Grant Playter

On March 27, 2023, the US Supreme Court heard oral arguments from Amgen and Sanofi in a case that could have broad ramifications on the state of patents in the United States. The crux of the case concerns the enablement requirement, and whether “genus claims” (i.e., patents that cover various structurally and functionally related chemicals) satisfy it.

Amgen and Sanofi are in dispute over Amgen’s Repatha (evolocumab) and Sanofi’s Praulent (alirocumab), both of which are monoclonal antibodies that lower the levels of low-density lipoprotein cholesterol. Amgen initiated the suit, claiming that Sanofi was infringing on its patent, while Sanofi has argued that the patents themselves are invalid.

All patents are required to fulfill an “enablement” requirement, which has traditionally been defined as allowing “those skilled in the art to ‘make and use’ the claimed invention; genus claims are predicated on this definition of enablement. However, Sanofi is arguing that this definition does not actually fulfill the enablement requirement, and that it instead must enable “those skilled in the art to reach the full scope of claimed embodiments without undue experimentation.” After back-and-forth resolutions in the lower courts, the Supreme Court is now tasked with answering this question surrounding functional language.

If Amgen wins the case, the victory would allow the company to claim all antibodies that use this mechanism of action shared by evolocumab and alirocumab; this would extend to other patents, which has left some companies worried about their intellectual properties. Due to these concerns, as well as the fact that broad patent protection would make it more difficult to bring competitive drugs to market, major pharma companies such as Pfizer, Johnson & Johnson, and Eli Lilly and Company have publicly backed Sanofi (1).

Conversely, if Sanofi wins the case, then that outcome would likely result in the death of broad genus claims. Some, including Kisuk Lee, a patent lawyer specializing in biopharma operations, feel that a Sanofi win could depress innovation. According to Lee, while it requires billions in R&D to bring a molecule to market, it is not incredibly difficult to extrapolate research concerning one molecule to similar ones.

“Nowadays, antibody production is quite automated,” says Kisuk Lee, principal, St. Louis Metro Office. “If you have the roadmap as described in Amgen’s specification, with computer modeling anybody can quickly produce antibodies.”

Depending on how this case is ruled, individuals such as Lee are concerned about how it will impact funding of discovery efforts. If broader patents are struck down, pharma companies will not only need to make more patent applications, an expensive process which Lee notes typically takes three-to-six years, but pharm companies may also not be granted crucial patents that competitors could use for their own molecules.

“If [the Supreme Court] decision only focuses on functional language, there will still be a good outcome for industry,” says Lee. “But if they say broad patent claims hinder competition and follow-on inventions, and you need to provide enabling disclosure for all variants falling within the scope, then it will be really damaging for our industry.”

Wingrove, P. Amgen-Sanofi Patent Case Divides Makers of Antibody Drugs. 

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The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

US Supreme Court Weighs Biologics Patents in Amgen vs. Sanofi Case

On March 29, 2023, FDA announced its approval of Narcan (four milligram naloxone hydrochloride nasal spray) for over-the-counter (OTC), nonprescription use. Naloxone, a standard treatment for reversing the effects of opioid overdoses, has been available via prescription (Rx) since 2015. The approval was granted to Emergent BioSolutions, a biotechnology company specializing in opioid treatment products, as well as vaccines and antibody therapeutics for infectious diseases.

According to an agency press release, more than 100,000 individuals suffered fatal overdoses from October 2021 to October 2022. Primarily driven by synthetic opioids, such as illicit fentanyl, the expanded approval from FDA is designed to fulfill a “dire public health need.”

“[FDA] remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said Robert M. Califf, commissioner, FDA, in the release. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, director, Center for Drug Evaluation and Research, FDA, in the release. “[FDA] is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

According to an Emergent BioSolutions company press release, the product is scheduled to be available OTC in the United States late summer 2023. This timeline was chosen to account for manufacturing changes needed for the transition from Rx packaging to OTC.

“Today’s landmark FDA OTC approval for N[arcan] Nasal Spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” said Robert G. Kramer, president and CEO, Emergent BioSolutions, in the company press release. “We are dedicated to improving public health and assisting those working hard to end the opioid crisis—so now with leaders across government, retail, and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with N[arcan] Nasal Spray to help save a life.”

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

FDA Approves First Over-the-Counter Naloxone Nasal Spray

As part of ongoing coverage of DCAT, the PharmTech editors touched base with Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific. In in our discussion, Anil discussed various topics within the outsourcing market, including:

The increased interest in technologies like cell and gene therapies and oral biologics

The continued rise of the "end-to-end" CDMO model and why biopharma partners are seeking it out

Recent investments made in new spaces by Thermo Fisher Scientific

For more of our coverage on DCAT in 2023, viewers can visit 

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, discusses the growing role of CDMOs in the biopharma industry

Discussing the Growing Role of CDMOs with Anil Kane (DCAT 2023)

As part of ongoing coverage of DCAT, the PharmTech editors touched base with Stephen Houldsworth, vice-president and head of Platform Management & Marketing at CordenPharma. In in our discussion, Stephen touched on various topics within the outsourcing market, including:

Recent investments and the strategic rationale behind them.

Ongoing industry trends and what customers are looking for.

Bold predictions for where the industry will be five years down the line.

Stephen Houldsworth, VP and Head of Platform Management & Marketing at CordenPharma, dives into ongoing trends in the outsourcing space.

Illuminating the State of Outsourcing with Stephen Houldsworth (DCAT 2023)

 editors were in attendance at DCAT Week 2023 from March 20 - March 25! Bookmark this page for highlights from various interviews conducted throughout the week.

Discussing the Growing Role of CDMOs with Anil Kane

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, discusses the growing role of CDMOs in the biopharma industry.

Setting Sustainability Goals with Pierre Luzeau

Pierre Luzeau, CEO of Seqens, discusses Seqen's commitment to sustainability and how one can work toward it within their own company.

Highlights from DCAT Week 2023, hosted from March 20 - March 25.

DCAT 2023 Highlights

Polyplus, a French provider of solutions for advanced biologic and cell and gene therapy production, announced a novel cationic lipid nanoparticle (LNP) formulation for messenger RNA (mRNA) therapeutic and vaccine development on March 14, 2023. Set for release in April 2023, the LipidBrick IM21.7c is a formulation designed to expand the scope of LNP usage in various therapeutic and oncology applications, as well as prophylactic vaccines.

The formulation is designed to overcome current-generation ionizable lipid challenges used in current LNPs by enabling a wider 

biodistribution and decreasing accumulation in the liver. According to a company press release, proof of concept work demonstrated that it successfully modulates the overall charge of LNPs, improving drug efficiency and formulation stability with no additional safety concerns.

“Polyplus draws on over 20 years legacy in cationic polymer and lipid-based delivery systems for both 

 models to power mRNA therapeutics,” said Mario Philips, CEO, Polyplus, in the release. “As we carry forward this legacy, we are working to ensure that our offer opens new possibilities to improve LNP formulation to meet the growing demand of the mRNA therapeutic market. LipidBrick IM21.7c is already used in jetMESSENGER and liposomal formulations for mRNA delivery, as a ready-to-use solution that requires no onsite formulation.”

Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.