The big life sciences IP developments in September

Market radar:

WIPO launches new medicines patent database – At the end of September, the World Intellectual Property Organisation launched an open-access database of patents on approved medicines around the world. Established in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Patent Information Initiative for Medicines (Pat-INFORMED) serves as one of the few resources that directly links patents to medicines, thereby helping procurement agencies to make better and quicker purchasing decisions. It also provides agencies with a direct means of communicating with 20 participating patent owners. At launch, Pat-INFORMED contained information on more than 14,000 patents for 600 patent families and 69 INNs. Thomas Cueni, Director General of IFPMA said: “This initiative is a practical way of reducing the complexity around access to patent information, something health experts have long been calling for. By easing access to patent information for public health authorities, Pat-INFORMED can help them take more informed decisions about procurement options available to them, and will be an important contribution to global health.”

‘No deal’ Brexit may mean no UPC, says UK government – The United Kingdom government released a notice on the likely implications for patents in the event of a ‘no deal’ Brexit. Relevant EU legislation, such as that relating to Supplementary Protection Certificates for drugs, compulsory licences and the patenting of biotechnology innovations, will be retained in UK law under the EU Withdrawal Act 2018 in such a scenario, it reassures rights holders. Such legislation will form the basis of an independent UK patent regime in which existing rights and licences will automatically remain in force. No such certainty is provided regarding the prospective Unified Patent Court (UPC), however. If the pan-European court is fully ratified, but the UK leaves the EU without a deal, the country would not necessarily be part of the UPC or the unitary patent system, the government admitted. However, any unitary patents that exist at the point of the UK’s departure will automatically give rise to patent protection within the UK.

District of Delaware loses Judge Sleet to retirement, but is back at full strength following new appointments – Senior Judge Sleet retired from the Federal District Court for the District of Delaware, having served on the court since 1998. Developments at the District of Delaware are of the utmost importance for those involved in patent disputes – especially in the pharmaceuticals field – because the court is by far the most popular venue for ANDA litigation; and in 2017 it extended its lead over other districts. Earlier this year, Lex Machina’s Owen Byrd expressed concern to IAM that Judge Sleet’s retirement, following the recent retirement of Judge Robinson, could put strain on the court’s ability to handle its large caseload, leaving it with only two judges. However, such a scenario was averted in August when the District of Delaware was able to fill its vacancies, appointing Colm F Connolly and Maryellen Noreika to its bench.

BIO supports bill to boost IP protection for small businesses – The Biotechnology Innovation Organisation (BIO) welcomed the passage of the Small Businesses Innovation Protection Act by the US House of Representatives and Senate. The Act seeks increased cooperation between the US patent office and the Small Business Administration as a means of boosting IP protection for SMEs. “Strong patents are the lifeblood of the biotechnology industry…Yet too often, small businesses lack the resources and know-how to protect their valuable IP assets,” commented BIO’s Tom DiLenge. “The vast majority of biotechnology companies are small and have no products on the market. Thus, their research and development activities are funded through massive amounts of private sector investment over many years, sometimes even decades. Without strong, predictable and enforceable protections for patented inventions, investors will shy away from investing in biotech innovation…I urge President Trump to act swiftly to sign this important legislation into law.”

Further data shows PTAB no “death squad” for pharma patents, despite rise in proceedings – A new study provided additional insights into the impact Patent Trial and Appeal Board (PTAB) proceedings have had on the pharma patent landscape since their introduction in 2012. While revealing that post-grant challenges have become increasingly popular with generic drug companies seeking to invalidate Orange Book patents, it confirmed an earlier study’s findings that – contrary to the fears of many rights owners – such patents have enjoyed a relatively good chance of surviving the PTAB. More significantly, The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents showed that the challenges have seldom been used - successfully or otherwise – against companies’ commercially-crucial active ingredient patents, and may have cleared the way for generic entry on only a handful of occasions. This further drags into doubt the infamous description of PTAB proceedings as “death squads” for patents – at least as it applies to pharmaceuticals rights.

