Search the archive.

Charlie Katebi,, 02-14-2024, "Patent Abuses Keep Prescription Drugs Unaffordable," No Publication, – Adi WH

DRUG PATENTS

Pharmaceutical companies gain an average three years in monopoly protections on branded drugs by filing multiple secondary patents, throughout and beyond the development process, a study by UCLA Anderson’s Charu Gupta. Unlike primary patents, which apply to a drug’s active ingredient, secondary patents can cover things like how the drug is administered, what disease it will treat and dosing. These exclusivity extensions cost U.S. patients, insurance companies and other drug buyers about $148.3 million per drug by delaying competition from producing far cheaper generic brands, according to estimates Gupta describes as conservative in a working paper. In a sample of 355 branded drugs, she finds extended monopoly protection raised consumer costs by $52.6 billion. As big as it seems, that figure covers only a subset of years and of the total drugs that enjoy patent extensions, as explained below.

Wayne Brough, 5-23-2024, "Bad Patents Keep Drug Prices High," R Street Institute, – Adi WH

Skyrocketing prescription drug prices remain a pressing political issue. that a large majority of voters in both parties support efforts to reduce drug prices, and President Joe Biden’s reelection highlights his administration’s efforts to do so under the .

(Michael Nega, attended Chicago Kent College of Law – majored in Economics – minored in Philosophy at the University of Chicago, The Chicago-Kent Journal of Intellectual Property welcomes academic and professional author submissions on topics in all areas of intellectual property law including patents, copyrights, trade secrets, and trademarks, 02/19/2023, How Do Patents Impact Drug Prices?, Chicago Kent Journal of Intellectual Property, https://studentorgs.kentlaw.iit.edu/ckjip/how-do-patents-impact-drug-prices/, Accessed 6/29/2024) Blaine -- WH

Patent law gives inventors the right to exclude others from using and benefitting from their invention for a specified period. “During patent exclusivity, prices of products are typically set higher that permit patent holders to realize greater profits that would be achievable in a competitive marketplace.”[24] Pharmaceutical patents are typically “composition of matter” patents that cover specific molecules or combinations of molecules. [25] Many of the patents that pharmaceutical companies obtain cover either the tangible item (i.e., the composition of matter itself) or specific production processes to make the said composition. [26] “During the span of the patent, no other entity is allowed to sell a generic version of the drug, which keeps competition and lower prices at bay.” [27] When the patent system was first developed, its goal was to encourage innovation by giving certain protections to inventions. However, today’s pharmaceutical companies no longer operate primarily to innovate new medication but to monopolize existing ones. [28] It is estimated that about 80% of new patent applications are not for new medicines. [29] About 70% of the most popular drugs on the market have had an additional patent filed for them or have had their existing patent terms extended to further monopolize the market for that drug. [30] “An analysis of the ten best-selling drugs of 2019 found that, on average, these drugs held more than 69 patents with 37.5 years of patent protection, well past the 20 years of patent life intended by Congress. Furthermore, the prices for these drugs increased 71% over the previous five years.” [31]

John Commins, Senior Editor at HealthLeaders Media, interviewing Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo Clinic, 12/21/23, “Modest Drug Costs Hikes Predicted for 2024. Drug Expenditures Are a Different Story.” Dummy Head | HealthLeaders Media, . ES - HW

The pharmaceutical sector is a hive of activity these days, buzzing with breakthrough treatments for stubborn diseases such as Alzheimer's and obesity, and with sickle cell anemia, an outfight cure.

(Council for Informed Drug Spending Analysis, “High Drug Prices and Patient Costs: Millions of Lives and Billions of Dollars Lost,” CIDSA, ., Shah – WH)

Existing Problem

(Michael Nega, attended Chicago Kent College of Law – majored in Economics – minored in Philosophy at the University of Chicago, The Chicago-Kent Journal of Intellectual Property welcomes academic and professional author submissions on topics in all areas of intellectual property law including patents, copyrights, trade secrets, and trademarks, 02/19/2023, How Do Patents Impact Drug Prices?, Chicago Kent Journal of Intellectual Property, https://studentorgs.kentlaw.iit.edu/ckjip/how-do-patents-impact-drug-prices/, Accessed 6/29/2024) Blaine -- WH

Patent law gives inventors the right to exclude others from using and benefitting from their invention for a specified period. “During patent exclusivity, prices of products are typically set higher that permit patent holders to realize greater profits that would be achievable in a competitive marketplace.”[24] Pharmaceutical patents are typically “composition of matter” patents that cover specific molecules or combinations of molecules. [25] Many of the patents that pharmaceutical companies obtain cover either the tangible item (i.e., the composition of matter itself) or specific production processes to make the said composition. [26] “During the span of the patent, no other entity is allowed to sell a generic version of the drug, which keeps competition and lower prices at bay.” [27] When the patent system was first developed, its goal was to encourage innovation by giving certain protections to inventions. However, today’s pharmaceutical companies no longer operate primarily to innovate new medication but to monopolize existing ones. [28] It is estimated that about 80% of new patent applications are not for new medicines. [29] About 70% of the most popular drugs on the market have had an additional patent filed for them or have had their existing patent terms extended to further monopolize the market for that drug. [30] “An analysis of the ten best-selling drugs of 2019 found that, on average, these drugs held more than 69 patents with 37.5 years of patent protection, well past the 20 years of patent life intended by Congress. Furthermore, the prices for these drugs increased 71% over the previous five years.” [31]

John Commins, Senior Editor at HealthLeaders Media, interviewing Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo Clinic, 12/21/23, “Modest Drug Costs Hikes Predicted for 2024. Drug Expenditures Are a Different Story.” Dummy Head | HealthLeaders Media, . ES - HW

The pharmaceutical sector is a hive of activity these days, buzzing with breakthrough treatments for stubborn diseases such as Alzheimer's and obesity, and with sickle cell anemia, an outfight cure.

