patents Archives - The National Law Forum

Huawei U.S. Patent Grants Drop 24% in 2023; BOE Drops Out of the Top 10

Accordingly to analysis by Harrity Patent Analytics, Huawei ranked 10^th for US patent grants in 2023, down 3 spots from 2022 with a 24% drop in patent grants. BOE Technology Group Co., Ltd. dropped even further to 19^th down from 8^th in 2022. BOE had a 38% drop in granted US patents. Tencent was 54^th this year with an 11% drop in patent grants. Oppo was down 32%. Baidu was up only 1%. Xiaomi was down 7% and didn’t make the top 100 in 2023. Alibaba was down 49%. In contrast, US companies advanced with Qualcomm patent grants up 46%, Alphabet (Google) up 23% and Apple up 11%.

The drop in Chinese patent grants reverse the trend of growing US patent grants for Chinese companies. Huawei’s patents grants in 2022 were up 3%, BOE up 27%, Baidu up 43% and Xiaomi up 33%.

Possible reasons for the drop in grants to Chinese entities may include a poorly performing Chinese economy, the reduction and elimination of government subsidies for foreign patent grants, the impact of COVID-19 on patent application filings the past few years; and geopolitical tensions.

Top 10 Chinese Grantees of U.S. Patents in 2023

Rank	Company	2023 Patents	% Change from 2022
10	HUAWEI TECHNOLOGIES CO., LTD.	2290	-24%
19	BOE TECHNOLOGY GROUP CO., LTD	1695	-38%
54	TENCENT HOLDINGS LTD	702	-11%
67	BAIDU, INC.	626	+1%
77	LENOVO GROUP LIMITED	530	-16%
84	OPPO MOBILE TELECOMMUNICATIONS CORPORATION	516	-32%
101	XIAOMI INC.	461	-7%
115	TSINGHUA HOLDINGS	372	-3%
121	ZTE CORPORATION	351	-14%
122	BYTEDANCE LTD.	350	+119%

Source: https://harrityllp.com/patent300/

Patenting a Nice Cool Glass of Nicotinamide Riboside? Claims Covering Milk Invalid under § 101

The US Court of Appeals for the Federal Circuit found that claims covering a naturally occurring composition were not patent eligible under 35 U.S.C. § 101 merely because one component of the composition had been “isolated.” ChromaDex, Inc. v. Elysium Health, Inc., Case No. 2022-1116 (Fed. Cir. Feb. 13, 2023) (Chen, Prost, Stoll, JJ.)

ChromaDex sued Elysium (a former ChromaDex customer) for infringement of its patent directed to dietary supplements containing nicotinamide riboside (NR). Elysium moved for summary judgment, arguing that the asserted claims were invalid under the § 101 prohibition against patenting natural phenomena. After the district court granted summary judgment, ChromaDex appealed.

The asserted claims were directed to a composition comprising:

Isolated NR
One or more of tryptophan, nicotinic acid or nicotinamide
One of 22 carriers
Increased NAD+ biosynthesis after eating.

Both parties conceded that milk satisfies every element of the asserted claims with the exception that its NR is not “isolated.” Both parties also conceded that milk is a naturally occurring material and thus not patent eligible under § 101.

On these facts, the issue presented was whether the claim limitation that the NR must be “isolated” (which does not occur in nature) was sufficient to make the claims patent eligible. The Federal Circuit responded “no.”

The Federal Circuit analyzed the asserted claims under two tests: the “markedly different characteristics” test set out in Chakrabarty, and the Alice two-step test (unsure whether Chakrabarty remains controlling precedent).

Under the Chakrabarty test, a claimed composition is not a natural phenomenon if it has “markedly different characteristics” from what occurs in nature. The Federal Circuit found that ChromaDex’s claimed composition had no markedly different characteristics from natural milk. While ChromaDex argued that isolation potentially allowed for unnaturally high concentrations of NR, the claims did not require such concentrations. The claims included compositions structurally and functionally identical to milk and therefore failed the “markedly different characteristics” Chakrabarty test.

Proceeding to the two-part Alice test, under step 1 the Federal Circuit found that the claims were directed to a product of nature because there were no structural differences between the claimed composition and natural milk. Under step two, the Court found that there was no “inventive step” because the claims were merely directed to increasing NAD+ biosynthesis, which was a natural principle that resulted from drinking milk.

Practice Note: During claim drafting, care should be taken to avoid claims that encompass all structural and functional components of a naturally occurring material.

Article By Alexander Piala, PhD of McDermott Will & Emery

For more intellectual property legal news, click here to visit the National Law Review.

Supreme People’s Court Upholds China’s First Patent Linkage Ruling – Decision Released

On August 28, 2022, 知识产权那点事 published the first patent linkage decision from the Supreme People’s Court (SPC). The SPC upheld the Beijing IP Court ruling that Wenzhou Haihe Pharmaceutical Co., Ltd.’s application for marketing authorization for a generic form of “Aidecalcidol Soft Capsule” did not fall within scope of protection of the relevant patent. China’s patent linkage system prevents marketing authorization for a generic prior to the expiration of the patent term on the branded equivalent unless the Beijing IP Court or the China National Intellectual Property Administration (CNIPA) rules that the generic does not fall within the scope of the relevant patent rights or is invalid.

On November 10, 2021, the Beijing IP Court announced that the plaintiff of the case, Chugai Pharmaceutical Co., Ltd., a subsidiary of Roche, claimed that it was the patentee as well as the holder of the marketing license for the patented drug “Aidecalcidol Soft Capsule”, and the patent involved in the drug was CN 2005800098777.6 entitled “ED-71 preparation.” The plaintiff discovered that the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. had applied to the National Medical Products Administration (NMPA) for a generic drug marketing license application named “Aidecalcidol Soft Capsule”. The public information on the Chinese listed drug patent information registration platform showed that the defendant had made a 4.2 category statement regarding the generic drug (the generic drugs do not fall into the scope of protection of the related patents). Therefore, the plaintiff filed a drug patent linkage lawsuit with the Beijing Intellectual Property Court in accordance with the provisions of Article 76 of the Amended Patent Law, requesting the court to confirm that the generic drug “Aidecalcidol Soft Capsule” that the defendant applied for registration fell into the scope the rights of Patent No. 2005800098777.6 enjoyed by the plaintiff.

