Publications

At PakPat, our team of dedicated intellectual property attorneys is committed to staying ahead of the curve in the IP field. Continuously monitoring the latest advancements and nuances in the field, our attorneys regularly contribute to prestigious international journals. These publications serve not only to showcase our expertise but also keep our valued clients abreast of the ever-evolving legal landscape. If you would like to receive a complementary e-mail issue, just let us know and we will send you the same. If you want us to speak to your company or organization, please contact us directly. 

The standard three-tier approach for patentability (i.e., novelty, inventive step, industrial applicability) as provided in the World Trade Organization’s (WTO) agreement on Trade Related Aspects of Intellectual Property (TRIPs) is well-documented in the national laws and legal frameworks of most of the TRIPs member countries; nonetheless exclusion of certain inventions from patent-eligible subject matter under TRIPs agreement (such as scientific theories or mathematical methods, abstract ideas, laws of nature, natural phenomenon, business methods, programs for computers, and diagnostic methods) has been implemented by different member states, differently. Evolution of ever-new technologies in biological and computer sciences has created the need for ….  Read More

Enoxaparin sodium (Clexane®/Klexane®/Lovenox®) is one amongst the few drugs that have assumed a central role as drug of treatment and/or prevention against thromboembolic complications during COVID-19. The increase in demand resulting in many generic (or biosimilar) versions entering the market has increased the risks of quality and safety (including immunogenicity) related issues. Under the circumstances, development of stringent regulatory approaches has received much attention as investigation of new drug delivery systems for improved therapeutic activity. As one of the measures to increase quality testing and ensure uninterrupted supply of this life-saving drug globally, ….  Read More

Generating functional protein variants with novel or improved characteristics has been a goal of the biotechnology industry and life sciences, for decades. Rational design and directed evolution are two major pathways to achieve the desired ends. While rational protein design approach has made substantial progress, the idea of using a method based on cycles of mutagenesis and natural selection to develop novel binding proteins, enzymes and structures has attracted great attention. Laboratory evolution of proteins/enzymes requires new tools and analytical approaches to create genetic diversity and identifying variants with desired traits. In this pursuit, ….  Read More

Heparin is a subject of ever-growing interest for laboratory researchers and pharmaceutical industry. One of the driving factors is its critical life-saving drug status, which during the COVID-19 pandemic has assumed a central role in disease treatment and/or prevention. Apart, heparin is one amongst few drugs enjoying a “demand constant” status. In 2020, heparin market size was valued to US$6.5 bn., and given the ongoing stability in the COVID-19 health crisis, it is expected to reach US$11.43 bn. by 2027 with yearly growth rate momentum (CAGR) of 3.9% during the forecast period (Pepi et al., Mol Cell Proteomics 20:100,025, 2021). As patent is a limited monopoly, every year, many patents on low molecular weight heparin (LMWH; a chemically or enzymatically degraded product of unfractionated heparin) are losing market exclusivity worldwide, inviting the generic/biosimilar drug manufacturers to capture market share with cheaper drug products. By tracking patent expiration, ….  Read More

Directed (or in vitro) evolution of proteins and metabolic pathways requires tools for creating genetic diversity and identifying protein variants with new or improved functional properties. Besides simplicity, reliability, speed, versatility, universal applicability and economy of the technique, the new science of synthetic biology requires improved means for construction of smart and high-quality mutant libraries to better navigate the sequence diversity. In vitro CRISPR/Cas9- mediated mutagenic (ICM) system and machine-learning (ML)-assisted approaches to directed evolution are now ….  Read More

Epitomizing one of the rapidly maturing segments of pharmaceutical industry, biologics gestalt has severely implicated treatment algorithms of many life-threatening diseases especially in oncology, immunology, diabetes, and irresistible infections through integration of biologics in the clinical practice guidelines. As of 2021, the impact is expected to gain resilience as more patents on new biological drugs (such as Erbitux, Avastin, Orencis) are going off. Growing acceptance, trusting on stringent risk-benefits assessment, cost-effectiveness, and potential for return on investment, drive the global market of biosimilars is expected to remain steadfast in the following years; hence knowing about regulatory requirements for approval, opportunities, and barriers to biosimilars ….  Read More

