In theory, product claims provide the strongest patent protection because they are not limited to the use or preparation of the Traditional Chinese Medicine (TCM) product. In reality, however, infringement assessment often involves looking at the methods used to prepare the TCM product.
Traditional Chinese Medicine, or TCM, is a subset of herbal medicine. TCM patent applications generally fall into four categories.
These categories reflect the main objectives of TCM patent protection: namely, to protect the formula, craft, original materials, and commercial products.
Method Claims
Method claims are useful when the TCM products preparation, purification, or extraction process is innovative, but the final composition is unclear. Its important to define the claim form based on the characteristics of raw materials, the process, and dosage. Raw materials should include all components and proportions used to prepare the TCM product. The process should include all steps and conditions, such as temperature, pressure, time, etc. The dosage can be broadly described as medicament, if a person skilled in the art could understand what that means in light of the patent; otherwise, the dosage needs to be specific. Below is an example of a TCM method claim:
A method for producing a medicine for postpartum treatment, prepared from:20-30 parts by weight of motherwort, 3-9 parts by weight of angelica, 1-6 parts by weight of ginseng, 6-12 parts by weight of astragalus, and 5-13 parts by weight of Polygonum multiflorum, Peach kernels 4-7 parts by weight, Cyperus rotundus 6-9 parts by weight, mixed with water and decocted twice, the amount of water added each time is 10 times the amount of raw materials, and the decoction is 1-3 hours each time. The decoction is combined, filtered, and the filtrate is concentrated into a clear paste with a relative density of 1.25 to 1.28, 40 to 70 parts by weight of brown sugar and 5 to 10 parts by weight of dextrin are added to make granules, which are dried into granules.
A method claims scope extends to the product obtained by the method. Article 11 of Chinas Patent Law provides that after the invention patent right is granted, unless otherwise provided in this law, no entity or individual may exploit the invention without the permission of the patentee, that is, not use, promise to sell, sell, or import products directly obtained in accordance with the patented method.
Use Claims
Use claims are useful when the TCM products application is innovative.The Examination Guidelines provides this basic formula: The application of substance X in the preparation of therapeutic drug Y. Further, if effective ingredients are known, the claim can be written as [t]he application of substance X in the preparation of therapeutic drug Y, where the effective ingredients are Z.
A use claims scope, however, is limited to the claimed use.Therefore, obtaining a corresponding method claim is advantageous when applicable to protect the preparation, packaging, and promotion of the TCM products.
Product Claims
Lastly, product claims are useful when the TCMs final composition is known. In theory, they provide the strongest patent protection because they are not limited to the use or preparation of the TCM product. In reality, however, infringement assessment often involves looking at the methods used to prepare the TCM product. The bottom line is that there needs to be sufficient evidence that a product prepared by a different method is the same product prepared by the inventor.
As discussed before, method claims are useful when the TCM products preparation, purification, or extraction process is innovative, but the final composition is unclear. Most TCM patents fall under this category and these patents present some unique challenges in litigation.
For example, Beijing Yadong Biopharmaceutical Co., Ltd. (Yadong) and Guizhou Kangna Shengfang Pharmaceutical Co., Ltd. (Kangna) were involved in a TCM patent dispute in the Beijing No. 1 Intermediate Peoples Court. [(2006)??????8603?.] The Court found that claim 3 of Patent No. ZL02134148.6 was different from Yadongs TCM capsules. Specifically, the Court found that in claim 3, Fructus corni is decocted three times with waterdrug residue plus 5 times the amount of 90% ethanol for reflux extraction twice, 1 hour each time, where Yadongs capsule was Fruit Cornus plus ethanol refluxed for a second timedrug residue for use, which constituted a significant difference.Therefore, the prescription and preparation method of Yadongs capsules did not fall within the protection scope of claim 3.
Another example includes the appeal of a patent infringement dispute between Guizhou Baixiang Pharmaceutical Co., Ltd. (Baixiang) and the patent owner Zhao Shusheng. [(2011)???????6?.] Baixiang, the defendant, obtained drug registration approval and disclosed its preparation method in the drug label. The most significant difference is that the asserted patent recites using two ethanol reflux and the defendant adopted the technique of three ethanol refluxes, and the time of each reflux was also different.
