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I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter

The Initiative for Medicines, Access & Knowledge (I-MAK) has responded to a letter it received from Senator Thom Tillis (R-NC) in January asking the organization to address claims that its data on the effects of pharmaceutical patents on drug pricing is faulty. In the letter, I-MAK defended its underlying patent data and, in reference to the question of why the data differs significantly from public sources like the Food and Drug Administration’s (FDA’s) Orange Book and court filings, explained that “relying on public sources and court filings is not an accurate methodology for identifying all patents on a drug.” I-MAK’s view is that the U.S. patent system creates patent monopolies that lead to the practice of “evergreening”, in which innovator pharmaceutical companies extend their rights beyond the original patent terms, preventing competition from generics, which in turn causes drug prices to remain high. As part of its mission, I-MAK has developed a database of patents covering key drugs. Its reports are often cited by academics, including in law journals, policymakers and in congressional hearings. As a result, I-MAK has become one of the most authoritative sources for information on patents in this space.

CAFC Affirms ITC Denial of Broadcom’s Request for Ban on Renesas Products Under Section 337

On March 8, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed decisions by the International Trade Commission (the Commission) and the Patent Trial and Appeal Board (the Board or PTAB) both 1) declining to ban Renesas Electronics Corporation and other companies from importing into the United States products alleged to infringe upon Broadcom Corporation’s two patents and 2) finding certain claims of Broadcom’s patents obvious. Broadcom filed a complaint at the Commission alleging a violation of 19 U.S.C. § 1337 (Section 337) based on the importation of products by Renesas and other companies that are asserted to infringe U.S. Patents 7,437,583 and 7,512,752. Broadcom’s ’583 patent is “directed to reducing power consumption in computer systems by ‘gating’ clock signals with circuit elements to turn the signals ON and OFF for downstream parts of the circuit.” The ’752 patent is “directed to a memory access unit that improves upon conventional methods of requesting data located at different addresses within a shared memory.”

Patent Filings Roundup: Realtor Files IP Edge Declaratory Judgment in Hawaii After Demand Letter; Dog Collar IPR Instituted Over Lengthy Fintiv Arguments; IP Edge Files Another 25+

It was a banner district court week, with 104 patent filings and 64 cases terminated, mostly file-and-settle non-practicing entity (NPE) litigation, and 26 Patent Trial and Appeal Board (PTAB) cases, including Nokia challenging NPE TQ Delta, LLC; Dexcom, Inc. filing against Abbot Diabetes Care Inc.; and Samsung filing against the Fortress IP-funded Netlist, Inc. In a week where IP Edge filed almost 30 new district court cases, one letter recipient filed a declaratory judgment (DJ) action…. This isn’t the first time this year a party has DJ’d IP Edge (a relative rarity given how small the sums involved are), suggesting either that smaller companies are getting fed up or that their campaigns have been broadly applied.

Forum Selection Clauses May Bar an IPR

Almost anyone can, by statute, request an inter partes review (IPR) of an issued patent, but may limit their right to do so contractually, such as through licensing agreements or non-disclosure agreements (NDAs). These agreements may contain clauses that limit the forum in which any dispute between the parties can be litigated. The Patent Trial and Appeal Board (PTAB) itself has consistently declined to enforce such forum selection clauses, finding that it lacks authority to enforce contracts between the parties, and, in any case, its jurisdiction is statutory and not limited by private agreements between the parties. However, in Nippon Shinyaku Co. v. Sarepta Therapeutics, Inc., the U.S. Court of Appeals for the Federal Circuit recently held that a petitioner was barred from bringing an IPR as a result of a contractual agreement with the patent owner.

