LexBlog IP

APRIL 29, 2022

The BsUFA is a law authorizing FDA to assess and collect fees from drug manufacturers that submit Biological License Applications for biosimilar products. The testimony spanned many topics, but notably the FDA discussed the progress of biosimilar approvals, including its impact on cost. decrease in price (for insulin glargine) to a 42.2%

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Licensing Law Intellectual Property 52

LexBlog IP

JUNE 16, 2022

Sometimes the FTC will do reports on its own initiative (such as the recently announced pharmacy benefit managers (PBMs) study ), but other times, Congress will, through legislation, require the Commission to prepare a report on a specific topic, and that is often done as part of the agency appropriation process.

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Reporting Law Intellectual Property 52

SpicyIP

NOVEMBER 8, 2023

Trends such as the association of AI with life sciences, the growth of start-ups / non-traditional companies investing in life sciences, reduced spending on small molecule-drugs and promising new biotech treatments, indicate that windows of opportunity for investment in this sector are opening up. In Asthristis Relied Plus Ltd.

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Invention Patent Art Patent Law 69

SpicyIP

NOVEMBER 8, 2023

For context, these trials are conducted by pharmaceutical companies as R&D to, evaluate the efficacy, risks, and health benefits of new drugs/components. Access to clinical trial data not only helps drug innovation but also impacts consumer benefits and drug pricing. and Class 5.2 Read Anupriya’s excellent post here.

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LexBlog IP

JULY 16, 2023

As with the agency’s earlier studies on these same topics (2021), the refreshed data again demonstrates that Orange Book patents are very rarely subject to AIA trial proceedings, and that abusive, serial petition filings have been effectively outlawed for years now.

Patent 52

Patent Litigation Intellectual Property 52

LexBlog IP

OCTOBER 27, 2021

The first study covering these topics was released on March 13, 2018, and the second on July 18, 2019. Food and Drug Administration’s (FDA’s) electronic Orange Book database. Orange Book patents cover only drug compound, formulation, and method claims. Trends Over Time. See 21 C.F.R. § § 314.53(b).

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Patent Settlement Litigation Reporting 52

43(B)log

AUGUST 9, 2021

5, 2021) Scilex sells an FDA-approved, prescription-strength topical analgesic self-adhesive patch, ZTlido (lidocaine), which is allegedly often prescribed off-label, including for general neuropathic pain (e.g., the rate and extent of drug absorption.” Scilex Pharmaceuticals Inc. Sanofi-Aventis U.S. LLC, 2021 WL 3417590, F.Supp.3d

False Advertising 59

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SpicyIP

AUGUST 15, 2021

Topical Highlight. Ensuring Access to TB drugs: Is Compulsory License the Way? They highlight that this failure is typified by the stark realities that have come to light in a pending public interest litigation before the Bombay High Court [BHC], regarding access to life saving drugs. Thematic Highlight.

Licensing 83

Licensing Government Reporting Patent Law 83

SpicyIP

JULY 5, 2021

Topical Highlight. which the defendant as per the plaintiff’s allegations is infringing upon via use of its domain name www.tatacliqsmart.com to sell various TATA products which are likely fake, at throwaway prices. He also said that MSD wants to join the UN-backed Medicines Patents Pool (MPP) to expand access to the drug.

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Intellectual Property Trademark Licensing Copyright 105

LexBlog IP

FEBRUARY 18, 2022

On the consumer protection side, the topic was initiating a Mag-Moss rulemaking concerning earnings claims – the statements that businesses may make when trying to encourage consumers to work for them or sell their product or service. So how did things roll out at the meeting?

Marketing 52

Marketing Marketing Business Blogging 52

SpicyIP

AUGUST 2, 2021

Topical Highlight. The US Senate Judiciary Committee discussed four bills aimed at reducing drug prices for consumers. A Parliamentary Standing Committee Report that Challenges the Fine Balances Within the IP System. He notes the list of recommendations in the Report while highlighting the pro-industry nature of the same.