The plaintiff argued that three-reflux and two-reflux are technologically equivalent. The Court disagreed for two reasons. First, although three-reflux and two-reflux both extract the active ingredients from yantuo, the plaintiff did not provide sufficient evidence that they achieve the same extraction results. Second, the defendant showed that three-reflux had far better extraction results than two-reflux. Plaintiffs witnesses also admitted that increasing the number of refluxes was more efficient.
These are typical examples of TCM patent disputes where the active ingredients are mostly characterized by extraction and preparation methods, making it difficult to enforce patent rights.
TCM, as a subset of herbal medicine, has similar patent protection principals and challenges in the United States. Composition claims are useful when the active ingredients are known and can be limited to a specific use. For example, Frisun, Inc. (Wuhan, China) obtained U.S. Patent No. 7,575,772 on Process and composition for syrup and jam from Luo Han Guo fruit that brings all the advantages of Luo Han Guo together to meet todays market demand for a natural, sugar-free sweetener. In TCM research, Luo Han Guo (or Monk fruits) is known to have the potential to be natural sweetener with a low glycemic index and can therefore be an alternative to sugar for diabetic populations. See, e.g., Ying. Z., Yan. Z., Jeff. E., Chi-Fu. H., Insulin secretion stimulating effects of mogroside V and fruit extract of Luo Han Kuo (Siraitia grosvenori Swingle) fruit extract., Acta Pharmaceutica Sinica., 44 (11): 1252-1257 (2009).
The number of patent acquisitions for herbal medicines has grown significantly.From 1976 to 2003, the U.S. Patent and Trademark Office (USPTO) granted a total of 1,968 herbal patents. [Surge in US patents on botanicals, NATURE BIOTECHNOLOGY VOLUME 22 NUMBER 6 JUNE 2004.] Since 2019, the USPTO has received more than 4,000 herbal patent applications since 2019. This number is fairly conservative, because many new application forms have not yet been made public.Below are a few:
Patent protection for TCM can present many challenges because of the various types of TCM products and the uncertainty of the active ingredients. As herbal medicine patents become more popular, we can expect to see similar challenges in enforcing patent rights in herbal medicine technology.
Shui Li is an intellectual property lawyer with Robins Kaplan. Her experience is in cross-border disputes, and she has worked with a variety of technology industries, including medicinal chemistry, biotechnology, video streaming, telecommunication, and semiconductors.
Yongfeng Zheng is General Counsel of Tasly Holding Group Co. Ltd. He holds a Doctor of Law, Master of Medicine, and is Vice-President of China Patent Protection Association.
Chunxuan Li is a partner and patent attorney at the Beijing Lifang Law Firm.
See the article here:
Protecting Traditional Chinese Medicine Products in the United States and China - IPWatchdog.com
- Ed's Guide to Alternative Therapies - pathguy.com - December 8th, 2016 [December 8th, 2016]
- Complementary and Alternative Medicine Guide | University ... - December 8th, 2016 [December 8th, 2016]
- Complementary and Alternative Medicine (CAM) Overview - December 26th, 2016 [December 26th, 2016]
- Alternative Medicine, Holistic Doctors,Naturopathic ... - January 5th, 2017 [January 5th, 2017]
- Alternative Medicine Degrees - Excite Education - January 13th, 2017 [January 13th, 2017]
- Alternative Medicine | Category | Fox News - January 13th, 2017 [January 13th, 2017]
- Alternative Medicine - Disabled World - January 13th, 2017 [January 13th, 2017]
- Alternative Medicine Degree, BS - Everglades University - January 23rd, 2017 [January 23rd, 2017]
- Alternative Medicine | Duke University Press - January 23rd, 2017 [January 23rd, 2017]
- Bill to rein in alternative medicine practitioners - Bangalore Mirror - February 8th, 2017 [February 8th, 2017]
