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 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data. Innovator drug companies have been actively wooing generic drug-makers, to have a foot in the innovative and generic segments of the pharmaceutical landscape. Hailed as the “hybrid model”, this strategy though, may not quite be the right way forward for the long term, observes Mr Murray Aitken, Senior Vice-President with IMS Health, a leading provider of market intelligence to pharmaceutical and healthcare companies. More ... http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/12/is-hybrid-model-good-long-term-strategy.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author? Add Comment  Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data. In recent quarters, expiring patents in the product lines of the major pharmaceutical companies has become a hot topic. Over the next five years drug companies are expected to lose several patents. In order to compensate for expiring drug patents drug companies have been focusing on mergers and acquisitions in order to shore up their patent lines. Biotech firms in particular have been a beneficiary of this drive to sign agreements with smaller companies. More... http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/12/drug-manufacturers-how-will-expiring.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data. Industry giants are facing major new challenges as patents run out on many of the drugs that have kept them in clover. Lipitor is one of the biggest-selling prescription drugs in the world. It is produced by the giant pharmaceutical company Pfizer and has revolutionised the treatment of patients with high cholesterol. In 2009 Lipitor topped the best-selling prescription drug charts, generating $5.7bn in sales in the US and an additional $5.7bn outside the US. These revenues ultimately come from the drug's active ingredient, atorvastatin. Lipitor is what is known in the industry as a classic "blockbuster drug". More... http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/12/big-pharma-kisses-its-blockbuster-years.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data. This was an application brought by AstraZeneca under the provisions of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for 20 and 40 mg esomeprazole magnesium tablets until after the expiry of Canadian Patent No. 2,139,653 (the '653 patent). If successful on the application, this would have prevented Apotex from marketing a generic version of NEXIUM in Canada for treating conditions wherein a reduction of gastric acid secretion is required until May 27, 2014. Apotex, on the other hand, sought early market entry by arguing that the '653 patent was invalid for lack of sound prediction, anticipation (or lack of novelty), and obviousness. More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/09/apotex-vs-astra-zeneca-court-finds.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current pharmaceutical and clinical research updates, patent news, views and data. Lilly sued Novopharm for infringement under Canadian Patent No. 2,041,113, a selection patent for the compound olanzapine (sold under the brand name Zyprexa), owned by Lilly. Olanzapine is used to treat schizophrenia. Novopharm argued that the ’113 Patent is invalid. A Federal Court judge (the trial judge) agreed with Novopharm and dismissed Lilly’s action. The Federal Court of Appeal reversed. On appeal, the question raised by the parties was: Do the conditions for a valid selection patent constitute an independent basis upon which to attack the validity of a patent? More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/07/eli-lilly-canada-v-novopharm-ltd.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  In this case, Pfizer listed six patents in the Orange Book for Lipitor. Apotex filed a Paragraph III certification on U.S. Patent No.4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five. Pfizer sued Apotex on only two of the five challenged patents. In its Answer, Apotex filed declaratory judgment counterclaims of non-infringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity. Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution. In an Opinion ... More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/07/apotex-vs-pfizer-in-lipitor-patent.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  The US Supreme Court recently issued its long-awaited decision in the case of Bilski v Kappos which is considered to be one of the most anticipated patent decisions of recent time. What this means to you? Holders of existing business method patents can breathe a sigh of relief. By not foreclosing the patent-eligibility of all business methods and rejecting the exclusivity of the machine-or-transformation test, the Supreme Court has given existing business method patents new life. Going forward, the Patent Office must now consider how to adapt. The machine-or-transformation test remains important, and processes that meet this test are likely to be deemed patentable, provided other statutory criteria (e.g., for novelty and non-obviousness) are satisfied. However, the machine-or-transformation test is not the exclusive test for patent-eligibility, and some business methods that do not meet this test could be patent-eligible, if not too abstract. While abstract ideas, laws of nature, and mathematical formulae are not patent-eligible, as noted by the Supreme Court, "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Indeed, the inventors in Bilski have themselves promised to go back to the Patent Office seeking the allowance of revised claims. The Federal Circuit will likely revisit the scope of patent eligibility very soon, as the Supreme Court vacated and remanded two cases (Classen Immunotherapies Inc. v. Biogen Idec and Mayo Collaborative Services v. Prometheus Laboratories) in light of Bilski. More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/07/us-supreme-court-hedges-its-bets-on.htm A free white paper is available on request. Contact@Innoworksltd.com Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharmaceutical and clinical research news, views and data. The UAE government has announced proposals to introduce major amendments to the IP regime in the UAE. These proposed changes will have an impact across three areas:
Confidential Information The biggest impact of the amendments is likely to be in relation to the protection of confidential information. The proposed amendments will for the first time... Patents The proposed amendments... Designs The proposed amendments... Integrated Circuits The proposed amendments will for the first time introduce protection in the UAE for the layout designs for integrated circuits. The amendments envisage... More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/05/united-arab-emirates-major-changes-to.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author? Canada: The Patent Pendulum 01/18/2010
In the past 12 months, two significant decisions (one in Canada, the other in the United States) have the potential to dramatically recalibrate the scope of patent protection for so-called "business methods" (and possibly "software inventions" as well). These cases may herald a backward swing of the patent law pendulum towards less protection for business methods. In Canada, the Canadian Patent Appeal Board rejected a patent application of Amazon.com Inc. for its novel "one-click" online product ordering system. In the US, the Court of Appeals for the Federal Circuit in the Bilski case has narrowed extensively the ambit of patent protection in a decision involving a commodities-hedging system. The Bilski decision is under appeal to the US Supreme Court, and the Amazon decision is also being appealed to the Federal Court of Canada. This is welcome, because each decision is unsatisfactory. But the importance of their ultimate respective determinations cannot be underestimated. Therefore it is worth taking stock, even at this interim stage, of the issues presented by them — and of what exactly is at stake in what will be their final judicial resolutions. Importance of Patents Before going into the two decisions, just a reminder of why patents are so incredibly important: in essence, it is because they afford the strongest form of intellectual property (IP) protection. While copyrights and trade secrets are useful as far as they go, they actually do not go that far because they protect only against copying. For example, independent creation is always a full defence to a copyright or trade secret claim. By contrast, independent creation (subject to some nitty-gritty nuances) is generally not a defence in a patent claim. That is, you can never successfully be sued under copyright/ trade secret law for ripping off someone else's software if you never had access to it; but you certainly can be sued for infringing a third party's patent even if you know nothing about it. Therefore, for the duration of the patent (roughly 20 years), the patent holder can assert an effective monopoly on the invention it covers (and presumably charge monopoly profits on its sale or licensing for such time period). Patents, in a word, are incredibly valuable IP assets. Hurdles to Patenting Not surprisingly, given their significant value, the government agency that issues patents — in Canada, the Canadian Patent Office (CPO) — does not hand them out willy-nilly, but only very carefully and selectively, applying the patentability criteria with rigour and discipline. By contrast, copyright arises automatically, as does trade secret protection so long as you take appropriate steps to keep secret your proprietary information. In general terms, the invention for which you desire to be issued a patent must be new and inventive. In terms of novelty, essentially this means that no one, anywhere in the world, can have disclosed or used something similar to what you want patented. And even if you satisfy this requirement, then your invention must not be obvious — it has to embody some degree of inventive spark that an average technical person in your space would not have come up with (in short, there has to be some creative ingenuity buttressing your invention). In addition, your invention must come within one of the categories of patentable subject matter permitted by the Patent Act; namely, it has to be a "new and useful art, process, machine, manufacture or composition of matter." It was this latter requirement that was found to be missing in the Amazon case. Amazon's One-Click Invention To understand the genius behind Amazon's "One-Click" online ordering invention, you have to cast back your mind to the mid-1990s, and the infancy of business-to-consumer e-commerce. Unlike today (when Amazon is a leading online retailer — or "e-tailer"), back then, Amazon was one of many struggling new online businesses, each trying to set themselves apart from the others in a new, crowded and difficult marketplace. One particular difficulty was that more than 60 per cent of online prospective consumers who started to order products from websites never completed the purchase because they found the "shopping cart/checkout line" process cumbersome, frustrating and time-consuming. Finding something to buy online was easy, particularly given the cookie technology that most e-tailers used (by sending your computer a cookie — a bit of software code — when you first visited their site, the next time you came back to the site, the cookie would allow the e-tailer to "recognize you" so that ads tailored to your own preferences — based on what you looked at last time — would be served up to you). It seems like magic — "My, how fortuitous that all of these ads