Canada’s drug pricing plan prompts backlash

The final version of guidelines issued by Canada’s federal drug price regulator has caused uproar among the pharma industry.

The guidelines, which will come into force on January 1, 2021, provide for a “risk-based approach to regulating ceiling prices for patented pharmaceuticals” and change the list of countries with which the Patented Medicine Prices Review Board (PMPRB) compares domestic prices.

Under the new rules, the PMPRB will compare Canadian list prices to prices in Australia, Belgium, Japan, Netherlands, Norway, Spain, the UK, Sweden, France, the UK and Italy.

Several life sciences associations immediately criticised the guidelines, saying patients will be denied access to treatments.

Judicial review

Innovative Medicines Canada (IMC), an association that represents drugmakers in Canada, said that it has raised concerns about the negative impact that PMPRB’s amendments to the Patented Medicines Guidelines and Regulations will have on Canadian patients for the last five years.

“The final guidelines released today do nothing to relieve those concerns. If implemented, they will have a negative impact on Canadian patients,” said IMC.

It added: “Specifically, innovative new medicines will not launch in Canada, depriving patients of potentially life-changing new treatments; we will see further reductions in the number of clinical trials in this country; and our life sciences sector will lose out on critical investments.”

In 2019, IMC and 16 of its member companies had filed an application for a judicial review of the plan, claiming that the federal government doesn’t have authority to “fundamentally alter” the role of the PMPRB through the recent changes to the Patented Medicines Regulations.

The government had proposed three main amendments to the Regulations in August 2019: new mandatory economic factors for the PMPRB to use in determining whether a price is “excessive”; a replacement of the basket of comparator countries (removing the US from the comparison); and a requirement that the selling price reported to the PMPRB take into account rebates provided by the manufacturer.

In June 2020, the Federal Court of Canada ruled on the application, finding that the government’s amendments relating to use of economic factors in price assessments and the reconstitution of the basket of countries was within its broad regulation-making authority.

However, the court did strike out the provision on reporting of rebates, finding that it was beyond the scope of the government’s regulation-making authority.

The original implementation date (July 1, 2020) was also delayed to January 1, 2021.

“The federal government knows the new regulations are a regulatory barrier.” Life Sciences Ontario

Calls for a revisit

According to the Canadian Forum for Rare Disease Innovators (RAREi), Canadian rare disease patients are worse off because of the new price controls.

Bob McLay, chair of RAREi, said: “These changes run directly counter to the federal government throne speech commitment to pursue a national rare disease strategy. They have a disproportionate impact on the most vulnerable people in society.”

Members of RAREi, which is a group of the Canadian operations of global biopharmaceutical companies with a specific focus on treatments for rare diseases, include Biogen Canada, Horizon Therapeutics Canada and Sanofi Genzyme.

Not-for-profit organisation Life Sciences Ontario warned that the new guidelines create a “highly risky and uncertain pathway for commercialising new medicines and vaccines in Canada”.

“The federal government is also exempting COVID-19 vaccines and therapeutics from the new pricing regime, demonstrating that the federal government knows the new regulations are a regulatory barrier, despite their dozens of claims over the past three years to the contrary,” said Life Sciences Ontario.

All of the associations have called on the federal government to revisit its new price controls.

“In the meantime, we will continue to ask that Health Canada delay the January 1, 2021 implementation of the final PMPRB guidelines until after the COVID-19 crisis is passed,” said IMC.

Image: / vepar5


Regeneron sued over antibody protein used to treat Trump’s COVID-19 symptoms

Regeneron Pharmaceuticals is facing claims that its “antibody cocktail”, which was administered to President Donald Trump to treat his COVID-19 symptoms, was developed with the unauthorised use of a fluorescent protein.

Allele Biotechnology and Pharmaceuticals sued Regeneron at the US District Court of the Southern District of New York on October 5 alleging that Regeneron did not have permission to use its mNeonGreen protein. It is also seeking royalties for the use of the protein in Regeneron’s development of the experimental treatment to combat COVID-19.

