McDermott+ Check-Up: February 7, 2025
THIS WEEK’S DOSE
Key Nominations Move Forward. Having advanced from the Senate Finance Committee this week, Robert F. Kennedy Jr.’s nomination for secretary of Health & Human Services will now go to the Senate floor.
Pathway on Reconciliation Is Uncertain. While the House Budget Committee was expected to start the reconciliation process this week with a markup of a budget resolution, that did not happen.
House Energy & Commerce Health Subcommittee Holds Hearing on Drug Threats. Members examined solutions to the opioid crisis.
Trump Issues EO Modifying the Regulatory Process. The executive order (EO) calls for fewer regulations and rescinds changes to the regulatory cost-benefit analysis.
Administration Modifies Public Health Data. The Centers for Disease Control & Prevention scrubbed its websites of mentions of gender identity and diversity, equity, and inclusion.
Legal Challenges Continue in Response to Trump Administration Actions. Federal judges have taken additional actions to block efforts to freeze certain federal funding, and a lawsuit was filed in response to a Trump EO on care for transgender youth.
CONGRESS
Key Nominations Move Forward. The Senate Finance Committee advanced Robert F. Kennedy (RFK) Jr.’s nomination to lead the US Department of Health & Human Services (HHS) in a 14 – 13 vote along party lines. The nomination now moves to the Senate floor. If every Democrat opposes the nomination in the floor vote, RFK Jr. could lose up to three Republican votes and still be confirmed as HHS secretary.
The Senate confirmed Russell Vought as director of the Office of Management & Budget (OMB) by a 53 – 47 vote. The Senate voted to confirm Doug Collins to lead the US Department of Veterans Affairs in a vote of 77 – 23. Dr. Mehmet Oz, President Trump’s nominee to lead the Centers for Medicare & Medicaid Services (CMS), began meeting with senators on Capitol Hill this week, the first step in his nomination process. He has not spoken publicly on Medicaid much before, but he was quoted this week as saying, “We have to take care of the most vulnerable among us. It’s a social calling for all of us . . . that funding freeze was not designed to affect Medicaid at all.”
Pathway on Reconciliation Is Uncertain. While the House was expected to start the reconciliation process with a markup of a budget resolution in the Budget Committee this week, that did not happen. House Republicans continue to negotiate with one another about the level of spending cuts and held a meeting at the White House with President Trump, after which they announced they were moving closer to an agreement. Because this will be a partisan process, Republicans need to be largely unified in order to proceed. During this uncertainty, Senate Budget Committee Chairman Lindsey Graham (R-SC) made it clear that the Senate is prepared to move forward with its own budget resolution, which would begin a two-bill approach to reconciliation, with an immigration, energy, and defense bill completed first and a tax bill tackled later in the year. Senate Republicans are set to meet with President Trump Friday night at Mar-a-Lago to promote this approach. The budget resolution is a necessary first step in the reconciliation process, and healthcare programs are expected to be on the table for spending cuts. For an overview on the budget reconciliation process and its impact on health policies, read our +Insight.
House Energy & Commerce Health Subcommittee Holds Hearing on Drug Threats. The hearing discussed the importance of expanding access to addiction and mental health services and ensuring wide availability of Narcan. Republican members primarily focused on the importance of border security in combatting the opioid crisis, and Democratic members emphasized the funding freeze’s adverse impacts on medical research and the critical roles that Medicaid and federally qualified health centers play in enabling access to care for substance use disorders.
ADMINISTRATION
Trump Issues EO Modifying the Regulatory Process. This EO requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed. The EO tasks the director of OMB with ensuring standardized measurement and estimation of regulatory costs, and it requires that, for fiscal year 2025, the total incremental cost of all new regulations, including repealed regulations, be significantly less than zero. It is unclear what this 10 – 1 ratio means in practice or how it will be implemented.
Administration Modifies Public Health Data. To comply with President Trump’s EOs related to gender identity and diversity, equity, and inclusion, the Centers for Disease Control & Prevention first removed, then uploaded a modified version of, public information and data related to HIV and health information for teens and LGBTQ+ people on both its data directory and main webpage. In response, a medical advocacy group has sued multiple health agencies, stating that the removal of data deprives physicians and researchers of access to necessary information.
COURTS
Legal Challenges Continue in Response to Trump Administration Actions. Following legal challenges last week to the Trump administration’s now-rescinded OMB memo directing agencies to freeze certain federal funding, more federal judges have acted to halt the federal freeze. On January 31, a federal judge in Rhode Island granted a temporary restraining order to block the freeze, following a lawsuit from Democratic attorneys general from 22 states and the District of Columbia. On February 3, a federal judge in the District of Columbia issued a similar injunction in a lawsuit filed by several coalitions of nonprofits.
PFLAG National, GLMA, and transgender individuals and their families filed a federal lawsuit against the Trump administration’s EO “Protecting Children from Chemical and Surgical Mutilation.” The EO states that federal agencies shall not “fund, sponsor, promote, assist, or support the so-called ‘transition’ of a child from one sex to another.” Plaintiffs in the lawsuit, filed in the US District Court for the District of Maryland, argue that the EO will create harm by denying access to physician-prescribed, medically recommended care. Read the press release here.
