Patent Docs

BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)

April 26, 2022

By Kevin E. Noonan —

The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if the agreements do not contemplate these possibilities and account (or attempt to account) for them. Such was the case in the Federal Circuit's recent decision in BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation.

The lawsuit involved a complicated set of licenses and co-development activities between the Commonwealth Scientific and Industrial Research Organisation (CSIRO), a research branch of the Australian government, and BASF. CSIRO is assignee of U.S. Patent Nos. 9,926,579; 9,951,357; 9,970,033; and 9,994,880 (termed Group A patents), as well as Nos. 9,994,792 and 9,932,541, all of which involve genetic engineering of plants to produce oils, such as canola oil, non-native to these plants. These claims were directed generally to production of Omega-3 long chain polyunsaturated fatty acids (abbreviated LC-PUFAs in the opinion) and specifically to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both known to be beneficial to human heart health. The commercial goal of the research was to produce oils to be used in farm-raised salmon and other fish to improve their nutritional value and flavor to be closer to free-range fish. CSIRO and BASF (in collaboration in part and independently in part) pursued this effort beginning around the turn of the century, specifically introducing certain genes encoding enzymes in biosynthetic pathways (derived in microorganisms) for LC-PUFAs into plants including Brassica napus or rapeseed (that naturally produced canola oil). At all relevant times, CSIRO's efforts were limited to introducing these enzymes into a laboratory strain called Arabidopsis thaliana; according to the Federal Circuit opinion CSIRO had not introduced these enzymes into commercially relevant species. BASF, on the other hand, had introduced enzymes from the biosynthetic pathway into tobacco and linseed as well as Arabidopsis and a plant closely related to rapeseed, Brassica juncea. Although during some of the time relevant to this lawsuit CSIRO and BASF were working together on a "focused research project," the opinion states that the parties were working on introducing different enzymes from the pathway. Thereafter, the parties each developed collaborations with other commercialization partners; in BASF's case the partner was Cargill and their joint efforts resulted in BASF depositing recombinant seeds with the American Type Culture Collection (ATCC) in support of its own patent applications.

Licensing negotiations aimed at BASF obtaining a license to CSRIO's patents were not fruitful and BASF sued CSIRO (and other defendants no longer in this lawsuit) for a a declaratory judgment that it did not infringe (related to patents other than the ones in this lawsuit). BASF thereafter filed an amended complaint naming only CSIRO. In its answer, CSIRO asserted infringement of the six patents named in this lawsuit; claims 1, 31, 32, and 33 of the '357 patent were deemed representative and reproduced in the Federal Circuit's opinion:

1. A recombinant plant cell which synthesizes eicosapentaenoic acid (EPA), comprising more than one heterologous polynucleotide, wherein said polynucleotides encode:
    a) a Δ6 desaturase, a Δ6 elongase and a Δ5 desaturase; or
    b) a Δ5/Δ6 bifunctional desaturase and a Δ5/Δ6 bifunctional elongase;
    wherein the more than one polynucleotides are operably linked to one or more promoters that are capable of directing expression of said polynucleotides in the cell, wherein the enzymes encoded by said polynucleotides comprise at least one desaturase which is able to act on an acyl-CoA substrate, and wherein the synthesis of EPA requires the sequential action of said enzymes.

31. The plant cell of claim 1 which is a Brassica napus cell or Arabidopsis thaliana cell, wherein the heterologous polynucleotides encode a Δ6 desaturase, Δ6 elongase and a Δ5 desaturase.

32. The cell of claim 31, comprising a heterologous polynucleotide encoding a Δ5 elongase which catalyzes the conversion of EPA to DPA [docosapentaenoic acid] in the cell.

33. The plant cell of claim 32, wherein said cell is capable of synthesizing DHA.

(It was important for BASF's allegation that CSIRO's asserted claims did not satisfy the written description requirement that claim 1 was not limited to Brassica napus nor Arabidopsis thaliana cells while claims 31-33 were so limited. Other asserted claims shared this pattern, wherein, inter alia, claim 5 of the '579 patent, claim 5 of the '033 patent, claim 1 of the '792 patent, and claims 15 and 20 of the '541 patent were limited to Brassica cells, whereas asserted claims 2 and 10 of the '880 patent were not.)

CSIRO's complaint also named Cargill, a BASF commercialization partner, as co-defendant. BASF countered by asserting it owned the patents-in-suit through the co-development agreement with CSIRO entered into in 2008. Cargill moved the trial court to dismiss them from the suit for lack of personal jurisdiction; the trial court denied the motion and the case went to trial. The parties stipulated to infringement of all but the '541 patent, which the jury found was infringed. The jury also found that BASF had not established the patents lacked adequate written description support but did find BASF co-owned the '792 patent due to the earlier co-development agreement. The District Court ruled CSIRO had adduced insufficient evidence of willful infringement and precluded the jury from considering enhanced damages on this basis. In addition, the Court dismissed the jury from hearing evidence of damages but held a separate bench trial in which the District Court denied an injunction and awarded an ongoing royalty on the infringed patents but no damages for past infringement. Somewhat predictably, the parties appealed on those grounds where they lost at trial.