The company filed a separate federal lawsuit in San Diego against Pfizer and BioNTech SE, accusing the companies of using the same protein without its authorisation.

The disputed fluorescent protein works by being injected into cells so researchers can monitor and evaluate how a virus reacts to an antibody. According to Allele, the patent for mNeonGreen, issued in March 2019, has been referred to by scientific journals as the “gold standard” for testing the efficacy of antibody and vaccine candidates.

“Early studies indicate Regeneron’s treatment, which Trump received on October 2, may help suppress the virus.”

According to Allele’s founder, chief executive Jiwu Wang, mNeonGreen is so bright when used in testing that the camera can detect changes in a split second, which enables researchers to look at different antibodies to see which works best in less time. The fluorescent protein was developed without funding from the federal government and most of its licences are academic and non-transferable, Wang added in a statement.

Allele said it reached out to Regeneron on many occasions to negotiate a licence but received no reply.

According to a report in Bloomberg, Regeneron surged as much as 9.8% in New York trading following news that Trump had received the treatment. Early studies indicate Regeneron’s treatment, which Trump received on October 2, may help suppress the virus.

Further commenting on the suits, Wang said: “I am pleased that mNeonGreen has played a pivotal role in the fight against COVID-19. In no way does Allele want to prohibit, or slow down development of vaccines or therapeutics discovered using this technology.

“Our goal is to have these companies recognise, as many others have before them, the hard work that went into developing this technology and to respect our IP.”

Image: / Corona Borealis Studio


Teva withdraws Shield patent oppositions

Israeli generics company Teva has withdrawn its oppositions to two patents owned by Shield Therapeutics before the European Patent Office (EPO).

Shield, a pharmaceutical company which focuses on iron deficiency products, announced the withdrawals on October 19.

Teva has withdrawn its appeal against the EPO’s decision with regard to Shield’s patent number 2,668,175, which covers a “Process for preparing an iron hydroxypyrone”, and its opposition with regard to Shield’s patent number 3,160,951 which covers “Crystalline forms of ferric maltol”.

The withdrawal of the ‘175 appeal means that the April 2019 decision of EPO’s Opposition Division will become final, and the patent will be maintained as amended in March 2019.

“The patent will be maintained as amended in March 2019.”

The EPO has now confirmed that it has no cause to continue the ‘951 proceedings of its own motion and has cancelled the hearing. The patent is maintained as granted and will continue to provide protection through to October 2035.

Lucy Huntington-Bailey, Shield’s general counsel, said: “We are delighted that the EPO has decided not to continue proceedings following the withdrawal of the opposition by Teva and saw no reason to amend the patent as originally granted.

“This publicly demonstrates the validity of the patent and the strength of the defence that Shield provided to robustly defend its patents.”



Abbott sues ex-employee over COVID-19 tests

Abbott Laboratories has asked an Illinois court to stop a former employee using its name and trademarks to sell COVID-19 diagnostic tests.

Abbott, in a suit filed on October 20 at the US District Court for the Northern District of Illinois, alleged that its ex-employee was fraudulently claiming that he is still employed by the company to sell diagnostic test and testing equipment.

The former sales representative was reportedly fired in April for falsifying expense records. According to Abbott, he was also secretly working for another company at the same time.

He has “refused to return his Abbott-issued laptop, and he is using Abbott confidential information and trade secrets—including contact information for Abbott’s customers and his old Abbott emails—to solicit Abbott’s customers”, said the suit.

The ex-employee has registered the domain name “” and created an email account using this domain, according to the claim. He is using this email account and an email signature “that is nearly identical to the email signature designed by Abbott for use by its employees” and which features Abbott’s trademarks.

“The ex-employee pretended to be continuing his duties for Abbott and tried to sell COVID-19 tests and testing equipment.”