The Beijing IP Court held:

The technical solution used by the generic drug involved is neither the same nor equivalent to the technical solution of claim 1 of the involved patent, so the technical solution does not fall within the protection scope of claim 1 of the involved patent. Since claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug involved does not fall within the protection scope of claim 1, it also does not fall within the protection scope of claims 2-6. Accordingly, the plaintiff’s claim that the involved generic drug falls within the protection scope of claims 1-6 of the involved patent cannot be established, and the court will not support it.

In the decision, the Supreme People’s Court stated there were two key points:

1. In the process of drug marketing review and approval, disputes arising from the patent rights related to the drug to be registered between the drug marketing license applicant and the relevant patentee or interested parties are only one type of the related patent rights between the two parties – often referred to as drug patent link disputes. For chemical generic drugs, the drug regulatory department of the State Council conducts drug marketing review and approval based on the application materials of the generic drug applicant, and decides whether to suspend the approval of the relevant drugs according to the effective judgment made by the people’s court [or the China National Intellectual Property Administration] on such disputes within the prescribed time limit. Therefore, when judging whether the technical solution of a generic drug falls within the scope of patent protection, in principle, it should be compared and judged on the basis of the application materials of the generic drug applicant. If the technical solution actually implemented by the generic drug applicant is inconsistent with the declared technical solution, it shall bear legal responsibility in accordance with the relevant laws and regulations on drug supervision and administration; if the patentee or interested party believes that the technical solution actually implemented by the generic drug applicant constitutes infringement, a separate lawsuit for patent infringement may also be filed. Therefore, whether the technical solution actually implemented by a generic drug applicant is the same as the application materials is generally not within the scope of examination to confirm that the dispute falls within the scope of patent protection.

2. The court of second instance held that both the donation [to the public] rule and the estoppel rule can constitute a restriction on the application of the principle of equivalence, both of which aim to achieve a reasonable balance between equitably protecting the interests of the patentee and safeguarding the interests of the public. If the conditions for limiting the application of the principle of equivalence are met, there is usually no need to judge whether the two features constitute similar means, functions, and effects, and whether those skilled in the art can conceptualize them without creative work. In this case, since Haihe Company claimed the application of the estoppel rule by virtue of the amendment of the claims by Chugai Pharmaceutical Co., Ltd., and claimed the application of the donation rule by the patent text as the result of the amendment, the court of second instance first rendered a judgment on whether the rules on estoppel should be applied on the basis of the amendment of the claims by the patentee.

The case numbers are:

北京知识产权法院（2021）京73民初1438号民事判决书

最高人民法院（2022）最高法知民终905号民事判决书

The full text of the decision courtesy of 知识产权那点事 is available here (Chinese only).

Article By Aaron Wininger of Schwegman, Lundberg & Woessner, P.A.

For more intellectual property legal news, click here to visit the National Law Review.

Tillis Bill Tries to Fix Section 101

This recently introduced bill would replace section 101 with a lot of text. The commentators are all commentating, but I have yet to read whether or not the “outlaw” status of claims to diagnostic methods—led by varying interpretations of Mayo v. Prometheus—has been clearly lifted by this bill. Here are the relevant parts, at least setting up the discussion on this point.

Section 101. Patent Eligibility

(a) IN GENERAL—Whoever [post- Thaler v. Vidal, we know that this must be a human being] invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefore, subject only to the exclusions in section (b) and to the further conditions and requirements of this title.

(b) ELIGIBILITY EXCLUSIONS.—

(1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such:

***

(B) A process that—

***

(iii) occurs in nature wholly independent of, and prior to, any human activity.

(D) An unmodified natural material, as that material exists in nature.

(2) CONDITIONS.—

***

(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs (C) and (D) of paragraph (1), a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified.

(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined

(A) By considering the claimed invention as a whole and without discounting or disregarding any claim element; and

(B) Without regard to—

***

(ii) whether a claim element is known, conventional, routine, or naturally occurring

***

Well now, does this bill abrogate Mayo v. Prometheus and permit patents on diagnostic assays as simple as “If A, then B” (If assay indicates high homocysteine then diagnostic conclusion is low cobalamin)? Let’s start with a simple “If A, then B” claim, like the one in Athena (If autoantibodies to MuSK are detected, subject may be afflicted with MG). The presence of antibodies that bind to MuSK occurs in nature wholly independently and prior to any human activity. See, section I (B) (iii). So to be patentable, a process comprising the detection of the antibodies or of a MuSK-antibody complex in order to diagnose MG must fall within one of the “conditions” of the statute as set forth in 2(B).

The problem, and I hope it is not a big one, is that 2(B) does not mention “processes” employing “natural materials.” Applicants are left to argue that the anti-MuSK antibodies per se are altered by human activity, e.g., by binding to MuSK, and so are “modified.” They can also argue that the antibodies are employed in a useful discovery since they are the biomarker for MG. But, of course, the applicants wanted to claim a process, not just the biomarker detected by the assay.

Regarding diagnostics, is the key phrase “otherwise employed in a useful invention or discovery”? Of course, the argument is that the useful invention or discovery is the diagnostic process, from initial sampling to drawing a diagnostic conclusion. For years I have proposed that s. 101 bills on diagnostic clams need a sentence like, “A process includes recognition of the utility of a naturally occurring correlation.” In other words, you are not trying to patent the correlation itself, like “blood containing antibodies that bind to MuSK”. The necessary steps include both isolation and detection of the antibodies and recognition that their presence indicates something about the patient. (Note that Mayo did not invent the correlation between the level of the metabolites of the administered drug and the need to adjust the dose of the drug. Mayo took a known correlation and refined the optimal range of metabolite concentration that arose after administration of the “parent drug”. One could call this the recognition that an improved correlation could be reached, but nothing in the Tillis bill says that, apart from novelty, the invention needs to be improved over any earlier version or alternative. This draft of the bill needs some work but it is a valuable start to ending the s. 101 nightmare.

Article By Warren Woessner of Schwegman, Lundberg & Woessner, P.A.