In response to a lawsuit brought by unions representing federal workers, a federal judge in Massachusetts paused the deadline for the administration’s buyout program for federal workers. There is another hearing set for next week.
QUICK HITS
HHS OCR Announces Action on Anti-Semitism. The HHS Office for Civil Rights (OCR) will initiate compliance reviews related to reported incidents of anti-Semitism at four medical schools.
House Democratic Leaders Send Letter to GAO on Medicare Drug Price Negotiation. In the letter, Energy & Commerce Ranking Member Frank Pallone (D-NJ), Ways & Means Ranking Member Richard Neal (D-MA), and Education & Workforce Ranking Member Bobby Scott (D-VA) urged the US Government Accountability Office (GAO) to monitor the Medicare Drug Price Negotiation Program to ensure the Trump administration complies with the Inflation Reduction Act, which directed and authorized the GAO to conduct oversight of the program.
CMS Releases Statement on DOGE Collaboration. The short statement notes that two senior CMS officials are working with Elon Musk’s Department of Government Efficiency (DOGE).
NEXT WEEK’S DIAGNOSIS
Both chambers will be in session next week. The House Veterans’ Affairs Health Subcommittee will hold another hearing on community care, the House Ways & Means Health Subcommittee will hold a hearing on modernizing healthcare, and the Senate Special Committee on Aging will hold a hearing on optimizing longevity. As noted, the House Budget Committee may mark up a budget resolution that would start the budget reconciliation process, or the Senate could move first. The full Senate is on track to approve RFK Jr.’s nomination, and we expect the administration to continue taking executive action related to healthcare.
MA Cannabis Commission Releases New HCA Resources
Last week, the Massachusetts Cannabis Control Commission (“CCC” or the “Commission”) released new resources for navigating the rocky waters of community impact fees (“CIFs”) and host community agreements (“HCAs”). This announcement likely comes in response to the ruminating and yearning for additional guidance by operators and municipalities following the CCC’s release of new regulations and host community agreement template last year. See our prior blog post, “CCC’s Model HCA & Approval Process,” for more information on those regulations and HCA template.
This new release details several new resources available to cannabis businesses and their host communities in Massachusetts. Kimberly Roy, the Commissioner and Chapter 180 Working Group HCA Co-Chair stated, “[t]hese guidance documents are meant to serve as compliance tools to help clarify and streamline the new processes. As we approach the one-year mark in March of the new HCA requirements, the Commission continues to exercise its statutorily given authority to review and approve Host Community Agreements to ensure these contracts are compliant with current law.”
Some of these resources provided by the CCC include:
A form invoice that host communities could use in charging annual community impact fees permitted under Massachusetts law.
A guidance document on community impact fees and tangible “dos and don’ts” of practices that are permitted and prohibited in the view of the Commission. The guidance document also shines some light on the CCC’s new regulations relating to host community agreements and covers topics including: payments of CIFs, dispute resolution processes, responsibilities of operators, and CIF certification procedures by the Commission.
A sample Host Community Cannabis Business Application Standard Evaluation Form to assist municipalities in evaluating equity metrics of an operator applying for a host community agreement with the hosting community.
EPA Releases Third Triennial Report to Congress on Biofuels and the Environment
The U.S. Environmental Protection Agency (EPA) announced on January 21, 2025, the availability of a final document entitled “Biofuels and the Environment: Third Triennial Report to Congress” (Third Report). 90 Fed. Reg. 7135. The document was prepared by EPA’s Offices of Research and Development (ORD) and Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE). The report builds on the first and second triennial reports, released in 2011 and 2018, respectively. According to EPA, it reinforces the broad conclusions from those reports on biofuels in general and further evaluates the attribution of those effects to the Renewable Fuel Standard (RFS) Program more specifically. The Third Report updates the previous assessments of the environmental impacts of the RFS Program and includes new analyses to separate better the effects of the RFS Program from the broader set of factors influencing biofuels. According to EPA, in the first two reports, it could not separate the effects of the RFS Program from the impact of other factors (e.g., market or other policy effects). The Third Report includes an “attribution analysis” that better separates the effects of the RFS Program from other factors that affect biofuels production and consumption in the United States. The Third Report concludes that the RFS Program had a modest positive effect on biofuel production and consumption and thus had a modest negative effect on the environment. EPA states that these endpoints include air and water quality, water quantity, ecosystem health and biodiversity, soil quality, invasive species, and international impacts. The impacts of the RFS Program overlap with the more significant effects of biofuels as an industry.
The New Administration and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Developments — A Conversation with Jim Aidala [Podcast]
This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group (Acta®), to discuss the early days of the new Administration, what changes we can expect at the U.S. Environmental Protection Agency (EPA) generally, and key issues the Office of Pesticide Programs (OPP) can be expected to tackle. Jim’s unique perspective as a former Assistant Administrator of what is now called the Office of Chemical Safety and Pollution Prevention (OCSPP) and keen understanding of the pesticide world always make for a wonderful and insightful conversation.