The history of Pakistan’s trade mark law dates back to 1940. Until March 2001, the governing law for registration, maintenance and enforcement of trade mark rights was the Trade Marks Act of 1940. On 13 April 2001, exercising powers conferred by the various provisions of the Constitution of Pakistan, the President of the Islamic Republic Pakistan promulgated the Trade Marks Ordinance, 2001 (the 2001 Ordinance). The principal aim and objective of the 2001 Ordinance is to provide better scope of protection to trade marks and to create an effective deterrence against ….  Read More

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 ….  Read More

This article highlights the increasing challenges faced by the innovator companies owing to pre-grant opposition proceedings in Pakistan. On one hand, the generic drug makers are using the system as a legal tool to frustrate the process of patent grant, while on the other paralysing the innovator companies from initiating patent infringement proceedings against them. In the recent opposition proceedings between Otsuka and Pharmatec, the Pakistan Patent Office had correctly applied the relevant provisions of the Patent Ordinance 2000 to decide the question of limitation, but failed to apply its judicial wisdom while denying protection to ….  Read More

This review presents before the stakeholders a picture which is sketched out with the impetus that has triggered the legislature to design the patent linkage scheme to give due recognition to the rights of the generic and innovator drug companies, while avoiding the length and high costs of litigation. The case of Pakistan is presented as a role model, while that of India provides distinction and guidance in resolving ….  Read More

Since Pakistan’s accession to the WTO’s TRIPS Agreement in 1995, legislation providing protection to the breeders of new plant varieties for the effective exploitation of their rights has sought to strike the balance between the rights of the biotechnology companies and the breeders of traditional plant varieties. In 2016, the Government of Pakistan enacted the Plant Breeders’ Rights Act, which is principally designed after the 1991 Act of the UPOV Convention. This article highlights the striking features of the new legislation, the extent of its harmonization with the UPOV 1991, and the provision that contravenes or stands in apparent conflict with the provisions

of the International Treaty on Plant Genetic Resources for Food and Agriculture, resulting  ….  Read More

Worldwide, the concept of establishing special intellectual property (IP) courts and tribunals has emerged as one of the strategies to deal with the complex and technical nature of IP litigation; and Pakistan is no exception. In the last three decades, IP infringement proceedings had been receiving a secondary treatment before the regular courts in Pakistan. This has resulted in a substantial backlog of IP cases in the courts. On the other hand, since at least 2000, various conflicting provisions in the TRIPs-compliant IP laws of Pakistan, especially the patent law, have resulted in ….  Read More

The long-awaited decision in Pfizer Products Inc. et. al. v Hilton Pharma (Pvt) Ltd, involving Pfizer’s branded drug ‘Lyrica’, containing pregabalin, the Sindh High Court was called upon to decide: (i) whether proceedings for patent infringement can be instituted without awaiting sealing of the patent; and (ii) whether based on these proceedings, the plaintiff can seek perpetual injunctive relief (including interim injunction), restraining the defendant from acting in any manner that would infringe the patent, not yet sealed. While rejecting Pfizer’s arguments ….  Read More

On 3 April 2013, the Pakistan Patent Office (PKPO) by a unanimous order disposed of several notices of pre-grant oppositions filed by generic companies against Pfizer’s patent application seeking protection for a method comprising conversion of 2-isobutylsuccinonitrile into (S)-3-cyano-5-methylhexanoic acid – a useful intermediate in the synthesis of (S)-3-(aminomethyl)-5-methylhexanoic acid (pregabalin). The PKPO rejected the application holding that: ….  Read More

The question of what type of subject matter is eligible for patent protection is often met with confusion and uncertainty, especially when the technology under consideration is complicated. Through the passing of legislation and the increase in judicial precedents examining the doctrine of patent eligibility, patent-eligible subject matter has begun to be defined. This chapter examines the grey areas between ….  Read More

