2023 Patent News Year in Review

2023 was a relatively quiet year in the patent world. Nevertheless, there were a few major developments, including a Supreme Court decision that directly affects patent applicants and several pieces of proposed legislation that would make significant changes to patent law. 

Below are a few of the most important patent developments over the past year. 

At the USPTO 

The USPTO made a number of updates — including to the systems most patent attorneys use every day and have been familiar with for many years. 

Out with the old, in with the new

The Office announced in November that, as part of its IT modernization efforts, it was retiring the decades-old EFS-Web and Private PAIR systems. This follows the Office’s July 2022 retirement of the Public PAIR system. In their place, the Office is now using the Patent Center, a “one-stop-shop” for filing, application, and customer self-administration management. Patent Center offers several benefits for users, including: 

• • The ability to upload patent application specifications, claims, abstracts, and drawings in a single DOCX file 
  • The ability to upload multiple documents at once using a drag-and-drop interface
  • The ability download multiple documents at once in a single PDF or ZIP file
  • The ability to confirm the status of submitted documents and payments with separate submission and payment receipts
  • A training mode to allow new users to familiarize themselves with the system without making official submissions 

Director Vidal states that Patent Center will also lead to better processing and greater efficiency for the Office. 

USPTO releases COVID-19 diagnostics patents survey 

In October, the Office released a study that examines innovation in COVID-19 diagnostics titled Diagnosing COVID-19: A perspective from U.S. patenting activity. The study made several key findings. First, COVID-19 diagnostic patents made up about 30% of all COVID-19 patents, and applications for such patents peaked in April, May, and June of 2020. Bucking the USPTO norm, in which large companies make up the bulk of patent filings, small companies and universities dominated in this space. While diagnostic technologies can implicate a wide range of technologies and scientific methods, nearly 80% of all COVID-19 diagnostic patents fell into just two CPC subclasses: G01N (Analyze materials by chemical/physical properties) and C12Q (Measuring enzymes, nucleic acids, microorganisms). The study is the first to focus specifically on COVID-19 diagnostic patents. 

One millionth design patent issued 

Design patents account for only 5.8% of all applications filed at the USPTO, according to Juristat data. Applicants in Technology Center 2900, which handles design patents, enjoy a 99% allowance rate — significantly higher than the USPTO’s overall allowance rate of 74%. In September, the Office announced that it had issued its one millionth design patent. Granted to Agustina Huckaby of Fort Worth, Texas, the patent claims an ornamental design for a dispensing comb. Huckaby is a cosmetologist who markets her products under the name Pomp and Powder.  

USPTO releases five-year strategic plan 

The USPTO released its 2022-2026 Strategic Plan in June. The Plan sets out five major goals: 

1. 1. Drive inclusive innovation and global competitiveness
   2. Promote the efficient delivery of reliable intellectual property (IP) rights 
   3. Promote the protection of IP against new and persistent threats
   4. Bring innovation to impact the public good
   5. Generate impactful employee and customer experiences by maximizing agency operations

Each of these goals encompasses one or more objectives (i.e., measurable, specific initiatives the USPTO will undertake to accomplish each goal), strategies (i.e., specific activities the USPTO will perform to accomplish those objectives), and key performance indicators (i.e., change indicators that allow the USPTO to measure its progress toward each objective objectively). 

In the courts 

The Supreme Court decided a single patent case in 2023. However, there was no shortage of action elsewhere in the court system, including an unusually bitter and public dispute among colleagues at the Federal Circuit. The Supreme Court is also considering a number of petitions for certiorari in patent-related cases.

Amgen v. Sanofi 

In Amgen, Inc. v. Sanofi, 598 US  ___ (2023), the Court was asked to determine whether certain claims in two Amgen patent applications failed to satisfy the Patent Act’s enablement clause. Under 35 USC § 112(a), a patent specification “must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same…”

The patent applications at issue contained claims for entire genuses of certain antibodies — specifically, antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors].” While the application’s specification identified 26 example antibodies that would meet the above definition, it clarified that the full genus it was claiming was much larger than those examples. 

The Court held that the claims were not enabled within the meaning of § 112(a), explaining that If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the specification must enable a skilled artisan to make and use the entire class.

