (section 2A) of the Patents Act 1990 that ‘the patent system balances over time the interests of producers, owners and users of technology and the public’ (emphasis added).
The scheme for extending the term of pharmaceutical patents inherently involves a balancing act. Its primary purpose is to ensure that patentees are not excessively disadvantaged by delays in securing regulatory approval to market patented products. For example, if a drug is not approved for use until 10 years or more after a patent application is filed, the patentee may have less than half of the standard 20 year patent term remaining to compensate for its investment in discovery and development before becoming exposed to generic competition. On the other hand, an extended period without competition necessarily exposes the wider public to higher costs of medical treatment. In an effort to balance these competing interests, the relatively complex provisions of the Patents Act aim to ensure that a ‘typical’ pharmaceutical patentee benefits from up to 15 years of exclusivity, by granting extensions of the patent term of up to five years, i.e. to a maximum of 25 years from filing. (A 2013 review of pharmaceuticals patents – which the government initially declined to release – found that 53% of such patents have an effective life of 15 years, while 89% have an effective life of over 10 years.)
The primary provisions of the Patents Act governing extensions of patent term are:
section 70, which sets out the conditions that must be satisfied before a patentee can apply for an extension of the term of its patent;
section 71, which sets time limits for filing of applications for extensions of term; and
section 77, which specifies how the duration of an extension of term is to be calculated.
In each of Ono and MSD, the patentee sought to obtain an advantage, or avoid disadvantage, by arguing for beneficial interpretations of the extension of term provisions. In each case they failed. And in both cases the Full Court upheld the principle that the purpose of the extension of term scheme is to balance the competing interests of the patentee of a pharmaceutical substance against the public interest in the unrestricted use of the pharmaceutical invention after expiry of the patent. In Ono, in particular, the Full Court rejected the proposition that sections 70, 71, and 77 should be construed to achieve a commercial outcome for the patentee. In MSD the Full Court again invoked the principle of ‘balance’ in declining to permit an extension of term based on a later Australian marketing approval, in circumstances where the patentee had already obtained the benefit of an ‘export only’ approval of a substance falling within its patent claims with an effective life of over 15 years.
The relevance of the Full Court’s focus on balancing of interests, and its references to the objects clause, could extend beyond these cases. The three judges here are all among the five who recently heard the appeal in the Thaler ‘AI inventor’ case, in which the competing interests of developers and owners of ‘invention machines’, and of the broader public (who might not see the same benefit in granting patent monopolies on automatically-generated inventions), are potentially at stake. It will be interesting to see whether they adopt a similar approach to weighing up the balance of interests in that case, also.