For more intellectual property legal news, click here to visit the National Law Review.

CareDx v. Natera – The Broad Road to Patent Ineligibility

In CareDx v Natera, Appeal No. 2022-1027, (Fed. Cir., July 18, 2022), a three judge panel of Judges Lourie, Bryson and Hughes, affirmed the district court’s finding that the claims of U. S. patent nos. 8703652, 9845497 and 10329607 are invalid for failing to survive the Alice/Mayo test for patent eligibility. I subtitled this post using Mathew 7:13-14: “Enter through the narrow gate. For wide is the gate and broad is the road, that leads to destruction.” The appeal to the Federal Circuit, which I wrote about on October 15, 2021, never got on the narrow road that leads to viable diagnostic claims. It may not have been possible to overcome the obstacles that blocked the road, but CareDx managed to hit them all, and ended up with three invalid patents on natural phenomena.

The claims were directed to a method for detecting transplant rejection or organ failure by isolating and genotyping a sample from the subject who received the donation, quantifying the cfDNA, and diagnosing the transplant status for an increase in donor cfDNA over time. An increase indicates possible transplant failure.

Judge Lourie summarized the claims, some of which are more than a page long, this way:

“Here, as in Ariosa, the claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health, to identify a potential rejection, none of which was inventive. The claims here are equally as ineligible as those in Ariosa.”

Let’s take a quick look at how CareDx got onto the broad road. CareRx hoped to avoid Ariosa by arguing that it was doing more than just measuring a biomarker correlated to an existing phenomenon. Problem 1 is that CareDx did not discover the correlation; it just improved on it (or did it?). Louie writes:

“CareDx argues that the patents’ claims are directed not to natural phenomena, but to improved laboratory techniques. CareDx contends that the ‘claimed advance’ is an ‘improved, human-designed method for measuring increases in donor cfDNA in a recipient’s body to identify organ rejection.’ … In particular, CareDx identifies the use of digital PCR, NGS, and selective amplification to more accurately measure the donor SNPs of cfDNA transplant recipients. However, CareDx does not actually claim any improvements in laboratory techniques … Furthermore the specification admits that the laboratory techniques disclosed in the claims require only conventional techniques and off-the-shelf technology.”

In fact, CareDx had at least one claim in the ‘497 patent that recites that the assay detects the donor-specific circulating cfDNA from the organ transplant when the donor-specific circulating cfDNA [makes] up at least 0.3% of the total circulating cfDNA in the biological sample. I presume that this claim limitation was put into the claim so that “improvement” could be argued, but the limitation is not mentioned in the opinion.

Let’s look at a few other things CareDx encountered on its broad road to legal destruction. The panel looked at every step of the method in isolation. In other words, once CareDx argued “improvement” it was forced to admit that the specification disclosed that all those analytical techniques, such as PCR, NGS and “selective amplification”, would be considered as conventional in the art. CareDx might have relied on some of the decisions finding patent eligibility where physical equipment was necessarily involved, such as XL LLC v. Trans Ova Genetics or Illumina v Ariosa.

The finding of conventionality of individual steps permitted the court and the panel to effectively rule that the method was directed to a natural product, since the devices used to carry it out were given no weight. Therefore, the patents failed to pass Step 1 of Mayo/Alice. Could it have been argued, if that was the case, that the equipment used to carry out the method was arranged in a novel sequence? (Also, is someone going to argue that PCR involves replicating small amounts of DNA to afford useful amounts? – This is accomplished by the hand of man.)

These are minor thoughts, CareDX should left the word “diagnostic” out of the claims and the specification. This is certainly no more of a diagnostic test than the Mayo range-finding step was. It is presently clear that in the life sciences, recognition of the utility of a naturally occurring correlation is not enough to avoid patent ineligibility. Of course, and this is cold comfort to CareDx, would it have helped to get this method into the safe harbor of methods of medical treatment? In other words, the first step could recite the actual transplantation step and/or the final step of the process could recite some sort of medical intervention. Narrower claims might have returned CareDx to the narrow path of patent life.

Article By Warren Woessner of Schwegman, Lundberg & Woessner, P.A.

For more intellectual property legal news, click here to visit the National Law Review.

Russian Sanctions Create Patent Risks

While multi-national sanctions recently imposed on Russia were intended to punish Russia for its aggression in Ukraine, the effects of the sanctions have led to a need for tough decisions for U.S. entities with patent interests in Russia. The prohibitions on financial exchanges with certain Russian banks will essentially prevent any payment of fees to Rospatent (the Russian patent office), and although a general license from the Department of the Treasury provides a short window for winding down certain administrative transactions, U.S. entities engaged in patent transactions with Rospatent only have a short time to make decisions about current and future patent activities in Russia.

Prohibited Activities

On February 28, 2022, the Department of the Treasury initiated prohibitions related to transactions involving certain financial institutions in Russia, including the Central Bank of the Russian Federation.¹ The directive specifically prohibits a United States person (unless otherwise excepted or licensed) from engaging in any transaction involving the listed financial institutions, including any transfer of assets to such entities or any foreign exchange transaction for or on behalf of such entities. Under the directive, the prohibitions are specifically worded to include: (1) any transaction that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions of the directive; and (2) any conspiracy formed to violate any of the prohibitions of the directive.

Notably, the prohibited activities do not expressly prevent any transactions of a U.S. person with Rospatent. And although the United States Patent and Trademark Office (USPTO) has cut off direct engagement with Rospatent for carrying out activities such as use of the Global Patent Prosecution Highway (GPPH) program², Rospatent is not currently a sanctioned entity under the directive. This, however, is essentially a distinction without a difference. Moreover, since the USPTO (and also the European Patent Office) has already cut ties with Rospatent, there still remains the possibility that Rospatent itself will be added to the sanctions at a future date and thus completely eliminate any pursuits by U.S. persons with Rospatent.

