API and IP Newsletter
Contents
DMFs filed in the month of August 2023
In August 2023, total 72, Type-II DMFs were filed, out of which about 23 DMFs were filed by Indian companies, Aurobindo and MSN were at the top of list by filing 3 DMFs each. Chinese companies had overtaken Indian DMF filings in August. Chinese companies filed 25 DMFs. In last few quarters there’s increase in DMF filings by Chinese companies.
Some of our product specific observations are as below.
General information
New cost-cap system for UK patent disputes to start in early 2024
UK patent proceedings are notorious for their high costs. However, a new cost-cap system could make the UK patent courts more attractive for SME claimants in future. The pilot project is expected to start at the beginning of next year.
The Civil Procedure Rules Committee (CPRC) has now approved a proposal for capping costs for patent cases in the Shorter Trial Scheme (STS). The proposal submitted by the Intellectual Property Lawyers’ Association (IPLA) adopts the current procedures for the STS, adding a single total cost cap of £500,000.
News here.
Delhi HC Grants ₹11 Lakh Damages To Woodland
The suit was related to the trademark ‘WOODLAND’ in which the plaintiff (Aero Club) sought injunction against the defendant entity (M/s. Sahara Belts) to restrain it from manufacturing, offering for sale, selling, advertising, directly or indirectly any products bearing the registered trademark of the plaintiff.
A Single Bench of Justice Prathiba M. Singh observed, “The Defendant’s use of the ‘WOODLAND’ mark and logo on substandard goods not only violates the Plaintiff’s statutory and common law rights but also jeopardizes the Plaintiff’s brand equity and dilutes its marks.
News here
Intellectual Property
Cloudbreak vs Allgenesis
Cloudbreak Therapeutics, LLC (Cloudbreak) owns US Patent No 10,149,820 (the ’820 patent), which discloses compositions and methods for treating pterygium.
Pterygium is an eye condition in which a tumour-like growth extends from the nasal or temporal side of the eye to the cornea.
Allgenesis Biotherapeutics Inc. (Allgenesis) challenged the validity `820 patent before the USPTO. In USPTO, the Patent Trial and Appeal Board (PTAB) held that Allgenesis failed to prove claims 4 and 5 of U.S. Patent No. 10,149,820 are unpatentable in an inter partes review.
Inter partes review is a trial proceeding conducted at the Board to review the patentability of one or more claims in a patent only on a ground that could be raised under sections 102 (novelty) or 103 (the differences between the subject matter sought to be patented and the prior art), and only on the basis of prior art consisting of patents or printed publications.
Allgenesis appealed in The United States Court of Appeals for the Federal Circuit (CAFC)
This invention relates to treatment of pterygium. Historically, the only treatment option was surgery to remove the growth. This surgery, however, provides no guarantee against tumour recurrence
Recognizing these drawbacks, the ’820 patent sought to provide a new treatment option for pterygium, administering multikinase inhibitors to the eye to inhibit specific growth factors that contribute to tumour growth and hyperaemia.
The patent discloses that nintedanib in particular may be one of the most powerful multikinase inhibitors for reducing corneal neovascularization, i.e., new blood vessel growth on the front part of the eye that is associated with hyperemia and pterygia.
The claims which were under dispute are as below:
4. The method of claim 3, wherein the multikinase inhibitor is nintedanib and the nintedanib is administered to the affected eye in the form of a topical ocular formulation and is administered topically to the affected eye.
5. The method of claim 4, wherein the topical ocular formulation is a solution or a suspension.
The Board first determined Allgenesis failed to show the claims were anticipated by, or would have been obvious over, Allgenesis’ PCT Application Publication No. WO 2016/209555 (Allgenesis’ PCT).
Specifically, the Board determined Allgenesis’ PCT, which claims priority to a U.S. provisional application filed 22 June 2015, does not qualify as prior art because claims 4 and 5 may claim priority to Cloudbreak’s U.S. Provisional Application No. 62/172,063 (the ’063 provisional), filed 06 June 2015.
In reaching this priority determination, the Board found the ’063 provisional provides sufficient written description support for claims 4 and 5.
The Board also determined Allgenesis failed to show claims 4 and 5 would have been obvious over King2 and Amparo.3
2 U.S. Patent Application Publication No. 2013/0012531.
3 Amparo et al., Safety and Efficacy of the Multitargeted Receptor Kinase Inhibitor Pazopanib in the Treatment of Corneal Neovascularization, 54 INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCI. 537–44 (2013).
The Board credited the ’820 patent’s description of the unexpected result that nintedanib provided improved efficacy and has a better safety profile compared to the closest prior art, sunitinib.
Allgenesis appealed, challenged the Board’s finding that the ’063 provisional provides written description support for claims 4 and 5 and its unexpected results analysis.
Allgenesis asserted it has standing to appeal the Board’s decision based on (1) its potential infringement liability and (2) the Board’s priority determination. CAFC concluded that Allgenesis had failed to meet its burden to establish standing on either ground.
Allgenesis had failed to establish it has nonspeculative, concrete plans for future activity that creates a substantial risk of future infringement. CAFC therefore concluded Allgenesis had failed to show an “injury in fact” based on potential infringement liability.
In general, Allgenesis must have suffered an "injury in fact," meaning that the injury is of a legally protected interest which is (a) concrete and particularised and (b) actual or imminent.
Allgenesis argued it has suffered an “injury in fact” based on the Board’s priority determination. Specifically, the Board determined claims 4 and 5 of the ’820 patent are entitled to the 06 June 2015 priority date of the ’063 provisional.
Based on this, the Board determined Allgenesis’ PCT, which has a later effective filing date of 22 June 2015, is not prior art.
According to Allgenesis, because claims 4 and 5 of the ’820 patent and Allgenesis’ PCT both relate to the same invention (i.e., nintedanib treatments for pterygium), the Board’s relative priority determination affects the scope Allgenesis’ own patent rights.
Allgenesis asserted it suffered an “injury in fact” because the Board’s determination will have a preclusive effect on the scope of its pending patent application, Ser. No. 17/750,400, which claims priority to Allgenesis’ PCT.
However, CAFC concluded, Allgenesis had not established that the Board’s decision will have preclusive effect. Again, Allgenesis’ allegations of harm are not sufficiently specific to establish any injury in fact.
Federal Circuit concluded that Allgenesis failed to establish an injury and therefore dismissed the appeal.
Decision here
