Proposed U.S. Sensible Classification Act of 2023

U.S. Senators John Cornyn and Mark Warner have proposed an act as part of the National Defense Authorization Act which would update the U.S. government’s classification system.  The press release from Senator Cornyn’s office states:

WASHINGTON – U.S. Senator John Cornyn (R-TX) and Senate Select Committee on Intelligence Chairman Mark Warner (D-VA) released the following statements after their Sensible Classification Act of 2023, which would increase accountability and oversight of the classification system, limit overclassification, and direct federal agencies to justify security clearance requirements, passed the Senate as part of the Intelligence Authorization Act included in the National Defense Authorization Act:

“Sensitive information helps the U.S. stay one step ahead of our adversaries, but it’s also important for the federal government to be transparent with the American people and our allies,” said Sen. Cornyn. “By streamlining and modernizing the declassification process, this bill would help strike the delicate balance between transparency and secrecy, and it is critical it be included in the final defense authorization legislation.”

 “The government systematically overclassifies too much information, at a dangerous cost to both the nation’s security and the public trust.  At the same time, we too often fail to protect the nation’s most important secrets.  As chairman of the Senate Intelligence Committee, I think it is clear that our security classification system is badly in need of change,” said Sen. Warner. “Given the explosion in digital records, the status quo is no longer tenable. We’ve got too many people with access to a system that is devoid of accountability and has grown increasingly byzantine, bureaucratic, and outmoded. We need to protect our national security secrets, and then declassify those secrets when protections are no longer necessary.  I’m glad that Congress is taking some action to establish accountability.”

The legislation is also cosponsored by Senators Jerry Moran (R-KS), Ron Wyden (D-OR), Susan Collins (R-ME), Angus King (I-ME), Mike Rounds (R-SD), Martin Heinrich (D-NM), James Lankford (R-OK), and Bob Casey (D-PA).

Background:  

The classification system is in urgent need of reform. Technology has made it easier to classify files, but greater accountability and oversight is needed to ensure appropriate and timely declassification to rebuild trust between the government and the American people. Too many people have access to classified information, which contributes to rampant overclassification and lack of accountability.

The Sensible Classification Act of 2023 will codify classification authority, streamline the processes for declassification, direct training focused on sensible classification, invest in new technology to modernize the classification system, and direct a review regarding the necessity of existing security clearances to identify potential areas for additional reforms. This legislation:

• Codifies classification authority as the President, Vice President, head of an agency, or the individual to whom such authority has been delegated in line with current practice pursuant to Executive Order 13526 and specifies how the authority is delegated and the training required to receive it;
• Promotes efficient declassification for records under the Freedom of Information Act or Mandatory Declassification Review;
• Requires training to promote sensible classification;
• Improves the Public Interest Declassification Board (PIDB) by allowing for additional staff to be hired and allowing members to serve until a successor is appointed;
• Directs the federal government to develop a federated and integrated technology solution to the issue of classification and declassification;
• And directs federal agencies to conduct a study on the necessity of number and types of security clearances with sufficient justification.

Bipartisan Letter from U.S. Senators on Drug Patent Thickets

In June, U.S. Senators Leahy (Democrat) and Cornyn (Republican) (and others) sent a letter to the United States Patent and Trademark Office requesting that the USPTO review practices concerning granting “an excessive” amount of patents on pharmaceuticals, such as biologics, that may be driving up drug pricing costs. 

The press release concerning the letter states:

Senators Patrick Leahy (D-VT) and John Cornyn (R-TX) led a bipartisan letter Wednesday asking the U.S. Patent and Trademark Office to address an issue that is a significant cause of soaring drug prices.  Senators Richard Blumenthal (D-CT), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Mike Braun (R-IN) also joined the letter.

The senators explained that drug companies and other large companies sometimes artificially extend the period in which they can charge high prices by filing many patents on nearly the same invention, creating a so-called patent thicket of dozens of patents on a single drug.  Those thickets make any challenge to the patents, or to the drug companies’ pricing of the covered drug, nearly impossible.  Because of the exorbitant cost of taking on each of the patents in these patent thickets, generic manufacturers are impeded from entering the market, hurting competition and raising prices for American consumers.  The secondary patents, which are similar to the originals, often receive less scrutiny from the Patent Office but have an outsized effect on everyday Americans who struggle to afford expensive medication.

Leahy believes the Patent Office has the ability to address this abusive practice, and he is asking the agency to take action to rein in this misuse of the patent system.  The letter requests that the Patent Office look into specific ideas for curbing the abuse and “take regulatory steps to improve patent quality and eliminate large collections of patents on a single invention.”  The Patent Act clearly states an inventor may obtain a single patent for a single invention, not dozens.  The senators believe the Patent Office can and should stop these large companies from undermining the patent system, obstructing appropriate competition, stifling innovation, and hurting Americans, who end up paying for all of this at the pharmacy.

The letter contains several ideas for the USPTO and the public to consider concerning future potential rule-making:

1. Terminal disclaimers, allowed under 37 C.F.R. 1.321(d), allow applicants to receive patents that are obvious variations of each other as long as the expiration dates match. How would eliminating terminal disclaimers, thus prohibiting patents that are obvious variations of each other, affect patent prosecution strategies and patent quality overall?

2. Currently, patents tied together with a terminal disclaimer after an obviousness-type double patent rejection must be separately challenged on validity grounds. However, if these patents are obvious variations of each other, should the filing of a terminal disclaimer be an admission of obviousness? And if so, would these patents, when their validity is challenged after issuance, stand and fall together?

3. Should the USPTO require a second look, by a team of patent quality specialists, before issuing a continuation patent on a first office action, with special emphasis on whether the claims satisfy the written description, enablement, and definiteness requirements of 35 U.S.C. § 112, and whether the claims do not cover the same invention as a related application?

4. Should there be heightened examination requirements for continuation patents, 2 to ensure that minor modifications do not receive second or subsequent patents?

5. The Patent Act requires the USPTO Director to set a “time during the pendency of the [original] application” in which continuation status may be filed. Currently there is no time limit relative to the original application. Can the USPTO implement a rule change that requires any continuation application to be filed within a set time frame of the ultimate parent application? What is the appropriate timeframe after the applicant files an application before the applicant should know what types of inventions the patent will actually cover? Would a benchmark (e.g., within six months of the first office action on the earliest application in a family) be preferable to a specific deadline (e.g., one year after the earliest application in a family)?

6. The USPTO has fee-setting authority and has set fees for filing, search, and examination of applications below the actual costs of carrying out these activities, while maintenance fees for issued patents are above the actual cost. If the up-front fees reflected the actual cost of obtaining a patent, would this increase patent quality by discouraging filing of patents unlikely to succeed? Similarly, if fees for continuation applications were increased above the initial filing fees, would examination be more thorough and would applicants be less likely to use continuations to cover, for example, inventions that are obvious variations of each other?