Israel Patent Application No. 220476 to Mapi Pharma titled “Long Acting Depot System Comprising a Pharmaceutical Acceptable Salt of Glatiramer” was allowed and published for opposition purposes. Teva filed an opposition under Section 34 of the Law.
The application relates to a dosing regime of Glatiramer and salts thereof. The drug is an immunomodulator medication used to treat multiple sclerosis.
The application is a national stage of a PCT filed on 19 August 2010 which claims priority from an American patent application of 4 January 2010.
The patent was examined and published for opposition purposes on 31 March 2016. On 28 June 2016, Teva filed an opposition. After the parties submitted their statements of case, Teva withdrew their opposition for commercial reasons.
Under Section 34 of the Patent Law 1967, the Commissioner has to decide whether the suspended opposition provides a sufficient basis for the patent to be granted.
In their Statement of Case Teva raised various issues regarding the patentability of the claimed invention. Since no evidence was submitted, the Deputy Commissioner concentrated on the allegation that the publication of WO2005/041933 from 12 May 2005 anticipates the invention and negates novelty.
Claim 1 recites:
“A long acting parenteral pharmaceutical composition comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer, the composition being in a sustained release depot form which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.”
Paragraph 20 of the Statement of Case which from paragraph 58 of their counter statement, it appears the patentee accepts, construes claim 1 as follows:
- A long acting pharmaceutical composition
- For parenteral dosing
- comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer,
- the composition being in a sustained release depot form
- which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.
WO2005/041933 describes a process for creating nanoparticles for the slow release of glatiramer. The period over which the slow release takes place is not defined in the publication, but it is clear that a slow rather than instant release is intended. See page 10, lines 29-33 and page 10 lines 17-20 thereof. The publication also describes using the formulation in various ways, including intraveniously, for treating multiple schlerosis.
It appears that there is no argument that the preparation can be dispensed parenterally [i.e. not orally or rectally – MF] – seepage 13 lines 18-24.
It is also noted that WO2005/041933 notes that such nano-particles may be dispensed from a depot:
The Applicant claims that WO2005/041933 does not provide the duration of the slow release claimed in claim 1 [about one week to six months – MF] and so is not anticipated. The Applicant also alleges that WO2005/041933 teaches away from the invention but doesn’t explain how.
Despite this differences, here is nothing in the Applicants statement of case to indicate that the depot is prepared differently of that its elements are different from those of WO2005/041933. Any difference in the slow release period would depend on one or other of these. Thus it appears that the actual slow release period is simply the result of implementing the teachings of WO2005/041933 and is thus an inherent characteristic thereof. See 41362-07-15 DSM vs. PMS Shielding Factory ltd, 22 January 2017.
As to inherent characteristics, the US case-law relates to this in Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249, 66 S. Ct. 81, 84 (1945):
“Where there has been use of an article or where the method of its manufacture is known, more than a new advantage of the product must be discovered in order to claim invention. See De Forest Radio Co. v. General Electric Co., 283 U.S. 664, 682. It is not invention to perceive that the product which others had discovered had qualities they failed to detect. See Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U.S. 358, 369.”
In a different matter:
“Finally, we address Bristol’s argument that new uses of old processes are patentable, that we should treat the expressions of efficacy as limitations because they distinguish the new use of the process over the prior art, and that claims should be read to preserve their validity. … Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.
(Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001))
It is also noted that the figures of the application indicae tha there is a formulation that provides release over a 32 day period, and various amorphous statements that the depot can be adjusted to release the drug over periods ranging from two weeks to a number of months. See page 9 lines 16-18:
“Depending on the duration of action required, each depot or implantable device of the present invention will typically contain between about 20 and 750 mg of the active ingredient, designed to be released over a period ranging from a couple of weeks to a number of months.”
The period of freeing the formulation is described in examples 6 and 7 of the Application. These examples describe how the formulation was injected into animals over various periods of once weekly, once fortnightly and once monthly. There formulation was not injected less frequently. The results of these experiments is not given in the application.
From that stated it appears that the basis of claim 1 that differentiates it from WO2005/041933 is not supported by examples and there is therefore doubt whether it is supported. In other words, there is doubt if the invention is supported by the specification as required by Section 13 of the Law.
On the other hand, if the specification does provide sufficient support, and persons of the art can practice the invention based on the specification, then there is nothing to differentiate the invention from the teaching of WO2005/041933 which similarly provides rough guidelines regarding the slow release of the active ingredient.
Claim 16 claims a medical device for treating Multiple Schlerosis having the same elements as claim 1, so the above arguments apply to claim 16 as well.
Dependent claims 2 and 17 add introduction of the depot in an appropriate par of th ebody. The Deputty Commissioner does not consider that this adds anything patentable over WO2005/041933.is similarly problematic.
Dependent claims 5 and 20 detail the elements of Glatiramer. This is the active ingredient of Copaxone™ which predates the effective filing date.
Claims 6 and 21 define Glatiramer as including between 15 and about 100 amino-acids. The application itself teaches that this was known about Glatiramer Acetate prior to the effective filing data.
The Deputy Commissioner likewise find the other claims invalid for reasons sated by Teva in their Statement of Case.
Under Regulation 74 of the Patent Regulations 1968, the Applicant has 30 days to respond to this detailed ruling and can request a hgearing under Section 74(c).
Ex-partes ruling by Depuy Commissioner Jacqueline Bracha on patentability of IL220476 to Mipa, 22 March 2018.
Copaxone provided MS sufferers and TEVA with a lifeline for many years. Now the drug is off-patent and both Teva and various generic competitors have tried to monopolize dosing regimes to monopolize the treatment. Following losses, drop in share price and cuts to try to make the company viable, Teva have laid off a number of Patent Attorneys. This may be the basis of them abandoning the Opposition. The Deputy Commissioner is correct to consider whether the Statement of Case was adequate to challenge the assumption of validity.