Companies allegedly contacted by the former representative included HealthTrust and Johns Hopkins Medicine, both Abbott customers.

In emails exchanged with Abbott customers, the ex-employee pretended to be continuing his duties for Abbott and tried to sell COVID-19 tests and testing equipment made by Bloom Diagnostics and LuminUltra, according to the claim.

Abbott has submitted claims of trademark infringement, counterfeiting, false designation of origin, dilution, cyberpiracy, violation of the Defend Trade Secrets Act of 2016, breach of contract, fraud and unjust enrichment.

The pharmaceutical company is seeking injunctive relief, the delivery of the former employee’s Abbott-issued laptop and any Abbott files, and triple damages.

Image: / Jason Watson


Australian court issues mixed vaccine patent ruling

In a mixed decision for Merck Sharp Dohme (MSD), the Federal Court of Australia has concluded that the pharmaceutical company is infringing one patent owned by Wyeth, but that two other Wyeth patents are invalid.

In a 959-paragraph ruling on October 14, Justice Burley concluded that MSD’s 15-valent pneumococcal conjugate vaccine would infringe one of Wyeth’s patents, Australian number 2,006,235,013.

However, the court also found that two other patents owned by Wyeth (which is a subsidiary of Pfizer) were infringed but invalid.

“It is perhaps not inappropriate that, at a time when the world is affected by the COVID-19 pandemic, the present dispute concerns attempts to improve disease immunity,” said Burley.

MSD had claimed that the three patents were invalid. Both the ‘013 and Australian patent no. 2,013,206,844 concern a “multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates”.

The third patent, Australian no. 2,012,216,628, is known as the container patent throughout the ruling and is called “Novel formulations which stabilise and inhibit precipitation of immunogenic compositions”.

Burley added: “Two pharmaceutical companies are in the race to develop better forms of immunisation against Streptococcus pneumoniae, which is a leading cause of meningitis, pneumonia and severe invasive disease in people, especially infants and young children, throughout the world. These proceedings concern an aspect of that race.”

“A spokesperson for Pfizer said it welcomed the decision that its ‘013 patent is valid.”

Infringement and injunctions

Wyeth sought declaratory, injunctive, and other relief against MSD in November 2019, claiming that MSD would infringe the ‘013 and ‘844 patents through the launch of its 15-valent vaccine. Then, at the commencement of the trial, Wyeth also argued that MSD would infringe the claims of the container patent.

“For the reasons set out perhaps far too fully above, I have found that the asserted ‘013 patent claims are valid and will be infringed by MSD’s 15-valent vaccine,” said Burley.

Under the Australian Patents Act 1990 (which applies to the ‘013 patent but has subsequently been amended), claims of a patent must be fairly based on the matter described in the specification.

MSD argued that the disclosure in the specification is of a composition with the 13 specified serotypes and no more, so that there is no “real and reasonably clear disclosure” of an immunogenic composition with more than 13 serotypes.

But the court sided with Wyeth, finding that there was a “real and reasonably clear disclosure,” so MSD’s fair basis challenge failed.

MSD was also found to have infringed the other two patents, but the court found both patents invalid. The parties have been directed to confer and propose short minutes of order giving effect to this judgment.

A spokesperson for Pfizer said it welcomed the decision that its ‘013 patent is valid and infringed by the proposed MSD vaccine. It plans to ask the court to grant an injunction preventing the launch of MSD’s proposed vaccine until expiry of the patent on March 31, 2026.

“Pfizer is additionally pleased with the Federal Court decision that another of its composition and a formulation patent relating to Prevenar 13 would be infringed by MSD’s proposed vaccine but is disappointed with the finding that the two patents are invalid. Pfizer intends to appeal this portion of the decision,” said the spokesperson.

MSD declined to comment.

Image: / Denizce


Two CRISPR scientists win Nobel Prize in historic first

French microbiologist Emmanuelle Charpentier and US biochemist Jennifer Doudna have achieved scientific history by jointly winning the Nobel Prize in chemistry for their seminal work on gene-editing technology, CRISPR.

