Monthly Archives: May 2021

In an earlier post, we discussed the patent linkage system implemented in the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. Another important change in the amendment is the introduction of Patent Term Extension (PTE) for pharmaceutical patents.

The new PTE provision is in the 3rd paragraph of Article 42 in the amended Chinese Patent Law, which reads and is translated as follows: In order to compensate for the time taken for regulatory review and approval of a new drug in China, the Patent Administration Department of the State Council, at the request of a patentee, may extend the term of an invention patent related to the new drug that has received regulatory approval for marketing in China. The patent term extension should not exceed five years, and the total remaining term of the patent after the regulatory approval should not exceed fourteen years.

Specific rules for implementing PTE will be provided in the amended Implementing Regulations of the Chinese Patent Law (Regulations). Draft amendments to the Regulations (draft Regulations) were released on November 17, 2020. A final version of the amended Regulations has not been promulgated.

Below is a summary of the PTE rules according to the amended Chinese Patent Law and the draft Regulations.

Eligibility

The amended Chinese Patent Law provides that PTE may be available for an invention patent related to a new drug. Under Section 85-4 of the draft Regulations, a new drug can be a new chemical drug, biologic drug, or traditional Chinese medicine, and PTE is only available for patents covering the drug, methods of manufacturing of the drug, and medical use of the drug. Thus, medical device and equipment patents are not eligible for PTE.

The draft Regulations also specify that the patent related to the new drug refers to a patent related to the drugs active ingredient that receives regulatory approval for the first time in China. However, it is not clear whether the active ingredient only includes the active moiety or also includes the salts, ester, or crystal forms of the active moiety.

Timing

The draft Regulations provide limitations on the timing of filing a request for PTE. Under Section 85-7 of the draft Regulations, a request for PTE must be filed within three months from the date when a new drug receives regulatory approval. The request should be filed with the Patent Administration Department of the State Council (i.e., China National Intellectual Property Administration (CNIPA)).

Thus, under the current version of the draft Regulations, drugs approved prior to March 1, 2021, will not be eligible for PTE. Some pharmaceutical companies have submitted their concerns on this requirement to the CNIPA. In particular, they asked for a transition period to include some drugs approved before March 1, 2021. They argued that drugs approved since April 2018 should be eligible for PTE consideration since the Chinese State Council executive meeting decided in April 2018 to provide up to 5 years term extension for patents related to drugs for which regulatory approval was simultaneously applied in China and abroad.

Another limitation on the timing is that a PTE request must be filed at least six months prior to the patents expiration date (without PTE). Since the amended patent law will come into force on June 1, 2021, it appears that patents expiring before December 1, 2021, will not be eligible for PTE considerations. No retrospective remedy is provided in the current version of the draft Regulations.

Calculation

The calculation of PTE under the amended Chinese Patent Law is different from PTE calculation in the U.S. and is more similar to that of the supplementary protection certificate (SPC) in the European Union. Section 85-5 of the draft Regulations provides that the extended term under PTE is the time period between a patents filing date and the date when the drug receives regulatory approval, reduced by five years. The total time period of PTE is also subject to limits under Article 42 of the amended patent law as discussed above.

Limitations

Section 85-7 of the draft Regulations further provides the following requirements and limitations on the request for PTE:

Also, under Section 85-6 of the draft Regulations, during a patents extended term under PTE, the scope of the patent is limited to the new drug and the approved indication(s) of the drug.

Conclusion

Along with other amendments, the introduction of PTE will strengthen IP protection for pharmaceutical patents in China. The real impact of the amendments will depend on the finalized Regulations, CNIPAs examination guidelines, and future judicial interpretations. We will provide more updates on any further clarifications and amendments.

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Patent Term Extension Introduced by the Fourth Amendment to the Chinese Patent Law - JD Supra

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Dallas Independent School District teacher Jocelyn Foshay was guiding a social studies lesson with her middle school class about the amendment that protects Americans from unreasonable search and seizure.

Where was the Fourth Amendment to protect Breonna Taylor? a student asked her, referring to a Black woman who was shot and killed in her apartment by Louisville police officers during a botched raid in 2020.

Foshay turned the question back to her students. What do you think? she asked, allowing students to process their thoughts and draw their own conclusions.

These are the kinds of conversations and questions that teachers say are typical of students, especially in the past year as the news cycle has exploded with stories about race relations, injustice and inequity. These sorts of conversations about current events often can be teachable moments and exercises for critical thinking for young minds, educators say.

But Texas educators say theyre concerned they wont be able to have these types of open, far-reaching conversations, often prompted by inquisitive students, if the Texas Legislature approves a bill that restricts how teachers can discuss current events in the classroom and teach about Americas historical treatment of people of color.

