API and IP Newsletter
Contents
Exelixis (EXEL) Settles Cabometyx Patent Litigation With Cipla
Emcure, Gennova settle legal dispute with US-based HDT Bio, sign agreement
Recent FDA approvals- Givinostat
We follow FDA approvals
In March 2024, FDA approved Givinostat, a medication used for the treatment of Duchenne muscular dystrophy. It is solid under brand name Duvyzat.
DUVYZAT (givinostat) oral suspension contains givinostat hydrochloride monohydrate, a histone deacetylase inhibitor.
Givinostat hydrochloride monohydrate is designated chemically as: [6-(diethylaminomethyl)naphthalen-2-yl]methyl[4(hydroxycarbamoyl) phenyl] carbamate hydrochloride monohydrate.
Givinostat hydrochloride monohydrate is a white to off-white, non-hygroscopic, crystalline powder that is very slightly to slightly soluble in aqueous media and slightly soluble in ethanol.
DUVYZAT contains givinostat 8.86 mg/mL (equivalent to givinostat hydrochloride monohydrate 10 mg/mL) and theinactive ingredients such as cream flavor, glycerin, non-crystallizing sorbitol solution, peach flavor, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium hydroxide, tartaric acid, and tragacanth.
Intellectual Property
WO1997043251A1 individualises givinostat in Example 12. Reported compound 4-[6-(Diethylaminomethyl)naphth-2-ylmethyloxycarbamoyl]-benzohydroxamic acid hydrochloride (ie givinostat anhydrous form)
WO2004065355 relates to Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester. This is marketed product for Duchenne muscular dystrophy.
WO2013114413A1 relates to use of Givinostat hydrochloride monohydrate for use in the treatment of muscular dystrophy. This could be important patent family for generic challengers. This will expire in US in March 2032 and generic launch could be difficult prior to 2032.
WO2017077436A1 relates to physically and chemically stable oral suspensions of givinostat. An equivalent of this family would expire in US in October 2036. Formulators should develop a stable and circumventing formulation to be able to launch generic givinostat prior to expiration of this patent in US.
Generic API
Raw material requirements for API synthesis are very common RMs like 2,6-Naphthalenedicarboxylic acid. Hence there could be many API companies developing generic API.
There’s already one DMF filed!! However DMF is filed by Chemi SPA.
Chemi SPA is an Italian pharmaceutical company, belonging to Italfarmaco Group who is the innovator of Givinostat.
General information
Exelixis (EXEL) Settles Cabometyx Patent Litigation With Cipla
Per the settlement, Exelixis will grant Cipla a license to market generic versions of Cabometyx in the United States beginning on Jan 1, 2031, upon FDA approval and subject to conditions and exceptions common to agreements of this type.
News here.
Emcure, Gennova settle legal dispute with US-based HDT Bio, sign agreement
Pune-based Emcure Pharma and its subsidiary Gennova Biopharmaceuticals have “amicably settled” legal disputes with US-based HDT Bio Corp by signing a new agreement to collaborate and develop mRNA vaccines, said the companies in a joint statement.
News here
Intellectual Property
Viagra-Vigoura Trademark Dispute-A decision by Delhi High Court
For a change, let us read about an interesting Trademark Dispute.
Pfizer Products Inc, the Plaintiff, through this lawsuit filed 20 years ago sought to protect their trademark rights in "VIAGRA," a well-recognized erectile dysfunction allopathic drug, by seeking permanent injunction and other ancillary reliefs to prevent the Defendants from marketing their homeopathic medicine under a confusingly similar trademark "VIGOURA," used allegedly for curing sexual disorders.
When the suit was initially filed, Pfizer focused on solely protecting its common law rights in the mark. Subsequently, with Pfizer securing statutory rights through trademark registration of "VIAGRA," the scope of reliefs was broadened, and Pfizer also alleged trademark infringement, in addition to passing off.
The lawsuit thus, raises critical questions concerning cross-border reputation and trademark protection for pharmaceuticals with similar-sounding names, but used for different mechanisms: in this case, one is a traditional homoeopathic medicine, while the other is a conventional allopathic drug.
By addressing these questions, the Court determined whether the Defendants' (Renovision Exports) use of "VIGOURA" infringes upon Pfizer's "VIAGRA" trademark and/ or constitutes passing off.
In 1995, Pfizer adopted the trademark "VIAGRA" for its revolutionary drug Sildenafil Citrate, developed to treat erectile dysfunction. Following the approval by the USFDA declaring "VIAGRA" to be a significant improvement in treatment of erectile dysfunction on 27 March 1998, the drug was introduced in the US market in 1998.
In February 2005, Pfizer discovered that Defendant trading as Renovision Exports Pvt. Ltd., was selling products described as "Nervine Tonic for Men" and "Homeopathic Medicine Invented in Germany" under the infringing mark "VIGOURA". Subsequent investigations revealed variants of "VIGOURA" products, such as "VIGOURA 2000", "VIGOURA 5000", and "VIGOURA 1000".