The Federal Circuit, in an opinion by Judge Taranto joined by Judge Chen and (in part) by Judge Newman ruled as follows:

First, we affirm the district court's determination that venue as to Cargill was proper in the Eastern District of Virginia. Second, regarding the jury's verdict rejecting the written-description challenge to the asserted Group A patent claims, we affirm as to the claims that are limited to canola plants (the only ones either side meaningfully discusses), but we reverse as to the broader genus claims. Third, we affirm the jury's verdict that five patents were not co-owned by BASF but reverse the contrary verdict as to the sixth, with the result that infringement of all valid claims of the six patents at issue is now settled. Finally, on the remedy issues, we affirm the district court's refusal to submit willfulness to the jury and its decision on the evidentiary issue concerning past damages. But we remand for reconsideration of the remedy, while leaving the current remedy in place pending such reconsideration.

On Cargill's venue challenge, the Federal Circuit agreed with the District Court that there was proper assertion of personal jurisdiction (which Cargill did not appeal) and venue. Factors favoring venue included a "partnership" between BASF and Cargill, BASF's deposit of seed with the ATCC (which was within the trial court's jurisdiction and was deemed an infringing "use"), and it filing its declaratory judgment action in the District (these activities being "central to the partnership"). The panel rejected Cargill's reliance on Home Depot U.S.A., Inc. v. Jackson, 139 S. Ct. 1743 (2019), which related to the removal statute (28 U.S.C. § 1441(a)) based on "textual similarity" to 28 U.S.C. § 1400(b). The issue in Home Depot involved removal rights to third party defendants, the position Cargill was in here. While there was some force to Cargill's argument by analogy, the Federal Circuit held that Cargill had not provided "sufficient justification for departing from the ordinary meaning of the term 'defendant'" and thus venue was proper ("[i]n short, to hold that § 1400(b) covers third-party counterclaim defendants would require us to determine that, for patent suits only, two civil actions can exist in one lawsuit, with the counterclaim qualifying as a 'civil action for patent infringement' that triggers the protections of § 1400(b) for counterclaim defendants—except for the original plaintiffs who under General Electric [Co. v. Marvel Rare Metals Co., 287 U.S. 430 (1932)] would be held to have forfeited venue protection."). And on the facts here upon which the District Court made its decision, the Federal Circuit found no basis for disturbing it.

Turning to the merits, the panel considered and affirmed the District Court's distinction that the asserted claims satisfied the written description requirement when limited to canola oil-producing species and related plants, but not satisfied more broadly for all plants. Not required were "commercially desirable or other specific levels of production," however. But the panel asserts that the evidence from the specification is focused on canola oil-producing plants and related species, as well as being supported by expert testimony from both parties, and provides working examples in Arabidopsis which "a very reliable model for Brassica napus" wherein "LCPUFA production in Arabidopsis was highly predictive of positive results in canola."

In this way the panel distinguished as being "materially different" the factual circumstances here with Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc., 923 F.3d 1368 (Fed. Cir. 2019). BASF's expert testimony to the contrary, that the skilled worker would not accept the Arabidopsis results as being predictive provided "no sound reason" in support of BASF's position that the patents-in-suit all failed to satisfy the written description requirement. Moreover, the panel found CSIRO's "failure" to produce LCPUFA's in Brassica napus occurred due to focus on optimizing production in Arabidopsis thaliana rather than lack of possession of the claimed invention when limited to canola oil-producing species.

The genus claims presented a different story to the panel, which held that these claims were invalid for failure to satisfy the written description requirement. The parties had "not given [the Court] much to work with" on this question according to the opinion, with disclosure and testimony being "focused" on canola oil-producing species. The panel understood that "BASF has argued for the inadequacy of the written description as to all the asserted Group A claims on a common ground—that the magnitude of the leap from success in producing LC-PUFA in Arabidopsis to success in any other plant is too great for the written description to support claims to any other plant" (emphasis in opinion). The panel agreed that CSIRO's disclosure was insufficient to show description beyond the narrow limitations of canola oil-producing plants. (While the Court's reasons for coming to this conclusion are couched in whether CSIRO had possession of the invention outside the scope of canola oil-producing plants, the rationale blends here somewhat into the question of whether the disclosure enabled production in other plant species, bolstered by reference to experts' testimony regarding whether the skilled worker would have believed disclosure of the former would indicate possession of the latter.)

Regarding the patent ownership question, the Federal Circuit's opinion notes that BASF did not base its ownership claim on co-inventorship or sole inventorship by an inventor obliged to assign her rights to BASF. The argument was limited to co-ownership and, according to the opinion, was based "entirely" on the prior co-development agreement between the parties. The Court found this inadequate because, as a matter of contract interpretation BASF's ownership's claims were not supported. The opinion cites to specific sections of the agreement, the Court finding three categories of ownership: "(1) constructs that were developed under the Evaluation if they contained both CSIRO and BASF genes; (2) results, data, or information derived from the Evaluation respecting the CSIRO-BASF-gene-combination constructs developed under the Evaluation; and (3) Intellectual Property subsisting in the first two categories." The panel appreciated BASF's co-ownership claims to rest solely on the third category, but the Court rejected this argument, saying that a reasonable jury could only find no co-ownership for any of the patents-in-suit. But even though "none of the six patents claim the BASF-CSIRO-gene-combination constructs or properties of them or uses of them" BASF contended that CSIRO obtained the claims of these patents "by drawing on the lessons it learned from the experiments involving both BASF and CSIRO's materials" (emphasis in opinion). This argument makes no legal sense to the panel because CSIRO's inventions would need to be considered inherent in the "results, data, or information" from the joint work for which BASF was not (and did not claim to be) a joint inventor. Nor did it make commercial sense, because interpreting the agreement in this way would "create an ever-threatening cloud over independent post-[agreement] work and the investments in such work." The opinion then dissected the claims of the patents-in-suit and affirmed the jury's verdict for all but one of them that BASF is not a co-owner. And for the one patent where the jury found to the contrary (the '792 patent) the Court finds BASF's evidence for co-ownership equivalently lacking and relying on "an impermissible level of speculation."

