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  • Saturday, June 30, 2018 3:23 AM | Deleted user

    Patent protection in the pharmaceutical industry is different from protection in other sectors.

    The pharmaceutical industry relies on innovation to develop new medical treatments, but bringing a product to market is high risk and high cost. It can take between 10 and 15 years to develop a new medicine and according to a new study by the Tufts Center for the Study of Drug Development, can cost as much as $2.56 billion.

    Once a new product has been developed, protecting intellectual property (IP) can also be costly. Every industry needs to evolve individual IP policies, management style and strategies, but patents and trademarks are critical for the pharmaceutical industry in particular.

    Patents help to protect companies from IP infringement and copycats looking to reproduce generic products at a low cost and high volume.

    Unique Challenges with Pharma IP — How to Protect

    The pharmaceutical industry is unique in that, while it can cost almost nothing to manufacture a drug, it costs millions to create it. For this reason, patent protection in the pharmaceutical industry is different from protection in other sectors.

    The high cost associated with R&D means the majority of pharmaceutical companies apply for patent protection during research stages and before clinical trials. This can reduce the effective patent life for medicines to an average of just 11.5 years.

    Early patenting not only reduces the patent life of a product when it reaches the market, but shortens the time available for marketing a new drug. Pharmaceutical companies need to protect ideas quickly. They rely on a logical, flexible, IP strategy as early as possible in the R&D process. “Methods of use” and “Formulation” patents can be filed later — at the clinical trial stage of drug development and when the products use is properly defined.

    The issue of reduced patent life has been addressed in legislation in the United States, where patent applicants can now apply for a term extension. However, the time periods permitted for such extensions do not equate to the time lost. In the U.S., patents are only extended for half the time period that was consumed by the regulatory approval process.

    Trade secrets are becoming an increasingly useful tool for pharma, particularly in the U.S. where recent changes to guidelines for examination at the U.S. Patent and Trademark Office have applied severe limitations on the patentability of natural products and methods using laws of nature.

    While patent protection in many territories is limited to 20 years from the date of filing, the period of protection conferred by a trade secret can be indefinite. Trade secrets entail significant risk but can speed up the process of drug development.

    Trends: The Emergence of Biotechnology

    Pharma IP can be challenging but it has not stopped innovation developing at an extremely fast pace. Over the last century technology has played an increasingly important role in driving pharmaceutical innovation.

    Biotechnology is a collaboration of traditional bioscience processes and modern technology and it is spearheading the development of targeted treatments. As these two industries come together, healthcare could be transformed.

    The increase in the aging population, and the need for better technologies to diagnose and monitor the progression of human diseases is driving innovation in the wearable technology market sector and personalized medical devices.

    For example, Israel-based Teva Pharmaceuticals, the world’s largest generic drug manufacturer, is partnering with chip-making giant Intel to create a wearable device that tracks the progress of Huntington’s disease. Progression of the disease is different for each individual, but wearable technology can track the stages of deterioration and inform treatment.

    HabitAware is a smart wearable bracelet dedicated to controlling Obsessive Compulsive (OCD). OCD can be felt with varying levels of intensity and cover a number of different behaviours. The wearable monitors movement and sends a subtle alert if a person shows signs of doing something compulsive.

    Trends: Will 3D Printing Revolutionize the Pharmaceutical Industry?

    Technology has the potential to improve a pharmaceutical company’s internal R&D processes and reduce operating costs.

    For example, drug R&D can be drastically improved by 3D printing. The technology could be used to print pills or even human organs and tissue. This would allow companies to test drugs cheaply — without compromising safety or ethical standards.

    According to a new report from IMS Institute for Healthcare Informatics, the largest global pharmaceutical companies need to reduce their combined operating costs by $36 billion before 2017 to maintain operating margins and current levels of R&D. As a result of improved target selection, preclinical tests, clinical trials, chemical synthesis, and product management, research becomes more efficient.