Eye-Catching: Biosimilars Injunction Prevails
Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a preliminary injunction, finding that there was a proper exercise of personal jurisdiction and that no substantial question of invalidity had been raised for the patents at issue that would prevent the injunction from issuing. Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 24-1965 (Fed. Cir. Jan. 29, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)
Regeneron holds a Biologics License Application for Eylea®, a therapeutic product containing aflibercept (a VEGF antagonist used in various treatments for eye diseases). Regeneron owns multiple patents related to its Eylea® product, including a patent directed to intravitreal injections using VEGF formulations. Mylan, Samsung Bioepis (SB), and other companies filed abbreviated Biologics License Applications (aBLAs) with the US Food and Drug Administration (FDA) seeking approval to market Eylea® biosimilars. Regeneron brought suit against these parties asserting infringement of its patent and filed a motion for a preliminary injunction.
The district court granted the preliminary injunction against SB, enjoining it from offering for sale or selling the subject of its aBLA without a license from Regeneron. SB appealed, arguing that:
The exercise of personal jurisdiction over it was improper.
There was a substantial question of invalidity of the patent under either obviousness-type double patenting or lack of adequate written description.
There was no causal nexus established.
The Federal Circuit upheld the exercise of personal jurisdiction on SB, finding that SB had minimum contacts with the state of West Virginia. SB is headquartered in South Korea and entered into a development and commercialization agreement with Biogen for a biosimilar to Eylea®, SB15, that gives SB continuing rights and responsibilities as the agreement is implemented. The Court found that SB did not have to distribute the product itself under the agreement for it to be subject to personal jurisdiction. Further, the Court found that SB’s aBLA and internal documentation indicated an intent to distribute SB15 US-wide, which was sufficient to establish intent to distribute the product in West Virginia.
The Federal Circuit also upheld the district court’s grant of the preliminary injunction. SB invoked another patent in the same family as the asserted patent that was directed to an intravitreal injection containing a VEGF trap as the reference patent for an obviousness-type double patenting theory. The Federal Circuit upheld the district court’s findings that the stability requirement, the “glycosylated” requirement, and the “vial” limitations in the claims of the asserted patent were all patentably distinct from the reference patent. The Court found that the stability requirement recited in the asserted patent was more specific than, and not inherent within, the reference patent. The Court further agreed that the reference patent embraced both non-glycosylated and glycosylated aflibercept, not only the glycosylated aflibercept contained in the asserted patent claims.
The Federal Circuit then addressed SB’s arguments that the specification lacked sufficient written description for the claimed glycosylation and stability requirements of the asserted patent. The Court rebuffed SB’s argument, finding that the specification described an embodiment with glycosylated aflibercept and crediting expert testimony that a person of ordinary skill in the art (POSA) would understand from the example that aflibercept could be glycosylated at those specific residues. The Court also disagreed with SB’s argument that the upper and lower bounds of the stability requirements were not described in the specification because a specification does not need to express the details of every embodiment of the invention, and credited expert testimony that a POSA would understand from the specification that those bounds would be included.
Finally, the Federal Circuit addressed SB’s argument that the district court erred in finding a causal nexus between SB’s infringement and Regeneron’s irreparable harm. The Court found no evidence that SB possessed or planned to commercialize a noninfringing product and found that the combination recited in the asserted claims (essentially the Eylea® product) was what drove consumer demand.
New PTAB Guidance on Enabling Requirement Under § 102 of the AIA and Construction of Chemical Compound
Synopsis: In a recently issued final written decision, the Patent Trial and Appeal Board (the “Board”) found all challenged claims of U.S. Patent No.11,572,334 (“the ’334 patent”) unpatentable.1 The Board’s decision centered on two issues: (1) when does a prior art patent need to be enabled under § 102 of the America Invents Act (“AIA”) to qualify as an anticipatory reference and (2) as a matter of claim construction, is the claim phrase “the compound of Formula (III) is (Z)-endoxifen” limited to the free base form of endoxifen or does it also encompass other forms of endoxifen (i.e., salts, crystalline forms, solvates, etc.).
On the first point, the Board held that under the current AIA § 102, an anticipation reference must be enabling as of the earliest possible effective filing date of the challenged patent. That is a departure from the Federal Circuit’s precedent under pre-AIA § 102(b), which requires anticipation references to be enabling one year before the effective filing date of the challenged patent. The Board also clarified several procedural aspects related to enablement challenges of anticipation references, including that it is a Patent Owner’s initial burden to prove that an anticipation reference is not enabling, and the types of evidence that a Petitioner may rely on to rebut an enablement challenge.
Turning to claim construction, the Board initially construed the claim phrase “the compound of Formula (III) is (Z)-endoxifen” as encompassing various forms of (Z)-endoxifen in its institution decision. At trial, however, the Board requested additional briefing on the issue, and in its final written decision reversed course and construed the phrase as being limited to only the free base form of (Z)-endoxifen.
The Board’s holdings on these issues offer important guidance to both patent practitioners generally and Hatch-Waxman attorneys specifically.
