Establishing the Groundwork for Clinical Trials With Hiccupops® for Hiccup Palliation

Objective Because hiccup palliation remains an unmet clinical need, we report here on an early experience with Hiccupops, ® a patented product designed for the express purpose of providing a mechanism-based intervention for hiccup palliation. Methods Meter Health, the developer and manufacturer of this patented product, used a purposive sampling approach to allow individuals with hiccups and a desire for hiccup palliation to purchase their agent and then to report on its efficacy or lack thereof. The authors of this report were provided these outcome data and allowed to analyze, report, and publish with no input from Meter Health with the exception of comments on accuracy. Results This report focused on 43 surveys that were completed. In response to the question, “Did the Hiccupops work for the person they were purchased for?” 29 (67%) responded, “yes.” Seven individuals (16%) responded, “no;” and 7 (16%) were “not sure.” Write-in comments appeared to substantiate the effective palliative nature of the intervention: “A friend with 10 days of hiccups following… brain tumor surgery, after 2 days, they stopped!!!#.” Another noted the following: “I like that if my hiccups get painful they’re there as a quick relief.” Less favorable comments were also noted: “She couldn’t get past the…. taste.” Another read as follows: “They were not effective in stopping my father’s intractable hiccups…. I like that there is someone out there who cares about trying to stop people’s hiccups.” Conclusions This patented product appears to palliate hiccups in some individuals and merits further study.

Revisiting the working of patent requirements under Indian patent law

This article aims to analyse the working of patent requirements under Indian patent law. A patent working requirement generally entails that the patentee must work or apply the patented product in the patent granting country. This article evaluates the compatibility of the patent working requirement with the TRIPS Agreement from the perspective of international human rights law. A human rights approach suggests that the rights of the patentee must be reconciled with the interests of the general public. In such pursuance, this article argues that there is a need to recalibrate the patent working requirement under the Indian law to strike a right balance between the rights of the patentee and the public interest. Particularly, this article argues that India must modify the present patent working disclosure requirements to ensure that foreign patentees are able to do business in India without bureaucratic hassles.

Sitagliptin (Januvia) patent litigation: Another link in the judicial train of ‘Proactive Infringement’ of patented rights in developing countries

Driven by increasing instances of successful ‘at-risk’ launch of patented drugs in America and Europe, the strategy of using ‘proactive infringement’ as a legal tool is now getting-in, in developing countries. The rationale behind launch-at-risk is to counterbalance the innovator companies’ strategies of getting the patented product life extended through protecting improvement innovations and maintain market exclusivity even after the expiration of the compound patent. The battle for market and drive for higher profits between generics and innovator drug companies has extended the application of at-risk launch of the generic drugs even when compound patent is still running. Sitagliptin (Januvia) may be ranked at top of the drugs that have been fiercely litigated in the developing countries during their patent term. This article reviews the outcome of sitagliptin patent litigation and impact on the market exclusivity in some developing countries. This takes the position that the existing conflict between the innovators and generics can be resolved by diluting the misconception that patents on improvement innovations are misuse of patent system or inappropriate extension of patented product life on the part of innovator companies. Whether trivial, simplified or complex, if novel and non-obvious, further improvements in the precursor drugs are patentable within the legal framework of the patent system. The real issue is the scope of monopoly granted to the secondary or follow-on patents. Once the compound patent has expired, follow-on patents on improvements relating to the same compound should not be allowed to use as legal-barrier for the generic medicines entry to the market.

Interim injunctions and working of patents: A short note from India

The article looks at how jurisprudence has evolved in Indian courts on granting or refusing injunctions to patentees, especially when such patentees are not working/commercially using their patented product in India. The author also presents his views on the recent Eisai v. Dr Reddys case.

