When Hill’s decision makers placed their hopes on generic drugs and biosimilars to solve the country’s drug pricing crisis, lawyers and advocates from generic drugs and biosimilar companies waited nervously for the decision. GlaxoSmithKline v. Teva. This case may subvert their ability to sell generic indications without infringing on the broader patent portfolio of branded drugs, thereby reversing decades of practice.
On July 13, generics and biosimilars advocates from the Association for Accessible Medicines (AAM) urged the Senate Subcommittee on Competition Policy, Antitrust, and Consumer Rights to take action to protect generics and biosimilars under the Hatch-Waxman Amendment of 1984. Rights of biosimilar companies. The law allows these companies to bring low-cost alternatives to the market, even if manufacturers of brand-name drugs still have patents for specific drug use methods, a process commonly referred to as “thin labeling.”
The testimony of the advocate echoes the testimony of President Biden on July 9 Executive order on competition, Where he supports the use of thin labels for drugs with multiple indications. He asked Congress to protect the ability of patent challengers to “dig out” a potential use from a large number of patents to help the drug be marketed in a timely manner.
“Such a peel or’thin label’ may be an effectiveAn effective way for generic drugs to bypass weak or limited patents The company may increase when the drug patent term is nearing the end To maintain its exclusive market position for all drug uses,” Professor Robin Feldman and Evan Frandorf of the University of California Hastings School of Law in their article published in Harvard Legislative Review.
However, this tool is currently under fire in the Federal Circuit GlaxoSmithKline v Teva, The claimant waits for a potential industry definition decision.
how is it GlaxoSmithKline v Teva May affect the competition between generics and biosimilars
In October 2020, the Federal Circuit affirmed a jury’s verdict valued at $234 million against Teva. The ruling stated that the Israeli company “induced infringement” of GlaxoSmithKline’s patents and claimed that its generic drug Coreg Luo) is chemically equivalent to GlaxoSmithKline’s drug and cites patents that are still being patented. Used in press releases. GlaxoSmithKline believes that this is enough to allow doctors to prescribe their generic drugs for the treatment of mild to severe chronic heart failure hypertension (CHF) patented use.
The Tour is currently deciding whether and how it may narrow its October 2020 decision, Agreed to retry the case In February. If not, some lawyers worry that just by saying that a drug is “AB” (meaning that it is as safe and effective as its reference drug), generic or biosimilar companies with thin labels on the market may be accused of inducing different types of drugs. The indications infringe on the still valid patent.
The court’s original and now-cancelled 2-1 decision was made under the strong opposition of Chief Justice Prost—and the common concerns of generic drug stakeholders, including the co-author of the Hatch-Waxman Act.
in a About Friends of the CourtFormer U.S. Congressman Henry Waxman stated that the October decision by the majority “threatens to destroy the compromise at the heart of the Hatch-Waxman Act, which in turn threatens the generic drug industry.”
In itself briefly, AAM argued that the court had exceeded its authority, saying: “If hatched-Waxman And induce The law needs to be rewritten. This is the job of Congress.“
GlaxoSmithKline disputes these Worries in january Responding to the briefing,debate: “A kindvery long As generic drugs are fully engraved for patented uses, they can continue to enjoy engraving-The protection of laws and regulations.“
The expert group considered the arguments of both parties and took a middle course: agreed to re-examine the narrow question of whether Teva induced doctors to infringe the GSK patent within three years, and GSK reinforces a patent for the drug with slightly different reasons Protection of indications. Oral argument occur February 23.
AAM lawyers recommended to the Senate Judicial Subcommittee on July 13 to deal with the drug competition issue. This period of hesitation caused confusion and triggered further lawsuits.
“In fact, since then, there have been at least five cases involving brand-name pharmaceutical companies claiming patent infringement based on engraved labels,” AAM Wrote in a statement To the committee.
The court’s decision to reopen the case has made some intellectual property lawyers cautiously optimistic that generic drugs and biosimilars will safely compete on narrower indications.
“The initial decision must have had a chilling effect on the biosimilar and generic drugs industry,” Axinn Veltrop partner Chad Landmon said in a video interview.
“It’s very unusual to go through a review with the same team and have them change their decision-this is usually On the bench,” he pointed out. “But many of Teva’s arguments during the review were related to Congress’s intentions. It would be helpful for the court and Congress to clearly agree on this issue. “
However, the panel may be able to avoid addressing the question of whether claims of the same quality as brand-name drugs that still enjoy any level of patent protection are sufficient to prove infringement of generic drugs.
Dmitry Karshtedt, a professor at George Washington University, said in an email: “Maybe the court has arranged for a retrial, so further arguments can help the panel to draft an opinion that clearly states the AB rating In addition, the understanding of patent activities is not enough to induce.”