Restaurants Take Aim at Google, Alleging Deceptive Online Ordering Scheme

The operators of a number of Lime Fresh Mexican Grill franchises have filed a lawsuit in the Northern District of California on behalf of a nationwide class of restaurants claiming that Google, LLC has engaged in deceptive practices and misappropriation of their goodwill and tradenames by directing consumers to Google-operated pages for online ordering and delivery. The complaint explains that Google changed the way it displays restaurant search results in 2019, confusing customers into ordering through Google-designed ordering buttons and pages, thereby robbing the restaurants of direct online orders. Instead, customers are fooled into ordering through delivery service providers Google has contracted with, which charge exorbitant fees to the restaurants, says the complaint.

Solid Form Patents: Part I – Introduction and Laying the Genus/Species Foundation

Pharmaceutical products are typically dosed as solids, liquids (e.g., solutions) or gases. In gases and liquids, the molecules are tumbling; in solids, however, the molecules are essentially frozen in place, forming three-dimensional networks. When those networks are ordered, they are called crystalline…. Where the same chemical compound can exist in multiple crystalline forms is called polymorphism, with each crystalline form called a polymorph. When the compound is an element, as with carbon, it is referred to as allotropism. Predicting whether a chemical compound will be polymorphic, what that polymorph might be, and the properties thereof are notoriously challenging feats. Because polymorphs or other crystalline forms can have significantly different drug solubility and dissolution properties, it is not surprising that they are often the subject of patent applications in the pharmaceutical arts. 

Energy Demand Response Programs and Patent Exposure

The core business model of energy producers and providers does not traditionally create significant patent litigation risk. Despite the complexity of the modern energy grid, the basic business and technology of energy generation has not changed significantly in the past 100 years. However, new programs, including residential demand response, executed via smart home appliances and controls, may expose utility companies to increased liability. Demand response programs allow utility providers to reduce grid load and energy pricing by offering customers pricing incentives to reduce energy usage during times of peak demand…. While such programs have been generally available for commercial customers, recently, demand response opportunities for residential customers have been expanding. Where these residential demand response programs allow energy providers to directly control, through the internet, consumers’ smart thermostats and appliances, energy providers may be exposed to patent liability.

Judge Michel Asks Supreme Court to Grant Petition in USR v. Apple to Save U.S. Innovation

On March 2, amicus briefs were presented to the U.S. Supreme Court in support of petitioner Universal Secure Registry’s (USR’s) appeal from the U.S. Court of Appeal for the Federal Circuit (CAFC), which challenges that court’s application of the Alice/Mayo framework on Section 101 subject matter patent eligibility in invalidating patent claims owned by USR. Both amicus filings urge the Supreme Court to rein in the Federal Circuit’s expansive application of Alice/Mayo, which has gone far beyond the original bounds intended by the Court. One of those briefs is made even more persuasive by the fact that it was authored by Judge Paul R. Michel, the former Chief Judge of the Federal Circuit.

This Week in Washington IP: Overview of SBIR and STTR Programs, Securing American Manufacturing of Electric Vehicles, and AI Innovation’s Impact on Social Welfare

This week in Washington IP news, the House of Representatives will host committee meetings to consider the reauthorization of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs managed by the U.S. Small Business Administration, as well as ways that Congress can encourage more domestic manufacturing of the next generation of electric vehicles. In the Senate, the Judiciary Committee discusses several judicial nominees by the Biden Administration, including a few that would serve in U.S. district courts important to IP law. Elsewhere, The Brookings Institute hosts a conversation with Columbia University Professor Joseph Stiglitz on the potential impacts of AI innovation on social welfare, while the Hudson Institute explores ways that Japan and the U.S. can further collaborate on our 5G mobile networking future.

End of a Patent Battle, Beginning of a Licensing Fight For CRISPR

By now, news of MIT and Harvard’s Broad Institute’s victory over the CVC group (the University of California-Berkeley, the University of Vienna, and Emmanuelle Charpentier) in a dispute over genome-editing CRISPR technology has spread like wildfire in the biotech industry and academia. To recap, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) ruled that the Broad Institute (Broad) was the first to invent single-guide CRISPR-Cas9 gene-editing technology for use in eukaryotes. Furthermore, the judges ruled that “CVC fails to provide sufficient, persuasive evidence of an earlier reduction to practice or conception, as they are legally defined, of each and every element of Count 1 before Broad’s evidence of reduction to practice.” While the decade-long patent battle over the Nobel Prize-winning technology might have come to an end with Broad breathing a sigh of relief and CVC contemplating whether to take it to the next level, this has left some biotech companies scrambling to renegotiate their licensing agreements.