    Using 3D printing for medical applications could help with commercializing medical developments. Dental implants have already been commercially successful: it is predicted almost 50,000 custom-fit Invisalign braces are printed each day.

    Organovo also is using 3D printing technology to create functional, three-dimensional tissues that can be implanted or delivered into the human body to repair or replace damaged or diseased tissues. According to research from Markets and Markets, using 3D printing for medical applications could have a market value of $2.13 billion by 2020.

    The Future of Pharmaceutical IP

    With a history of high cost R&D and high-risk IP strategies, pharmaceutical companies were forced to battle copycats and settle for reduced periods of patent protection. This impacted the motivation — and investment — that is necessary for pharmaceutical innovation.

    The emergence of biotechnology has revitalized the pharmaceutical industry and fuelled innovation in technology that could significantly alter the effects of diseases in the future.


  • Monday, June 12, 2017 3:00 PM | IIPLA Team

    The Supreme Court Redefines Patent Exhaustion

    Michael Q. Lee, Paul A. Ainsworth, and Krishan Thakker

    In Impression Products, Inc. v. Lexmark International, Inc., No. 15-1189 (U.S. May 30, 2017), the Supreme Court fundamentally changed patent licensing in the United States by eliminating a key limitation on patent exhaustion, and eliminating the distinction between U.S. and foreign sales. Impression addressed two issues: (1) “whether a patentee that sells an item under an express restriction on the purchaser’s right to reuse or resell the product may enforce that restriction through an infringement lawsuit” (Id., Slip Op. at 1), and (2) “whether a patentee exhausts its patent rights by selling its product outside the United States, where American patent laws do not apply.” (Id. at 2.) In its decision, the Court overruled the Federal Circuit on both issues.

    The ruling is expected to demystify the “cloud of uncertainty” for downstream purchasers/licensees and end-users of patented components in the global market who risked continuing liability for infringement even after authorized sales to consumers occurred. But for other businesses, the ruling could hamper investment in R&D and innovation because of the limits placed on a patent owner’s ability to obtain fair value for its intellectual property.

    Post-Sale Restrictions Do Not Avoid Patent Exhaustion

    In Impression, the Supreme Court held that the sale of a patented good exhausts all patent rights in the good even where the product is sold subject to a lawful, and clearly communicated restriction on re-sale. In this case, Lexmark sold patented ink cartridges under a customer “Return Program,” that provided for a significant price discount under the condition that buyers use the cartridges only once, and refrain from transferring the spent cartridges to anyone but Lexmark. Lexmark brought suit after Impression refilled and resold spent “Return Program” cartridges.

    The Supreme Court held that the “single-use/no-resale restrictions in Lexmark’s contracts with customers may have been clear and enforceable under contract law, but they do not entitle Lexmark to retain patent rights in an item that it has elected to sell.” (Id. at 5.) The Court reasoned that its decision is consistent with the “well-established exhaustion rule [that] marks the point where patent rights yield to the common law principle against restraints on alienation” (Id. at 6), and provided an example of “a shop that restores and sells used cars. The business works because the shop can rest assured that, so long as those bringing in the cars own them, the shop is free to repair and resell those vehicles. That smooth flow of commerce would sputter if companies that make the thousands of parts that go into a vehicle could keep their patent rights after the first sale.” (Id. at 7.)

    The Court characterized its decision as “long held” (Id. at 8), and stated its “recent decision in Quanta Computer, Inc. v. LG Electronics, Inc. settled the matter.” (Id. at 9.) But the Quanta decision is far from clear on this point. Unlike Lexmark, Quanta involved an unrestricted license grant. Quanta, 553 U.S. 617, 636 (2008). The Impression Court characterized Quanta as involving “contracts requiring purchasers to use those processors with other parts that the company manufactured” (Impression, Slip Op. at 9), but practitioners and commentators – as well as the Court itself in Quanta – characterized those provisions as no more than notice provisions. Quanta, 553 U.S. at 636. This was particularly the case since the contracts at issue specified that breach of the notice provision would not be grounds for termination. Id. at 623-624, 636-637.