- Peroxide ingestion, promoted by alternative medicine, can be deadly - Science Daily - February 8th, 2017 [February 8th, 2017]
- Can Peroxide Kill You? Yes, Say Doctors About This Alternative Medicine Favorite - Medical Daily - February 8th, 2017 [February 8th, 2017]
- Marijuana tension between clinical, alternative medicine ... - Washington Times - February 9th, 2017 [February 9th, 2017]
- Cannabis providers feel tension between clinical and alternative medicine - The Cannabist - February 11th, 2017 [February 11th, 2017]
- Happy Healthy YOU - Tillsonburg News - February 15th, 2017 [February 15th, 2017]
- Health dept cracks down on alternative meds containing sildenafil citrate - NYOOOZ - February 18th, 2017 [February 18th, 2017]
- Alternative Medicine Conferences | Traditional Medicine ... - February 24th, 2017 [February 24th, 2017]
- American Institute of Alternative Medicine - February 24th, 2017 [February 24th, 2017]
- Alternative medicine to treat pain and other ailments on the rise locally - Rockford Register Star - February 25th, 2017 [February 25th, 2017]
- Alternative Medicine Career Information and Education ... - February 27th, 2017 [February 27th, 2017]
- Why is alternative medicine so popular? - Alternative ... - February 27th, 2017 [February 27th, 2017]
- Potential dangers and dubious history of alternative medicine are often unknown to its consumers - MinnPost - February 28th, 2017 [February 28th, 2017]
- New form of alternative medicine comes to OU - Oaklandpostonline - March 1st, 2017 [March 1st, 2017]
- OPENING THE PLAYBOOK ON ALTERNATIVE MEDICINE - Dope Magazine - March 2nd, 2017 [March 2nd, 2017]
- Ask a Doctor: Is there an alternative medicine treatment for constant pain? - Chattanooga Times Free Press - March 7th, 2017 [March 7th, 2017]
- Alternative medicine grows in Sugar Land, Missouri City - Community Impact Newspaper - March 7th, 2017 [March 7th, 2017]
- Medicine with a side of mysticism: Top hospitals promote unproven therapies - STAT - March 7th, 2017 [March 7th, 2017]
- Abstracts: Obamacare Replacement, Alternative Medicine, and More - Undark Magazine - March 8th, 2017 [March 8th, 2017]
- For Prairie Village practitioner, personal experience led to interest in alternative medicine techniques - Shawnee Mission Post - March 8th, 2017 [March 8th, 2017]
- Financial Planning + Alternative Medicine - March 8, 2017 ... - KHTS Radio - March 9th, 2017 [March 9th, 2017]
- Premier U.S. Hospitals Are Selling Unproven Alternative Therapies ... - KQED - March 11th, 2017 [March 11th, 2017]
- Speakers lay stress on use of alternative medicine - The Nation - March 11th, 2017 [March 11th, 2017]
- Top U.S. hospitals promote unproven medicine with a side of ... - PBS - PBS NewsHour - March 11th, 2017 [March 11th, 2017]
- Medical cannabis expert discusses treatment options - Herald-Whig - April 8th, 2017 [April 8th, 2017]
- 5 ALTERNATIVE MEDICINES EVERY MAN SHOULD BE AWARE OF - TORO Magazine - June 6th, 2017 [June 6th, 2017]
- CID unearths fake 'council of alternative medicines' in Behala - Millennium Post - June 11th, 2017 [June 11th, 2017]
- Parents who believe in 'alternative nutrition' convicted after baby dies of malnutrition - Telegraph.co.uk - June 14th, 2017 [June 14th, 2017]
- Times of Malta Alternative medicine - Times of Malta - June 16th, 2017 [June 16th, 2017]
- Suffering from severe pain? Experts say THIS form of alternative medicine will work just as well as drugs! - Zee News - June 20th, 2017 [June 20th, 2017]
- IBAM Indian Board of Alternative Medicine - June 20th, 2017 [June 20th, 2017]
- Alternative medicine practitioner charged with sexual assault in Burlington - Hamilton Spectator - June 20th, 2017 [June 20th, 2017]
- Mind, body, spirit: Nurse opens holistic health store to promote overall wellness - Muscatine Journal - June 21st, 2017 [June 21st, 2017]
- Four of the Most Misused Terms in Alternative Medicine - ATTN: - June 24th, 2017 [June 24th, 2017]