I. Background
Atossa Therapeutics, Inc. (“Atossa” or “Patent Owner”) owns the ’334 patent, which is titled “Methods for Making and Using Endoxifen.” ’334 patent at Title. The ’334 patent explains that endoxifen is an active metabolite of a drug known as tamoxifen. Id., 2:36-38. “Tamoxifen is a selective estrogen receptor modulator that is used for the treatment of women with endocrine responsive breast cancer.” Id., 1:63-66.
The ’334 patent also explains that there are two isomers of endoxifen: (Z)-endoxifen and (E)-endoxifen. Id., 3:1-44. Of these two isomers, “[i]t is widely accepted that (Z)-endoxifen is the main active metabolite responsible for the clinical efficacy of tamoxifen.” Id., 2:36-38.
With those two points in mind, the ’334 patent discloses “industrially scalable methods of making (Z)-endoxifen or a salt thereof, crystalline forms of endoxif[e]n, and compositions comprising them” as well as “methods for treating hormone-dependent breast and hormone-dependent reproductive tract disorders.” Id., Abstract. The ’334 patent issued with 22 claims, including the following independent claims:
An oral formulation comprising an endoxifen composition encapsulated in an enteric capsule, wherein the endoxifen composition comprises a compound of Formula (III):
wherein at least 90% by weight of the compound of Formula (III) is (Z)-endoxifen.
A method of delivering (Z)-endoxifen to a subject, the method comprising administering to the subject an oral formulation comprising an endoxifen composition encapsulated in an enteric capsule, wherein the endoxifen composition comprises a compound of Formula (III):
wherein at least 90% by weight of the compound of Formula (III) is (Z)-endoxifen.
Id., claims 1 and 15.
Intas Pharmaceuticals Ltd. (“Intas” or “Petitioner”) markets endoxifen under the brand name Zonalta® in India where it is approved “[f]or the acute treatment of manic episodes with or without mixed features of Bipolar I disorder.”2 After the ’334 patent issued on February 7, 2023, Intas filed a petition requesting post-grant review (“PGR”) of all issued claims of the ’334 patent based on one anticipation ground and five separate obviousness grounds. PGR2023-00043, Paper 37 at 6. All six grounds relied on U.S. Patent No. 9,333,190 (“Ahmad”) as a prior art reference. Id.
II. The Board’s Final Written Decision
Anticipation references under AIA § 102 must be enabled as of the effective filing date of the challenged patent
The Board began its decision by noting, among other things, that because the ’334 patent’s earliest possible effective filing date is September 11, 2017, it is subject to the provisions of the AIA. Id. at 7. Likewise, the provisions of AIA § 102 were applied to Petitioner’s anticipation and obviousness grounds. Id., 15-20. That became highly relevant to the Board’s decision because although it has long been a requirement that “[a]n anticipatory reference must also be enabling,” there was “no controlling case law specifically addressing the timeframe of enablement of an anticipatory reference under the current AIA § 102.” Id., 15, 18-19.
The Board explained that “under pre-AIA § 102(b), the Federal Circuit held that the relevant timeframe for determining whether prior art reference is enabling is one year before the effective filing date of the patent-in-suit.” Id., 18 (citing Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001); In re Samour, 571 F.2d 559, 562–63 (CCPA 1978)). In other words, under pre-AIA § 102(b), a prior art reference must be enabling to a person of ordinary skill in the art (“POSA”) at least one year before the priority date of the challenged patent. That requirement was borne out of the one-year bar date of pre-AIA § 102(b). Id., 19.
Turning to the requirements of AIA § 102, the Board held that “[a]lthough AIA § 102(b)(1) provides for a one-year grace period under certain circumstances, that exception does not apply to the facts of this case.” Id. As a result, the Board agreed with Petitioner and “determine[d] that Ahmad need only be enabling prior to the earliest possible effective filing date of the ’334 Patent, i.e., on September 11, 2017.” Id.
Finally, Patent Owner argued that “[p]ost-effective filing date evidence offered to illuminate the post-effective filing date state of the art,” and to establish that an anticipatory reference is enabled, “is improper.” Id. (quoting Patent Owner Sur-reply at 12). The Board disagreed and clarified that under Bristol-Myers Squibb, “the Federal Circuit expressly held that ‘[e]nablement of an anticipatory reference may be demonstrated by a later reference.’” Id. (quoting 246 F.3d at 1379 (citing Donohue, 766 F.2d at 532; Samour, 571 F.2d at 562)). And the Board made clear that it is “Patent Owner’s burden to establish by a preponderance of the evidence that [an anticipatory reference] is not enabling,” consistent with the Federal Circuit’s prior holdings on that issue. Id., 17.
Application of the Board’s AIA § 102 enablement holding to Petitioner’s anticipation ground
Applying its new rule to Petitioner’s grounds, the Board found the claims anticipated. Notably, Patent Owner did not contest the fact that the prior art reference (Ahmad) disclosed every limitation of the challenged claims of the ’334 patent. Id., 20. Rather, Patent Owner argued that Ahmad did not enable the claimed invention as required by AIA § 102. Id. “Specifically, Patent Owner assert[ed] that Ahmad [did] not teach a POSA how to achieve 90% pure (Z)-endoxifen, as required by each of the claims.” Id. “Petitioner argue[d] that Ahmad [was] enabling because using 90% pure (Z)-endoxifen was in the public’s possession, as shown” by other references. Id., 20-21. The Board agreed with Petitioner and held that because Ahmad sufficiently enabled the claims, Patent Owner failed to carry its burden to prove that Ahmad was not enabling. Id., 21, 31.