Bigger deal in biosimilars
Although the drug in question is GlaxoSmithKline v Teva It is a small molecule drug, and the advocates of biosimilar companies believe that it will have a greater impact on this emerging but explosive and high-growth market.
according to Quintai, Sales of biological agents Increased by 70% Reached in the past five years US$232 billionA March IQVIA report It is found that since 2014, the expenditure of bio-derived drugs has grown at a compound annual growth rate (CAGR) of 14.6%, which is significantly higher than the 1.6% compound annual growth rate of small molecule drugs. IQVIA infers that with the expiration of a large number of high-priced biological patents, biosimilars may receive an increase of US$80 million in the next five years.
Biosimilars are unbranded versions of monoclonal antibodies and other macromolecular drugs, and their quality, safety, and effectiveness are comparable to licensed biopharmaceuticals (also called “reference” drugs).
Although Europe is developed guide In order to approve these drugs in 2005, the United States did not develop its own Guidelines, At last Update November 2020.
Despite the slow start of the United States, IQVIA analyst Elyse Muñoz possible Based on the current growth in the use of biosimilars, and for the future of biosimilar adoption in the next few years, he said all the evidence indicates that “a healthier competitive market is coming.”
However, first, biosimilars must obtain market approval, which is a major obstacle.
under Biological Product Price Competition and Innovation Act (BPCIA) was passed as part of the “Affordable Care Act,” and biologics received a total of 12 years of market protection in each indication. This means that if a drug can treat multiple sclerosis, narcolepsy and arthritis, then each of these indications will be patented for 12 years without competition. If a company staggers its patents, this may lead to a long tail effect of market exclusivity, leading to higher drug prices and lower competition for biosimilars.
This is why AAM wrote to Congress that thin labels “are more important in the context of biologics-brands often get many indications for diseases such as cancer, and patents for any one of these indications should not exclude non-patent indications. competition.”
However, this strategy is not without risks. Because the small molecule generic drugs regulated by Hatch-Waxman are considered interchangeable with their reference products, and state substitution laws require them to be used when they are available, the company hardly needs to bring them to the market.
On the other hand, biosimilars will require a lot of marketing, especially because they are not yet considered interchangeable with their predecessors.This makes them Litigation risk is greater According to several biosimilar legal experts including Landmon, they are accused of using a superficial label to induce infringement.
Unlike small-molecule generic drugs regulated by Hatch-Waxman, biosimilars require marketing activities and detailed instructions from doctors to promote adoption. Landmon stated that these activities opened a Pandora’s box of infringement risk:
“If a biosimilar drug company is sued for inducing an infringement of an indication that is not on the label of a biosimilar drug, the court will more extensively review the company’s statements when marketing its products to see if they have said any Remarks deemed to induce infringement. The claimed method of use.”
Landmon believes that this issue may need to be fixed by legislation: “Congress can make it clear that as a biosimilar applicant, if you remove the indication and put a thin label, you will not infringe.”
Karshtedt doesn’t care too much GlaxoSmithKline The impact of the decision on biosimilars is more important than other factors: the challenge of establishing clinical similarity and the non-patented means of market exclusivity enjoyed by innovative biologics companies.
“However, depending on the claims involved, inducing infringement may become a bigger problem (specific patents must be selected for patents). Patent dance) And how GlaxoSmithKline’s opinion was ultimately drafted,” Kastedt said.
The path of hope for biosimilars?
President Biden signed two bipartisan bills to promote the use of biosimilars on April 23: Ensuring innovation law (To align the biosimilar law with the Hatch-Waxman Act in a critical and pro-competitive manner) and Advance the Biosimilar Education Act (Promote the public’s understanding of the safety and effectiveness of biosimilars). The Ensuring Innovation Act encourages biopharmaceutical companies to be very specific in obtaining FDA exclusivity, and aims to limit market protection to truly innovative products.
On his July 9th Executive order, He called for a drug pricing report to be submitted within 45 days. The report will describe ways to curb the high prices of prescription drugs in the United States by promoting competition between generics and biosimilars, and allow medical insurance to negotiate drug costs.
Biden ordered agencies to act quickly to support biosimilar competition. He told the FDA to fully implement the agency plans issued in 2017 and 2018 to clarify the drug approval process. He recommended that the FDA implement recent legislation to prevent brand manufacturers from restricting competitors’ access to drug samples needed to test new generic drugs, and promote the FDA Cooperate with the Patent and Trademark Office and prevent patent extensions aimed at delaying competition between generics and biosimilars.
Time will tell how many of the country’s drug pricing problems will be resolved in the congress hall, and what the judiciary will decide. But one thing is certain: someone somewhere needs to provide much-needed clarity to this industry.
Photo: cagkansayin, Getty Images
