Gibbons Law Alert

Gibbons Law Alert

Gibbons Law Alert

Category: USPTO

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

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Posted in Biotech / Patent / USPTO

On July 18, 2018

The Supreme Court recently agreed to review Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., a case with broad implications for the pharmaceutical industry. In the opinion below, the Federal Circuit held that after the America Invents Act (“AIA”), “if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” for the sale to be invalidating under Section 102. The Court granted Helsinn’s petition for certiorari to answer “[w]hether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Before the AIA, § 102(b) barred the patentability of an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” By enacting the AIA, Congress amended § 102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” In its petition for certiorari, Helsinn argued...

Senator Hatch Proposes Legislation Forcing Challengers to Choose Between Filing a Hatch-Waxman Action or Filing an IPR

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Posted in Patent / USPTO

On June 25, 2018

On June 13, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (“IPR”) process for pharmaceuticals. The senator published a press release summarizing and explaining the proposed legislation. The amendment, titled the Hatch-Waxman Integrity Act of 2018, intends to “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development” by “prevent[ing] alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design.” The proposed legislation would amend Sections 505(b)(2) and 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 355(b)(2) and 355(j)(2)(A) respectively) to require the applicant to certify to the FDA that “neither the applicant nor any party in privity with the applicant, has filed, or will file, a petition to institute inter partes review” in order to be eligible for abbreviated regulatory approval under the Hatch-Waxman Act. The applicant would further need to certify that it “is not relying in whole or in part on any decision issued by the Patent Trial and Appeal Board in an [IPR]” in making the certification that the relevant listed patent is invalid or will not be infringed. According to Senator Hatch, the impetus for the proposed amendment is that IPRs are “producing unintended consequences in...

USPTO Proposes a New Rule to Use Narrower Phillips Standard During Claim Construction in AIA Trial Proceedings

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Posted in Patent / USPTO

On May 11, 2018

On May 9, 2018, the United States Patent and Trademark Office (USPTO) proposed to amend the current rules to change the claim construction standard used in America Invents Act (AIA) reviews and bring it in line with the standard used in district court and ITC proceedings. Under the amended rules, the Patent Trial and Appeal Board (PTAB) would no longer use the broadest reasonable interpretation (BRI) standard for claim construction, and instead would use the narrower Phillips standard. The proposed rules would apply to claim interpretations occurring in inter partes review (IPR), post-grant review (PGR), and covered business method (CBM) patents proceedings. The Board currently construes unexpired patent claims and proposed claims in AIA trial proceedings using the BRI standard, as directed by 37 CFR 42.100(b), 42.200(b), and 42.300(b). Each of these sections currently provides that “[a] claim in an unexpired patent that will not expire before a final written decision is issued shall be given its broadest reasonable construction in light of the specification of the patent in which it appears.” This standard differs from the Phillips standard used by district courts. Under the proposed changes to these sections, the PTAB will adopt the Phillips standard and construe claims “given their ordinary and customary meaning,” which is “the meaning that the term would have to a...

Rule Change Alert! The Bayh-Dole Act Has New Time and Reporting Requirements

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Posted in Patent / USPTO

On May 7, 2018

On April 30, 2018, The National Institute of Standards and Technology (NIST) issued rule changes regarding the Bayh-Dole Act. The Bayh-Dole Act was enacted in 1980 as the Patent and Trademark Law Amendments Act (Pub. L. No. 96-517), amended in 1984 by the Trademark Clarification Act of 1984 (Title V of Pub. L. No. 98-620), and again in 2000 by the Technology Transfer Commercialization Act of 1999 (Pub. L. No. 106-404). The Bayh-Dole Act created a uniform policy that allows small businesses and nonprofit organizations the option to retain title to inventions made under government contracts, grants, or cooperative agreements that are for the performance of experimental, developmental, or research work. The implementing regulations are found at 37 C.F.R. Part 401 and Federal Acquisition Regulation (FAR) Subpart 27.3. The April 30, 2018 revisions to the Bayh-Dole Act are categorized as follows: No time limit for government to request title. Since implementation, the government had 60 days within which it could request title to any inventions. The new rule removes the 60 day notice period. Quicker timeframe to prosecute patent applications. Previously, contractors and grant recipients had to notify the agency who granted them money of their intent to prosecute a patent application and maintain it and enter into reexamination or opposition proceedings not less than...