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Reporting Designs Design Copyright 116

IP and Legal Filings

MARCH 7, 2022

In this scenario, the court might issue a temporary order for a certain period until the court issues final decisions on the topic. The mark “OCULFOX” was claimed by AI to be the name under which their drug was sold. The substance “ofloxacin” was used in the product, which gave it this name.

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Trademark Law Registering Trademarks Branding 60

IP and Legal Filings

MARCH 7, 2022

In this scenario, the court might issue a temporary order for a certain period until the court issues final decisions on the topic. The mark “OCULFOX” was claimed by AI to be the name under which their drug was sold. The substance “ofloxacin” was used in the product, which gave it this name.

Trademark 57

Trademark Law Registering Trademarks Branding 57

SpicyIP

JULY 11, 2021

Topical Highlight. I analysed Bajaj Healthcare’s application for compulsory license to manufacture Eli Lilly’s Baricitinib, an arthritis drug more recently used for Covid treatment. IPAB Issue Finally Comes to a Conclusion: Delhi HC Creates Specialist IP Division. News from around the World.

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Moral Rights Journalism Licensing IP 105

SpicyIP

JANUARY 2, 2022

This year, we have divided these developments into three categories: a) Top 10 IP Judgments/Orders (Topicality/Impact). Top 10 Judgments/Orders [Topicality/Impact]. Hetero Drugs Ltd [Delhi High Court]. Hetero Drugs claimed that the drug was not being used in India and the export was only for research and development purposes.

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IP Intellectual Property Copyright Trademark 143

Kashishipr

NOVEMBER 10, 2021

It may or may not grant compulsory licenses based on insufficient working, the dependency of patents, or the interest of consumers in obtaining a protected product at the lowest possible price. There has been a constant debate about issuing compulsory licenses to enable life-saving drugs, without which humanity may suffer.

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Licensing Invention Intellectual Property Marketing 105

SpicyIP

JULY 19, 2021

Topical Highlight. The National Pharmaceutical Pricing Authority (NPPA) has invoked the terms of paragraph 19 of the Drugs Prices Control Order (DPCO) – 2013 to cap the price of five medical devices: a pulse oximeter, a blood pressure monitoring machine, a nebulizer, a digital thermometer, and a glucometer.

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SpicyIP

DECEMBER 30, 2023

As in previous years, we have divided these developments into five categories: a) Top 10 IP Judgements/Orders (Topicality/Impact) b) Top 10 IP Judgements/Orders (Jurisprudence/Legal Lucidity) c) Top 10 IP Legislative and Policy Related Developments d) Other IP Developments; and e) Other Notable Developments. RDB and Co. Hari Shankar.

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IP Copyright Trademark Intellectual Property 124

Fish & Richardson Trademark & Copyright Thoughts

JANUARY 11, 2022

Litigation under the Biologics Price Competition and Innovation Act (BPCIA) in the district courts also decreased. Biosimilar Drug. BI had asked FDA to change its interpretation of the term “strength” as used in the BPCIA for parenteral solutions to mean “total drug content” without regard to concentration. Reference Product.

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SpicyIP

JANUARY 27, 2024

For larger-than-law-type posts on this topic, check Prof. In sum, ‘tis a very interesting topic. National Pharmaceutical Policy(ies) and Pricing of Drugs – In 2011, this month, Shan Kohli discussed the Draft National Pharmaceuticals Policy which sought to establish a regulatory framework for drug pricing.

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IP Licensing Copyright Blogging 64

SpicyIP

AUGUST 30, 2021

Topical Highlight. They also stressed that since the company had stocked up a large amount of the goods under consideration and since these were medicinal supplies, which on an average, had an expiration period of just one year, they should be allowed to make their drugs available for commercial supply in the market. Sun Pharma v.

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Patently-O

JULY 9, 2021

Prescription Drugs : Drug prices are higher in the US than in any other country — even for the identical product. Hospitals : Complete implementation of hospital price transparency rules. More to come on this topic. This is largely a construct of Federal Law. Hearing Aids : Sell these over the counter.

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Licensing Intellectual Property Privacy IP 101