The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more
4/4/2025
/ Appeals ,
FDA Approval ,
Hatch-Waxman ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Requirements ,
Statutory Interpretation
After eight weeks of shifts in governmental policies, the patent bar is feeling repercussions from all directions. One critical area in flux is the post-grant challenge arena.
With a reduced PTAB head count and a steady...more
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
4/3/2025
/ Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Patent Applications ,
Patent Litigation ,
Patent Ownership ,
Patent Re-Examination ,
Patent Term Extensions ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Reissue Patents ,
USPTO
Takeaways -
- Pre-AIA patents may be able to “swear behind” prior art applied in reissue and reexamination.
- “Swearing behind” has limits and obtaining sufficient evidence to establish prior invention may be difficult to...more
3/10/2025
/ America Invents Act ,
Central Reexamination Unit (CRU) ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Litigation ,
Patent Reissue Applications ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Reissue Patents ,
USPTO
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
2/26/2025
/ Central Reexamination Unit (CRU) ,
Intellectual Property Protection ,
Inter Partes Reexamination ,
Patent Applications ,
Patent Expiration ,
Patent Invalidity ,
Patent Litigation ,
Patent Reissue Applications ,
Patents ,
Prior Art ,
Reissue Patents ,
Supplemental Examination ,
USPTO
Takeaways -
-Intra-patent claim inconsistencies are errors correctible via reissue.
-Subtle legal distinctions in reissue may require PTAB appeals.
Patent prosecution errors occur. One such error that occurs is...more
2/14/2025
/ Administrative Procedure Act ,
Appeals ,
Central Reexamination Unit (CRU) ,
Claim Amendments ,
Claim Construction ,
Patent Litigation ,
Patent Prosecution ,
Patent Reissue Applications ,
Patent Trial and Appeal Board ,
Patents ,
Reissue Patents ,
USPTO
Takeaways -
- Requestor submissions in reexamination proceedings are exempt from triggering IDS size fees.
- Correcting filing benefit claims in reissue triggers the new continuing application fee.
As we noted in our...more
2/12/2025
/ Application Fees ,
Fees ,
Intellectual Property Protection ,
Inter Partes Reexamination ,
Patent Applications ,
Patent Litigation ,
Patent Reissue Applications ,
Patents ,
Regulatory Requirements ,
Reissue Patents ,
USPTO
The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key...more
2/4/2025
/ §315(e) ,
Administrative Procedure Act ,
America Invents Act ,
Appeals ,
Corporate Counsel ,
Director of the USPTO ,
Final Rules ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Rulemaking Process ,
Section 102 ,
Statistical Analysis ,
Statutory Interpretation ,
Technology ,
USPTO
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
2/3/2025
/ Ambiguous ,
Central Reexamination Unit (CRU) ,
Fees ,
Indefiniteness ,
Intellectual Property Protection ,
Patent Applications ,
Patent Litigation ,
Patent Reissue Applications ,
Patent Trial and Appeal Board ,
Patents ,
Regulatory Agenda ,
Reissue Patents ,
USPTO
According to recent U.S. Patent and Trademark Office (Office) data, the Office receives a burdensome number (13%) of information disclosure statements (IDSs) having in excess of 50 total items of information. 89 Fed. Reg....more
12/3/2024
/ Ex Partes Reexamination ,
Information Disclosure Statement ,
Patent Applicants ,
Patent Examinations ,
Patent Fees ,
Patent Litigation ,
Patent Ownership ,
Patent Re-Issue ,
Patent Reissue Applications ,
Patents ,
USPTO
Patent Examiners rely upon the Manual of Patent Examination Procedure (MPEP) to instruct application of the law to the most common patent prosecution situations. The MPEP’s forward refers to itself as a “guidance document”...more
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
11/27/2024
/ Central Reexamination Unit (CRU) ,
Ex Partes Reexamination ,
Information Disclosure Statement ,
Inter Partes Review (IPR) Proceeding ,
Manual of Patent Examining Procedure (MPEP) ,
Patent Applicants ,
Patent Examinations ,
Patent Fees ,
Patent Litigation ,
Patent Ownership ,
Patent Re-Issue ,
Patent Reissue Applications ,
Patents ,
Prior Art ,
USPTO
Ex parte reexamination proceedings have been available for over 40 years. The reexamination statutes, Public Law 96-517 of July 1, 1981 (also known as the Bayh-Dole Act), included 35 U.S.C. § 303, which codified, in part,...more