    After Impression, it may be more difficult for a patentee to spread the cost of its technology among different entities in the stream of commerce, or to leverage its technology in different business silos. The Court’s suggestion—to use contract law rather than patent law to enforce post-sale restrictions—presents additional challenges not the least of which is the possible lack of privity with downstream buyers.

    Even before the Court’s decision, practitioners were considering possible workarounds to avoid patent exhaustion, such as “covenant-to-sue-last” provisions. But the viability of those workarounds is unclear given the scope of the Court’s holding, as well as Federal Circuit precedent equating a covenant-not-to-sue with a patent license for purposes of patent exhaustion. See Transcore v. Electronic Transaction Consultants Corp., 563 F.3d. 1271 (Fed. Cir. 2009). It is more likely that patentees will take steps to establish privity with downstream purchasers. This may be transactionally difficult, however, and not possible for existing license agreements.

    Sales Outside the United States Exhaust U.S. Patent Rights

    Also in Impression, the Supreme Court held that authorized foreign sales of patented articles likewise exhaust the patentee’s U.S. patents. The Impression Court’s decision is aligned with the Supreme Court’s earlier decision in Kirtsaeng v. John Wiley & Sons, Inc., 568,U.S. 519 (2013), which held that foreign sales exhausted U.S. copyrights. Indeed, the Supreme Court cited Kirstaeng in support of its reasoning, stating that “[applying] patent exhaustion to foreign sales is just as straightforward.” (Impression, slip op. at 14) The Court was not concerned with the territorial limits of U.S. patents: “Exhaustion is a separate limit on the patent grant, and does not depend on the patentee receiving some undefined premium for selling the right to access the American market. A purchaser buys an item, not patent rights. And exhaustion is triggered by the patentee’s decision to give that item up and receive whatever fee it decides is appropriate.” (Id. at 15)

    The Court’s holding may result in companies increasing foreign prices to match those in the U.S. This may be especially true with patented products that can be easily imported into the U.S., such as pharmaceutical products, consumer products and electrical components. The Court’s decision also opens the door to compulsory licenses in foreign countries, that would effectively negate US patent rights. The Court seemed to acknowledge this possible consequence but remained unconcerned by the consequences: “The patentee may not be able to command the same amount for its products abroad as it does in the United States. But the Patent Act does not guarantee a particular price, much less the price from selling to American consumers.” (Id. at 15)

    Michael Q. Lee, Director

    Paul A. Ainsworth, Director

    Krishan Thakker, Associate

  • Monday, June 05, 2017 4:00 PM | IIPLA Team

    About The Author

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    Intellectual property is also regarded as IP law; include intangible creations of the mind. It protects creations by granting patents, copyright, and trademarks.

    The basis for legal protection may be that the creator has the right to own it. The theory is that it promotes further innovation for the benefit of society. Like all property rights, IP law allows the owners to gain from their work and investment in the creation.

    Intellectual property includes patents, trademarks, copyrights, registered designs and design rights. Some IP rights (such as patents, trademarks, and designs) require official ownership registration in the Intellectual Property Office, providing owners with protection and monopoly rights. Others such as copyright and design rights will automatically arise upon creation but do not protect a third party’s independent creation – only from copying. 

    Of course, intellectual property rights, protect the expression of ideas, not the ideas themselves, as a first step, it is important that appropriate confidentiality measures are made to ensure that negotiations with various parties from the beginning are protected and never disclosed.

    Intellectual property rights differ regarding duration and methods, but the effect is to make sure that the owner has the exclusive right to use and decide how to use those rights and to prevent the second part from using the same rights.

    A patent protects a new invention and has industrial applications. This allows the holder of a patent to use the invention to simplify business processes, gain competitive advantage and increase revenue by licensing or selling the patent to the third party.