The current sanctions directly affect entities seeking patent protection in Russia since payments of required fees related to patent applications and granted patents in Russia are processed through the Central Bank of the Russian Federation. This includes a number of financial transactions, such as payment of government filings fees for directly filing a patent application in Russia or filing a national phase of an international PCT application in Russia, as well as incidental fees incurred during prosecution of pending Russian patent applications and payment of yearly maintenance fees for issued Russian patents. This would also include payment of yearly maintenance fees for patents obtained through the Eurasian Patent Organization (EAPO) and maintained in Russia since such fees paid to the EAPO must be forwarded to Rospatent. Because of the intertwining of Rospatent with the Central Bank of the Russian Federation, any fees paid to Rospatent must be considered equivalent to making a transaction through said bank.

Patent prosecution in Rospatent requires engagement with a Russian patent practitioner. While U.S. entities pursuing patent interests in Russia are unlikely to directly engage Rospatent and pay fees that are ultimately processed through the prohibited bank, it is clear from the directive that strategies, such as routing payments through countries that are neutral in relation to sanctions, are prohibited. As noted above, the directive prohibits any transaction that actually “evades or avoids” the other prohibitions of the directive, as wells as any transaction that “has the purpose of evading or avoiding” the other prohibitions. This language appears to have the potential to ensnare purposeful non-adherence as well as actions that unwittingly end in non-adherence (e.g., forgetting to discontinue an automated payment of a patent maintenance fee to Rospatent).

Deadline for Administrative Transactions

U.S. entities still have time to complete administrative transactions with Rospatent despite the February implementation of the directive. On March 2, 2022, the Department of the Treasury issued a general license authorizing certain transactions that are otherwise prohibited by the directive.³ The license authorizes U.S. persons to pay taxes, fees, or import duties, and purchase or receive permits, licenses, registrations or certifications to the extent such transactions are prohibited under the directive, provided such transactions are ordinarily incident and necessary to such persons’ day-to-day operations in the Russian Federation. For at least U.S. entities whose day-to-day operations include securing and maintaining intellectual property, including in Russia, this license provides a window to complete activities and avoid violation of the directive. Currently, the transaction window provided under the license runs through 12:01 a.m. eastern daylight time on June 24, 2022.

Forming a Russian Patent Strategy

The incursion of Russia into Ukraine has been underway for shortly more than one month, but there is no way to know when hostilities may cease. Moreover, even when peace is achieved, it is impossible to know how long the current sanctions against Russia may continue. Those familiar with patent law know that the business of obtaining patents is a deadline-driven venture, and uncertainty of time quickly breaks apart the paradigm. A “wait and see” approach thus has the potential to result in a loss of patent rights as well as possible liability for knowingly or unknowingly engaging in activities that are prohibited under the directive. Anyone engaged in patent activities in Russia thus would be advised to undertake a portfolio review and utilize the time remaining under the General License to form a plan that ensures compliance with the current sanctions. This can include at least the following items.

Anyone engaged in patent activities in Russia thus would be advised to undertake a portfolio review and utilize the time remaining under the General License to form a plan that ensures compliance with the current sanctions.

Proceeding with Grant of Presently Allowed Applications – For Applicants that have received a Notice of Allowance with a due date after expiration of the General License, one may consider early payment of the fees. This should only be done, however, to the extent that it is possible to confirm that payment will be processed through Rospatent and the Central Bank of the Russian Federation prior to the expiration of the General License on June 24, 2022.
Annuities on Granted Patents – Any patent annuity paid to Rospatent after the General License expires should be assumed to be in violation of the current sanctions. Patent holders that engage a patent annuity service should contact their provider to confirm that they have a plan in place for compliance with the sanctions. Some annuity services have, in fact, already announced that they will no longer make payments to the Rospatent until further notice. Presumably, for Russian patents with annuities due in 2022, early payment could be made in the hope that normalcy will ensure prior to the deadline in 2023, but such action should only be taken to the extent one can ensure that payment is processed through Rospatent and the Central Bank of the Russian Federation before the deadline. Even then, it may be advisable to consider whether “early” payment of patent annuities would be considered to be “ordinarily incident” to day-to-day operations of a person’s patent pursuits. In the alternative, a patent owner should confirm that any Russian patents are under a “do not pay” order with their annuity provider to avoid an unintentional, automated payment in violation of the sanctions.
Filing a Direct or National Phase Patent Application – If a new patent application in Russia is planned, or if the deadline for national phase entry of a PCT application is approaching, one may consider early filing prior to the expiration of the General License. This could be done in the hope that a deadline for payment of future fees to Rospatent do not arise before the time that sanctions are lifted. This is seen to be a risky proposition since it is unknown how quickly Rospatent processes paid fees through the Central Bank of the Russian Federation, and it is likewise unknown to what extent a fee paid to Rospatent before expiration of the General License but only processed through the Central Bank of the Russian Federation after expiration would be viewed as being in violation of the sanctions. Moreover, if Rospatent itself is later added to the sanctions, any early filings would be at significant risk for abandonment due to an inability to continue transactions with Rospatent.
Filing Through EAPO as an Alternative to Russia – Russia is one of several countries where patent protection can be secured based on a granted patent from the EAPO. As of this writing, the banks utilized for processing financial transactions for the EAPO (AO UniCredit Bank and AO Raiffeisenbank) are not included in the U.S. sanctions. As such, direct filing or national stage entry with the EAPO can provide an alternate pathway for patent protection in Russia. The cessation of interaction between the USPTO and the EAPO would not have a bearing on this option, but care would need to be taken to ensure that all documents otherwise transferrable directly between the offices are handled by other routes. Once a patent is granted by the EAPO and Russia is elected as a country for maintenance of the patent, annuities paid to the EAPO are forwarded to Rospatent. As such, this alternative pathway is only effective for patents where annuities in Russia would not become due until after lifting of sanctions. As the average length of time for completion of patent prosecution with the EAPO is generally two or more years, one would hope that the current situation in Russia would be resolved within that timeframe. Again, however, uncertainty remains.
Using Russia as an International Search Authority – Rospatent is one of the limited number of patent offices available for use as the ISA in a PCT application, and Rospatent may be preferred because of the relatively low cost relative to other ISA options. Search fees paid to the World Intellectual Proper Organization (WIPO) are forwarded to Rospatent when chosen as the ISA, and it is not possible to ensure that such fees paid to WIPO will be forwarded to Rospatent, and then to the Central Bank of the Russian Federation before the expiration of the General License deadline. As such, it is recommended to not use Rospatent as the ISA in any PCT application from now until sanctions are lifted.
Enforcement of Granted Russian Patents – A comprehensive patent strategy in Russia must now also consider the relative value of any Russian patents in light of the recent decree on patent enforceability in Russia.⁴ Therein, any holder of a Russian Patent from a so-called “unfriendly” foreign state is required to give a mandatory license with no compensation to anyone in Russia wishing to exercise the right of use without consent of the patent owner. As with the entire situation, uncertainty reigns with this decree, and it is impossible to know when (if ever) rights of Russian patent holders from “unfriendly” states will be returned. Accordingly, a Russian patent strategy must consider not only options for proceeding in the near term to secure rights to the extent possible but must also consider the reality that any “rights” that are secured with a Russian patent are of no effect and will be for the foreseeable future.