showcase books that are of interest to me! It's as though they know me!" But it's not magic, of course; it's just simple cookie technology at work. While the new e-consumer was wowed by the personalization features of e-tailers' websites, they were underwhelmed by the check-out buying process. Each time the "shopping cart" was ready to be pushed through the online cash register process, multiple screens confronted the customer with information to complete, instructions to follow, and precious time to waste (usually typing in the same information they had given on their previous visits). As noted above, the statistics showed that well over half the people who started this check-out process never completed it. To address this real, practical problem, the clever folks at Amazon.com invented, developed, perfected and deployed on their own website their so-called "One-Click" product-ordering system. Essentially, when you wanted to purchase something from their site the second and subsequent time, you could do so by merely clicking the "One-Click" button (this would populate your order with the same information you used the last time you ordered something, thereby getting you through the check-out process in a fraction of the time). In essence, if you used Amazon, you only had to endure the check-out hassle once; after that the Amazon computer remembered who you are (courtesy of the cookie they put on your computer that first visit) and, by using your previously provided check-out data, could give you a much more satisfying online purchasing experience. Amazon's US One-Click Patent Amazon obtained a US patent for the One-Click invention. In the fall/Christmas season of 1999, it used this patent to great effect when, on the strength of it, Amazon successfully obtained an injunction against Barnes and Noble, preventing them from using a similar one-click check-out system on the B&N website (at the time B&N was a key rival of Amazon). In this injunction case, B&N argued that the Amazon patent should be found invalid given all the other online ordering systems that B&N brought to the court's attention (that B&N argued proved that Amazon's system was neither novel nor inventive). The court considered each of these examples of prior art, but concluded that none actually implemented a "one-click" type functionally. This was an important patent victory for Amazon, and forced B&N to redesign its check-out system for that critical 1999 Christmas e-commerce season. (It should be noted that subsequent litigation ensued, and the parties ultimately settled their dispute in 2002). Amazon's Canadian Patent Application Amazon filed for a Canadian patent for the One-Click invention, but so far has been unsuccessful in having it issued. The initial review was undertaken by an Examiner at the CPO. In Amazon's case, the Examiner concluded that the One-Click idea was not inventive, and moreover that it did not constitute patentable subject matter. Amazon appealed to the Canadian Patent Appeal Board and the Commissioner of Patents (collectively, the "Board"). Interestingly, on the issue of inventiveness, the appeal was successful. There was one particular book on the subject of online e-commerce that pre-dated the patent application, and the Examiner held that various references in this book anticipated what Amazon had developed in its One-Click invention. The Board carefully reviewed the book, and concluded otherwise. While use of cookies to enhance the e-consumer experience was at that time obvious, the Board found that Amazon's single-action ordering system was not obvious: the Board concluded that a skilled technician would not have directly and without difficulty conceived of the One-Click system. Canadian Subject Matter On the other hand, in what cannot be termed anything but a surprising decision, the Board concluded that a patent should not be issued to Amazon for the One-Click invention because it did not constitute patentable subject matter. In essence, the Board stated unequivocally that in its view, a pure business method that has no "technological effect" is not patentable in Canada. This is startling for several reasons. First, the current CPO Manual of Patent Office Practice expressly states that business methods are not automatically excluded from patentability by jurisprudence or statute. In its decision, the Board considered and rejected that statement in the Manual. Therefore, for the Board to take such a hard and unnuanced view of business methods is disappointing (more recently, a proposed amendment to the Manual would bring it in line with the Amazon decision, also denying patentability to business methods). The second surprising aspect of the Amazon decision is that the Board found that the term "art" and "process" in the Patent Act are confined to acts performed by "some physical agent upon some physical object and producing in such object some change of character or condition." That is, the Board believes that all categories of invention in the Patent Act are physical in nature; they involve tangible object or instruments. The decision also seems to ignore the prevalence of computers and processing systems in today's environment in assessing the "technological effect" issue. Describing this conclusion in another way, the Board stipulates that the common characteristics of the five categories of invention is that they are "technological" in nature. And the Amazon One-Click invention does not qualify because it is only a retailing concept and some rules for ordering items. (As the Board stated, "Single-action ordering without checkout ... involves streamlining the rules for practice for shopping, that is, it relates to a business decision with business implications. There is nothing technical about this aspect of the claimed invention."). The authorities relied upon by the Board for its