With regard to the remedies decided by the District Court, the Court affirmed the District Court's decision that CSIRO could not submit its assertion of willful infringement to the jury nor that CSIRO was entitled to damages for past infringement. Otherwise, the Court remanded based on the changes in the substantive determinations regarding infringement, invalidity, and ownership (albeit including in the opinion extensive assessments of the allegations by CSIRO of error, or lack of it, for consideration on remand).

Judge Newman's dissent was based solely on the co-inventorship issue for the '792 patent, the Judge being persuaded that the jury had substantial evidence with which to come to its conclusion that BASF was a co-owner of this patent.

BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)
Panel: Circuit Judges Newman, Taranto, and Chen
Opinion by Circuit Judge Taranto; opinion dissenting in part by Circuit Judge Newman
U.S. Chamber of Commerce Supports House and Senate Legislation Prohibiting Biden Administration from Negotiating Modifications to WTO TRIPS Agreement Without Congressional Authorization

April 24, 2022

By Donald Zuhn —

Earlier this month, the U.S. Chamber of Commerce sent a letter to members of Congress indicating that the Chamber "strongly supports" recent House and Senate legislation that the Chamber noted "would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress." The Chamber contended that "[i]nternational negotiations on IP, focused on undermining the WTO TRIPS agreement, are fundamentally misguided," suggesting that "[a]ny agreement that undermines IP would limit the ability of innovative companies to develop the cure for the next pandemic or global health threat and bargain away US competitiveness." According to the Chamber, the global community should instead "focus on the overwhelming problem of vaccine distribution," as well as "the real issues preventing more shots in arms, such as logistical hurdles, supply chain bottlenecks, and vaccine hesitancy."

The House and Senate bills that have garnered the support of the Chamber are the "Protecting American Innovation Act" (H.R. 7430) and the "No Free TRIPS Act" (S. 4063), which were introduced on April 6, 2022 and April 7, 2022, respectively. H.R. 7430 was introduced by Rep. Adrian Smith (R-NE) and co-sponsored by Rep. Vern Buchanan (R-FL), Rep. Drew A. Ferguson, IV (R-GA), Rep. Jackie Walorski (R-IN), Rep. Darin LaHood (R-IL), Rep. Brad R. Wenstrup, Brad (R-OH), Rep. Gregory Murphy (R-NC), Rep. Ron Estes (R-KS), Rep. Carol D. Miller (R-WV), Rep. Lloyd Smucker (R-PA), and Rep. Kevin Hern (R-OK). S. 4063 was introduced by Sen. Marsha Blackburn (R-TN) and co-sponsored by Sen. Thomas Tillis (R-NC), Sen. Tommy Tuberville (R-AL), Sen. Kevin Cramer (R-ND), Sen. Bill Hagerty (R-TN), Sen. Cynthia M. Lummis (R-WY), Sen. Marco Rubio (R-FL), and Sen. Mike Lee (R-UT).

The longer of the two bills, H.R. 7430, which is intended "[t]o establish limitations on modifications to trade agreements," would prevent the President from "enter[ing] into any suspension of or modification to a trade agreement," unless the President complied with all of the consultation requirements set forth in the Act and Congress either enacted legislation or adopted a resolution approving of the suspension or modification. The House bill sets forth several findings of Congress, including the following:

• "Section 8 of article I of the United States Constitution provides Congress with authority over international trade. Congress has used that authority to approve a number of trade agreements, including the WTO Agreement."

• "Section 8 of article I of the United States Constitution provides Congress with authority to provide intellectual property protections in order to 'promote the progress of science and useful arts'."

• "The United States may not withdraw or otherwise alter the rights and obligations for the United States arising from a congressionally approved trade agreement without the consent of Congress."

• "Innovators in the United States successfully and rapidly brought to fruition vaccines that provide highly effective protection against COVID–19."

• "Longstanding intellectual property protections are critical to efforts by the United States and the biopharmaceutical industry to develop and manufacture vaccines for both people in the United States and around the world."

• "Many experts on vaccine production and distribution are warning that waiving intellectual property protections will undermine the global response to the COVID–19 pandemic and compromise vaccine safety, including by disrupting the distribution of scarce raw materials for vaccines that existing vaccine makers with proven track records for delivering high-quality, safe, and effective vaccines need to continue their own production."

• "The United States Trade Representative announced without any consultation with Congress that the United States will support a waiver of intellectual property protections under the TRIPS Agreement for COVID–19 vaccines."

• "The Trade Representative has not explained how a waiver of the TRIPS Agreement will expand vaccine production and access . . . ."

• "Waiving intellectual property protections . . . raises serious economic and national security concerns."