Next Steps

For anyone with significant patent interests in Russia, time is of the essence for cementing a strategy for moving forward. For some, the most expeditious approach could be to simply close your file on any Russian patents and patent applications. If such approach is taken, careful attention must be made, as noted above, to ensure that any possibility of a fee being paid to Rospatent after June 24, 2022, is eliminated. For others, investments in Russia may not allow for a complete abandonment of possible future patent enforcement rights in Russia. If actions as noted above are taken to “batten down the hatches” of the Russian patent portfolio prior to the deadline in order to weather this storm, timing is again crucial in order to avoid unintentional engagement in sanctioned activities. Also, moving to patent filings through the EAPO as a starting point for Russia can be an effective workaround so long as Russian sanctions get lifted before any patent annuities through an EAPO patent would become due in Russia. Finally, in forming a strategy, one also must consider that even before its recent decree on patent enforceability, Russia was already one of nine countries on the United States Trade Representative (USTR) “Special 301 Report” of trading partners presenting the most significant concerns regarding insufficient IP protection or enforcement or actions that otherwise limited market access for persons relying on intellectual property protection.

¹ Directive 4 Under Executive Order 14024, “Prohibitions Related to Transactions Involving the Central Bank of the Russian Federation, the National Wealth Fund of the Russian Federation, and the Ministry of Finance of the Russian Federation,” February 28, 2022, Office of Foreign Assets Control, Department of the Treasury. See, https://home.treasury.gov/system/files/126/eo14024_directive_4_02282022….
² USPTO Statement on Engagement with Russia, the Eurasian Patent Organization, and Belarus, March 22, 2022. See, https://www.uspto.gov/about-us/news-updates/uspto-statement-engagement-r….
³ General License No. 13, “Authorizing Certain Administrative Transactions Prohibited by Directive 4 Under Executive Order 14024, Office of Foreign Assets Control, Department of the Treasury, March 2, 2022. See, https://home.treasury.gov/system/files/126/russia_gl13.pdf.
⁴ Decree of the Government of the Russian Federation of 06.03.2022 No. 299 “On Amendments to Clause 2 of the Methodology for Determining the Amount of Compensation Paid to a Patent Owner When Deciding to Use an Invention, Utility Model or Industrial Design without His Consent, and the Procedure for its Payment.” See, http://publication.pravo.gov.ru/Document/View/0001202203070005?index=0&r…

Article By Ryan Cagle of Womble Bond Dickinson (US) LLP

For more intellectual property legal news, click here to visit the National Law Review.

To Search or To Sink: The Importance of Clearing Your Brand

So many times in my three decades of practice I’ve shaken my head at the perils a trademark owner can so easily avoid by searching and clearing a mark. The litigations! The unnecessary attorneys’ fees! The time and resources lost! All because my client (or adversary) didn’t conduct a proper trademark search.

Adopting a Trademark

So what’s all the fuss about? Well, before adopting a trademark (that is, a brand name for goods or services) you should have an attorney commission a proper clearance search, review it, and provide you with a well-reasoned opinion as to the availability of the brand for “use” and “registration.” (Yes, they are different things, as explained below.) I’m not talking about an Internet search or an online search of U.S. Trademark Office records, though both can be useful to make sure there aren’t any easily found barriers to use or registration of a mark before a full search is commissioned.

I’m talking about a full clearance search done by a reputable vendor the attorney commissions to uncover all uses (registered and not) of the same or similar marks for the same or similar goods/services as you want to use your brand for. The resulting vendor’s report sent to the attorney is typically anywhere from 300 pages up to 1000 pages. Then the (experienced trademark) attorney reviews it and lets you know in a detailed opinion if the mark is free for you to use and register without entangling you in the risk of a dispute/lawsuit. If it’s not available, you pick another brand, and search again.

Using a Brand and Registering It

So what’s the difference between freedom to use a brand and freedom to register it? In the U.S., “common law” trademark rights can exist based solely upon use (that is use of a trademark without registration). That’s because consumers can associate a brand with a single source (the trademark owner/producer of goods/services) even if it’s not registered. (It’s different in other countries, and searches should be done in every country for which you want to use your brand.)

So it’s possible that there’s a barrier to use but not to registration, because a common law (unregistered) trademark is too similar to the brand you want to use, and is being used in connection with identical or related goods/services as your proposed brand. That’s why you want clearance to both use and register a mark. (Registration is important because it provides you with nationwide rights in your brand; common law trademarks cover only the geographic territory where sales under the brand occur.)

So please clear your mark. It’s pennies on the dollar compared to what you will spend in a dispute or (heaven forbid) litigation. Here’s to happy searching!

Article By Jeanne Hamburg of Norris McLaughlin P.A.

For more intellectual property legal news, click here to visit the National Law Review.

The Time Has Come for Trademark Modernization Act Regulations

On Dec. 18, 2021, regulations implementing the Trademark Modernization Act of 2020 (TMA) went into effect. Trademark owners and practitioners should be aware of the new procedures and ensure they are ready for the changes.

Trademark Modernization Act Regulations

Our posts “Three Things to Know About the Trademark Modernization Act of 2020” and “The Trademark Modernization Act of 2020: New Rules and Procedures” from March and May 2021, respectively, gave an overview of the changes that will be implemented with the act. Most notably, the TMA provides for new procedures to challenge trademark registrations based on nonuse – expungement, and reexamination. It is intended that the new ex parte expungement and reexamination proceedings will be faster and more efficient alternatives to cancellation procedures before the Trademark Trial and Appeal Board. You can read the final rule here.