USPTO Issues Guidance Applying SAS Institute to Pending and Future PTAB Trials

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Posted in Patent / USPTO

On May 1, 2018

On April 26, 2018, the United States Patent and Trademark Office (USPTO) issued a guidance, applying SAS Institute v. Iancu to the America Invents Act (AIA) trial proceedings. The U.S. Supreme Court in SAS Institute held that when the Patent Trial and Appeal Board (PTAB) institutes an inter partes review, it must decide the patentability of all claims challenged in the original petition. The USPTO guidance gives a general outline of how the PTAB will review patents in the future, and how it will handle cases that are already pending. The memo makes clear that the PTAB will no longer have partial institutions: “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.” For pending trials in which the PTAB has instituted trial on only some of the petitioned claims, “the panel may issue an order supplementing the institution decision to institute on all challenges raised in the petition.” The final written decision will address, to the extent claims are still pending at the time of decision, “all patent claims challenged by the petitioner and all new claims added through the amendment process.” When supplementing the institution decision, the panel has discretion to manage the trial proceeding. The panel may permit “additional time, briefing, discovery, and/or oral argument, depending on...

While the PTO Director has Discretion to Institute an IPR, the Board Must Review All Petitioned Claims Upon Institution

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Posted in Patent / USPTO

On April 25, 2018

The U.S. Supreme Court in SAS Institute v. Iancu held that when the Patent Trial and Appeal Board (PTAB or “the Board”) institutes an inter partes review (IPR), it must decide the patentability of all claims challenged in the original petition. Here, in a case with wide-reaching implications, the questions centered on the United States Patent and Trademark Office (USPTO) Director’s discretion and subsequent control of an IPR. In the underlying case, SAS filed a petition for IPR alleging that all 16 claims of a particular patent were unpatentable. The Board instituted review on nine of the challenged claims and denied review on the rest, eventually finding eight of the instituted claims unpatentable in a final written decision. The Federal Circuit rejected SAS’s argument on appeal that 35 U. S. C. §318(a) required that the Board decide the patentability of all 16 claims challenged in the petition. The Supreme Court, in a 5-4 opinion authored by Justice Gorsuch, reversed the Federal Circuit, striking down partial IPR decisions. The Supreme Court held that the plain text of §318(a) conclusively answers the question presented. The section directs that “[i]f an inter partes review is instituted and not dismissed under this chapter, the [Board] shall issue a final written decision with respect to the patentability of any patent claim...

The USPTO Under Recently Appointed Director Andrei Iancu Will Promote Innovation and Increase Reliability in Issued Patents

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Posted in Patent / USPTO

On April 18, 2018

Speaking to the U.S. Chamber of Commerce on April 11, 2018, recently sworn-in USPTO Director Andrei Iancu gave an impassioned speech about his vision for the patent system. Director Iancu outlined challenges facing the USPTO and goals the agency aspires to achieve, focusing on two main objectives: (1) creating a new pro-innovation, pro-IP dialogue, and (2) increasing the reliability of the USPTO granting patents. Stakeholders should take note of the Director’s objectives and should anticipate policy changes that further strengthen the patent system. Creating a new pro-innovation, pro-IP dialogue One thing is clear from Director Iancu’s remarks: the USPTO under his leadership will strive to help the inventor and incentivize innovation. Consistent with this goal, the USPTO will “create a new narrative that defines the patent system by the brilliance of inventors, the excitement of invention, and the incredible benefits they bring to society.” “And it is these benefits,” Director Iancu continued, “that must drive our patent policies.” Much of the narrative of the patent system in recent memory has focused on curbing abuses of non-practicing entities sometimes referred to as “patent trolls.” And Director Iancu’s remarks suggest that the USPTO will actively try to change that narrative. Iancu explained that errors and abuse should be “identified and swiftly eliminated,” but on the whole, the...

