API and IP Newsletter
Contents
Delhi High Court demystifies law on product-by-process claims-Ferric Carboxymaltose
Wipro GE Healthcare to invest Rs 8K cr in 5 yrs on medical devices, R&D
Paragraph-IV filings
We follow Paragraph -IV filings at USFDA.
In January 2024, ANDA with P-IV certificate was filed for Lasmiditan Succinate.
Only one ANDA was filed on NCE-1 date.
Lupin, Alembic and Teva had imported innovator samples, must be for generic development and one of them could have filed ANDA on NCE-1 date.
Lasmiditan, sold under the brand name Reyvow, is a medication used for the acute (active but short-term) treatment of migraine with or without aura.
A crystalline Form D di-hydrate of the hemisuccinate salt is covered in US 11053214 and would be valid till 2037. The ANDA filer must have circumvented US 11053214 for filing at NCE-1 date.
Two DMFs have been filed one by Shandong Anhong Pharmaceutical Co Ltd and another by Moehs Iberica SL. The only ANDA filer might have used DMF of one of these DMF holders.
This is very challenging product from polymorph point of view.
Innovator had discloses solid crystalline Form A, Form B and Form C of lasmiditan hemisuccinate in US 8697876 (This is non-OB listed patent, expiration 2031).
The most interesting would be US11053214 (OB listed, expiration in 2037), discloses new pseudo-polymorphic crystalline Form D, Form E and Form F of lasmiditan hemisuccinate. It also discloses that starting with either Form A or the amorphous lasmiditan hemisuccinate, addition of water alone or water/solvent mixtures results in the conversion from Form A or the amorphous form to one of the pseudo-polymorphic Forms D, E, or F.
Form A is the dominant form in the absence of water (up to 10% by volume of water; a water activity of approximately 0.6) or at low water activities, e.g. in pure ethanol, at any temperature. At higher water activities, temperature and water content are determinative.
Further US11053214 discloses that conversion of Form A to Form D occurs as water is introduced, for example, through high humidity conditions or in solvent-water mixtures with a high water activity. Form D is the most stable form at intermediate water activities and higher temperatures. Polymorphic Form A of lasmiditan hemisuccinate is unstable in the presence of water and can convert to other pseudo-polymorphic Forms such as D, E or F. It also discloses that lasmiditan in the form of the dihydrate form D can be produced by subjecting the form A of lasmiditan to a wet granulation process using purified water as the granulating medium.
This complex polymorph situation makes formulating Lasmiditan challenging, if ANDA filers decides to circumvent polymorph patents.
General information
Delhi High Court demystifies law on product-by-process claims-Ferric Carboxymaltose
On July 24, 2023, the Learned Single Judge refused an interim injunction to Vifor by holding that a product-by-process claim was essentially a “process” claim for arriving at the given product. Vifor appealed the decision before the Division Bench (DB) of the Delhi High Court. On February 7, 2024, the DB pronounced its decision and set aside the decision of the Learned Single Judge. In a scholarly treatise, the court demystified the law on product-by-process claims. This is the only litigation in India to elaborate on this issue.
News here.
Wipro GE Healthcare to invest Rs 8K cr in 5 yrs on medical devices, R&D
Wipro GE Healthcare on Tuesday said it will invest over Rs 8,000 crore in India over the next five years to increase local manufacturing and research and development (R&D) initiatives.
The company, a leading global medical technology, pharmaceutical diagnostics, and digital solutions provider, said as a part of the investment, its 'Made in India' PET CT Discovery IQ scanner will be exported to 15 countries.
News here
Intellectual Property
Pawan Kumar Goel (Plaintiff) vs Dr. Dhan Singh (defendant)-Delhi HC
The application has been filed by plaintiff Pawan Kumar Goel seeking interim injunction against defendant Dr. Dhan Singh restraining him from using, making, selling, exporting, distributing, advertising or taking any steps for manufacturing and dealing in any product including but not limited to 'Alpha Yohimbine' extracted from Rauwolfia Tetraphylla/Rauwolfia Canescens with purity greater than 90% (subject compound).
The plaintiff Pawan Kumar Goel had filed the suit claiming infringement of Indian Patent 369150 which is titled 'Novel Process for Extracting Alpha Yohimbine (Rauwolscine) from Rauwolfia Species'. The said compound Alpha Yohimbine /Rauwolscine HCl with purity/assay greater than 90% is extracted from Rauwolfia canescens/tetraphylla.
Summons were issued in the suit on 26 September 2022 but the Court mentioned that it was not inclined to grant an ad interim ex parte injunction at that stage.
Subsequently, defendant Dr. Dhan Singh appeared and filed the written statement. There were issues relating to confidential information which were filed by defendant Dr. Dhan Singh, in respect of the process that he adopted for the same subject compound.
Consequently, a confidentiality club was instituted by order of this Court dated 15 March, 2023. Initially redacted documents and pleadings were filed and thereafter, un-redacted documents and pleadings were shared as part of the confidentiality club which subsequently by orders of this Court, including directions made above, have been taken up on record in encrypted form.
The counsel for plaintiff Pawan Kumar Goel had stated that the suit patent IN 369150 is of a process which was invented by Pawan Kumar Goel for the purposes of extraction of the subject compound in industrial quantities, in order to make it commercially viable.