The award is the only science Nobel ever to be won by two women, and brings the number of women who have been awarded the chemistry prize to seven, compared to a tally of 185 men.

In 2011, Charpentier discovered an adaptive immune response in bacteria to fight off viral attacks, leading to a ground-breaking publication in the science journal Nature.

One year later, Charpentier co-authored a report with Doudna, professor of chemistry at the University of California, Berkeley (UC), outlining details of the CRISPR/Cas9 system and guidelines on how to use it as a genetic tool.

Considered a revolution in the fields of medicine, biotechnology and agriculture, the CRISPR technology can modify any genetic sequence in the cells of living organisms.

In 2014, Charpentier co-founded ERS Genomics in Dublin, alongside Rodger Novak and Shaun Foy, to provide patent rights to CRISPR/Cas9.

Eric Rhodes, chief executive officer of ERS Genomics, paid tribute to Charpentier’s achievement, and said: “We have been looking forward to this day for some time and we at ERS are so pleased for Emmanuelle.

“We offer our hearty congratulations for this well-deserved recognition of her fundamental contribution to the discovery of the CRISPR/Cas9 platform and its application to genome editing.”

Charpentier said: “Receiving the prestigious Nobel Prize, the highest distinction in science, is an extraordinary honour. I am very grateful and truly moved to receive this recognition for our work on the CRISPR/Cas9 system.”

“The USPTO granted UC its 20th US patent on CRISPR/Cas9 gene-editing technologies.”

The development of CRISPR has not been without controversy. The inventorship status of CRISPR/Cas9 triggered a long-running dispute between the UC, and its collaborators, and the Broad Institute, a collaboration between the Massachusetts Institute of Technology and Harvard University.

In June 2019, the US Patent and Trademark Office (USPTO) revived the dispute between the two parties by declaring a second interference proceeding between 13 patents and one application of the Broad Institute and ten patent applications filed by UC, all covering the use of CRISPR/Cas9 in eukaryotic cells.

Six months later, the USPTO granted UC its 20th US patent on CRISPR/Cas9 gene-editing technologies.

The two laureates will share a prize of 10 million Swedish krona ($1.07 million).

Image: / Minerva Studio


WTO fails to strike deal to waive COVID-19 IP

Talks on a landmark proposal to waive IP rights for vaccines and treatments related to COVID-19 have stalled, following the failure of the World Trade Organisation (WTO) to conclude an agreement.

During discussions on October 16, member states declined to suspend provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The talks followed a bid by India and South Africa earlier in October to persuade the WTO to encourage countries not enforce patents for COVID-19 drugs and vaccines by waiving provisions of the agreement.

In their proposal, they argued that IP was one of the main stumbling blocks in ensuring fair access to these essential drugs and that developing countries were being disproportionately affected by the pandemic.

In the letter to the WTO, issued October 2, the two countries warned the organisation that certain parts of the TRIPS Agreement that cover IP could prevent or delay access to essential medical products.

If agreed, the waiver would have suspended the implementation, application and enforcement of certain IP rights, such as patents on pharmaceutical products, facilitating the development and manufacture of more and lower-cost COVID-19 diagnostics, treatments and vaccines.

“The UK was among the countries that opposed the proposal.”

The UK was among the countries that opposed the proposal, arguing that it had not been proved so far that IP had curbed the availability of vaccines and therapeutics during the pandemic.

In a statement, UK government representatives defended its position: “Beyond hypotheticals, we have not identified clear ways in which IP has acted as a barrier to accessing vaccines, treatments, or technologies in the global response to COVID-19. A waiver to the IP rights set out in the TRIPS Agreement is an extreme measure to address an unproven problem,” a spokesperson said.

