In two recent decisions in Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit has made clear that broad functional patent claims must be fully enabled and underscored the high bar for enablement of broad biological compound claims including functional limitations. Amgen v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021). On June 21, the Federal Circuit denied Amgen’s petition for rehearing en banc, and the original panel authored an opinion responding to Amgen and the amicis’ concerns that the court’s decision created a new enablement test or eviscerated genus claims. Amgen Inc. v. Sanofi, Aventisub LLC, No. 20-1074, 2021 WL 2525530 (Fed. Cir. June 21, 2021). Patentees claiming biological materials should be aware that “[e]nablement is required, even for generic claims to biological materials[,]” and “as with genus claims to chemical compounds, if they encompass more subject matter than just a few species, they need to be enabled accordingly.” Id. at *1. Further, “[b]iological compositions not actually prepared need to be described constructively, if required to enable the full scope of the claims, with procedures and names of resultant compositions, as with chemical compositions.” Id. Continue Reading Federal Circuit emphasizes high bar for enablement of functional claims
On June 21, 2021, the Supreme Court held that “35 U.S.C. § 6(c) is unenforceable as applied to the Director insofar as it prevents the Director from reviewing the decisions of the [Patent Trial and Appeal Board] PTAB on his own.” United States v. Arthrex, Inc., No. 19-1434 slip op. at 22 (U.S. June 21, 2021). The Court therefore stated that “[t]he Director may engage in such review and reach his own decision.” Id. The Court rejected Arthrex’s argument that the entire inter partes review proceeding was unconstitutional because it disagreed with Arthrex that the “good cannot be separated from the bad.” Id. at 20. Instead, the Court found that the constitutional violation was the lack of review by the Director. By providing the Director authority to take control, the Administrative Patent Judges (APJs) properly function as “inferior officers” who are not appointed by the President. Id. at 21.
Also of note, the Court limited its holding to the Director’s supervision of APJs in the inter partes review context, and specified that its holding did not look at other adjudications by the PTAB. Id. at 22.
As applied to the facts in Arthrex, the Court stated that “appropriate remedy is remand to the Acting Director for him to decide whether to rehear the petition filed by Smith & Nephew.” Id. at 22. The Court stated that this “provides an adequate opportunity for review by a principal officer.” Id. at 22-23.
In an inter partes review proceeding, the petitioner first files a petition to challenge the validity of a patent. In response to the petition, the patent owner can file a POPR. Typically, the PTAB then decides whether to institute an IPR trial. In recent years, the rules have provided petitioners with an option to reply to the POPR. But such replies are not available as a matter of right—petitioners must request leave to file from the PTAB.
The PTAB has discretion to either grant or deny the request, depending on whether the request satisfies “a showing of good cause” under 37 C.F.R. § 42.108(c). If the PTAB grants the request, then typically, the petitioner and patent owner both receive authorization to file another brief paper, usually around five pages, before the PTAB issues an institution decision.
To date, it has not been clear what qualifies as “good cause” when a petitioner decides to reply to the POPR. Is the filing of a reply a strong predictor of the institution decision? We analyzed the role of petitioners’ replies to POPRs in recent PTAB proceedings, and our research provides a fresh view on the replies’ impact on corresponding institution decisions. In addition, our findings include updated practice tips for IPR practitioners.
We have previously written about the Patent Trial and Appeal Board’s (“PTAB”) precedential decision in Apple Inc. v. Fintiv, Inc., which set forth six factors the PTAB will consider when assessing whether to discretionarily deny an IPR petition in light of co-pending district court litigation. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (March 20, 2020). The PTAB has been applying the Fintiv factors in subsequent IPRs, many of which involve a stayed district court litigation. The PTAB has now designated as precedential a decision instituting IPR in Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (Dec. 1, 2020). In this IPR, although the co-pending district court case was not stayed, Sotera Wireless (“Sotera”) filed a stipulation relinquishing all potentially duplicative arguments. The PTAB allowed the IPR to proceed, noting that the stipulation avoided duplication and prevented conflicting results, chief components of the Fintiv factors. More detail on this decision is below. Continue Reading One More Tool to Avoid Fintiv IPR Denial: File A Stipulation in District Court Relinquishing Potentially Duplicative Arguments
On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must submit to the Food and Drug Administration (“FDA”) and FDA must publish in the “Orange Book.” See H.R. 1503, 116th Cong. § 2(a)–(d) (2021). The amendments require “manufacturers to share complete and timely patent information with the . . . (FDA), ensure that periods of exclusivity listed in the Orange Book are promptly updated, and clarify that patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed from the Orange Book promptly, but not before time for appeal has expired.” H.R. Rep. No. 116-47, at 3–4 (2019). The amendments also require FDA and the Comptroller General to submit reports to Congress about the types of patents that should and should not be listed in the Orange Book. See H.R. 1503 § 2(e)–(f). Continue Reading Orange Book Transparency Act of 2020 Signed Into Law
As part of the post-grant proceedings created in 2012 by the America Invents Act, a Patent Owner can choose to file a motion to amend its patent when that patent is challenged. See 35 U.S.C. § 316(d) (“Amendment of the patent.”); 37 CFR § 42.121 (“Amendment of the patent.”). For example, a Patent Owner may file a contingent motion to amend in lieu of filing a Patent Owner Response after institution of an inter partes review, cancelling the original, challenged claims. Or, the Patent Owner may file a noncontingent motion to amend with its Patent Owner Response, which allows the Patent Owner to argue that both the proposed and the original claims are patentable. However, the Petitioner in an instituted review can challenge the patentability of any proposed amended claims, arguing, for example, that the claims were anticipated by the prior art, or would have been obvious, or fail the requirements of 35 U.S.C. § 112. See Aqua Prods., Inc. v. Matal, 872 F.3d 1290, 1315 (Fed. Cir. 2017).