The House bill also indicates the sense of Congress as including the following:

• "intellectual property protections for COVID–19 vaccines have not impeded vaccination efforts for COVID–19;"

• "intellectual property protections in fact help ensure the safe and efficient manufacturing of COVID–19 vaccines;"

• "waiving intellectual property protections could lead to the production of substandard, ineffective, and potentially unsafe COVID–19 vaccines;"

• "the Trade Representative must consult with Congress before taking a position on the current TRIPS Agreement waiver proposal before the WTO and any further proposals to waive or weaken intellectual property obligations under the TRIPS Agreement;" and

• "the United States must oppose any waiver to intellectual property obligations under the TRIPS Agreement for the response to the COVID–19 pandemic until those implications are fully analyzed."

Among the "consultation requirements" set forth in the House bill are two reports to be submitted to Congress. One report would be prepared by the Secretary of Commerce, in consultation with the Trade Representative, the Secretary of Health and Human Services, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control and Prevention, and would assess the impact of a TRIPS waiver on the following:

(i) access to vaccines in the United States;
(ii) access to vaccines globally;
(iii) global supply chains of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies;
(iv) the gross domestic product of the United States;
(v) exports and imports by the United States of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies;
(vi) manufacturing in the United States of COVID–19 vaccines and related technologies and the inputs needed to produce those vaccines and related technologies; and
(vii) investment in vaccine production in the United States and in research and development for future vaccines[.]

The other report would be prepared by the Secretary of Defense, in consultation with the Secretary of Commerce, the Secretary of Health and Human Services, and the Trade Representative, and would determine the effects of a TRIPS waiver with respect to addressing the COVID–19 pandemic on U.S. national security.

The House bill would also require the U.S. Trade Representative to publish a notice in the Federal Register identifying the objectives of any trade agreement negotiation, the rationale for why the trade agreement does not allow the U.S. to meet those objectives, and the provisions of the trade agreement that would be suspended or modified. In addition, the bill would require the U.S. Trade Representative to:

[C]onsult closely and on a timely basis with the appropriate congressional committees, keeping those committees fully apprised of those negotiations, and provide to those committees, including staff with appropriate security clearance, access to the text of any negotiating proposal or any other document presented by the United States that presents concepts or considerations for the negotiations . . . .

The bill also calls for the International Trade Commission to publish a report on the suspension or modification of any provisions of the trade agreement being proposed by the U.S. Trade Representative and to conduct a public hearing on the proposal.

S. 4063, by comparison, is far more concise. In particular, the bill states that:

The President, and any official, employee, or agent of the United States, may not negotiate or conclude any withdrawal, suspension, waiver, or modification to the TRIPS Agreement without obtaining explicit authorization from Congress before beginning negotiations with respect to that withdrawal, suspension, or modification.

H.R. 7430 has been referred to the House Ways and Means and House Rules committees. S. 4063 has been referred to the Senate Finance committee.

For additional information regarding this topic, please see:

• "Senators Send Letter to Commerce Secretary Regarding WTO Waiver Compromise," March 28, 2022
• "The Proposed WTO IP Waiver: Just What Good Can It Do? — An Analysis," March 24, 2022
• "IP Associations 'Concerned' by Reports of TRIPS Waiver Compromise," March 24, 2022
• "More on Leaked WTO COVID-19 Vaccine Patent Waiver Compromise," March 21, 2022
• "Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver," March 16, 2022
• "Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver," December 12, 2021
• "U.S. Trade Representative Responds to Letters from Senators Regarding TRIPS Waiver," November 14, 2021
• "U.S. Chamber of Commerce Urges Administration to 'Double Down' on Global Vaccine Distribution," November 3, 2021
• "Is This the WTO Waiver End Game?" July 25, 2021
• "BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP," June 24, 2021
• "GOP Legislators Write in Opposition to Proposed TRIPS Waiver," May 16, 2021
• "Population of Patents at Risk from Proposed WTO Patent Waiver," May 12, 2021
• "Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver," May 12, 2021
• "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver," May 10, 2021
• "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" May 9, 2021
• "The Road to Hell Is Paved with What Everybody Knows," May 6, 2021
• "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver," May 6, 2021
• "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
• "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
• "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
• "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
• "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
• "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
• "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021
Conference & CLE Calendar

April 24, 2022

April 26, 2020 – 2022 Global Series Spring Session (Federal Circuit Bar Association and European Patent Lawyers Association) – 8:30 am to 6:00 pm (ET), Washington, DC

April 26, 2022 – "Trending Topic in Brazil: Discussion on the Possibility of Patent Term Adjustment (PTA) in View of the Delay of the BPTO (Brazilian Patent Office)" (Dannemann Siemsen) – 12:00 pm (BRT)

April 26-27, 2022 – Paragraph IV Disputes Conference (American Conference Institute) – New York City

April 28, 2022 – "The Influence of Women in IP: Women and the Unified Patent Court" (OxFirst Limited) – 15:00 to 16:00 (GMT)

April 28, 2022 – "Patenting and Litigating Pharmaceutical Salts" (IPWatchdog and Barash Law) – 12:30 pm (ET)

April 28, 2022 – "The Power of Corporate Pledges" (Intellectual Property Owners Association) – 2:00 pm to 3:00 pm (ET)

May 24, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 9:00 am to 11:00 am (ET)

May 25, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 1:00 pm to 3:00 pm (ET)