Petitions for certiorari 

As of December 2023, the Supreme Court is considering petitions for certiorari in several patent-related cases. Those petitions, as well as the issues they present to the Court, are below:  

• • Intel Corporation v. Vidal: Whether 35 USC § 314(d), which bars judicial review of the determination whether to institute inter partes review (IPR), also applies to claims brought under the Administrative Procedure Act challenging the non-statutory factors the USPTO applies in deciding whether to institute IPR
  • MacNeil IP, LLC v. Yita, LLC: (1) Whether it is legal error for the Court of Appeals for the Federal Circuit to substitute its own findings of fact for those of an agency (in this case, the Patent Trial and Appeal Board (PTAB)) and reverse on that basis instead of remanding, and (2) whether the Federal Circuit’s expanding practice of reversing agency decisions in lieu of remand is in conflict with the Courts precedents. 
  • VirnetX, Inc. v. Mangrove Partners Master Fund, Ltd., at al.: (1) Whether the Federal Circuit erred in upholding the joinder of a party to an IPR proceeding where the joined party did not properly file a petition for IPR within the statutory time limit, and (2) Whether the Commissioner of Patents’ review of a PTAB decision on behalf of the Director of the USPTO while the Director’s office was vacant violated the Federal Vacancies Reform Act. 
  • Realtime Data, LLC v. Fortinet, Inc., et al.: Whether certain patent claims directed to improvements in the functioning of computer systems through novel uses of data compression techniques are ineligible for patent protection under the abstract idea exception to 35 USC § 101. 
  • Fleur T. Tehrani v. Hamilton Technologies, LLC: (1) Whether the Federal Circuit erred by declaring a non-expert a person of ordinary skill in the art despite evidence presented to the contrary; (2) whether the Federal Circuit erred by relying on unsupported statements against the petitioner in the face of reliable published evidence to the contrary; (3) whether the Federal Circuit erred by affirming a decision of the PTAB invalidating certain challenged patent claims while none of the requirements of those claims wiremen by any combinations of the alleged prior art; (4) whether the Federal Circuit erred by using (a) a paper presenting untrue results and (b) a fatal device against certain challenged patent claims; and (5) whether the Federal Circuit erred by affirming a decision of the PTAB invalidating certain challenged patent claims while none of the requirements of obviousness under 35 USC § 103(a) were met by either of the alleged grounds. 
  • Traxcell Technologies, LLC v. Sprint Communications Company, LP, et al.: (1) Where the petitioner’s patent claims were not fully rejected until a district court judge approved the magistrate judge’s ruling disposing of the same, whether the petitioner’s conduct in pressing its claims in the meantime and before that final ruling by the district court can be relied upon to conclude that the petitioner “knew or should have known” its claims were baseless such that this was an “exceptional” case under 35 USC § 285 justifying an award of attorney’s fees, and (2) whether the magistrate judge’s decision rejecting the petitioner’s infringement claims — a decision to which it timely objected — is a final ruling such that the petitioner should have known that its claims were baseless even when that ruling had not yet been adopted by the district court judge as a final disposition. 

Given that the Court hears very few of the cases presented to it, it is unlikely that the Court will grant certiorari in many of these cases — particularly in light of its recent history of declining to review cases presenting § 101 issues. 

Update: Federal Circuit Judge Pauline Newman suspended from hearing cases for one year

A special committee of the Court of Appeals for the Federal Circuit had found that Judge Pauline Newman’s refusal to cooperate with certain orders of the committee constituted “serious misconduct” and that the committee was recommending a suspension of case assignments to Judge Newman for one year or until she ceases her misconduct. 

Judge Newman, 96, has been accused by colleagues and staffers of being unfit to discharge her duties due to mental disabilities associated with her advanced age. According to an order of the Judicial Council, the special committee investigated a complaint against Judge Newman in March and, after conducting more than 20 interviews with court staff, determined that she may be experiencing “significant mental problems including memory loss, lack of comprehension, confusion, and an inability to perform basic tasks that she previously was able to perform with ease.” The committee ordered Judge Newman to undergo a neurological examination and a neuropsychological examination. Judge Newman refused to cooperate with the order, even going so far as to file suit against her colleagues. 

Now, the Judicial Council has unanimously made the following findings: 

1. 1. The evidence establishes reasonable concerns that Judge Newman suffers from a disability preventing her from effectively discharging the duties of her office. 
   2. The Judicial Council is being deprived of information that is important to a fully informed determination with reasonable medical certainty of whether Judge Newman has a disability that renders her unable to effectively discharge the duties of her office as an active judge because she has refused to undergo the ordered medical evaluations, refused to produce relevant medical records, and refused to sit for an interview.
   3. Judge Newman has not established good cause for her failure to cooperate with the special committee’s investigation through her refusal to undergo the ordered testing, produce medical records, or sit for an interview. 
   4. Judge Newman’s refusal, without good cause, to cooperate with the special committee’s investigation constitutes serious misconduct, as it has prejudiced the effective and expeditious administration of the business of the courts.

Accordingly, the Judicial Council ordered that Judge Newman be barred from hearing any cases, either at the panel or en banc level, for a period of one year. The suspension may be renewed at the end of that period if Judge Newman continues to refuse to cooperate or may be modified or rescinded if she chooses to cooperate. 

In Congress 

Three patent-related bills were introduced in Congress in 2023. As in previous years, a handful of legislators have been responsible for the bills, most notably Thom Tillis, Chris Coons, and Dick Durbin. The bills are bipartisan in nature and would make significant changes to both patent prosecution and post-grant practice. 