If there are any issues with evidence in this file, please tell your lab leaders which piece(s) of evidence have issues, what those issues are, and ask them to tell me (jam) about those issues

A preliminary word is in order. The reader must note that the term "patent," as understood prior to the establishment of the U.S. federal system, is nothing similar to its current meaning and it is not what we now know as a "patent."

According to the World Intellectual Property Organization Model Law for Developing Countries on Inventions, the term 'patent' is defined as an idea of an inventor which permits in practice the solution to a specific problem in the field of technology. . 5 Not all inventions are patentable. Three substantial requirements should be satisfied for an invention to enjoy patent protection: novelty, inventive step and industrial application. It is important to see how to apply these three requirements in outer space. The third element of industrial application is easy to satisfy as long as the invention can be made or used in any kind of industry actually or constructively. . 6 Such invention need not be perfect or incapable of further improvements to constitute actual industrial application. . 7 The requirement is satisfied if the invention is useful and operable by providing a tangible benefit.

The Solo Cup court also held that an article covered by an expired patent should be considered an unpatentable article as a matter of statutory interpretation. 109 The statute, the Federal Circuit concluded, was "unambiguous." 110 Curiously, the Federal Circuit did not explain why it considered the statutory language unambiguous. The term "patent" may refer to either the "governmental grant" of the patent rights or to the "official document" that describes the invention. 111 [[Footnote 111 begins]] Black's Law Dictionary 1156 (8th ed. 2004); see also, e.g., Kemin Foods, L.C. v. Pigmentos Vegetales del Centro S.A. de C.V., 301 F. Supp. 2d 970, 974 (S.D. Iowa 2004) ("A patent is a legal document that defines the metes and bounds of the patentee's invention."). [[Footnote 111 ends]] Although the governmental grant of rights has clearly ended after the patent has expired, the document describing the invention and granting the rights continues to exist. Thus, an article described in an expired patent, and marked with the number of an expired patent document, may be viewed as covered by a patent rather than "unpatented."

8. Subdivision (i) of Section 2.1 lists the following category of specific assets conveyed by the Acquisition Agreement: "all Owned Intellectual Property Rights, including, without limitation, . . . the name 'Finman LLC' as used by the company." The term "Intellectual Property Rights" is defined by the contract to include "rights in copyrightable subject matter," as well as "all other intellectual and industrial property rights of every kind and nature."

The term "intellectual property rights" is often accepted as a given among much of the Westernized world. It is a phrase that is often authoritatively (and perhaps cavalierly) used to define a whole set of creative endeavors that deserve protection under the laws of patents, copyrights, and trade secrets. Such a phrase, however, is far from innocuous. The use of the words "property" and "rights" carries substantial, ideological flavor that may or may not be shared by other nations of the world.

(Id. at D01323.) The term "Intellectual Property Rights" is defined to include "trademarks, service marks, trade dress, trade names, logos and corporate names and registrations and applications for registration thereof and Internet domain names together with all of the goodwill associated therewith." (Id. at D01350.)

(DE 214-2 at 33-34 (Stock Purchase Agreement, Section 6.17)) (underlining in original). The term "Intellectual Property Rights" is defined in the Stock Purchase Agreement as follows:

rights in and to United States and non-United States (a) patents, patent applications, statutory invention registrations and similar protections for inventions and discoveries, (b) trademarks, service marks, trade names, trade dress and other identifiers of source or goodwill, together with the goodwill associated therewith, (c) copyrights, including rights in software and data, (d) designs, (e) inventions (whether patentable or not), including invention disclosures, technology and discoveries, (f) trade secrets, know-how and other confidential information, and (g) registrations and applications for registration of the foregoing.

As intellectual property has given heightened attention as a valuable business asset, the claims for the protection of U.S. intellectual [*412] property rights outside the United States have increased. 17 In some field of laws, such as admiralty, antitrust, securities, and trademark laws, courts have applied U.S. law to conduct that occurred outside of the United States. 18 Nonetheless, courts generally presume not to apply U.S. law beyond U.S. borders. 19 This presumption is called the "presumption against extraterritoriality" 20 This section will discuss the presumption against extraterritoriality with a particular focus on intellectual property laws.

A. Courts Generally Employ the Presumption Against Extraterritoriality in Federal Law.

Striking this crucial balance becomes increasingly complicated when American copyright holders do business with other countries as intellectual property law tends to be "territorial in nature." 20 The infringement suit in Kirtsaeng v. John Wiley & Sons, Inc. provided the Supreme Court a platform through which to clarify the applicability of certain American copyright laws in relation to foreign markets. The Court granted certiorari to determine whether the "first sale" doctrine applies to copyrighted works manufactured and purchased abroad and then resold in the United States without the copyright owner's permission. 21 In Kirtsaeng v. John Wiley & Sons, Inc., the Supreme Court held that the "first sale" doctrine was not intended to be geographically limited, and, as such, was applicable to copyrighted work regardless of place of production, so long as the work was originally produced in compliance with American copyright law. 22

For all WTO member countries, domestic intellectual property laws are required to reflect the robust obligations of the TRIPS Agreement. The TRIPS Agreement reflected a significant upgrade from prior multilateral arrangements in terms of its comprehensive scope and, notably, the opportunity to enforce the new rules.

At this stage, however, it could be submitted that TRIPS does not significantly depart from national decisions that are decided under domestic private international law. This is because, TRIPS requires the minimum standard [*185] in protection and at the national level. Domestic intellectual property rules are in fact rules reflecting their international character. 217Local intellectual property rules afford national treatment to foreign private owners based on the state's obligations under international law (TRIPS or Berne). 218