House Bill 3979, which mirrors legislation making its way through state legislatures across the country, has been coined the critical race theory bill, though neither the House nor Senate versions explicitly mention the academic discipline, which studies the ways race and racism have impacted Americas legal and social systems.

Supporters of the bill argue they are trying to combat personal biases bleeding into public education.

We want to do our part to preserve the system and yes to talk about our history, warts and all, said state Sen. Bryan Hughes, R-Mineola, on the Senate floor Friday. But present it truly and accurately, especially those founding principles, which have made Americans so special.

A new version of the bill, which was substituted on the Senate floor late Friday night and approved, says teachers cant be compelled to discuss current events and if they do, they must explore it from multiple positions without giving deference to any one perspective. The bill also has already passed out of the House.

It bars students from getting course credit for civic engagement efforts, including lobbying for legislation or other types of political activism. It also added a civics training for teachers to be developed by the state and a list of founding documents students must be required to be taught.

The Texas Education Agency estimates that the new training program will cost $15 million annually starting in 2023.

Teachers say the language of the bill is often vague and its unclear to them how the bill will directly impact or change their lessons. But the fear of being at odds with the law alone could create a chilling effect, they said.

Part of his bill that kind of makes me freeze up is like feeling like I cant talk about race or feeling like Im going to say something thats out of my lane, out of my professionalism as a teacher, Foshay said. If kids arent able to make those connections [about] why this [lesson] matters to them here sitting in the classroom right now ... were really losing a piece of making school matter to kids.

Supporters of the legislation say they have concerns teachers are unfairly blaming white people for historical wrongs and distorting the founding fathers accomplishments. In recent years, there have been calls for more transparency about historical figures racist beliefs or connections to slavery.

Do you want our Texas kids to be taught that the system of government in Texas, in the United States, is nothing but a cover-up for white supremacy? asked state Rep. Steve Toth ,as he laid out HB 3979, which he sponsored, on the House floor in early May. Do you want them to be taught a souped-up version of Marxism?

Toth, R-Spring, told The Texas Tribune he is still having discussions about whether he will accept the new Senate's changs and send the bill straight to the governor to sign, or reject the amended legislation and request a conference committee made up of members from both chambers to resolve differences.

The fight to ban critical race theory discussions from schools has increasingly become a rallying cry among conservatives as America has grappled with racial injustice and inequities over the past year. The movement was encouraged by former President Donald Trump, who directed the federal government in 2020 to stop diversity and inclusion trainings that support similar sentiments, calling them propaganda.

Recently, 20 state attorneys general sent a letter to the U.S. Education Secretary Miguel Cardona and expressed concern with critical race theory. The letter writers, including Texas Attorney General Ken Paxton, specifically mention the 1619 Project, a reporting endeavor from The New York Times that examines U.S. history from the date when enslaved people first arrived on American soil, marking that as the countrys foundational date. The Texas legislation would specifically prohibit schools from teaching the 1619 Project.

To suggest that America is so racist at its core and its so irredeemable and they can never overcome biases and treat each other fairly that's a real problem, Hughes said of the project.

But teachers and historians contend its impossible to teach Americas history without discussing race and injustice, especially when current events mirror historical lessons.

There is this misunderstanding that the past is walled off from the present by the bills authors, said Trinidad Gonzales, a history professor and assistant chair of the dual enrollment program at South Texas College. It is the opposite: The present and past are interconnected. That is history. The bills authors are obviously not historians.

After the Jan. 6 insurrection at the U.S. Capitol, Foshay said her school had a schoolwide discussion and showed the students news clips, making sure to present the event as it happened, without bias. But she worries the bill would force her to equivocate and not give students a straight answer.

Its going to feel like Im grasping at straws to present two sides of something, she said.

On Friday, Hughes tried to reassure Democrats against the bill that it would not require teachers give moral equivalency to perpetrators of horrific violence.

Third grade teacher Lakeisha Patterson, who fielded questions from her students this past year about the Black Lives Matter movement, said shes worried that constrained conversations about difficult real-life issues will ultimately disadvantage students.

If were not allowing teachers the opportunity to have these honest and intellectually appropriate conversations with their feelings about the past, then were basically silencing those communities, Patterson said. Were saying, not only are we ashamed of your heritage and your culture, but were not even at liberty to discuss it. And it just goes back to whitewashing history.

Juan Carmona, a history teacher in the Rio Grande Valley town of Donna, said he thinks this kind of legislation is in direct response to the broadening of voices and perspectives examined in the classroom as the student populations also become more diverse.