Recent Federal Circuit Decision Illustrates Challenges in Proving Obviousness

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Posted in Patent / USPTO

On January 11, 2018

This non-precedential decision is of interest not for any new exposition of patent law but merely as a convenient marker to demonstrate how far the pendulum has swung away from the recent loose standards allowing disparate references to be combined to support an obvious rejection of a patent claim. In the district court below, a bench trial on a Hatch-Waxman infringement suit brought against defendants Dr. Reddy’s and Teva by Genzyme and Sanofi resulted in a decision for the plaintiffs. The court held that the defendants had failed to prove that the sole claim in issue (claim 19) was invalid for obviousness and as infringement was not disputed the verdict of infringement was entered. The technology in the case related to a method for mobilizing and harvesting stem cells in a subject by first treating the subject with G-CSF and then with plerixafor thereby increasing the number of stem cells available for harvesting from the blood for use in treating leukemia by transplantation. The defendants had relied on a combination of references to effectuate an obviousness defense. In a first combination, a paper by Hendrix et al. was cited to show that plerixafor produced increased white blood cells (WBCs) in the circulation. The authors suggested that the action of this agent may cause “release of...

Constitutionality of IPRs and PGPs

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Posted in Biotech / Patent / Pharmaceuticals / USPTO

On September 5, 2017

Recently, the Supreme Court granted certiorari in Oil States Energy Services v. Green’s Energy Group, Case 16-712 that may have implications on the constitutionality of America Invents Act (AIA) patent review proceedings such as Inter Partes Review (IPRs) and Post Grant Proceedings (PGPs). The case being reviewed involved a fracking patent granted to Oil States. Green’s Energy petitioned to have the Oil States patent reviewed in an IPR (6,179,053). The IPR resulted in the Oil States patent claims being held unpatentable. But, upon review at the Federal Circuit, Oil States challenged the decision and added that IPRs were not allowed under Article III and the Seventh Amendment of the Constitution. In particular, the Oil States argument advanced that the patents must be tried before a jury because invalidity of patent claims traditionally have been a jury issue before a court of competent jurisdiction. The Oil States argument then indicated that Congress could not delegate that right to an administrative agency. The Federal Circuit affirmed the USPTO’s IPR decision of invalidity, without the issuance of an opinion. Following that decision, Oil States petitioned for certiorari to the Supreme Court regarding three issues. The one issue was whether IPR was in violation of the Constitution’s Article III provision since there was no jury trial adjudication of the...

The Regulatory Accountability Act of 2017 May Require a Revisit of Recent Precedent

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Posted in Patent / USPTO

On March 22, 2017

The Regulatory Accountability Act of 2017 is currently pending before the Senate Committee on Homeland Security and Governmental Affairs, which was recently passed by the House of Representatives with a 238-183 vote. If enacted, this bill would repeal the Chevron deference standard (“Chevron standard”), among other reforms, which potentially will require the courts to reconsider and overturn past precedent regarding the patent statute. The Chevron standard frequently appears in litigations involving federal agencies. This standard is rooted in the U.S. Supreme Court case, Chevron U.S.A. Inc. v. Nat. Res. Def. Council, 467 U.S. 837, 104 S. Ct. 2778 (1984), where the Court held that it should defer to agency interpretations of a statute that is “silent or ambiguous with respect to the specific issue.” Under this bill, courts instead would have to review relevant questions of law in these cases de novo. This bill would affect agency guidance from all federal agencies including the U.S. Food and Drug Administration, Environmental Protection Agency, and the agency most relevant to patent practitioners, the United States Patent and Trademark Office (“USPTO”). Although it is difficult to determine the reach of the implications from this bill, if enacted, it is possible that patent practitioners could see the effects. For instance, the 2011 America Invents Act gave the USPTO the...

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