In the field of chemicals (particularly pharmaceuticals and agrochemicals) two structurally different but functionally equivalent molecules (the chemical equivalent to the wings of birds, on the one hand, and insects, on the other) are referred to as ‘analogs’. Historically, existence of ‘analogs’ has been problematic for those who desire to secure ‘per se’ patents for their new chemical entities (NCEs), or biological products (such as novel genes/DNA sequences). It presents the classic issue of what is ….  Read More

The statutory criterion in many jurisdictions in considering the validity of diagnostic-type claims (i.e. claims drawn on assays or methods involving use of a biomarker, for instance, to determine the presence or absence of a disease condition, or to monitor disease progression during treatment) is substantially built on the well-recognized rule of “manner of new manufacture”. However, differing approaches and patent draftsmen’s art, especially in restructuring invalid claims on a scaffolding that may let them surmount the initial barrier of patent ineligibility, has modified the legal concept of ….  Read More

Inspired by the insight of Judge Rich J. Giles In re Papesch, the question of obviousness is decided irrespective of the technology involved. In this context, rejection based on the contention that inventions relating to different technologies have different standards of non-obviousness are avoided through allowance of the same percentage of pharmaceutical applications as in other technologies. Yet for inventions relating to biotechnology the frequent juxtaposing in Pakistan of an ‘obviousness’ rejection with a rejection on the basis ….  Read More

The quid pro quo behind grant of a patent in a country other than that of its origin is to help making scientific advances by dissemination of knowledge and transfer of technology. Exploitation of patented invention without prejudicing commerce and industry in the country of grant is considered to be the best mode of achieving this objective. In order to prevent any abuses which might result from the exercise of exclusive rights, ….  Read More

The statutory requirement contained in the Pakistan patent law that “claim or claims of a complete specification shall relate to a single invention” impliedly suggests that there may be two inventions housed in one specification but to the extent of claims these shall be directed to one invention only. Unity being a question of fact, what may be regarded as a single invention is generally decided ….  Read More

To be patent-eligible, apart from being novel, non-obvious and industrially applicable, patent laws require an invention must not fall within the list of subject-matter specifically excluded from patent protection. Such a listing in Pakistan effectively precludes patenting of “substances that exist in nature or if isolated therefrom”. However, ….  Read More

Whilst product patent in Pakistan confers on its owner the exclusive right to make, use, offer for sale, sell or import for these purposes that product, the scope of protection under a process patent is also extended to acts done against “at least” the product directly obtained by that process provided, however, a claim drawn on a process for the production of X (direct product) is there to determine the extent of protection. Import is one among the acts against which ….  Read More

The general test for anticipation in the Pakistan Patents Ordinance 2000 is that “an invention must not form part of the ‘state of the art’; that is it must not be ‘disclosed’ to the public anywhere in the world by publication in tangible form, by oral disclosure, use or in any other way. Whether or not such a disclosure is ‘enabling’ or make the underlying technology available to the public is not decisive. Given this, a prior generic disclosure of ….  Read More

From the standpoint of patent laws, every patent application is allowed to cover one invention only or a group of inventions linked by a unifying underlying concept. For instance, a product and a process especially adapted for the manufacture of that product; a process and means for carrying out the process are widely accepted as constituting unity. In chemical and pharmaceutical product patents, a single claim covering alternatives of a new chemical entity (NCE) ….  Read More

Since the enforcement of TRIPs compliant patent law of Pakistan – the Patents Ordinance 2000, the PK-PO approach towards determination of the question of patentability against genetically modified plants cum plant varieties related applications remained overly-narrow and strict. According to the PK-PO as plants are excluded generally from the scope of patentable inventions, the scope of exclusion extends to ….  Read More