“Pursuing the proposed path would be counterproductive and would undermine a regime that offers solutions to the issues at hand. Rather, we should consider how to meet the objectives of prevention, containment and treatment of COVID-19 as set out in the communication.”

According to the UK’s statement, multiple factors need to be considered to ensure equitable access for all to COVID-19 vaccines.

“These include increasing manufacturing and distribution capacity, measures to support or incentivise technology transfer, ensuring global supply chains remain open, and ensuring that effective platforms are utilised to voluntarily share IP and know-how,” the statement said.

Amnesty International, however, criticised the failure of the WTO countries to reach an agreement.

Steve Cockburn, Amnesty International’s deputy director for global issues, said: “Faced with an unprecedented pandemic, there is an urgent need to remove any barrier that may prevent the development and production of sufficient quantities of affordable COVID-19 diagnostics, treatments and vaccines.”

He added: “Now more than ever, the world needs governments and companies to work together and share their knowledge and technologies. With more than a million lives already lost to this virus, action is desperately needed to ensure global access to these medical products as soon as possible.”

Image: / EQRoy


Moderna won’t enforce COVID-19 patents

Biopharmaceutical company Moderna has announced that it will not enforce patents related to its COVID-19 vaccine while the pandemic is ongoing, and that it is prepared to licence the patents to others after the pandemic is over.

The announcement comes after the Biomedical Advanced Research and Development Authority (BARDA), and the Pentagon’s research arm, the Defense Advanced Research Projects Agency (DARPA) both confirmed in September they would investigate whether Moderna fully disclosed information on government funding in patent applications for Zika and COVID-19 vaccines.

Moderna has seven US patents related to its vaccine against coronaviruses, including the one that causes COVID-19.

In a statement released on October 8, Moderna said: “As a company committed to innovation, Moderna recognises that IP rights play an important role in encouraging investment in research. Our portfolio of IP is an important asset that will protect and enhance our ability to continue to invest in innovative medicines.”

It added: “Beyond Moderna’s vaccine, there are other COVID-19 vaccines in development that may use Moderna-patented technologies. We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.”

In September, acting director of BARDA, Gary Disbrow, revealed in a letter that the agency would probe the company in response to a complaint from Knowledge Ecology International (KEI), a non-profit that focuses on the provision of access to medical technology.

According to a report published by KEI on August 28, Moderna failed to disclose that it had received about $25 million in grants from DARPA to develop its technology in its vaccine patents to the US Patent and Trademark Office.

“Moderna has seven US patents related to its vaccine against coronaviruses.”

In a statement, James Love, director of KEI, welcomed Moderna’s move describing it as “very good” and called for other companies to do the same.

He pointed out, however, that a particular “nuance” within Moderna announcement was that the company held that its list of COVID-19 vaccine patents was only “representative” of the issued US patents relevant to the vaccine. He added that this “suggests that the list is not complete and does not extend to patent applications”.

Love said: “It includes only one of the granted patents that KEI cited in our letter to DARPA regarding failures to disclose federal funding, and DARPA and BARDA are both investigating several applications and granted patents for failures to disclose federal funding.”

He urged Moderna and other biopharmaceutical companies to participate in pools established by the World Health Organization and the United Nations to ensure greater access to patents and technology.

“Every manufacturer of a vaccine, drug or diagnostic should follow suit and publish the patents relevant to the technology, waive or license rights in those patents, and provide constructive transfer of manufacturing know-how and access to cell lines and data when necessary,” Love said.

Image: / Mongkolchon Akesin


Boehringer Ingelheim loses parasite control patent appeal

The Federal Court of Australia has rejected Boehringer Ingelheim’s animal health unit’s attempt to stop the registration of a patent owned by Intervet International on various grounds.

In 2011, veterinary medicines company Intervet—a subsidiary of MSD—applied for a standard patent called “Injectable formulation of a macrocyclic lactone and levamisole”.