Pfizer's attorneys immediately addressed the issue by sending a cease-and-desist letter to the Defendant Renovision Exports on 03 February 2005. A reminder letter was sent on 01 March 2005.
A response to the above-noted letters was received on 11 March 2005, wherein Defendant Renovision Exports disputed Pfizer's claims and asserted their rights in their "VIGOURA" trademark. Renovision Exports filed applications for registration of their marks "VIGOURA 2000" and "VIGOURA 5000"
Pfizer, in turn, filed notices of opposition to the said applications. While the suit was pending adjudication, Pfizer’s opposition to "VIGOURA 2000" was allowed by the Registrar of Trademarks, Kolkata on 29 April 2009, resulting in rejection of Renovision Exports application.
As regards the trademark application for the mark "VIGOURA 5000", since Renovision Exports did not file a counter-statement to the opposition, the application was deemed to be abandoned by the Registrar of Trademarks.
Pfizer’s arguments
Renovision Exports' "VIGOURA" mark is deceptively similar to Pfizer's well-established "VIAGRA" trademark. This similarity is an intentional attempt by Renovision Exports to capitalize on the goodwill and reputation associated with "VIAGRA".
Both marks share similar elements:
they begin with 'Vi', end with 'Ra', and
have three syllables,
making them phonetically comparable.
Additionally, both products target the same consumer segment (those seeking remedies for medical conditions), thereby increasing the likelihood of confusion regarding the source and affiliation of the products.
Renovision Exports position
Renovision Exports is an established specialists in the homeopathic domain. Renovision Exports is a registered oil company with a strong reputation for manufacturing homeopathic medicines, which includes the drugs "VIGOURA 1000", "VIGOURA 2000", and "VIGOURA 5000".
The impugned products are distinct medicines, intended to address varied ailments. "VIGOURA 1000" focuses on vitality and regulating menstruation in women and is therefore, distinct from the Pfizer’s product, which addresses male erectile dysfunction. This distinction renders the product "VIGOURA 1000" irrelevant to the present dispute.
"VIGOURA 2000" and "VIGOURA 5000" are homeopathic medicines formulated as non-steroid aphrodisiacs designed to stimulate metabolic processes.
Homeopathic medicines operate on different principles than conventional allopathic pharmaceuticals like Pfizer's "VIAGRA". While "VIAGRA" is utilized for instant relief, Renovision Exports' "VIGOURA" demonstrates gradual effects after consumption for two to three months.
The difference in the composition and nature of the two medicines coupled with the fact that both are prescription drugs, reduces the likelihood of confusion for consumers.
The adoption of the impugned mark "VIGOURA" by Renovision Exports is honest, genuine, and bona fide.
It is a fanciful mark derived from the English term 'Vigour'.
Besides, the impugned products have a significant market history, with "VIGOURA 2000" being first manufactured and marketed by Renovision Exports in 1999.
Renovision Exports also sought trademark registration for "VIGOURA 2000" on 21 January, 2003, and for "VIGOURA 5000" on 30th December, 2003 in class 05.
In addition, Renovision Exports secured a copyright registration for the artistic work vested in the packaging of "VIGOURA 2000" on 27 April 2005. Thus, the Defendants' products have been in the market for a significant time before Pfizer's trademark registration.
Various other entities have secured registration rights in trademarks that resemble the word "VIAGRA" for Ayurvedic medicinal or pharmaceutical drugs falling under class 05, much prior to Pfizer.
In support, the written statement submitted by Renovision Exports enlisted registrations held by third parties for the marks "VIGORA", "VIGOR PLUS", and "VIGOUR MALT".4 3.5.
The mark "VIAGRA" has not been assigned in favour of the Plaintiff Pfizer Products Inc by its owner Pfizer Inc. Therefore, the Plaintiff Pfizer cannot claim proprietorship over the said mark.
The decision
The Court decisively refuted this argument, emphasizing that the unauthorized use of a trademark by others does not grant a carte blanche to the Defendant Renovision Exports to infringe upon the trademark in question.
The Court noted that third-party use of similar mark is irrelevant to the legal analysis of whether Renovision Exports has violated Pfizer’s trademark rights.
The primary concern remains the protection of the trademark's distinctiveness and the prevention of consumer confusion, regardless of actions or inactions taken against other parties.
Thus, the infringement and the need for injunctive relief are to be determined by Renovision Exports actions alone, without consideration of third-party use that have not been contested by Pfizer.
Pfizer has valued their damages' claim at Rs. 20 lakhs, however, no evidence has been led by Pfizer to prove the damages. Thus, in absence of any evidence, on the question of computation to damages, the Court was unable to concur with the quantum of damages prayed for. However, since Renovision Exports have been held to be guilty of infringement and passing off, the Court considers it appropriate to award nominal damages of Rs. 3,00,000/- plus actual litigation costs.
Decision here