Legal radar:

Broad Institute scores crucial CRISPR-Cas9 victory at federal circuit – The US Court of Appeals for the Federal Circuit handed down its much-anticipated decision in the widely-discussed CRISPR-Cas9 patent dispute between the Broad Institute and the University of California, Berkeley. Upholding the USPTO’s Patent Trial and Appeal Board’s ruling, it struck a major blow against the West Coast university by finding that the claims of its CRISPR-Cas9 patent application are not interfered with by the Broad’s core gene-editing rights, which cover separately patentable inventions. However, the dispute between the two innovators is set to continue, with administrative and district court proceedings still open to the University of California, and a slew of other CRISPR-Cas9 patent applications likely to give rise to further conflict.

Brazilian Supreme Court postpones decision on decade-old patent dispute – Life sciences companies in Brazil were made to wait even longer to learn the outcome of a long-standing constitutional challenge to articles 230 and 231 of the country’s patent law, which established a ‘pipeline patent’ mechanism in the mid-1990s. Without providing a reason or replacement date, the Supreme Court postponed its ruling in the decade-old case just one day before the scheduled announcement in early September. This prolongs uncertainty over a question whose outcome could have a significant impact on several infringement and damages actions relating to patents granted according to articles 230 and 231. It also highlights the slowness of the country’s highest court in dealing with key patent law questions.

CAFC majority upholds district court decision to invalidate four Acorda patents – Acorda Therapeutics failed to persuade the Court of Appeal for the Federal Circuit to overturn a district court decision to invalidate four of its patents for multiple sclerosis drug Ampyra. The patents were successfully challenged as obvious in ANDA litigation by Roxane Laboratories, Mylan and Teva. The Delaware district federal court invalidated the rights, finding inter alia that an Elan Corp patent, relating to the same product and licensed exclusively to Acorda was a “blocking patent” which accounted for Ampyra’s commercial success – success which therefore could not be used as evidence of non-obviousness. In its appeal, Acorda claimed that the court had erred in its interpretation of the “obvious to try” standard established by KSR International Co v Teleflex Inc, and the “blocking patent” doctrine articulated in Merck & Co v Teva Pharmaceuticals. The appeal was identified by former CAFC chief judge Paul Michel, writing for IAM, as one of 2018’s cases to watch, because of its potential to eliminate confusion surrounding the concept of obviousness, which is at the heart of many patent disputes. In a majority decision handed down at the start of September, the CAFC affirmed the lower court’s ruling, finding that a person skilled in the art would have had a reasonable expectation of success in achieving the claimed invention in light of the prior art. In doing so, it rejected Acorda’s main arguments, most notably that “the court improperly applied a categorical rule that a blocking patent (the Elan patent) negates any findings in favour of Acorda on the objective indicia of commercial success, failure of others, and long felt but unmet need”. But the ruling has certainly not settled debates surrounding the “blocking patent” doctrine, with Judge Newman dissenting vigorously from her colleagues’ decision, agreeing with Acorda’s contention that the Elan “blocking patent” was irrelevant to the question of  Ampyra’s commercial success.

Deal Watch:

Novartis sells hundreds of generic products as drive towards specialisation continues – Swiss pharma giant Novartis has agreed to sell upwards of 300 products from its Sandoz generic business to Aurobindo Pharma. The deal sees $900 million changing hands immediately, with a potential $100 million more to be paid by the India-based firm which is set to become the second biggest seller of prescription generics in the United States. The move follows Novartis’ recent sell-off of its eyecare business, Alcon, for as much as $25 billion, and the sale of its consumer healthcare unit, JV, for $13 billion. As such, the agreement is part of Novartis’ strategic approach of selling non-core assets in order to focus on key treatment areas, such as oncology.

Alexion pays $1.2 billion for Syntimmune - Alexion Pharmaceuticals agreed to purchased US biotech Syntimmune for what could add up to $1.2 billion: $400 million straight away with $800 million in possible milestone payments. The deal was driven by the desire to acquire SYNT001, a late-clinical-stage antibody, which may be used to treat rare autoimmune diseases.