After several years of experience with post-grant proceedings involving motions to amend, the PTAB studied various aspects of the practice surrounding these motions. The PTAB then proposed two major changes to the motion to amend process, and implemented them in March 2019 in a Motion to Amend Pilot Program. The PTAB’s changes provided:
- A Patent Owner can request “preliminary guidance” from the PTAB regarding the patentability of proposed amended claims, when filing a motion to amend; and
- A Patent Owner can file a revised motion to amend regardless of whether the Patent Owner requests preliminary guidance.
Now, Tyler Bowen and Katherine Nesler, Ph.D., have published a short research paper entitled The Impact of the PTAB’s Motion to Amend Pilot Program [PDF], examining how the Pilot Program affected motion to amend practice. Tyler and Katherine’s research identified proceedings that involved a motion to amend, among the nearly 5,000 trials completed by March 31, 2020, and characterized and compared the outcomes of motions filed before versus after the Pilot Program began. In their paper, Tyler and Katherine identify trends in the data and provide practical tips, for both Patent Owners and Petitioners, regarding the motion to amend process.
We encourage you to download the paper, and hope you find the authors’ insights informative and helpful.
On December 4, 2020, the Board designated three cases from October as precedential. Together, the rulings help understand the Board’s approach to both serial challenges to issued patents and application of 35 U.S.C. § 315’s limitations on proceedings. Two of the newly precedential decisions address the real party in interest (“RPI”) requirement and the third concerns follow-on petitions and joinder motions. See RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 (P.T.A.B. Oct. 2, 2020) (“RPX”); Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9 (P.T.A.B. Oct. 28, 2020) (“Apple v. Uniloc”); SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 (P.T.A.B. Oct. 6, 2020) (“SharkNinja”).Read more about these decisions below. Continue Reading PTAB designates three precedential cases on Section 315’s time-bar and estoppel provisions
Today, the PTO’s Patent Trial and Appeal Board (PTAB) issued a final rule related to trial proceedings under the America Invents Act. The final rule goes into effect 30 days after publication in the Federal Register (scheduled for December 9, 2020); it makes changes to institution practice and sur-replies, and eliminates an evidentiary presumption in favor of a petitioner on certain institution-related fact issues. Continue Reading PTAB Publishes Final Rule on Institution and Presumption in AIA Trials
To guide and inform the public about the Patent Trial and Appeal Board’s practice surrounding post-grant proceedings, the Board periodically designates certain of its decisions as precedential or informative. As noted by the PTAB:
A precedential decision establishes binding authority concerning major policy or procedural issues, or other issues of exceptional importance, including constitutional questions, important issues regarding statutes, rules, and regulations, important issues regarding case law, or issues of broad applicability to the Board. Standard Operating Procedure 2, 2-3, 11.
An informative decision provides Board norms on recurring issues, guidance on issues of first impression to the Board, guidance on Board rules and practices, and guidance on issues that may develop through analysis of recurring issues in many cases. Standard Operating Procedure 2, 9.
Relatedly, the Patent Office uses a Precedential Opinion Panel “to decide issues of exceptional importance to the Patent Trial and Appeal Board (e.g., issues involving agency policy or procedure).” That Panel is composed of the Director of the Patent Office, the Commissioner for Patents, and the Chief Judge of the PTAB.
Recently, the U.S. Patent and Trademark Office announced that it established two online portals, to facilitate submitting 1) requests to designate precedential and informative decisions, and 2) amicus positions regarding requests for Panel review. Continue Reading PTAB Adds Online Public-Submission Forms
Since the start of post-grant proceedings, the Patent Office has published a Patent Trial Practice Guide to provide a framework for conducting those proceedings, including setting out the structure and times for taking action in each of the new proceedings (e.g., Inter Partes Review and Post Grant Review). The first Trial Practice Guide issued in August 2012, and updates were issued in August 2018, July 2019, and November 2019 (Consolidated Trial Practice Guide). To guide post-grant practice, the Patent Office has also designated more than 40 decisions as precedential or informative. A topic of continued interest is the Patent Office’s practice surrounding its decision whether to institute a post-grant proceeding after a petition is filed.
Recently, the Patent and Trademark Office issued a Federal Register notice regarding a Request for Comments on Discretion To Institute Trials Before the Patent Trial and Appeal Board. The full text of the notice can also be found in PDF format here and here. Continue Reading PTAB Seeks Comments On Its Approach To Institution Decisions