IP Audits for the Emerging Life Science Company: A Staged and Strategic Approach for Value

The trend is here to stay – large life science companies are basing their growth strategies on research and development happening at early-stage companies. It is easier, and less risky, for large companies simply to acquire these enterprises working on new and innovative therapeutic candidates that have advanced to a certain stage. For early stage life science companies (ESLSCs), intellectual property is the asset. Although 2021 saw what appeared to be a slowdown in deal-making activity compared to 2020, the top M&A and licensing deals were valued at well over $50 billion dollars. Whether to attract the attention of one of the larger players in the space – for a potential license or acquisition, to entice investors, or to remain competitive – a methodical and focused IP review should ensure clear alignment with business objectives and maximum return on investment. Not only does the IP audit provide the ESLSC a chance to broadly inventory and strategically review their IP, it also prepares them for any potential third-party diligence.

A Modest Proposal for a U.S. Patent Validity Court

Administrative patent judges of the U.S. Patent and Trademark Office’s (USPTO’s) Patent Trial and Appeal Board (PTAB), who are inferior officers under the appointments clause, can overrule validity decisions of U.S. district court judges, who are Officers of the United States. District court judges with no training or experience in technology construe patent claims and decide validity. A political appointee can overrule PTAB judges’ validity decisions…. This article proposes a new system of patent justice. Major issues during patent litigation would be decided at the trial level ONLY ONCE, and by the government entity best positioned to decide the issue.

Banksy’s Dilemma: IP or Art?

The struggles that most artists endure include creativity blocks and economic hardship; however, British artist Banksy seems unaffected by either of these. His street art is celebrated all over the world for its anti-authoritarian tone and his extremely secretive personal identity. Recently, he has even been venturing into Non-Fungible Tokens. But unwittingly, and rather humorously, Banksy is facing a different kind of dilemma in terms of either revealing his overtly confidential identity or losing exclusive rights to his works.

Other Barks & Bites for Friday, March 4: Judge Michel Urges SCOTUS to Fix Section 101, CAFC Puts Appellate Bar on Notice of Sanctions for COVID-19 Protocol Violations, and Fifth Circuit Modifies Verdict on Trade Secret Misappropriation

This week in Other Barks & Bites: the Senate Judiciary advances the controversial nomination of Gigi Sohn to serve on the FCC; the Fifth Circuit nixes “license-to-all” arguments in an antitrust case brought against an SEP owner refusing to license a components supplier; the Fifth Circuit also modified a district court judgment on trade secret misappropriation to avoid double recovery; the Federal Circuit issues a decision putting the appellate bar on notice that violations of its revised in-person argument protocols will lead to sanctions; Judge Michel and Intertrust both urge the Supreme Court to take up an appeal that would help the Court rein in the Federal Circuit’s expansive application of Alice/Mayo; Sony and Honda sign a memorandum of understanding to collaborate on electric vehicle development; an a copyright case brought by photographers against Instagram for its embedded photo tools is being appealed to the Ninth Circuit.

OpenSky Attorney Emails Expose the Seedy Underbelly of PTAB Practice

The Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has been a lightning rod since it was established on September 16, 2012. In recent years, it is undeniable that the PTAB has become fairer, although there are still obvious improvements that can and should be made. Unfortunately, the fact that the tribunal has become more even handed and offers more meaningful process and procedural protections to patent owners does not mean that the overall PTAB process is in any way fair to patent owners, as recently evidenced by an astonishing offer to throw a case, including tanking efforts of third parties seeking to join, if the patent owner paid up.

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