    Copyright protects original literary works (for example, computer programs, and instruction manual), musical works, dramatic works of art (such as logos, maps, architectural drawings, prints, photographs and architectural works). The copyright owner is the first author of the copyrighted work. So, if you contact Law Firm Abu Dhabi orConstruction Lawyerto carry out survey, write a report, create a website or a piece of software that parties own the copyright, even if you have paid for it. However, copyright does not protect ideas.

    Trademark is a sign that can distinguish the goods or services of one merchant from another. A sign includes words, logos, images, or a combination of them. A sign to be registered must be different, not misleading and not similar or identical to any earlier marks for the same goods and services.  Keep in mind that simple registration of your company with the Companies’ House does not guarantee trademark protection. Similarly, if you have a website, you must have a trademark as a domain name and vice versa.

    Creating awareness of IP law among the people is essential for maximizing the value of intellectual property and the wealth of your business and reducing the possibilities of accidental non-confidential disclosures, which could reduce the demands of a successful patent and a negative impact on the value of their intellectual property and ultimately their companies’ property.

    Regular training of people on intellectual property is essential and should include the following:

    • How to Identify and Protect Intellectual Property;
    • How patents are used to improve technology;
    • Understanding the patent process,
    • How confidential information are to be treated;
    • Intellectual Property record keeping, including Lab Log and Intellectual Property Protection; and
    • Who to contact in case of need.

  • Saturday, April 08, 2017 11:59 PM | Azam Ghani (Administrator)
    Over the past few days, you may have heard some chatter about ‘IP Czar’ nomination. No surprising.

    Vishal J. Amin, Senior Counsel on the House Judiciary Committee, has been nominated by President Trump as the next White House Intellectual Property Enforcement Coordinator. Amin will be part of Executive office of the President. After confirmation, Amin would succeed Daniel Marti, who handled the responsibility of the IP Enforcement Coordinator during the President Obama’s second regime.

    On behalf of International Intellectual Property Law Association (IIPLA), in the capacity of Director, I welcome his nomination.

    Amin is not new to the government of the United States. He served at various positions in the administration of President George W Bush at the White House, including:
    • Associate Director for Domestic Policy,
    • Special Assistant at the US Department of Commerce and
    • Associate Director for Policy in the Office of the Secretary.

    We believe thoughtful contemplation and prompt appointment for this position is critical for the Intellectual Property Industry. Vishal is smart thoughtful leader and we commend President Trump for his choice.

    Azam Ghani,
    Founder Director, International Intellectual Property Law Association (IIPLA).
    CEO, Menteso, Inc. (

  • Monday, June 06, 2016 8:00 AM | Azam Ghani (Administrator)

    San Jose/London, June 6, 2016.

    USPTO Deputy Commissioner, Mr. Mark Powell, attending IIPLA 2nd Global IP Summit 2016 London at The Law Society of England and Wales on June 6, 2016.

    IIPLA's 2nd Global IP Summit is being organized for IP lawyers, in-house and external IP counsel, law firm partners, legal service providers, legal outsourcing service executives, policy makers, IP service buyers and investors in the IP world, along with the stakeholders in the legal and Intellectual Property Industry. The attendees further include educators & learners from global universities.

    IIPLA's 2nd Global IP Summit 2016 is the next step towards the unification of IP trends Worldwide. IIPLA's 2nd Global IP Summit aims to create an International Forum of Intellectual Property for In-house IP lawyers, partners, IP Agencies, Law firms and providers of other services in the  legal industry. IIPLA's 2nd Global IP Summit facilitates exchange of experience & ideas and encourages cross border cooperation. Thus, IIPLA's 2nd Global IP Summit would enrich the participants with IP knowledge, resources and its application in future.

  • Wednesday, July 29, 2015 8:00 AM | Azam Ghani (Administrator)

    Speaker Mark Powell, Deputy Commissioner, Office of International Patent Cooperation, spoke in Session Two: Improving Global Patent Prosecution at IIPLA Global IP Summit 2015 London. For more information, please visit the below USPTO reference:

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