Another significant change is the requirement for filers to verify their identity with the United States Patent and Trademark Office (“USPTO”). This is part of the USPTO’s efforts to protect the integrity of the register and combat fraudulent filings, which have been on the uptick. Beginning in early 2022, the following must verify their identity with the USPTO using one of the verification options that includes an electronic process by ID.me

Trademark owners and corporate officers not represented by an attorney, US-licensed attorneys (including in-house counsel), and Canadian attorneys or agents are required to verify their identity. Paralegals and other support staff working for an attorney must be sponsored by a verified attorney. Trademark owners who are represented by an attorney do not currently need to verify their identities to sign electronic forms sent by their attorney; however, if the representation by that attorney ends, the owners will need to submit to the verification process.

It is important that trademark holders and practitioners prepare for these new policies and procedures to ensure they can complete filings on a timely basis.

Article By Danielle M. DeFilippis of Norris McLaughlin P.A.

For more intellectual property legal news, click here to visit the National Law Review.

Intellectual Property Consolidation in the Agriculture Industry

Ever since agencies around the world such as the USPTO, USDA, and Union for the Protection of New Varieties of Plants (UPOV) have started recognizing and enforcing intellectual property rights relating to plants, there has been a slow yet massive consolidation in global seed markets. This article discusses a brief history of how intellectual property rights and lax antitrust enforcement in the seed industry created one of the largest industry consolidations and how the current Administration seems to be taking steps in the right direction.

Intellectual Property in the Agriculture Industry

In 1930, the United States began granting plant patents and the USPTO issued the first plant patent in 1931 for a rose. The UPOV is an international organization that was founded in 1961 to acknowledge and make available exclusive property rights for breeders of new plant varieties in all member states to the UPOV Convention. The U.S. Plant Variety Protection Act (PVPA) was enacted by Congress in 1970 to encourage the development of new varieties and to make them available to the public. The Plant Variety Protection Act established in the Department of Agriculture an office to be known as the Plant Variety Protection Office. These regulations are all very important for the protection and continued innovation of certain varieties of crops and plants. However, when genetically modified seeds were introduced in 1996, seed companies began to take advantage of these protections and began to invest heavily in amassing as many seed-related IP rights as they could. As these companies have merged and acquired smaller businesses, they remove competition from the industry, harming farmers, families, and consumers.

There are many ways that companies protect intellectual property in the agricultural industry. For example, companies file for utility patents to protect a wide variety of plant-related inventions, such as breeding methods, plant-based chemicals, plant parts, and plant products. Plant patents are unique to the United States and provide protection to any distinct and new variety of plant that has been asexually reproduced, other than a tuber-propagated plant or a plant found in an uncultivated state. Plant Variety Protection certificates, which are similar to plant patents, provide certain exclusive rights to breeders of any new, distinct, uniform, and stable sexually or asexually reproduced or tuber-propagated plant varieties. Other rights, known as Breeders’ Rights, exist in other countries outside the United States and are very similar to the Plant Variety Protection regulations. These protections generally last for 20 years from the date of filing and, according to the World Intellectual Property Organization, the patent owner has the right to decide who may – or may not – use the patented invention for the period in which the invention is protected.

The Key Players in the Agriculture Industry

Monsanto was a multinational agricultural biotechnology corporation founded in 1901 and based in the United States. In 1970, Monsanto scientist John Franz discovered that glyphosate was an herbicide and quickly patented it as such. In 1974, Monsanto brought the patented glyphosate herbicide to the market using the tradename “Roundup.” In 1996, Monsanto created the first genetically engineered (GE), glyphosate-resistant crop, causing Roundup-resistant soybeans to be planted commercially throughout the United States. By 1998, glyphosate-resistant corn was available on the market, and Monsanto became the largest supplier of these new GE, “Roundup-Ready” seeds. This was such a breakthrough in the agriculture industry that in 2003, Roundup-Ready seeds accounted for about 90% of the genetically modified seeds planted around the globe.

As with many industries, the agriculture industry has those companies that are at the top and those that are not. The agriculture industry’s “Big Six” companies—Monsanto, DuPont, Syngenta, Dow, Bayer, and BASF—turned into the “Big Four”—ChemChina, Corteva, Bayer, and BASF— after a series of mergers and acquisitions that took place in the last decade with very little oversight from some of the antitrust authorities in the United States and around the world. As a result of these mergers, the “Big Four” companies now control around 60% of the proprietary seed in the world market.

The Consolidation of the Seed Industry

Dr. Phil Howard from Michigan State University discussed the tremendous consolidation of the commercial seed industry in one of his first publications, 2009’s Visualizing Consolidation in the Global Seed Industry: 1996-2008. Dr. Howard describes how the hybrid-seed corn industry of 1930, the enforcement of patent-like protections, and especially the commercialization of fully patent-protected transgenic, genetically engineered seeds in the mid-late 1990s triggered a wave of consolidation in the agricultural industry. To make matters worse, when these companies consolidated and amassed massive intellectual property portfolios, it was not uncommon for seed rights to be bundled with other inputs to protect profits in other, agrochemical divisions. For example, as Dr. Howard details in Visualizing Consolidation, in order to use Monsanto’s herbicide-tolerant transgenic seed, farmers are required to also use Monsanto’s proprietary glyphosate herbicide, rather than a generic herbicide. Essentially, if you were buying Roundup-Ready seed, you were buying Roundup herbicide, and if you were using Roundup herbicide, it was probably a good idea to buy Roundup-Ready seed. This type of competitive business practice is one that eventually creates a multitude of problems for smaller, independent businesses, breeders, and farmers.

Antitrust and Anti-Competition in America

Antitrust laws are not a new concept in American society. Antitrust laws are statutes and regulations that are designed to promote the overall competition in the market by promoting free, open, and competitive markets. Congress passed the first antitrust law in 1890 when it wrote the Sherman Act, which made it illegal for companies to enter into agreements to compete with one another, resulting in price fixing and monopoly power. Several years later, in 1914, Congress passed the Clayton Act and Federal Trade Commission Act to protect American consumers by giving the Federal Trade Commission (FTC) and the Department of Justice (DOJ) the authority to oversee and review mergers and acquisitions that are likely to stifle competition. Under the Hart-Scott-Rodino Act, the FTC and DOJ review most of the proposed transactions that affect commerce in the United States and either agency can take legal action to block deals that it believes would “substantially lessen competition.”