The Patent Eligibility Restoration Act of 2023

The Patent Eligibility Restoration Act of 2023 was introduced by Senators Tillis (R-NC) and Coons (D-DE) in June. The bill would make significant, sweeping changes to patent eligibility law. Specifically, it would abolish all of the judicially created exceptions to § 101 (i.e., abstract ideas, laws of nature, and natural phenomena) and replace them with the following categories of inventions that would be ineligible for patent protection: 

1. 1. A mathematical formula that is not part of a useful process, machine, manufacture, or composition of matter, or any useful improvement thereof 
   2. A mental process performed solely in the mind of a human being
   3. An unmodified human gene, as that gene exists in the human body 
   4. An unmodified natural material, as that material exists in nature
   5. A process that is substantially economic, financial, business, social, cultural, or artistic 

With regard to the fifth category, the bill clarifies that such processes include, for example, methods of doing business, performing dance moves, offering marriage proposals, and the like. Furthermore, adding a non-essential reference to a computer by merely stating “do it on a computer” is not enough to render a patent-ineligible process patent-eligible. However, any process that cannot be practically performed without the use of a machine is eligible for patent protection. 

Senator Coons stated that he believes changes to patent eligibility law are necessary because “[c]ritical technologies like medical diagnostics and artificial intelligence can be protected with patents in Europe and China, but not in the United States.” Likewise, Senator Tillis believes that “our current Supreme Court’s patent eligibility jurisprudence is undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations.”

The Interagency Patent Coordination and Improvement Act of 2023

The Interagency Patent Coordination and Improvement Act of 2023 was introduced by Senators Durbin (D-IL), Tillis (R-NC), Grassley (R-IA), Coons (D-DE), Welch (D-VT), and Feinstein (D-CA) in January. The bill would establish a task force to increase cooperation between the USPTO and the FDA on issues related to pharmaceutical patents. There is a significant degree of regulatory overlap between the USPTO and FDA when a product claimed in a patent application is also subject to FDA approval. For many years, industry experts have alleged that applicants frequently make contradictory statements to the two agencies or fail to act with complete candor in disclosing information perceived to be harmful to their respective applications. 

To remedy such inefficiencies, the task force would carry out the following functions: 

1. 1. Share information on the general processes of the USPTO and FDA, including what each agency considers in its respective review of applications and how each agency evaluates those applications
   2. Share information on new approvals of patents, human drugs and biological products, new technologies and prior art, and scientific trends and developments.
   3. Establish a process that requires the Director of the USPTO to request from the Commissioner of Food and Drugs (and for the Commissioner to provide) certain information regarding drug products for use by patent examiners 
   4. Establish a process to ensure that, at the request of the Director of the USPTO, the Commissioner of Food and Drugs will furnish specific information to the USPTO concerning certain applications, responses, or affidavits after rejections

The PREVAIL Act 

The PREVAIL Act (i.e., the Promoting and Respecting Economically Vital American Innovation Leadership Act) was introduced by Senators Coons (D-DE), Tillis (R-NC), Durbin (D-IL), and Hirono (D-HI) in July. Its purpose is to overhaul post-grant proceedings at the PTAB to remedy perceived abuses inherent in the current scheme and to even the playing field between petitioners and patent owners. The PTAB has long been viewed as a petitioner-friendly venue, with one judge famously referring to it as a “death squad for patents.” 

The bill would make several changes to post-grant law and procedure, including: 

• • Requiring Article III-style standing for IPR petitioners. Currently, anyone who is not the owner of the patent may file a petition for IPR or post-grant review. 
  • Preventing multiple challenges to the same patent by prohibiting any entity that is financially contributing to a PTAB challenge from mounting its own challenge. 
  • Preventing time-barred parties from joining post-grant proceedings brought by other parties. Currently, joinder is permitted for petitioners who are time-barred (i.e., those who fail to file a post-grant challenge against an asserted patent within one year of being sued for infringement).
  • Preventing parties from challenging the same patent multiple times by applying estoppel when a petition is filed. This contrasts with the current practice of applying estoppel only upon the issuance of a final written decision. 
  • Applying the “clear and convincing” standard used in district courts when determining invalidity. Currently, a petitioner at the PTAB must only show that the patent is invalid by a preponderance of the evidence. 
  • Barring parties from challenging the validity of a patent in multiple forums. Current practice allows for concurrent proceedings in the PTAB and district court.
  • Barring parties from asserting the same prior art or arguments in multiple USPTO proceedings (such as in an IPR and a reexamination proceeding). 

The cumulative effect of the proposed changes likely would make it more difficult for patent challengers to succeed at the PTAB. 

Regardless of how developments over the past year play out, the best way to ensure that your patent practice is prepared for the challenges ahead is to base your decisions on objective data. Want to understand how Juristat can help you understand how industry changes impact examiner behavior, response strategies, and more? Request a demo today.