“New or subsequent use of a known product” is amongst the subject matters specifically excluded from the scope of patentable inventions in Pakistan [Sec. 7(4)(d) of the 2000 Ordinance]. Yet regardless of the said legal position prevailing since the 2000 Ordinance went into effect; the fact that mere changing the category of claim to give a specifically excluded subject matter an inventive gloss is not sufficient to evade the prohibition, as well as the well-recognized rule of claims interpretation that ….  Read More

From 1947 to 1997, Pakistan was among the countries that did not provide product per se patent protection for new chemical entities (NCEs) in the chemical, pharmaceutical, agricultural or biotech sectors. In 1997, when Pakistan became a signatory to the World Trade Organization agreement on trade related aspects of intellectual property rights, it amended its patent law and subsequently enacted a new one, which, among other things, provided product patent protection to inventions relating to medicine and agriculture. The statutory criteria for product patents in Pakistan are now ….  Read More

Exploitation of traditional knowledge (TK) and indigenous biological resources (IBRs) such as plants, microbes and genetic materials) of developing countries for the development of new medicinal products or synthetic reproduction of natural products, previously recognized for their therapeutic value, by the research-based companies typically from the developed world is a practice commonly referred to as ‘bio-prospecting’. This practice, when done unlawfully, ….  Read More

While biotechnology and life sciences inventions have been so long within the patent fold, and from their inception the industry has been sustained by such patents, patenting in this field still today poses considerable problems often provoking a rash of litigation. Although in Pakistan there has never been a general embargo on patents which involve living matter, yet for a long time, ….  Read More

Pakistan patent law provides for pre-grant oppositions. It has a peculiarity in that instead of calculating the time period for filing notice of opposition from the ‘date of gazette’, it provides that this date must be calculated from the date on which the relevant part V of the Official Gazette is ‘actually made available to the public’. The issues and complexities involved in so calculation are ….  Read More

Pakistan is amongst the countries where a two-staged opposition system – one pre-grant and the second post-grant (or belated opposition), is still surviving. While the rationale for pre- or post-grant opposition proceedings is principally to clear the Register of Patents of patents that are manifestly untenable yet opposition proceedings are very slow and this may hold up a patentee from suing an infringer, or where an infringement action is already instituted before a court, to stay proceedings until the opposition is resolved. Especially, at the pre-grant stage when the applicant’s rights are uncertain, ….  Read More

For product patents in chemical and pharmaceutical fields, it is a common and well-recognized practice to present a generic claim drafted in the so-called Markush group format, disclosing a class or group of compounds, ranging from few to a multitude, with an assertion that different variants or homologues or alternatives possess the same characteristics. The principal objective in this mode of drafting is to protect the new chemical entity (NCE) from being infringed through obvious modifications in structure, function and form, falling within the scope of the claim However, in this endeavour, it is often ignored that ….  Read More

Multinational companies (MNCs) engaged in the development of pharmaceutical and agricultural chemical products are a substantial source of Intellectual Property (lP) related activities in Pakistan. The said companies roughly account for more than 60% of the lP assets in the country. Since the enactment of the Patents Ordinance 2000 and availability of provisional protection in the form of exclusive marketing rights (EMR), the annual counts of applications filed at the Pakistan Patent Office (PPO) for pharmaceutical and agricultural chemical products protection ….  Read More

In patent process, patent claims hold significance analogous to a nucleus in an atom. May it be the question of novelty or infringement analysis work, or of invalidity, every step of patent process revolves around claims. Therefore, drafting of claims and interpretation has always been a matter of great importance for patent practitioners. Especially, under the rapidly changing face of intellectual property and multitude of international treaties and conventions, as well as regional agreements, claims drafting and interpretation has become even more sensitive and technical. While drafting claims, ….  Read More

The year 2005 is continuing to pose multi-dimensional challenges for both the patent practitioners and the Patent Office in Pakistan. January brought the end of the so-called Black Box/Mail Box filing era (hereafter, Black Box filing), which had come into existence after Pakistan signed the World Trade Organization’s agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement. Effective from the first day of January 2005, the old system of UNIFORM filing was restored in Pakistan. The applications kept in Black Box for the last decade ….  Read More