May 26, 2022 – Examination practices and procedural guidance for 35 U.S.C. § 103 obviousness rejections (Part 2) – virtual Instructor-Led Training (vILT) series (U.S. Patent and Trademark Office) – 5:00 pm to 7:00 pm (ET)
FCBA & EPLAW Global Series Spring Session

April 23, 2022

The Federal Circuit Bar Association (FCBA) and European Patent Lawyers Association (EPLAW) will be offering their 2022 Global Series Spring Session on April 26, 2020 from 8:30 am to 6:00 pm (ET) at the Army and Navy Club in Washington, DC. The program will include presentations on the following topics:

• International Trends in SEP/FRAND
• The Intersection of Data and IP
• Standard Setting – How Do Standards Impact Innovation and Trade?
• Section 101 – What If?
• Trade Secrets – From Enforcement to Unique Issues in the Virtual Setting
• Pros and Cons of Waivers
• USMCA and IP
• Experts – A Comparison of Different Jurisdictions and What Works Best

The registration fee for the program is $100 for private practitioners who are FCBA or EPLAW members and $50 for government/academic/retired FCBA or EPLAW members, and $400 for non-members. An agenda for the program, including detailed descriptions of the program's sessions, a list of speakers, and registration information can be found here.
Webinar on Patent Term Adjustment in Brazil

April 23, 2022

Dannemann Siemsen will be offering a webinar entitled "Trending Topic in Brazil: Discussion on the Possibility of Patent Term Adjustment (PTA) in View of the Delay of the BPTO (Brazilian Patent Office)" on April 26, 2022 at 12:00 pm (BRT). José Eduardo Cardozo of Martins Cardozo Advogados Associados, Justin Pine of the Biotechnology Innovation Organization (BIO), and Luiz Augusto Lopes Paulino of Dannemann Siemsen will address the ongoing debate regarding the possibility of PTA (Patent Term Adjustment) in view of the delay of the BPTO (Brazilian Patent and Trademark Office) in examining patent applications, a topic that surfaced after the Supreme Court revoked the right for applicants to have an automatic 10-year-term from grant, and which has resulted in patentees seeking PTA before the Brazilian courts.

Those wishing to register for the webinar can do so here.
Webinar on Women and the Unified Patent Court

April 23, 2022

OxFirst Limited will be offering a webinar entitled "The Influence of Women in IP: Women and the Unified Patent Court" on April 28, 2022 from 15:00 to 16:00 (GMT). Marina Tavassi of BonelliErede, and formerly the President of the Court of Appeal; Julia Dias of Huawei; and Katie Colart of Kirkland & Ellis will address the following questions relating to women in IP and ask what can be done to remove gender barriers in intellectual property:

• Under the Unified Patent Court (UPC), should the opportunities for women be stronger established?
• Should women judges, given equal qualification and competence, be given priority in the selection process?
• Should there be adjustments made to allow judges who are also parents to participate in the UPC?
• Is there a need to come to grips with more gender-neutral language under the UPC?

While there is no cost to participate in the program, those interested in attending the webinar should register here.
Webinar on Patenting and Litigating Pharmaceutical Salts

April 23, 2022

IPWatchdog and Barash Law will be offering a webinar entitled "Patenting and Litigating Pharmaceutical Salts" on April 28, 2022 at 12:30 pm (ET). Gene Quinn of IPWatchdog, Inc.; Stephen Byrn of Purdue University and Improved Pharma; Steven Zeman of Grünecker Patent Attorneys and Attorneys at Law; and Eyal Barash of Barash Law, LLC will focus on questions related to obviousness and inventive step, enablement and written description sufficiency, and scientific aspects of pharmaceutical salts, and address issues related to litigation of patents directed to such salts from both a legal and expert witness point of view.

There is no registration fee for this webinar. However, those interested in registering for the webinar, should do so here.
IPO Webinar on Corporate Pledges

April 23, 2022

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "The Power of Corporate Pledges" on April 28, 2022 from 2:00 pm to 3:00 pm (ET). Brett Alten of Hewlett Packard Enterprise; Bowman Heiden of the Tusher Center for the Management of Intellectual Capital, UC-Berkeley; Allen Lo of Meta Platforms: and Corey Salsberg of Novartis will discuss the origin of corporate pledges regarding lowering carbon footprints, increasing diversity within organizations, and sharing IP in the fight against COVID, how these pledges can impact organizations, and whether they work.

The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request). Those interested in attending the webinar should register here.
Senior Party Sigma-Aldrich Files Opposition to Broad Contingent Motion No. 2

April 21, 2022

By Kevin E. Noonan —

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party), asking the Patent Trial and Appeal Board to add claims 52-54 of Broad Application No. 16/177,403 to the interference, pursuant to the provisions of 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208 and Standing Order ¶ 203.2. The motion is contingent on the Board granting Broad's Substantive Preliminary Motion No. 1 to substitute the Count. On March 16th, Sigma-Aldrich filed its Opposition.

The claims that were the subject of Broad's Motion recite a CRISPR method in eukaryotic cells that cleaves both strands and repairs the break by integration of a template polynucleotide. Claim 52 is generic with regard to the guide RNA species, comprising dual-molecule and single-molecule (sgRNA) species:

52. A method comprising: introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
    (I) a Cas9 protein or one or more nucleotide sequences encoding the Cas9 protein,
    (II) an RNA or one or more nucleotide sequences encoding the RNA, the RNA comprising:
        (a) a first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and
        (b) a second RNA, and
    (III) a template polynucleotide,
    wherein, the second RNA forms an RNA duplex with the second ribonucleotide sequence, and wherein, in the eukaryotic cell, the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, whereby the Cas9 cleaves both strands of the DNA molecule and the cleavage is repaired by integration of the template polynucleotide into the DNA molecule in the eukaryotic cell.