The patent application (AU 2011268899 C1) covers “injectable formulations comprising a macrocyclic lactone and levamisole for controlling parasites in animals, and the use of such formulations in the preparation of a medicament for controlling parasites”.

Five years later, in 2016, Boehringer opposed the application but, following the filing of evidence and a hearing in August 2018, a delegate of the Commissioner of Patents decided to dismiss the opposition and directed the patent application proceed to grant.

Boehringer appealed against the decision, relying on nine grounds which the court summed up into the three issues of lack of novelty, lack of inventive step, and lack of utility.

On September 18, Justice Mark Moshinsky rejected all the arguments and allowed the patent application to proceed to grant.

Boehringer argued that the alleged invention claimed in Intervet’s patent application isn’t novel in light of Chinese patent application CN 1375291A, which it claimed discloses a formulation with macrocyclic lactone in solution and levamisole HCl in particulate form.

But, according to the court: “Boehringer’s experimental evidence does not establish that a formulation containing levamisole HCl in particulate form was an inevitable result of making the formulation in example 3 of CN 291.”

Turning to the lack of inventive step, Boehringer argued that the alleged invention was obvious in light of the common general knowledge considered alone, or in combination with the Chinese patent.

Again, the court rejected the argument, noting the fact that “by June 2010 no-one had suggested, let alone made, an oily injectable formulation with levamisole salt in particulate form” provided evidence that such an invention was not obvious. The priority date of the patent application is June 24, 2010.

“Boehringer argued that the alleged invention was obvious in light of the common general knowledge.”

Finally, Boehringer contended that the alleged invention is not useful, as the claims include embodiments that don’t “achieve the promise of a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole”.

Moshinsky stated that Boehringer had not established that the formulations detailed in Intervet’s international patent application failed to meet the promise of stability in the patent application (that is, stability for three months under accelerated conditions).

“It follows that the lack of utility ground is not made out,” he concluded, before dismissing the appeal.

A spokesperson for MSD said: “As an innovative pharmaceutical company, MSD Animal Health obtains patents to protect its novel medicines for animals, and these patents provide MSD Animal Health with the necessary incentive to assume the tremendous monetary risks associated with research and development.

“Without appropriate patent protection, imitators can copy our innovative medicines and technologies and take unfair advantage of MSD Animal Health’s research and development investment.”

Image: / ThamKC


English court issues mixed ruling in heart valve patent clash

The English High Court has handed a mixed ruling in a dispute between Edwards Lifesciences and its competitor Meril Life Sciences.

In a partial victory for medical device company Edwards, the court found that Meril had infringed a patent covering a heart valve delivery system. However, the decision also provides freedom to operate for Meril on its competing heart valve product and delivery system.

Justice Colin Birss—in a decision handed down on September 29—concluded that while Meril had infringed claims in one patent, the other patent cited by Edwards in opposition was invalid and so not infringed.

Edwards is respectively the owner and exclusive licensee of two patents: EP (UK) 1,267,753 called “Minimally-invasive heart valve” and EP (UK) 3,494,929 titled “Low profile delivery system for transcatheter heart valve”. The patents protect Edwards’ product family of prosthetic heart valves called Sapien.

India-based Meril was accused of infringing the patents through the sale of its Tavi product, which consists of a transcatheter heart valve called Myval, and a catheter-based delivery system for Myval called the Navigator.

In response, Meril denied infringement and counterclaimed for revocation of both patents on the grounds of obviousness, insufficiency and added subject matter.

Birss sided with Edwards on infringement of the ‘929 patent.

While Birss found that claims 1 and 2 of the patent were invalid, he concluded that claims 4, 5, 7, 8, 9, 11, 12 and 13 were independently valid, making the ‘929 patent partially valid.

Meril, according to the court, infringed six of the claims which are dependent on claim 1 and, although the literal infringement of claims 1 and 12 was not established, Meril’s Navigator product infringed each of them on the doctrine of equivalents.

