API and IP Newsletter
Contents
DMFs filed by Maithri Drugs
General information
IIT Madras partners with Ministry of AYUSH for AYURTECH 2022
Kerala High Court Directs DPIIT To Contemplate Compulsory Licensing Of Breast Cancer-Saving Drug Ribociclib
Intellectual Property
Fingolimod (Gilenya) :CAFC decision
DMFs filed by Maithri Drugs
Maithri as per their website a company established in 2014 at Hyderabad. The company had filed 39 DMFs, in last two years, each year they filed more than 10 DMFs. They filed 14 CEPs, 30 patent applications.
Not much information is available at their website about their R & D capabilities and production facilities.
Brief of our analysis of their filed DMFs is as below.
Observations:
1. Maithri is starting product development very early, much before FDA approval.
2. DMF portfolio is good mix of old and new products.
3. Some product selections are very interesting such as methimazole.
General information
IIT Madras partners with Ministry of AYUSH for AYURTECH 2022
The Indian Institute of Technology (IIT) Madras is partnering with the Ministry of AYUSH to organise a major event on the indigenous system of medicine in India, a statement from IIT Madras notified.
The institute aims to provide a forum for the AYUSH scientists and researchers to hear from the experts in academia and industry, and to get an overview of the expanding field of AYUSH sciences.
News here.
Kerala High Court Directs DPIIT To Contemplate Compulsory Licensing Of Breast Cancer-Saving Drug Ribociclib
Court was hearing a petition of a retired Bank employee who receives a monthly pension of Rs. 28000, and got diagnosed with HER2- Negative Metastatic Breast Cancer. The employee is undergoing 'targeted therapy’ treatment. The monthly cost of the medicines for treatment works out to Rs. 63,480.
“Ribociclib presently enjoys a patent monopoly and their manufacturers are hence prevented from producing the medicine without the consent of the patent holder,” stated the petitioner.
Counsel for the petitioner referred to Section 92 of the Patents Act, 1970 which provides for a compulsory license, and Section 100 which empowers the Government to requisition life-saving medicines in cases of extreme necessity.
In view of these submissions, Court directed “the DPIIT to take up the pending representation and pass a reasoned order thereon after consultation with the other authorities within four weeks.”
News here.
Intellectual Property
Fingolimod (Gilenya) :CAFC decision
U.S. Court of Appeals for the Federal Circuit (CAFC) upheld US 9,187,405 (the `405) related to regimen for Gilenya in January 2022. However, two days ago, CAFC issued the decision from a modified panel reversing its previous decision and now finding the patent invalid.
In August 2020, District Court of Delaware granted permanent injunction against HEC Pharma and HEC was restrained from launch until the expiration of the ‘405 patent ie till December 2027 (including paediatric exclusivity).
HEC Pharma was the only remaining ANDA filer challenging this patent.
Earlier, Novartis entered into settlement agreements with a number of other ANDA filers. Those ANDA filers would be able to launch fingolimod, before an undisclosed agreed date, which is prior to the expiration of `405.
Gilenya (fingolimod ) is used to treat relapsing remitting multiple sclerosis (RRMS), a form of multiple sclerosis (MS). MS is a debilitating immune-mediated demyelinating disease in which the immune system attacks the myelin coating the nerves in the central nervous system. Most MS patients initially present as RRMS patients.
HEC filed an ANDA seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA (partner Biocon Limited) infringes all claims of the ’405 patent
The ’405 patent claims methods to treat RRMS with fingolimod, at a daily dosage of 0.5 mg without an immediately preceding loading dose. A loading defined in a patent is a dose which is a higher than daily dose usually given as the first dose.
1. The `405 describes the results of an Experimental Autoimmune Encephalomyelitis (EAE) experiment and describes a prophetic human clinical trial (Prophetic Trial).
2. The district court found that HEC’s ANDA product would infringe ’405 patent
3. With respect to the written description for the claimed 0.5 mg daily dose, the district court found that a skilled person would understand that the inventors possessed a 0.5 mg daily dose based on one of the successful doses in the EAE experiment results. 0.3 mg/kg weekly dose.
4. The court credited the testimony of two of Novartis’s expert witnesses, Dr. Lawrence Steinman and Dr. William Jusko , to make the leap from a 0.3 mg/kg weekly rat dosage to a 0.5 mg daily human dosage.