11/7/2024
/ America Invents Act ,
Bayh-Dole Act ,
Central Reexamination Unit (CRU) ,
Ex Partes Reexamination ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
USPTO
This month we take a deeper dive into petitions practice for cases handled by the Central Reexamination Unit (CRU). As noted in our previous article, issues of first impression sometimes arise in cases before the CRU where...more
Takeaways:
1. ODP in reexamination and reissue remains unpredictable despite Allergan
2. Patent Owners should carefully review ODP rejections to ensure they are proper
Obviousness-type double patenting (ODP) is a legal...more
8/28/2024
/ Allergan Inc ,
Intellectual Property Protection ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Expiration ,
Patent Litigation ,
Patent Ownership ,
Patent Re-Examination ,
Patent Reissue Applications ,
Patent Term Extensions ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reissue Patents ,
USPTO
As mentioned in last month’s IP Practice Tips, reissue applications are subject to additional legal doctrines founded in requirements of 35 U.S.C. § 251. One doctrine that has been operative since the first reissue statute...more
The requirement for disclosure, candor, and good faith between an applicant/patent owner and the U.S. Patent and Trademark Office (USPTO) serves an important public interest. Succinctly, each individual associated with the...more
6/21/2024
/ Central Reexamination Unit (CRU) ,
Confidential Information ,
Duty to Disclose ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Ownership ,
Patent Reissue Applications ,
Patents ,
Post-Grant Review ,
Reissue Patents ,
USPTO
One of the advantages of filing a reissue application within two years of the original patent’s grant is the ability to seek broader claims. More often than not, however, a broadening Reissue will be rejected by the CRU...more
Takeaways:
-A requester can have a voice in ex parte reexamination prosecution.
- Requesters should strategically structure their request documents to hedge against potential patent owner amendment and argument.
The...more
A significant procedure for patent owners, Supplemental Examination, was established in the 2012 America Invents Act when Congress determined there should be a proceeding to turn events that in the past could lead to...more
4/19/2024
/ America Invents Act ,
Disclosure Requirements ,
Ex Partes Reexamination ,
Intellectual Property Protection ,
Patent Examinations ,
Patent Litigation ,
Patent Ownership ,
Patents ,
Prior Art ,
Supplemental Examination ,
USPTO
In our PTAB Spotlight Series, attorneys will share their valuable insights on PTAB practice today, the challenges and opportunities clients face, and the trends practitioners should follow.
Jason D. Eisenberg is a director...more
The recent resurgence in ex parte reexamination demonstrates the importance of this post-grant review vehicle. It has become particularly important for patent challengers who may be estopped from requesting inter partes...more
2/19/2024
/ America Invents Act ,
Ex Partes Reexamination ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Ownership ,
Patent Term Adjustment ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patentability Search ,
Patents ,
USPTO
This Year in Review synthesizes key events and decisions from 2023 into a digestible guide that we hope will serve as a helpful reference for those who practice before, or adjacent to, the PTAB. As in the past, many of our...more
2/12/2024
/ America Invents Act ,
Corporate Counsel ,
Ex Partes Reexamination ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Standard Essential Patents ,
USPTO
Recently, in an effort to increase transparency and predictability, the new USPTO Director Vidal published “Interim process for PTAB decision circulation and internal PTAB review.” This initiative was included in a May 24th...more
On Friday May 27, 2022, the Federal Circuit added another opinion to the Arthrex line of cases. As a short refresher, Arthrex was back at the Federal Circuit after being remanded to the Board for Director Review after Patent...more
6/6/2022
/ Appeals ,
Appointments Clause ,
Arthrex Inc v Smith & Nephew Inc ,
Constitutional Challenges ,
Federal Vacancies Reform Act ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing ,
Remand ,
Separation of Powers ,
USPTO