The Board distinguished this case from two Federal Circuit cases relied on by Patent Owner: Forest Lab’ys, Inc. v. Ivax Pharms., Inc., 501 F.3d 1263 (Fed. Cir. 2007) and Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008). In those cases, the Federal Circuit held that the prior art references did not enable a POSA to make substantially pure isomers (or enantiomers) of the drug compounds recited in the challenged patents. 501 F.3d at 1263; 550 F.3d at 1075. Here, however, the Board found that Ahmad, along with other references in the prior art, taught a POSA how to separate the (E)- and (Z)-isomers of endoxifen, and thus how to make a composition having 90 % pure (Z)-endoxifen. PGR2023-00043, Paper 37 at 21-31.
The Board also rejected Patent Owner’s argument that because “Ahmad does not contain any working examples of the synthetic method that result in a 90% pure (Z)-endoxifen,” the reference is not enabled. Id., 23. Rather, “as Petitioner note[d], the Federal Circuit does not require actual performance to be enabling.” Id. (citing Bristol-Myers, 246 F.3d at 1379). In addition, the Board agreed with Petitioner that two other references demonstrated that a POSA would have been enabled by Ahmad as of the effective filing date. Id., 20-25. While some of those references were published after Ahmad, Petitioner was allowed to rely on those references to demonstrate what was known by a POSA as of that effective filing date. Id.
The Board also rejected several additional technical and scientific arguments that Patent Owner presented, and briefly addressed the Wands factors. Id., 29-31. The Board concluded that “Patent Owner has not shown by a preponderance of the evidence that a POSA reading Ahmad would have been unable to make 90% pure (Z)-endoxifen.” Id., 29. Thus, because Ahmad enabled a POSA to make 90% pure (Z)-endoxifen (i.e., the free base form of (Z)-endoxifen), and because it disclosed every limitation of the challenged claims, those claims were found unpatentable as anticipated by Ahmad.
The claim phrase “the compound of Formula (III) is (Z)-endoxifen” construed as limited to the free base form of (Z)-endoxifen
Another important issue addressed in the Board’s decision was how to construe the claim phrase “the compound of Formula (III) is (Z)-endoxifen.” PGR2023-00043, Paper 37 at 10-13. The Board initially “construed sua sponte” this claim phrase in its Institution Decision because they “disagreed with Patent Owner’s argument that the phrase is limited to the free base form of (Z)-endoxifen.” Id., 10. Instead, the Board initially determined “that for purposes of the Institution Decision, the construction of ‘the compound of Formula (III) is (Z)-endoxifen’ includes the polymorphic, salt, free base, co-crystal and solvate forms of (Z)-endoxifen.” Id.
After post-trial briefing on this issue, requested by the Board “[d]uring trial,” the Board reversed course and held that “the intrinsic evidence supports construing the limitation ‘the compound of Formula (III) is (Z)-endoxifen’ to be limited to the (Z)-endoxifen free base form and excludes the salt and solvate forms.” Id., 10, 13. While the Board acknowledged that the specification broadly defines “the compound of Formula (III)” to encompass various forms of endoxifen (i.e., polymorphic forms, salts, etc.), “[t]he claim further narrows ‘the compound of formula (III)’ to ‘(Z)-endoxifen.’” Id., 12. And the Board explained that the question was “whether ‘(Z)-endoxifen’ should be construed broadly to include the free base and salt form or if it should be limited to its free base form.” Id.
The Board reasoned that “[w]hen read as a whole … the Specification consistently identifies (Z)-endoxifen salts as separate from (Z)-endoxifen.” Id., 13. Specifically, “the ’334 Patent refers to ‘(Z)-endoxifen and salts thereof,’ suggesting that references to ‘(Z)-endoxifen’ alone do not include the salt forms unless expressly identified as such.” Id. And the Board noted that the specification’s focus was on “preparations of endoxifen free base that are … at least 90% (Z)-endoxifen free base.” Id., 13 (emphasis added) (quoting ’334 patent at 83:43-45).
In view of “the language of the claims and the Specification as a whole,” the Board determined “that the intrinsic evidence supports construing the limitation ‘the compound of Formula (III) is (Z)-endoxifen’ to be limited to the (Z)-endoxifen free base form and excludes the salt and solvate forms.” Id.
III. Conclusion and Takeaways
The Board’s decision provides important guidance on several issues, most notably that a prior art patent must be enabling as of the earliest effective filing date of the challenged patent to serve as an anticipatory reference under AIA § 102. It is worth noting, however, that the Board implied that there may be situations under AIA § 102(b)(1), which “provides for a one-year grace period under certain circumstances,” in which an anticipatory reference may need to be enabled before the effective filing date of the challenged patent. Id., 19. Relatedly, the Board’s decision reaffirms that if a patent owner challenges whether an anticipation reference is enabled, the petitioner may rely on other references, including later-published references, to overcome the patent owner’s enablement challenge.