- How cupping therapy helps athletes like Michael Phelps as an alternative medicine - Sport360 - June 26th, 2017 [June 26th, 2017]
- Calimesa Alternative Medicine - Weedmaps - June 26th, 2017 [June 26th, 2017]
- Homeopathic Health Center | Columbus, OH - (614) 890-2589 - June 26th, 2017 [June 26th, 2017]
- Alternative Medicine | What Is Alternative Medicine? - June 26th, 2017 [June 26th, 2017]
- Quotes About Alternative Medicine (30 quotes) - June 26th, 2017 [June 26th, 2017]
- Alternative Medicine That Doctors Recommend | Reader's Digest - June 26th, 2017 [June 26th, 2017]
- Alternative Medicine Schools - Excite Education - June 26th, 2017 [June 26th, 2017]
- Medical journal takes aim at natural remedies - CBC.ca - June 26th, 2017 [June 26th, 2017]
- Healing through alternative medicine: Winona locals choose acupuncture as a cure - Winona Daily News - June 26th, 2017 [June 26th, 2017]
- Patrick Noel, DC: Restoring the body's innate ability to heal through chiropractic care - Colorado Springs Gazette - June 27th, 2017 [June 27th, 2017]
- Back Pain? Try Yoga - New York Times - June 29th, 2017 [June 29th, 2017]
- Jerusalem: Alternative healer indicted on rape charges - The Jerusalem Post - June 29th, 2017 [June 29th, 2017]
- Does Pink Himalayan Salt Have Any Health Benefits? - TIME - June 29th, 2017 [June 29th, 2017]
- Not all wellness is bullshit - Quartz - June 30th, 2017 [June 30th, 2017]
- What's happening in your body during acupuncture? - The Verge - July 1st, 2017 [July 1st, 2017]
- Natural and Alternative Medicine against Asthma - Radio Cadena Agramonte - July 3rd, 2017 [July 3rd, 2017]
- Alternative Medicine in Halacha: a Review - Yeshiva World News - July 3rd, 2017 [July 3rd, 2017]
- West Bengal's top doctors turn out fakes, arrests blow lid off thriving scam - Hindustan Times - July 5th, 2017 [July 5th, 2017]
- Sudbury woman chooses alternative treatments for stage 4 cancer - CBC.ca - July 6th, 2017 [July 6th, 2017]
- Unbiased reporting can help call time on pseudoscience - EuroScientist - July 6th, 2017 [July 6th, 2017]
- Holistic therapy for pets? Traditional vet care being blended with reiki, acupuncture - Georgia Voice - July 7th, 2017 [July 7th, 2017]
- A Memoir of Chronic Fatigue Illustrates the Failures of Medical Research - The New Yorker - July 10th, 2017 [July 10th, 2017]
- Valtrex after expiration - Alternative medicine for herpes simplex 2 - Van Wert independent - July 11th, 2017 [July 11th, 2017]
- Sacred Space, University of Miami partner to educate community on wellness - Miami Herald - July 11th, 2017 [July 11th, 2017]
- One FDA About-Face Doesn't Mean an Orphan-Drug Bonanza - Bloomberg - July 12th, 2017 [July 12th, 2017]
- 'Bridging medicine with nature' - The Torrington Telegram - July 12th, 2017 [July 12th, 2017]
- Gwyneth Paltrow's Goop posted a defense of its jade eggs for vaginas. It's a mess. - Vox - July 14th, 2017 [July 14th, 2017]
- Acupuncture for pets? Yes, it's a thing - MyDaytonDailyNews - July 15th, 2017 [July 15th, 2017]
- Create Ministry for traditional, alternative medicine - Association - Graphic Online - July 17th, 2017 [July 17th, 2017]
- Native American healing class sparks unique health textbook - ABC News - July 18th, 2017 [July 18th, 2017]
- Rav Elyashiv ZTL On Alternative Medicine By R. Yair Hoffman - Yeshiva World News - July 18th, 2017 [July 18th, 2017]
- Expedite action on the passage of the alternative medicine bill ... - GhanaWeb - July 18th, 2017 [July 18th, 2017]
- Is Gwyneth Paltrow's pseudoscience winning? - Vox - July 20th, 2017 [July 20th, 2017]
- Salt Therapy Gaining Popularity in Alternative Medicine Circles - Newsmax - July 22nd, 2017 [July 22nd, 2017]
- Vargas: Weeding out herbal remedies for our pets - News Chief - July 24th, 2017 [July 24th, 2017]
- Patients recognise over-worked GPs as majority agree to see alternative medical professionals - Herald Series - July 25th, 2017 [July 25th, 2017]
- Cancer controversies and traditional medicines - Regina Leader-Post - July 26th, 2017 [July 26th, 2017]