REMANUFACTURING WITH PATENTED TECHNIQUE ROYALTY UNDER ASYMMETRIC INFORMATION AND UNCERTAIN MARKETS

We study a dual-channel recycling closed-loop supply chain (CLSC) and investigate the royalty strategy involving cost-reducing technique for remanufacturing patented products. Facing information asymmetry and market uncertainty, we address the problem where the patent licensor (manufacturer) and licensee (remanufacturer) simultaneously compete in the sales market and the recycling market. We examine the optimal decisions of a decentralized CLSC (D-CLSC) with the manufacturer being the Stackelberg leader. Numerical examples are used to demonstrate how the patented technology (cost-reducing technique) affects the channel players’ behaviors and how to identify the optimal royalty fee. Based on the theoretical derivation and the numerical outcomes, we find that regardless of the CLSC structure (centralized or decentralized), the take-back prices and the total profits will rise with the increase of savings from the licensed technology. In the D-CLSC, (i) the expected profits of the manufacturer and the remanufacturer as well as the royalty fee will also rise with the savings from the licensed technology. (ii) In addition, the wholesale price, retail price, take-back prices, as well as the royalty fee will rise with the degree of information asymmetry. But the retailer’s expected profit will decline. (iii) Finally, the expected profit of the manufacturer will rise with the demand uncertainty and the return uncertainty. For the remanufacturer, this trend is not obvious. Our research provides guidance to resolve conflicts and intellectual property disputes between the original manufacturer and the remanufacturer of the patented product.

yeni susanti_165100114

The basis of patent law itself is very complete explained in the patent law regulation number 14 of 2001. In the government-compiled law it is written that the filing of patent rights on an invention or invention has requirements that need to be fulfilled.In Indonesia, patents will be highly protected to protect the intellectual property rights of every Indonesian. According to the applicable law, namely Number 14 of 2001 inventor who has patent rights for a product or idea, has full power and can process persons who commit plagiarism, distribute and trade the patented product into legal channels in accordance with the basis of patent law regarding violations of criminal provisions in Chapter XV.

Full Federal Circuit Curbs On Sale Bar's Threat to Patents

Morrison Foerster Client Alert, July 12, 2016Biotech and pharmaceutical companies received critical guidance from the Federal Circuit yesterday, when the en banc court exempted a broad category of common manufacturing and supply arrangements from the reach of the patent law’s “on sale” bar. In The Medicines Company v. Hospira, Inc., App. No. 14-1469 (Fed. Cir. 2016) (en banc), the Federal Circuit ruled unanimously that “the mere sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a ‘commercial sale’ of the invention” and does not create a potential bar to patentability under 35 U.S.C. § 102(b). The decision reduces the IP risk that smaller pharmaceutical companies faced when contracting out for manufacturing services during commercial development, and provides in-house counsel with signposts to craft agreements that will stay clear of the on sale bar.

Vertical Integration Smooths Innovation Diffusion

Does vertical integration of an input innovator with a downstream firm entail innovation foreclosure? We study the licensing incentives of an independent input producer owning a patented product innovation which allows the downstream firms to improve the quality of their final goods. We consider two-part tariff contracts for both outside and incumbent innovators. We find that the incumbent innovator has always the incentive to license its innovation to the rival firm so that under vertical integration complete technology diffusion takes place. In contrast, the external patent holder may prefer exclusive licensing depending on the innovation size as well as on the set of allowed contracts. As a result vertical integration does not entail innovation foreclosure, rather it facilitates innovation diffusion with respect to vertical separation. As for the profitability, the vertical integration with either downstream firm is always privately profitable and it is welfare improving for large innovations: this implies that not all profitable mergers should be rejected.

Bargaining over Entry with a Compulsory License Deadline: Price Spillovers and Surplus Expansion

We analyze bargaining between a developing country (South) and a multinational firm over the local price of its patented product. We use an alternating offers bargaining game in which the South can resort to compulsory licensing (CL) if the two parties fail to reach agreement by a certain deadline. The presence of international price spillovers introduces two novel features into the standard bargaining problem: the surplus from entry prior to the CL deadline may be negative, and CL can yield higher surplus than entry. We establish conditions under which equilibrium may exhibit immediate entry, preemptive entry just prior to the CL deadline, or the occurrence of CL. The South necessarily gains from the threat of CL if the joint payoff under entry is higher relative to CL but can lose if it is lower. (JEL D45, F11, F23, L24, L65, O34)