This decision also highlights the importance of claim construction in the context of patents that claim chemical compounds by structure and/or name. Indeed, whether a claim is limited to only the free base form of a compound (as was the case here) or if it also encompasses other forms of the compound (i.e., salts, polymorphs, etc.) can be critically important to both infringement and invalidity issues in litigation. While the Board determined that the ’334 patent was limited to the free base form of (Z)-endoxifen, it was admittedly a close call. Both patent prosecutors and litigators should review the Board’s decision here when considering whether a claimed chemical compound is limited to a particular form or if it more broadly encompasses multiple forms of the compound.
[1] Intas Pharms. Ltd. v. Atossa Therapeutics, Inc., PGR2023-00043, Paper 37 (PTAB Jan. 29, 2025)
[2] List of new drugs approved in the year 2019 till date. Central Drugs Standard Control Organization, Government of India. Available at: https:// cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/ UploadApprovalNewDrugs/newdrugaapproaldec2019.pdf.
From the Year of the Dragon to the Year of the Snake: China’s Food Law Year-in-Review 2024
The year of 2024 has witnessed a wave of positive developments in China’s food regulatory system, marked by legislative advancement and a strengthened focus on food safety. We saw the authority taking significant strides in refining its regulatory framework, such as releasing safety evaluation guidelines for genetically modified microorganisms (GMMs) in novel food applications, and the continued efforts to implement the “Three Reduction” initiative (i.e., reductions in fat, salt, and sugar) by proposing the voluntary front-of-pack nutrition labeling (FOPNL) scheme.
This article highlights some key developments of 2024 in the food regulatory space that may impact business operations in China, followed by a forward look at the regulatory trends and developments in 2025.
New requirements for the safety evaluation materials for “three new foods” (i.e., new food ingredients, new food additives, and new food packaging materials)[1], for the first time, detail the data required for applications of food ingredients/additives and food packaging materials involving GMMs. The regulatory pathway for those new foods involving GMMs is now clearly defined, under which companies can submit applications to the Chinese authority seeking approvals. More details can be found in our CRM – China Notifies Requirements for Safety Evaluation Materials for “Three New Foods.”
Food ingredients and additives continued to be approved by the Chinese National Health Commission (NHC) in 2024. Specifically, NHC approved a total of 12 food ingredients and 28 food additives through its 2024 announcements. Compared with 2023, the total number of applications for new food ingredients and additives increased, reflecting a growing recognition among companies of the benefits that come with the approval of novel foods. However, despite the surge in applications, the total number of approvals has experienced a slight decline, which could suggest a more stringent review threshold by the Chinese government. Notably, in 2024, China continued to review and approve new nutrition fortification substances produced by GMMs, such as 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT).
China’s food labeling system is poised for a significant update with the release of two draft regulations for prepackaged food labeling, namely Food Safety National Standard for the Labeling of Prepackaged Foods (GB 7718-xxxx)[2] and Measures for Supervision and Administration of Food Labeling[3]. The two drafts are the result of years of coordination between NHC and the State Administration of Market Regulation (SAMR), aimed at optimizing the management of food labels. However, gaps appear to remain in the released two drafts, and thus, industry may face new food labeling challenges once they are finalized, likely in 2025. For further information, please refer to our CRM – Two Chinese Food Agencies Release Drafts of New Food Labeling Requirements.
In the meantime, in line with China’s long-term agenda “Healthy China 2030” and its ongoing campaigns to reduce the intake of fat, salt, and sugar in food, the government, in August 2024, released a draft voluntary national standard Guidelines for Graphic Symbol of Front-of-Pack Nutrition Labeling for Prepackaged Food[4]. The standard outlines four types of FOPNL symbols tailored to four different food categories. For further information, please refer to our CRM – China Releases Draft Guidelines for Front-of-Pack Nutrition Labeling.
The regulatory system for special foods (e.g., foods making health claims and foods for special medical purposes (FSMP)) continued to evolve in 2024. One notable action is the authority’s call for the submission of new function claims for health foods. Submissions were reviewed in a dedicated program, offering a valuable opportunity for producers of health foods to propose health/functional claims accepted in other markets but not yet permitted in China. A more detailed discussion regarding this submission can be found in our previous CRM – China Calls for Submissions of New Health Claims.
It is worth mentioning that for special foods, China implemented[5] a significant regulatory adjustment in the Hainan Free Trade Port, temporarily amending the Food Safety Law (FSL) to facilitate the import and use of special foods, covering health foods and FSMP. In this new framework, special foods are exempted from pre-market registration from the central government under the FSL; instead, designated medical institutions within the Bo’Ao Lecheng International Medical Tourism Pilot Zone are permitted to temporarily import and use, upon approval of the local Hainan provincial government. The local authority further issued[6] two interim provisions outlining the application procedures and safety management requirements, as well as streamlining the customs clearance process. These measures may benefit overseas manufacturers by creating a more accessible and efficient pathway for the import of health foods and FSMP, despite the fact that its sale and use are limited to the designated medical institutions only.