One alternative design of Navigator, which Meril sought a declaration of non-infringement for, was also found to infringe. In a win for Meril, Edwards accepted that another design did not infringe its patent.

The court also found that while the Myval product falls within claim 1 of the ‘753 patent (which claims a prosthetic heart valve device), the claim was invalid as it lacked an inventive step.

Meril had contended that the ‘753 patent was obvious in light of published application WO 98/29057 (Cribier) which was published in July 1998, when read in conjunction with US patent number 5,411,552 (Andersen US) which was published in May 1995.

“Meril denied infringement and counterclaimed for revocation of both patents.”

“A major plank of Edwards’ case is that it fails to face up to Cribier’s criticisms of the Andersen design. Although other points were taken too, in my judgment it is the criticisms of Andersen in Cribier and their significance for the skilled team which is the key issue. The case turns on those,” said Birss.

The trial was conducted as a “hybrid” hearing using an audio/video system provided privately by the parties.

It is the first of three technical trials of patent disputes between these parties concerning Myval and Navigator, with the other two trials scheduled for before the summer vacation in 2021.

A spokesperson for Edwards said: “The decision to pursue this litigation was not taken lightly. Edwards’ goal is to improve and save patients’ lives through the advances of true innovation to address unmet patient needs.

“We are pleased that the court and patent system recognises and protects our decades of work on the Sapien innovations.”

Daniel Lim, one of the Kirkland & Ellis lawyers representing Meril, said: “The judgment gives our client Meril valuable commercial certainty and reassurance as to its freedom to operate over both of the patents asserted by Edwards in this trial.

“In this regard, the practical significance of the finding of non-infringement in respect of Meril’s delivery system design around should not be overlooked,” he added.

Image: / Yurchanka Siarhei


Biogen loses another battle over MS drug patent

In a blow for biotechnology company Biogen, a US federal judge has ruled that its lone surviving patent on multiple sclerosis drug Tecfidera (dimethyl fumarate) should remain invalid because the matter had already been resolved by another court.

Following a decision handed down by Judge Maryellen Noreika at the US District Court for the District of Delaware on September 16, Biogen has failed in its bid to revive the patent.

Biogen had hoped to overturn a ruling by a district court in West Virginia on June 18, which held that the Tecfidera patent, US number 8,399, 514, which was due to expire in February 2028, should never have been issued.

In the decision, which clears the way for generic drug companies to produce and market generic versions of the treatment, Noreika held that the West Virginia court had been correct in its ruling that the Biogen patent on a Tecfidera dosing regimen was “invalid because it did not sufficiently describe the claimed invention”.

“In the June ruling, the court found the specification of the Biogen patent to be overly broad.”

Last month, Mylan launched its generic version of Biogen’s drug, the first generic of any multiple sclerosis treatment in an oral solid dosage form available to patients in the US.

In the June ruling, the court found the specification of the Biogen patent to be overly broad. Mylan provided a convincing expert witness who testified that the Biogen patent would not direct a person of ordinary skill in the art towards a 480mg/day dose of dimethyl fumarate.

Biogen was unable to provide a clear written specification in its arguments, and instead relied upon testimony from the inventor, but the court ruled that this was “not sufficient”.

This latest ruling is a major setback for Biogen, which relied on Tecfidera for almost a third ($4.4 billion) of its 2019 sales.

Biogen’s total IQVIA sales in the US for the 12 months ending June 30, 2020, were approximately $3.79 billion for Tecfidera.

Image: / Vanatchanan


FTC demands AbbVie divests Crohn’s treatment in Allergan buyout

The US Federal Trade Commission (FTC) has approved a final order regarding charges that biopharmaceutical company AbbVie’s $63 billion acquisition of Allergan would violate US federal antitrust law.

The order, issued on September 4, comes after both companies agreed in May to divest assets to settle FTC charges that the merger would adversely affect market competition for drugs that treat exocrine pancreatic insufficiency (EPI), a condition that causes Crohn’s disease and ulcerative colitis.