In recent years, history teachers said they have worked to diversify history curriculum, providing additional context and perspectives. In recent years, the State Board of Education added a Mexican-American history course and an African American history course thats available to all high school students.

We have seen more student involvement because they can now see their own voices, their own people, their own culture being in history, Carmona said. They never saw themselves, so they werent engaged.

School Board of Education member Pat Hardy, who used to teach social studies, said the goal of the bill isnt to Pollyanna or make it only the positives, but she speculated that it is a response to instances in school districts across the state where parents feel biases are being taught. Hardy would not name specific school districts where there were issues.

We need to really stress what a unique country we have, she said. You think about so many kids coming here as immigrants ... and they dont know from their parents about American history, love of country and all that necessarily. And so we really feel like thats an area that needs to be delved into.

Educators also worry Texas students will be at a disadvantage when taking Advanced Placement or dual enrollment classes in high school if they dont receive thorough lessons about how race and gender have shaped American society.

Mallory Lineberger, a former history teacher who now serves as a policy fellow for the advocacy group The Education Trust in Texas, says AP history students are often scored on how well they can connect historical events and modern issues.

If we cant talk about contemporary issues or current events, how are they supposed to be able to have a thorough and critical analysis of how a topic has changed over time? she said.

In a letter to Lt. Gov. Dan Patrick and the Texas Senate, the American Historical Association also cautioned that this legislation would limit student access to college courses.

The uncertainty of how [the legislation] will be implemented and the likely loss of offerings for dual-enrollment and AP History courses could hurt Texass progress toward increasing its college-educated population, Jacqueline Jones, association president, said in the letter. Last year 12 percent of all college students in Texas were dual-enrollment students. History is the most offered course in dual enrollment.

More than 220 Texas historians and teachers across the state have signed a separate letter opposing the bill and sharing similar concerns.

Lineberger also identified around 190 current Texas Essential Knowledge and Skills, the state approved and required education standards, that she said directly conflict with the bill.

For instance, middle schoolers are expected to analyze the historical background of various contemporary societies to evaluate relationships between past conflicts and current conditions.

Teachers are also concerned students will be less likely to learn how to participate in the political and civic process if they are not able to assign those kinds of activities or award extra credit. Foshay in Dallas ISD says district leaders have put a large emphasis on an initiative called project-based learning in which students learn by trying to solve real-world problems, which she said can include internships or civic work in the community.

Bill supporters said the legislation would not prevent students from being able to participate in the political process, lobby lawmakers or attend rallies, but it would prevent teachers from requiring students participate in those events for credit or extra credit. The most recent version of HB 3979 approved by the Senate does clarify students can participate in community charitable projects, but Foshay worries it will mean fewer students become engaged in their broader communities.

Part of me wants to say kids will do this work whether or not they get a grade on it, she said. But I don't entirely believe that ... because I do think schools really do help them facilitate projects they do.

Disclosure: Education Trust and New York Times have been financial supporters of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

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Texas educators worry critical race theory bill will stifle learning - The Texas Tribune

Confirmed Judges, Confirmed Fears is a blog series documenting the harmful impact of President Trumps judges on Americans rights and liberties. Cases in the series can be found by issue and by judge at this link.

Nine Trump Ninth Circuit judges, including Patrick Bumatay, Mark Bennett, Ryan Nelson, Bridget Bade, Daniel Collins, Kenneth Lee, Daniel Bress, Danielle Hunsaker, and Lawrence VanDyke , argued in dissent that the full court should reverse a panel decision and rule that a federal border agent cannot be held liable for using excessive force and retaliating against a US citizen by getting the IRS to audit him. The full Ninth Circuit majority rejected that view and the victim will get a chance to prove his claims as a result of the panel decision in Boule v Egbert.

Robert Boule owns, operates, and lives in a small bed-and-breakfast in Washington adjacent to the US-Canadian border. Boule is a US citizen and has a record of cooperating with the US Border Patrol, including in inquiries about his guests. One day in 2014, he answered routine questions from Border Patrol agent Erik Egbert about a guest arriving that day from New York who had previously been in Turkey, and Egbert said nothing. When the car carrying the guest arrived, however, Egbert pulled into the inns driveway behind the car. Egbert got out and approached the vehicle carrying the guest, with no explanation. Boule twice asked Egbert to leave, the second time while standing in between Egbert and the car carrying the guest. Egbert refused to leave, gave no explanation, and shoved Boule against the car, and then grabbed him and pushed him aside and onto the ground. Boule later sought medical treatment for back injuries.