Claim 53 (dual molecule RNA species) and claim 54 (single-molecule RNA species) recite the two alternative species. Broad asserted that these claims were deemed allowable by the U.S. Patent and Trademark Office Examiner on November 15, 2021.

Sigma-Aldrich's Opposition notes that this motion will become moot should the Board deny Broad's Preliminary Motion No. 1 to change the Count. Sigma-Aldrich also asserts that none of the claims in the '403 application have been allowed (or considered in condition for allowance) by the Examiner, prosecution of that application having been suspended with the Declaration of this Interference. Should the Board reach the merits, Sigma-Aldrich contends that Broad has not applied the one-way obviousness test and to address whether these claims 52-54 satisfy the written description requirement of 35 U.S.C. § 112(a).

With regard to the allowability vel non of these claims, Sigma-Aldrich sets forth the Board's conditions for granting Broad leave to file Contingent Motion No. 2 but then asserts that Broad has not fulfilled the condition that the claims be in condition for allowance, characterizing Broad's position as being "misleading" and citing several assertions from the Contingent Motion that state or imply that the Examiner has made an allowability determination. Sigma-Aldrich cites (and relies upon) its earlier-filed Opposition to Broad Motion No. 1 on why claims 52-54 of the '403 application were not allowed by the Examiner.

On the merits, Sigma-Aldrich cites the one-way obviousness test in support of its position that Claims 53 and 54 are not patentable over Proposed Count No. 3 (they would have been obvious) and thus the Board should not grant the Motion. Finally, Sigma-Aldrich argues (as it has elsewhere) that the Broad P1 provisional application does not provide adequate written description support for Claims 52-54 of the '403 application. In this regard Sigma-Aldrich argues that "the limited Section 112 analysis for a constructive reduction [to] practice is not the same as a full Section 112 analysis for compliance with the written description requirement," citing Google LLC v. Parus Holdings, Inc., 2021 Pat. App. LEXIS 6203 at *11 (PTAB Oct. 29, 2021) (the distinction being that satisfaction of the former requires disclosure of but a single embodiment within the scope of the Count while satisfaction of the written description requirement must show an adequate description throughout the full scope of the claims corresponding to the Count, citing Zynga, Inc. v. IGT, 2014 Par. App. LEXIS 753 at *24 (PTAB Feb. 14, 2014)). Finally, Sigma-Aldrich argues that Broad did not even address whether Claims 52-54 of the '403 application were patentable in its Contingent Motion No. 2, nor that "Broad fails to address the fact that Broad's intervening AIA Application 61/842,322 disclosed and claimed 'wherein the gene product is luciferase,' which limitation was not disclosed or claimed in any of Broad's pre-AIA applications." Once again, Sigma-Aldrich refers to and relies upon its Opposition to Broad Preliminary Motion No. 1 which addressed many of these same issues.
Apple Inc. v. Zipit Wireless, Inc. (Fed. Cir. 2022)

April 20, 2022

By Kevin E. Noonan —

Personal jurisdiction is one of those basic concepts in civil procedure that evokes strong memories in most lawyers, of their first year in law school, cases like International Shoe, Burger King, Helicopteros, and World-Wide Volkswagen, and perhaps even a bit of painful nostalgia for a time when they were maybe a little overwhelmed by the process of learning the law. But there is a reason considerations like personal jurisdiction are part of the basic introduction to legal education, not the least of which is the real-world consequences that can arise involving them. A case illustrating this reality was decided recently in Apple Inc. v. Zipit Wireless, Inc. (and as a bonus, the Federal Circuit expressly disclaimed a misapprehension by the District Court that it had enunciated a bright line rule regarding personal jurisdiction in patent cases).

The lawsuit on appeal was a declaratory judgment action brought by Apple in the Northern District of California, but the dispute predated the filing of Apple's complaint by several years. As described in the Federal Circuit's opinion, Zipit approached Apple in 2013 regarding its assigned patents, U.S. Patent Nos. 7,292,870 and 7,894,837, which claimed "wireless instant messaging devices that use Wi-Fi to send and receive instant messages." For the next three years, there were "several rounds of correspondence" between them as well as an in-person meeting in Cupertino, home of Apple corporate headquarters (and in the Northern District). This correspondence and these communications involved whether Apple was willing to purchase the patents outright or license them, inter partes review proceedings involving the patents, and whether Apple was infringing based on technical details of its products (as well as the possibility of willful infringement). These discussions were fruitless and Zipit filed a patent infringement lawsuit in the Northern District of Georgia on June 11, 2020, which Zipit two weeks later voluntarily dismissed without prejudice; this was followed by Apple filing the declaratory judgment suit that was the basis for this appeal nine days after Zipit voluntarily dismissed its Georgia action.