Alternative proteins remain a priority on the regulatory agenda of the Chinese government. China is developing draft guidelines for assessing cultured meat and related products, underscoring its ongoing efforts to establish a regulatory framework for this emerging sector. Recently, a new definition for “cultured meat” was proposed in the national standard for food terminology[7], recognizing this innovative product category for the first time. In addition, in November 2024, the Chinese Institute of Food Science and Technology (CIFST) released a draft industry standard, i.e., QB/T×××××-×××× General Principles for Plant-based Foods[8], which, once finalized, will serve as the first industry-standard specifically designed for plant-based foods. These initiatives highlight China’s commitment to integrating alternative proteins into its food regulatory system, and a clearer regulatory guidance for products such as cultured meat is expected to be provided by the government so that China could join other countries starting to review and approve cultured foods.
National food safety standards such as testing methods for foods, food flavoring, maximum residue limits for pesticides in foods, standards for food products (e.g., milk powder), and food additives were further developed in 2024. For example, China published GB 2760-2024 General Standard for the Use of Food Additives[9] to incorporate the latest approvals of new food additives since the publication of its last version in 2014. It also updates the use principle and use scope of processing aids, food enzymes, as well as food flavoring substances. GB 2760-2024 will become effective on February 8, 2025. Industry should review this new standard to ensure compliance with the latest provisions.
At the enforcement level, the Supreme People’s Court issued a judicial interpretation on punitive damages for food and drug cases, strengthening the protection of consumer rights in China[10]. Its interpretation introduces penalties, including fines and detention, to combat illegal activities such as blackmailing for compensation or fabricated lawsuits. In addition to judicial actions, SAMR issued[11] a draft list of conditions in which first-time offenders and minor violations of food safety regulations can be exempt from penalties, which is anticipated to be finalized in 2025. These developments reflect a regulatory trend of enhancing consumer protection while fostering a more business-friendly environment in food sectors in China.
Outlook for 2025
As we look ahead to 2025, the Year of the Snake, China’s commitment to strengthening its food safety and applying innovation in the food industry is set to reach a new height. For starters, the Chinese General Administration of Customs (GAC) just proposed amendments[12] to the Regulations on Registration and Administration of Overseas Manufacturers of Imported Food (GAC Decree No. 248), marking a significant step forward in streamlining facility registration and addressing practical challenges for international stakeholders. More details can be found in our CRM – Breaking News: China To Revise Registration Requirements for Foreign Food Facilities.
[1] https://www.cfsa.net.cn/zxdt/tzgg/2024/14077.shtml[2] http://www.nhc.gov.cn/wjw/yjzj/202406/4269b464a5b94e66ab13d67668af2003.shtml[3] https://www.samr.gov.cn/hd/zjdc/art/2024/art_fbb1fe25da1d4627a914674412f3fa80.html[4] https://std.samr.gov.cn/gb/search/gbDetailed?id=02DDAC68065BAD4CE06397BE0A0A1546[5] https://www.gov.cn/yaowen/liebiao/202406/content_6960124.htm[6] https://www.hainan.gov.cn/hainan/szfwj/202412/66b8298908aa4939bedef4dcacfa026e.shtml[7] https://www.sac.gov.cn/xw/zqyj/art/2024/art_0178f1202a63482ca857504875c8501b.html[8] https://www.cifst.org.cn/a/dynamic/tongzhi/20241122/3186.html[9] http://www.nhc.gov.cn/sps/s7891/202403/a51bf4bd1c1545d4bada095735603b6f.shtml[10] https://www.court.gov.cn/fabu/xiangqing/440841.html[11] https://www.samr.gov.cn/hd/zjdc/art/2024/art_1dfab59163474e02bf6fc9fd19c79b7a.html[12] http://www.customs.gov.cn/customs/302452/302329/zjz/6297231/index.html
Legislators Introduce Feed Lot Testing Bill
On February 3, 2025, Senator Cory Booker and Representative Rosa DeLauro introduced a bill to provide FDA the authority to collect microbial samples at feed lots during foodborne illness outbreaks or when there is a public health need.
The bill is a response to the recent spread of H5N1 (bird flu), as well as persistent foodborne illness risks. According to Rep. DeLauro, the bill, titled the Expanded Food Safety Investigation Act, will “ensure FDA has the power to investigate corporate agribusinesses, respond effectively to public health threats, and protect American consumers.”
The goal of the bill, which is endorsed by several non-governmental organizations, is to allow FDA to enter feed lots, which have been linked to outbreaks involving fresh produce due to water runoff adjacent to irrigation canals causing contamination of crops.
The full text of the bill is not yet available. Keller and Heckman will continue to monitor the bill, along with other food safety legislation.
Bill Proposed to Block USDA from Using Funds to Implement Proposed Salmonella Framework
Last month, Representatives Steven Womack (Arkansas) and Tracey Mann (Kansas) introduced a bill which, if passed, would prevent USDA from finalizing, implementing, administering, or enforcing the proposed rule “Salmonella Framework for Raw Poultry Products.” 89 Fed. Reg. 64678 (Aug. 7, 2024).