While these laws are all beneficial in theory, their implementation in the agricultural industry has been lacking to say the least. According to a study in 2018, Bayer alone is estimated to control 35% of corn seed, 28% of soybean seed, and 70% of cottonseed in the global market! Even more alarming may be the USDA’s 2014 report citing concerns that glyphosate-resistant crops have become ubiquitous with American agriculture with 93% of soybeans, 85% of corn, and 82% of cotton planted being genetically modified to be glyphosate-resistant. The herbicides that are used to combat the weeds surrounding the crops, in many cases, are supplied by the same company that provides the seeds.

Promoting Competition in the Agriculture Industry

It has been almost a century since the first antitrust laws were enacted, and yet the problem of corporate consolidations remains in many industries across America. On July 9, 2021, the Biden Administration signed an executive order aimed to promote competition within various industries in the United States. The order includes 72 initiatives by more than a dozen federal agencies to promptly tackle some of the most pressing competition problems across our economy. According to the Administration, this order is a “whole-of-government” approach to drive down prices for consumers, increase wages for workers, and facilitate innovation. This was a major step in the right direction to weaken the power that major businesses have obtained as a result of corporate consolidation in industries like healthcare, technology, transportation, and especially agriculture.

This Executive Order also established the White House Competition Council to drive forward the Administration’s whole-of-government effort to promote competition. On September 10, 2021, the Competition Council held its inaugural meeting to discuss promoting pro-competitive policies and new ways of delivering concrete benefits to America’s consumers, workers, farmers, and small businesses. During the meeting, the heads of the Department of Health and Human Services, the Department of Transportation, the Department of Justice, the United States Department of Agriculture, and the Federal Trade Commission briefed the council members on their efforts to implement the directives of the Executive Order.

The Challenge of Facing the Consolidated Agriculture Industry

According to an October 20, 2021 report by Thomson Reuters, Tom Vilsack, the U.S. Secretary of Agriculture, said that the Biden Administration plans to take a hard look at the consolidation of the seed industry and figure out “why it’s structured the way it’s structured” and “whether these long patents make sense.” The White House Competition Council is certainly faced with a difficult challenge to parse through both anti-competition law and intellectual property law. For centuries these bodies of law have caused great debate. One body of law restricts monopolization wherein the later grants monopolistic opportunities.

There is no doubt that any changes to the current seed industry scene would shake things up. But what exactly would that look like? Are we going to see the “Big-4” morph into another, new identity? Are changes to the patent law system likely? Whatever happens, the agriculture industry will likely pay close attention to the actions of the White House Competition Council over the next couple months.

Article By Reinier R. Smit of Summa PLLC

Patentablity of COVID19 Software Inventions: Artificial Intelligence (AI), Data Storage & Blockchain

The Coronavirus pandemic revved up previously scarce funding for scientific research. Part one of this series addressed the patentability of COVID-19 related Biotech, Pharma & Personal Protective Equipment (PPE) Inventions and whether inventions related to fighting COVID-19 should be patentable. Both economists and lawmakers are critical of the exclusivity period granted by patents, especially in the case of vaccines and drugs. Recently, several members of Congress requested “no exclusivity” for any “COVID-19 vaccine, drug, or other therapeutic.”[i]

In this segment, the unique issues related to the intellectual property rights of Coronavirus related software inventions, specifically, Artificial Intelligence (AI), Data Storage & Blockchain are addressed.

Digital Innovations

Historically, Americans have adhered to personalized healthcare and lacked the incentive to set up a digital infrastructure similar to Taiwan’s which has fared far better in combating the spread of a fast-moving virus.[ii] But as hospitals continue to operate at maximum capacity and with prolonged social distancing, the software sector is teeming with digital solutions for increasing the virtual supply of healthcare to a wider network of patients,[iii] particularly as HHS scales back HIPAA regulations.[iv] COVID-19 has also spurred other types of digital innovation, such as using AI to predict the next outbreak and electronic hospital bed management, etc.[v]

One area of particular interest is the use of blockchain and data storage in a COVID/post-COVID world. Blockchains can serve as secure ledgers for the global supply of medical equipment, including respirators, ventilators, dialysis machines, and oxygen masks.[vi] The Department of Homeland Security has also deemed blockchain managers in food and agricultural distribution as “critical infrastructure workers”.[vii]

Patentability

Many of these digital inventions will have a hard time with respect to patentability, especially those related to data storage such as blockchains. In 2014, the Supreme Court found computer-related inventions were “abstract ideas” ineligible for patent protection in Alice v. CLS Bank.[viii] Because computer-implemented programs execute steps that can theoretically be performed by a human being but are only automated by a machine, the Supreme Court concluded that patenting software would be patenting human activity. This type of patent protection has long been considered by the Court to be too broad and dangerous.

Confusion

The aftermath of Alice is widespread confusion amongst members of the patent bar as well as the USPTO as to how computer-related software patents were to be treated henceforth.[ix] The USPTO attempted to clarify some of this confusion by a series of Guidelines in 2019.[x] Although well-received by the IP community, the USPTO’s Guidelines are not binding outside of the agency, meaning they are have little dispositive effect when parties must bring their cases to the Federal Circuit and other courts.[xi] Indeed, the Federal Circuit has made clear that they are not bound by the USPTO’s guidance.[xii] The Supreme Court will not provide further clarification and denied cert on all patent eligibility petitions in January of this year.[xiii]

The Future

Before the coronavirus outbreak, Congress was working on patent reform.[xiv] But the long-awaited legislation was set aside further still as legislators focused on needed measures to address the pandemic. On top of that, both Senator Tillis and Senator Coons who have spearheaded the efforts for patent reform are now facing reelection battles, making the future congressional leadership on patent reform uncertain.