Because it is relevant to the personal jurisdiction question, the opinion set forth in some detail the history of the negotiations between the parties:

The record before the district court indicates that Zipit first traveled to Apple's Cupertino headquarters on December 3, 2013. Following this in-person meeting, the parties had "at least" four "detailed calls" in December 2013, February 2014, and March 2014. During these meetings and calls, Apple and Zipit discussed licensing the patents-in-suit and Apple's contentions that it "does not practice any Zipit patent claims" and that the "patents[-in-suit] are invalid." Indeed, the parties went so far as to exchange competing drafts of a license agreement in August and September 2014 but ultimately did not reach any agreement. Zipit traveled to Apple's Cupertino offices for a second in-person meeting to continue discussions on January 13, 2015.

Following the January 2015 meeting, Apple and Zipit exchanged numerous letters and emails throughout 2015 and 2016. The first email, dated July 18, 2015, was sent by Mr. Stephen Risley (Zipit's outside counsel) regarding "Apple's Ongoing Infringement" of the patents-in-suit. This email, directed to Apple's in-house counsel (Mr. Rudhir Patel) sought a "definitive response" from Apple regarding the parties' ongoing discussion of Apple's "purchase and/or license" of the patents-in-suit. Referencing a discussion that had taken place the day prior, Mr. Risley also attached for Apple's review Zipit's opposition brief to a petition for IPR of the '837 patent. He also noted that additional briefs as to other patents were forthcoming. Mr. Risley concluded: "I understand that Apple will review Zipit's IPR briefs and respond to Zipit in 1-2 weeks."

Apple responded two months later. On September 25, 2015, Mr. Patel sent Mr. Risley a letter reiterating Apple's view that it "does not need a license" to the patents-in-suit "because Apple does not practice any" claims of the patents-in-suit and the claims are invalid. In describing its grounds for noninfringement, Apple referred specifically to deficiencies in claim charts it had received from Zipit. Apple also stated that its view that the claims were invalid was "confirmed by [its] review of the materials before the [Patent Trial and Appeal Board], and additional prior art not being considered" in the pending IPRs.

The discussions escalated. On October 14, 2015, Mr. Risley sent a responsive letter addressed to Mr. Patel (with Apple's Cupertino office listed on the address line) regarding "Apple's Ongoing Willful Infringement" of the patents-in-suit. In the letter, Mr. Risley conveyed Zipit's "continue[d]" belief that "Apple has and continues to willfully infringe" the patents-in-suit. He concluded the letter by referencing willful infringement a second time: "Zipit is confident that if it becomes necessary a Court will view your September 25, 2015 [letter] as nothing more than a transparent attempt by Apple to justify Apple's past, present, and future willful infringement of Zipit's patents." Apple responded to this letter on December 8, 2015. Mr. Risley sent another email to Mr. Patel five months later on April 7, 2016. In this email, Mr. Risley informed Apple that the Board had "confirmed the patentability of all claims" of the patents-in-suit. He concluded the letter by once again stating Zipit's belief "that Apple has and continues to infringe" the patents-in-suit.

The parties thereafter had another phone call on April 26, 2016, after which Mr. Patel, on May 2, 2016, responded in writing to Zipit's latest letter. Mr. Patel reiterated Apple's belief that the patents-in-suit are invalid notwithstanding the Board's patentability determination in the IPR proceedings. In response to Zipit's continued allegations of infringement, Apple explained that it had "repeatedly refuted those allegations" and that Zipit had failed to substantively respond to Apple's positions in this regard. The letter concluded: "Should Zipit substantively respond to Apple's explanation of why Apple's products do not fall within the scope of [the patents-in-suit] Apple will further consider Zipit's positions [citations to the record deleted throughout].

The District Court granted Zipit's motion to dismiss for lack of personal jurisdiction under Federal Rule of Civil Procedure 12(b)(2). Although the District Court found that Apple had established "minimum contacts" that satisfied the California long-arm statute and were consistent with constitutional due process limitations on jurisdiction (and that Zipit had not rebutted Apple's "presumptively reasonable" showing thereof), the District Court held that the Federal Circuit had set forth a bright-line rule that "the exercise of personal jurisdiction . . . would be unconstitutional when '[a]ll of the contacts were for the purpose of warning against infringement or negotiating license agreements, and [the defendant] lacked a binding obligation in the forum,'" under Levita Magnetics Int'l Corp. v. Attractive Surgical, LLC, Case No. 19-cv-04065-JSW, 2020 WL 4580504, at *6 (N.D. Cal. Apr. 1, 2020), and Breckenridge Pharm., Inc. v. Metabolite Lab'ys, Inc., 444 F.3d 1356, 1364 (Fed. Cir. 2006). This appeal followed.

The Federal Circuit reversed and remanded, in an opinion by Judge Stoll, joined by Judges Hughes and Mayer. The Court began by acknowledging that the California long-arm statute extended "to the full extent allowed by the due process clauses of the United States Constitution" and thus limited its analysis accordingly. Citing World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 297 (1980), the opinion asserts that the issue in determining the appropriateness of finding due process arising in personal jurisdiction situations was whether a defendant's "conduct and connection with the forum State are such that he should reasonably anticipate being haled into court there." The three factors set forth in Supreme Court opinions involving personal jurisdiction set out in the opinion are (1) whether a defendant has "purposefully directed" activities at forum residents; (2) whether the claim to be adjudicated "arises out of or relates to" defendant's activities in the forum; and (3) whether asserting personal jurisdiction over the defendant would comport with "'traditional notions of fair play and substantial justice" under the World-Wide Volkswagen decision. As the opinion sets out, "[t]he first two factors comprise the 'minimum contacts' portion of the jurisdictional framework . . . .," citing Jack Henry & Assocs., Inc. v. Plano Encryption Techs. LLC, 910 F.3d 1199, 1204 (Fed. Cir. 2018). Under circumstances where minimum contacts are satisfied, the Court says, assertion of personal jurisdiction is presumptively reasonable except where the presumption is successfully rebutted by the defendant.