Under the proposed rule, raw poultry containing 10 or more colony forming units (CFU) of any Salmonella and any detectable level of Salmonella serotypes of public health significance would be considered adulterated under the Poultry Products Inspection Act. If the standard is finalized, it would also be accompanied by routine USDA sampling and verification testing for Salmonella. The proposal would also require that poultry slaughter establishments develop and implement written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operations and maintain records documenting those procedures.
The bill was introduced the same week that the Government Accountability Office (GAO) issued a report noting that USDA’s Food Safety and Inspection Service (FSIS) had paused work on several microbial adulterant standards to work on the Salmonella framework and recommending that the agency develop a plan to prioritize its proposals and determine which standards are needed.
Biden USDA Issues Technical Guidelines for Climate-Smart Agriculture Crops Used as Biofuel Feedstocks
On January 17, 2025, the Biden U.S. Department of Agriculture (USDA) issued an interim final rule with a request for comment that establishes technical guidelines for quantifying, reporting, and verifying the greenhouse gas (GHG) emissions associated with agricultural production of biofuel feedstock commodity crops grown in the United States in the context of environmental service markets. 90 Fed. Reg. 5497. The rule establishes guidelines for the reporting and verification of practices and technologies used to produce certain commodity crops that result in lower GHG emissions or increases in carbon storage. The notice notes that these practices are referred to in the context of this rule as climate-smart agriculture (CSA) practices. The guidelines established through the rule articulate an approach for farm producers to quantify the GHG emissions associated with crops produced using one or more CSA practices. The guidelines also articulate a framework for how information regarding GHG emissions, resulting from the production of biofuel feedstock commodity crops, could be reported and tracked throughout the supply chain. The effective date was January 17, 2025. The notice states that USDA will consider comments received by March 18, 2025.
This Week in 340B: January 28 – February 3, 2025
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.
Issues at Stake: HRSA Audit Process; Contract Pharmacy; Rebate Model; Other
In one Health Resources and Services Administration (HRSA) audit process case, the plaintiff filed a brief in opposition to the government’s motion to dismiss.
In a Freedom of Information Act (FOIA) case, the government filed a motion for summary judgment.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants’ filed an amended answer and defenses to plaintiff’s second amended complaint, and plaintiff filed a response in opposition to defendants’ motion to compel plaintiff’s claims spreadsheet.
In several cases challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the court granted the parties’ joint motion for a stipulated protective order.
In a case challenging a proposed state law governing contract pharmacy arrangements in West Virginia, the court granted plaintiff’s third motion for an extension of time to respond to defendants’ motion to consolidate.
In a case challenging HRSA’s policy prohibiting manufacturer rebate models, three intervenors filed a motion to intervene.
In a case against HRSA alleging that HRSA prevented a 340B covered entity from accessing the 340B Program, the court granted the covered entity’s unopposed motion to stay all deadlines.
A drug manufacturer filed suit against HRSA to challenge certain of HRSA’s eligibility determinations.
House Committee Will Hold Hearing on “The State of U.S. Science and Technology: Ensuring U.S. Global Leadership”
The House Committee on Science, Space, and Technology will hold a hearing on February 5, 2025, on “The State of U.S. Science and Technology: Ensuring U.S. Global Leadership.” According to the Hearing Charter, the purpose of the hearing is “to assess the current condition of the United States’s science and technology enterprise and its vital role in the global innovation race.” By examining public and private investments in the United States, the Committee will also have the opportunity to discuss key objectives and strategies for maintaining U.S. leadership in driving future advancements. The Charter includes biotechnology on its list of critical technologies, stating that it has “wide-reaching applications for both commercial and military sectors, offering the potential to transform various critical industries.” Biotechnology breakthroughs include the development of improved medicines and therapeutics, agricultural productivity, biofuels and bioenergetic solutions, and substantial progress in material science and manufacturing techniques. The Committee is scheduled to hear from the following witnesses:
Heather Wilson, President, The University of Texas at El Paso, and Former Secretary of the U.S. Air Force;
Walter Copan, Vice President for Research and Technology Transfer, Colorado School of Mines, and Former Director of the National Institute of Standards and Technology;
Dr. Sudip Parikh, Chief Executive Officer and Executive Publisher, American Association for the Advancement of Science; and
Samuel Hammond, Chief Economist, Foundation for American Innovation.
The Hearing Charter lists the following overarching questions:
What is the current state of U.S. leadership in science and technology, and what is the outlook for continued leadership, particularly in areas that will help drive economic competitiveness and national security in the coming decade?
Why is it important for the United States to maintain leading capabilities in both fundamental research and technology development, and what are the consequences of loss of leadership, especially to China?
What makes the U.S. science and technology ecosystem of government, academia, and industry unique in the world, and how can we continue to use that system to our competitive advantage?
How has the relationship between the federal government and private industry for supporting science and technology changed in the last decade? How should we look to improve this cooperation in the future?