The FTC had also alleged that the acquisition would eliminate future direct competition between AbbVie and Allergan in the development and sales in the US of IL-23 inhibitor drugs for treatment of moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.

According to the complaint, only four companies sell pharmaceutical products to treat EPI. Of those, AbbVie and Allergan together control 95% of the market for these drugs.

AbbVie and Allergan have agreed to divest Allergan’s Zenpep and Viokase, other pancreatic enzyme preparations sold to treat EPI, to competitor Nestlé. AbbVie and Allergan are also required to transfer Allergan’s rights and assets related to Brazikumaz, an IL-23 inhibitor that is in development to treat moderate-to-severe Crohn’s disease and ulcerative colitis, to AstraZeneca.

AbbVie’s purchase of Allergan was first announced in the summer 2019.

The FTC carried out its investigation into the proposed merger after trade unions and consumer groups urged it to intervene, arguing it would “substantially harm competition”.

“AbbVie and Allergan together control 95% of the market for these drugs.”

After completing the vetting process of the proposed divestiture buyers, the FTC concluded that Nestlé had the expertise, US sales infrastructure, and resources to maintain the competition that otherwise would have been lost due to the proposed acquisition.

According to the FTC, it explored a wide range of theories of competitive harm potentially posed by the merger during the course of a ten-month investigation before it issued its order in May, including harm to innovation.

It said, however, that it had “uncovered no evidence of such harms beyond those remedied by the proposed consent, after conducting more than 40 interviews, reviewing extensive written submissions from third parties, and reviewing more than 430,000 documents”.

The deal had previously received approval from the EU. Abbvie shareholders will own approximately 83% of the company following the acquisition, with Allergan shareholders owning 17%.

Image: / Maridav


AbbVie slammed over ‘drip feed’ of Imbruvica patents

AbbVie has used a “drip feed” of patents to secure more than nine years of extra exclusivity on blood cancer drug Imbruvica (ibrutinib), a report has revealed.

The report, published in July by non-profit I-MAK, says that Imbruvica’s “patent wall” will cost the US public $41 billion until generic competition becomes available.

Imbruvica is a small molecule drug which was first approved by the US Food and Drug Administration (FDA) in 2013. It is used to treat B cell cancers including types of lymphoma and leukaemia.

Since its initial approval in 2013, the price of Imbruvica has increased by 57%, with the non-discounted annual price currently standing at $174,156 per person.

AbbVie owns 88 granted patents on Imbruvica and has filed 165 patent applications covering the drug.

Most of these (55%) were filed after the FDA first approved it in 2013, the I-MAK report revealed, with the most recent patent having been granted in September 2019.

This means that the most recent patent on the drug is currently set to expire in 2036, with the first Imbruvica patent having been filed in 2006.

Just over a third of the patents (38%) cover methods of treating specific diseases, while 28% cover the active substance in Imbruvica.

According to I-MAK, AbbVie has pursued a “drip feed” patenting strategy, designed to extend the company’s monopoly on the drug as far as possible.

“Imbruvica is projected to become the fourth highest grossing drug in the US by 2024.”

“Knowledge that is broadly disclosed in early patent applications is defined ever more narrowly and specifically in a spread of subsequent patent applications,” the report said.

This strategy is enabled by a flawed “one-size-fits-all patent system”, which does not differentiate between patents covering the main compound in a drug, and those covering more specific uses, the report argued.

As each patent grants the same period of exclusivity (20 years), AbbVie could extend its monopoly on the drug, at least for certain uses, even further beyond 2036.

“As long as subsequent patents are written specifically enough to be considered outside the scope of disclosure of the first patent(s), the potential to keep stacking additional patents on a single, already patented active substance is limitless,” the report said.

According to the report, Imbruvica is projected to become the fourth highest grossing drug in the US by 2024, with annual revenues of nearly $9 billion.

Image: / crystal light

Autumn 2020

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