Here, the Federal Circuit, considering the litany of contacts Zipit had with Apple, a resident of the forum, agreed with the District Court that the minimum contacts standard had been satisfied. This conclusion was supported by the Federal Circuit's finding of personal jurisdiction in Xilinx, Inc. v. Papst Licensing GmbH & Co., 848 F.3d 1346, 1356 (Fed. Cir. 2017), where defendant's activities consistent of two notice letters and a single visit with the accused infringer; the panel found "Xilinx [to be] virtually indistinguishable from the facts of this case, where Zipit likewise sent multiple communications to Apple in California and traveled twice to California to discuss allegations of infringement and the prospect of Apple licensing or purchasing the patents-in-suit." (The opinion sets forth several other decisions supporting personal jurisdiction under analogous circumstances.) The Federal Circuit rejected Zipit's argument that its conduct was not sufficient to raise a reasonable presumption that the minimum contacts standard had been satisfied based on the Court's decision in Autogenomics, Inc. v. Oxford Gene Tech. Ltd., 566 F.3d 1012, 1016 (Fed. Cir. 2009). The panel found significant differences ("material factual distinctions") in the facts here and in Autogenomics (which are set forth in a footnote).

The opinion traced back the District Court's error in finding a bright-line rule against asserting personal jurisdiction based on notice letters to Red Wing Shoe Co. v. Hockerson-Halberstadt, Inc, 148 F.3d 1355, 1360 (Fed. Cir. 1998), where the Federal Circuit said that "[p]rinciples of fair play and substantial justice afford a patentee sufficient latitude to inform others of its patent rights without subjecting itself to jurisdiction in a foreign forum." But while this sentiment and the policy arising from it are "no doubt relevant," according to the opinion, particularly to the extent it is directed towards settlement of incipient lawsuits, the panel rejected the argument by Zipit and the District Court's opinion that it reflects or establishes a patent-specific, bright-line rule, citing for example Trimble Inc. v. PerDiemCo LLC, 997 F.3d 1147, 1156–57 (Fed. Cir. 2021), and setting out several analogous personal jurisdiction decisions in other circuits over controversies in other areas of law.

But such a policy does not overcome the constitutional considerations set forth by the Supreme Court in Burger King and other personal jurisdiction cases, the panel opined. To be perfectly clear, the opinion states that:

[T]he district court erred in reading our precedent as creating a bright-line rule that communications directed to "the attempted resolution" of the parties' dispute regarding the patents-in-suit trumps all other considerations of fairness and reasonableness. Although some of our earlier precedent relying on Red Wing Shoe suggests that there is such a bright-line rule . . ., Supreme Court precedent (both pre- and post-Red Wing Shoe) has made clear that jurisdictional inquiries cannot rest on such bright-line rules—there are no "talismanic jurisdictional formulas." Rather, "'the facts of each case must [always] be weighed' in determining whether personal jurisdiction would comport with 'fair play and substantial justice'" [citations omitted].

Having dispensed with this ground of error, the opinion then assessed whether Zipit satisfied the Supreme Court's counter rubric regarding whether a defendant could overcome the reasonable presumption of personal jurisdiction on the basis of:

[1] "the burden on the defendant," [2] "the forum State's interest in adjudicating the dispute," [3] "the plaintiff's interest in obtaining convenient and effective relief," [4] "the interstate judicial system's interest in obtaining the most efficient resolution of controversies," and [5] the "shared interest of the several States in furthering fundamental substantive social policies."

While recognizing that Zipit had asserted some evidence relating to some of these factors (e.g., that there would be some burden in litigating in California because the company, its officers, and employees including inventors resided in South Carolina), on balance Zipit did not assert sufficient facts to convince the Federal Circuit that it had rebutted the reasonable presumption that the District Court could properly exercise personal jurisdiction over Zipit. (It didn't help Zipit's argument that their executives had travelled to the district twice to meet with Apple during licensing negotiations.) Even Zipit's filing its Georgia lawsuit was evidence that it should have "reasonably foreseen" that Apple would respond with a declaratory judgment suit according to the Federal Circuit.

While acknowledging that "we have no doubt that Zipit's initial contacts with California can be fairly viewed as attempting to settle its dispute with Apple out of court, e.g., by way of a patent license," which was "an important fact we consider and weigh in Zipit's favor," the opinion noted that "Zipit's communications with Apple arguably went further, extending over the course of several years and reaching beyond license negotiations to include the sale of its patents." While this attempt at settlement was on Zipit's side of the scales under the Burger King test, the panel held that, on balance, these considerations did not counterbalance their opinion that Zipit had not rebutted the reasonable presumption that the minimum contacts standard had been satisfied and that the District Court could exercise personal jurisdiction over Zipit within the bounds of constitutional due process.

Apple Inc. v. Zipit Wireless, Inc. (Fed. Cir. 2022)
Panel: Circuit Judges Hughes, Mayer, and Stoll
Opinion by Circuit Judge Stoll