5. The court noted that the 0.5 mg daily dose is also illustrated in the Prophetic Trial. The district court concluded that there was sufficient written description for the 0.5 mg daily dosage limitation.
6. With respect to the written description for the absent an immediately preceding loading dose limitation, the district court again found sufficient written description in the EAE model and the Prophetic Trial.
7. Neither the Prophetic Trial nor the EAE model recite a loading dose. The district court found that the Prophetic Trial describes giving a daily dosage of 0.5 mg fingolimod to treat RRMS, started initially.
8. The court found, crediting expert testimony, that, if a loading dose were directed, the Patent would say that a loading dose should be administered initially. Similarly, the district court found that the EAE example discloses a dosing regimen which does not involve a loading dose.
9. Thus, the district court concluded, the EAE model and the Prophetic Trial indicate to a person of ordinary skill that the claimed invention did not include the administration of a loading dose, and, thus, the patent provides sufficient written description of the negative limitation.
10. Hence after a four-day bench trial, the district court found that HEC’s ANDA infringes and that the claims are not invalid, either as anticipated by Kappos 2006 or for inadequate written description of the no-loading-dose or daily dosage limitations.
HEC appealed.
11. In the appeal court (CAFC) HEC argued that, as of the 2006 priority date, the inventors did not possess a 0.5 mg daily dose of fingolimod. It argued that, as of that date, 0.5 mg/day was considered too low to be effective to treat RRMS. It describes Novartis’s calculation of the 0.5 mg/day human dose as derived
12. The CAFC did not find HEC’s arguments convincing. The Court said, the Prophetic Trial and the EAE model provide sufficient written description to show that, as of the priority date, the inventors possessed a 0.5 mg daily fingolimod dosage as claimed in the ’405 patent.
13. The Prophetic Trial describes dosing RRMS patients with fingolimod hydrochloride at daily dosages of 0.5, 1.25, or 2.5 mg. The Prophetic Trial’s disclosure of two other dosages does not detract from the written description of the claimed dose.
14. One more argument was the term “daily dose” would not convey to a skilled artisan that no loading dose should be used. The CAFC said, the district court’s decision did not rely only on the term “daily dose”. Rather, the district court found that starting with a daily dose plainly implies that there is no loading dose as a loading dose is a larger than daily dose.
15. Thus the CAFC agreed with district court and upheld the patent `405.
HEC filed a petition for rehearing with the CAFC.
16. On 21 June 2022 CAFC issued a precedential decision granting a petition for rehearing from appellant HEC.
17. In granting HEC’s petition, the Court vacated a previous January ruling by CAFC, which had affirmed the District of Delaware’s final judgment that Novartis patent claims covering its Gilenya treatment for multiple sclerosis was not invalid for failing to satisfy the written description requirement under § 112.
18. Senior Circuit Judge Richard Linn authored a dissent arguing that the panel majority had improperly adopted a heightened written description standard and failed to take into account expert testimony from Novartis regarding a negative claim limitation.
19. Hon. Judge further stated that the question posed by the majority was misstated. According to him the question was not whether the patentee precluded the use of a loading dose but whether the claim language that precluded the administration of a loading dose is supported by the written description passages that disclose the effective administration of nothing more than a “daily dose.”
20. In context, that disclosure, according to the testimony of the Novartis’s experts, implies the absence of a loading dose to the ordinarily skilled artisan.
21. Judge said he sees no legal inconsistency in the district court’s treatment of the prior art. (Kappos 2006 abstract)
22. As the court explained, Kappos was an abstract with no presumption of enablement or completeness, and it in any event did not include the animal trials that form an important part of Novartis’s arguments with respect to the ’405 patent.
23. As importantly, the district court also found no evidence that Kappos 2006 was publicly available before the priority date because there was no evidence of public access.
24. The judge opined, while the panel majority acknowledged that certain circumstances can establish support for a negative claim limitation’s disclosure within the written description, but that the present case contained none of those circumstances.
25. CAFC issued the decision from a modified panel reversing its previous decision and now finding the patent invalid.
Battle is not over yet. Novartis plans to file a petition seeking further review of this decision. here