Egbert opened the car door and asked the guest about his immigration status. Boule made a phone call to summon a supervisor, who determined after arriving at the scene that the guest was lawfully in the country, and the agents then left. When Boule then complained about Egbert, the agent retaliated against Boule by asking the IRS to conduct an audit of him, which took several years and cost Boule $5000 in accountant fees. Egbert also got the Social Security Administration and several state and local agencies to conduct formal inquiries into Boules business activities which, like the IRS audit, did not result in any charges against him.

Based on these facts as alleged in his complaint, Boule filed a lawsuit against Egbert in federal district court for the use of excessive force under the Fourth Amendment and for retaliation in violation of the First Amendment. Because Egbert is a federal and not a state law enforcement official, Boule relied on the Supreme Courts long-established Bivens doctrine, which authorizes people to hold federal law enforcement agents accountable for constitutional violations that injure them under some circumstances. Because the Supreme Court has not stated specifically that Bivens applies to actions by Border Patrol agents and conduct that violates the First Amendment, however, the lower court granted summary judgment to Egbert and dismissed the case without a trial.

A three-judge panel of the Ninth Circuit reversed and ruled that Boule should have the chance to prove his claims. The panel acknowledged that the Court had not stated as yet that Bivens applies in those contexts, and that the Court has carefully instructed that before a federal court makes such an extension, it must consider the risk of interfering with the authority of the other branches of the federal government and ask whether there are sound reasons to think Congress might doubt the efficacy or necessity of a damages remedy, and whether the Judiciary is well suited, without Congressional action, to consider and weigh the costs and benefits of allowing a damages action to proceed under the Constitution. Based on those criteria, the panel determined that there were no adequate and available alternative remedies, and that Boule should be able to proceed with his claims under both the Fourth and First Amendments.

With respect to the Fourth Amendment excessive force claim, the panel explained that Boule was bringing a conventional charge of excessive force like those routinely brought under Bivens against federal law enforcement officials like FBI agents. Although the Court had twice declined to permit such lawsuits against Border Patrol agents, the panel went on, those cases were brought by foreign nationals and involved unique issues of national security. In contrast, the panel stated, Boules case was brought by a US citizen concerning excessive force by a rank-and-file border patrol agent against him on Boules own property and did not involve any national security or foreign policy concerns. The panel noted that numerous courts around the country, including the Ninth Circuit, had allowed such lawsuits against border patrol agents under the Fourth Amendment, and that Boules claim is part and parcel of the common types of claims unfortunately brought against law enforcement officials and should be allowed to proceed.

Although the Supreme Court had never specifically allowed a First Amendment damages claim against a federal official, the panel stated, it had explicitly stated in one case that such a claim may be brought. The Supreme Court has recognized, the panel continued, that it has long been the law that federal officials violate the First Amendment when they retaliate for protected speech. The Ninth Circuit had previously upheld a Bivens claim under the First Amendment, the panel went on, and a Supreme Court case that had failed to do so was clearly distinguishable because it involved a federal employee complaining about a supervisor, not a vengeful officer who the Court recognized could be sued under the First Amendment for retaliation. In short, there were no special factors suggesting the court should not allow Boules First Amendment retaliation claim.

Trump judges Bumatay and Bress wrote harsh dissents, joined by Trump judges Bade, Collins, Bennett, Hunsaker, Lee, Nelson, and VanDyke plus a few others. They would have corrected what Bumatay called the panels error through review by the full court. Bumatay called the Bivens doctrine a judicial usurpation of what he deemed the legislative function to create remedies for constitutional violations, about which he claimed the Court has since had buyers remorse and, in his view, has made any expansion of the doctrine whatsoever a dead letter. He asserted that the panel had disregarded Supreme Court precedents and improperly become a quasi-legislature. Bress similarly concluded that the panel decision was inconsistent with Supreme Court precedent.

Although the Trump judge dissenters may well be correct that the current Supreme Court would disagree with the panel ruling, that decision clearly explained that authorizing Boule to sue Border Patrol agent Egbert for excessive force and retaliation under the Constitution was consistent with Supreme Court precedent and the proper role of the courts, as discussed above. The case is yet another example of Trump judges voting against accountability for misconduct by law enforcement officials. Fortunately, because the Trump judges did not have enough votes, Boule will have the opportunity to seek such accountability. With several judges on the Ninth Circuit planning to take senior status, which means they would no longer be eligible to participate in full court votes like this one in the future, it is crucial to our fight for our courts that Biden nominees to fill these seats be confirmed as soon as possible,

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Trump Judges Try to Dismiss Claim Against Border Patrol Agent for Excessive Force and Retaliation: Confirmed Judges, Confirmed Fears - People For the...