The said patent was granted in 2021 with the priority date in November 2016. He therefore contends that the subject compound can be produced in industrial quantities only by adopting the patented process of Pawan Kumar Goel. He stresses on the fact that laboratory extraction is a very different situation than an industrial process and ensuring commercially viability.
Counsel for plaintiff Pawan Kumar Goel had further submitted that it is upon defendant Dr. Dhan Singh to place evidence on record to show that process adopted by Dr. Dhan Singh is not infringing the patented process.
The Counsel for plaintiff Pawan Kumar Goel argued thar Dr. Dhan Singh has relied on three categories of documents.
Firstly, Batch Manufacturing Record (BMR), documents which are necessarily linked to an export of a pharmaceutical product and demonstrate as to the process adopted by the manufacturer, stagewise, for achieving the said product; secondly, Certificate of Analysis by defendants and
thirdly, the documents which would exhibit the process adopted by defendants itself. In this case, he stated that only drafted flow charts have been given by Dr. Dhan Singh to show the process, which does not provide any sufficient detail.
The Counsel for plaintiff Pawan Kumar Goel stated that none of these documents discharge the defendant Dr. Dhan Singh’s burden of proof, as required by section 104A of the Patents Act, 1970 and makes the following submissions with regard to the same:
First, the BMRs provided by Dr. Dhan Singh are of the year 2015 which precede the priority date of plaintiff's patent and therefore, not be dispositive of the process adopted by defendants post 2018, when the patent application had been published.
Second, the certificate of analysis was of the year 2022, however, showed the compound in question, which shows the botanical source as 'Rauwolfia Vomitoria' and other certificates which are similar in nature. However, none of the certificates placed by defendants relate to botanical source being of Rauwolfia tetraphylla/canescens.
Third, the drafted flow charts purporting to show the process of Dr. Dhan Singh were inconsequential and sketchy at best and did not demonstrate that Dr. Dhan Singh’s process is different.
Therefore, the Counsel for plaintiff Pawan Kumar Goel contended that there is no proof, even prima facie filed by Dr. Dhan Singh, which would lead to a conclusion that Dr. Dhan Singh’s process which he continued to adopt post 2018, is not infringing the suit patent.
The Counsel for Dr. Dhan Singh however refuted these submissions primarily on the ground that there is enough evidence on record to show that they were in fact manufacturing, marketing and exporting the subject compound since the years 2014-15.
Therefore, he contends that Dr. Dhan Singh had adopted the process to produce the subject compound in industrial quantities much prior to patent application of Pawan Kumar Goel and in fact states on instructions that they continue to adopt the same process, which is not infringing that of Pawan Kumar Goel’s process. In support of this submission, attention of the Court has been drawn to various documents inter alia as under:
A licensing certificate issued by Assistant Drugs Controller cum Drug Licensing Authority dated 10 April 2014.
Date wise list of invoices of domestic and export sales of subject compound, since 2014-15, have been provided along with copies of the invoices. The same would show that the earliest of invoices which had been filed by defendant Dr. Dhan Singh is dated 30th January, 2015 of the subject compound which is consigned to an entity in Mumbai, Maharashtra for 2.2 kgs at a value of Rs.6,91,240/- (rest of the invoices referred to are till 2022-23).
Invoice for export sales of the subject compound, earliest of which is dated 9 April 2015, which shows the consignee as an entity in USA for 1.5 kgs for a value of USD7950 (rest of the invoices referred to are till 2022-23).
Reference is made to batch numbers which are mentioned in the export invoice and related BMR. An illustrative BMR is shown of date 6 January 2015 for the said subject compound, which shows the This is a digitally signed order.
Basis these documents, the counsel for Dr. Dhan Singh’s company submitted that not only were they manufacturing the subject compound prior to patent application of plaintiff Pawan Kumar Goel but it was also exactly the same compound of more than 90% concentration and being produced in industrial quantities for both domestic and international markets.
Further, the BMR would show that there was a process which was adopted. He, therefore contends that at this stage, this would be enough evidence to prove that they had adopted a legitimate process which was prior to patent application filed by plaintiff Pawan Kumar Goel for manufacture of the same subject compound in industrial quantities. It was emphasised that they continue to adopt the same process till date and are in no way infringing Pawan Kumar Goel’s process patent.
Decision
Based on these submissions, the Court opined, at this stage when the evidence is still to be led, plaintiff Pawan Kumar Goel’s plea for injunction may not be merited considering that prima facie there is evidence placed on record by Dr. Dhan Singh to show that his company was already manufacturing the said subject compound through a process for industrial quantities. The fact that plaintiff Pawan Kumar Goel secured a suit patent IN 369150 in 2018 effected from 2016 and granted in 2021, cannot suddenly exclude Dr. Dhan Singh from continuing to adopt the process which he did since 2014.
Possibly the question which would remain and which the counsel for plaintiff Pawan Kumar Goel has canvassed is that post 2018, Dr. Dhan Singh has to prove that he has not changed the process from pre-2018 process to a different process which is infringing the suit patent IN 369150. However, these aspects will be subject matter of evidence at trial, for which rights and contentions of the parties will remain open.
Decision here