Conclusion

Patents receive a lot of flak for being company assets, and like many assets, patents are subject to abuse.[xv] But patents are necessary for innovation, particularly for small and medium-sized companies by carving out a safe haven in the marketplace from the encroachment of larger companies.[xvi] American leadership in medical innovations had been declining for some time prior to the pandemic[xvii] due to the cumbersome US regulatory and legal environments, particularly for tech start-ups seeking private funding.[xviii]

Not all data storage systems should receive a patent and no vaccine should receive a patent so broad that it snuffs out public access to alternatives. The USPTO considers novelty, obviousness and breadth when dispensing patent exclusivity, and they revisit the issue of patent validity downstream with inter partes review. There are measures in place for ensuring good patents so let that system take its course. A sweeping prohibition of patents is not the right answer.

The opinions stated herein are the sole opinions of the author and do not reflect the views or opinions of the National Law Review or any of its affiliates

[i] Congressional Progressive Leaders Announce Principles On COVID-19 Drug Pricing for Next Coronavirus Response Package, (2020), https://schakowsky.house.gov/media/press-releases/congressional-progressive-leaders-announce-principles-COVID-19-drug-pricing (last visited May 10, 2020).

[ii] Christina Farr, Why telemedicine has been such a bust so far, CNBC (June 30, 2018), https://www.cnbc.com/2018/06/29/why-telemedicine-is-a-bust.html and Nick Aspinwall, Taiwan Is Exporting Its Coronavirus Successes to the World, Foreign Policy (April 9, 2020), https://foreignpolicy.com/2020/04/09/taiwan-is-exporting-its-coronavirus-successes-to-the-world/.

[iii] Joe Harpaz, 5 Reasons Why Telehealth Is Here To Stay (COVID-19 And Beyond), Forbes (May 4, 2020), https://www.forbes.com/sites/joeharpaz/2020/05/04/5-reasons-why-telehealth-here-to-stay-COVID19/#7c4d941753fb.

[iv] Jessica Davis, OCR Lifts HIPAA Penalties for Telehealth Use During COVID-19, Health IT Security (March 18, 2020), https://healthitsecurity.com/news/ocr-lifts-hipaa-penalties-for-telehealth-use-during-COVID-19.

[v] Charles Alessi, The effect of the COVID-19 epidemic on health and care – is this a portent of the ‘new normal’?, HealthcareITNews (March 31, 2020), https://www.healthcareitnews.com/blog/europe/effect-COVID-19-epidemic-health-and-care-portent-new-normal and COVID-19 and AI: Tracking a Virus, Finding a Treatment, Wall Street Journal (April 17, 2020), https://www.wsj.com/podcasts/wsj-the-future-of-everything/COVID-19-and-ai-tracking-a-virus-finding-a-treatment/f064ac83-c202-40f9-8259-426780b36f2c.

[vi] Sara Castellenos, A Cryptocurrency Technology Finds New Use Tackling Coronavirus, Wall Street Journal (April 23, 2020), https://www.wsj.com/articles/a-cryptocurrency-technology-finds-new-use-tackling-coronavirus-11587675966?mod=article_inline.

[vii] Christopher C. Krebs, MEMORANDUM ON IDENTIFICATION OF ESSENTIAL CRITICAL INFRASTRUCTURE WORKERS DURING COVID-19 RESPONSE, Cybersecurity and Infrastructure Security Agency (March 19, 2020), available at https://www.cisa.gov/sites/default/files/publications/CISA-Guidance-on-Essential-Critical-Infrastructure-Workers-1-20-508c.pdf.

[viii] Alice v. CLS Bank, 573 U.S. 208 (2014), available at https://www.supremecourt.gov/opinions/13pdf/13-298_7lh8.pdf.

[ix] David O. Taylor, Confusing Patent Eligibility, 84 Tenn. L. Rev. 157 (2016), available at https://scholar.smu.edu/cgi/viewcontent.cgi?article=1221&context=law_faculty.

[x] 2019 Revised Patent Subject Matter Eligibility Guidance, United States Patent Office (January 7, 2019), available at https://www.federalregister.gov/documents/2019/01/07/2018-28282/2019-revised-patent-subject-matter-eligibility-guidance.

[xi] Steve Brachmann, Latest CAFC Ruling in Cleveland Clinic Case Confirms That USPTO’s 101 Guidance Holds Little Weight, IPWatchDog (April 7, 2019), https://www.ipwatchdog.com/2019/04/07/latest-cafc-ruling-cleveland-clinic-confirms-uspto-101-guidance-holds-little-weight/id=107998/.

[xii] Id.

[xiii] U.S. Supreme Court Denies Pending Patent Eligibility Petitions, Holland and Knight LLP (January 14, 2020), https://www.jdsupra.com/legalnews/u-s-supreme-court-denies-pending-patent-55501/.

[xiv] Tillis and Coons: What We Learned At Patent Reform Hearings, (June 24, 2019), available at https://www.tillis.senate.gov/2019/6/tillis-and-coons-what-we-learned-at-patent-reform-hearings.

[xv] Gene Quinn, Twisting Facts to Capitalize on COVID-19 Tragedy: Fortress v. bioMerieux, IPWatchDog (March 18, 2020), https://www.ipwatchdog.com/2020/03/18/twisting-facts-capitalize-COVID-19-tragedy-fortress-v-biomerieux/id=119941/.

[xvi] Paul R. Michel, To prepare for the next pandemic, Congress should restore patent protections for diagnostic tests, Roll Call (April 28, 2020), https://www.rollcall.com/2020/04/28/to-prepare-for-the-next-pandemic-congress-should-restore-patent-protections-for-diagnostic-tests/.

[xvii] Medical Technology Innovation Scorecard_The race for global leadership, PwC (January 2011), https://www.pwc.com/il/en/pharmaceuticals/assets/innovation-scorecard.pdf.

[xviii] Elizabeth Snell, How Health Privacy Regulations Hinder Telehealth Adoption, HealthITSecurity (May 5, 2015),https://healthitsecurity.com/news/how-health-privacy-regulations-hinder-telehealth-adoption.

Copyright (C) GLOBAL IP Counselors, LLP

ARTICLE BY Wen Xie at Global IP Counselors.

For more on patentability, see the National Law Review Intellectual Property law section.

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