conclusion on patentable subject matter are strange, particularly in terms of its use of American authorities. For example, it cites the dissent in a Canadian Supreme Court decision that refers to the State Street Bank case, which did not involve a physical system! And the Board cites the Bilski decision, which as we shall see in the next TLQ, actually takes a much more nuanced view of business method patents. (After reviewing Bilski, we will also draw some conclusions about the practical — and strategic — impact of these two cases). Also at http://pharmaceutical-patents.blogspot.com/2010/01/canada-patent-pendulum.html Disclaimer : The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. On June 4, 2009, in Merck Frosst Canada Inc. v. Apotex, Inc., the Federal Court of Appeal released an important decision limiting the range of damages available in actions under section 8 of the Patented Medicines (Notice of Compliance) Regulations. In particular, the Court of Appeal confirmed that section 8 damages do not include either an accounting of the innovator's profits or any damages for loss of market share that extends beyond the period for which the generic company's approval was actually delayed. Background The Regulations The Regulations are intended to provide innovators with protection from early generic entry in light of Canada's scheme to allow early working of patented drugs by generic pharmaceutical companies ("second persons") for the purpose of seeking regulatory approval. Under the Regulations, a drug company that files an abbreviated new drug submission (ANDS) with the Minister of Health for approval of a generic version of an innovative drug must serve a notice of allegation for each relevant patent listed by the innovator on the Patent Register. If a generic company makes an allegation of invalidity or non-infringement in respect of any patent, the patentee may apply to the Federal Court for an order prohibiting the Minister of Health from approving the ANDS on the ground that it would result in the infringement of a valid patent. The Regulations provide that the filing of such proceeding automatically stays the Minister's approval of the ANDS for the duration of the proceeding, up to a period of 24 months. Triggering an automatic stay is not risk-free for patentees. Section 8 of the Regulations provides that a generic company may bring an action against the patentee to receive compensation for "any loss suffered" by virtue of a delay in receiving its approval. The period of delay is defined to be the period beginning on the date on which the ANDS would have been approved by the Minister "in the absence of these Regulations," and ending on the date of the withdrawal, discontinuance, dismissal or reversal of the proceeding brought under the Regulations. Subsection 8(4) states that the court may make such order for relief "by way of damages or profits" as the circumstances require. Apotex's Section 8 Claim Against Merck Frosst In Merck Frosst, Apotex brought an action in damages under section 8, following the Federal Court's dismissal of Merck Frosst's application for a prohibition order in respect of Apotex's proposed alendronate drug product. Merck Frosst defended Apotex's damages action on a variety of grounds, including the argument that Apotex could not claim an accounting of profits or damages for any permanent loss of market share (allegedly caused by the delay attributable to Merck's failed proceeding). In October 2008, the Federal Court held that section 8 does not enable second persons to claim an innovator's profits. They could claim damages for any permanent loss of market share caused during the period set out in section 8, as a result of the innovator's unsuccessful proceeding under the Regulations. That decision also dismissed several administrative and constitutional arguments as to why section 8 should not be enforced by the federal courts. The Federal Court of Appeal Limits the Damages Available Under Section 8 The Federal Court of Appeal affirmed the Federal Court's finding that section 8 does not authorize a generic company to claim an accounting of profits from the innovator for any delay allegedly caused by an unsuccessful proceeding under the Regulations. While disgorgement of profits is a remedy available to a patentee under the Patent Act, the Court of Appeal emphasized that a delayed generic company is not in the same position as a patentee. The Court of Appeal held that the use of the terms "damages or profits" in section 8 should be interpreted to mean "damages or lost profits" because the purpose of this provision is to compensate generics for any delay: "a measure which compels a first person to place the second person in the position in which it would have been, if the operation of the stay had not been triggered, fits well within the contemplated balance" (para. 90). The Court of Appeal also affirmed the Federal Court's decision on the administrative and constitutional arguments, permitting the section 8 claim to go forward. The Federal Court of Appeal reversed the Federal Court on the issue whether a second person may claim for any ongoing loss of market share. Relying on the wording of section 8, which defines the specific period of time for which damages are available, the Court of Appeal held that an innovator is not liable for any long-term losses caused by a failed proceeding under the Regulations. Although an innovator may be liable for lost sales during the defined period, Apotex's market share claim was barred to the extent that its alleged disadvantage (i.e., its late market entry) would result in lost sales after the period defined in section 8. Also at http://pharmaceutical-patents.blogspot.com/2010/01/canadas-federal-court-of-appeal-limits.html Disclaimer : This information is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. | AuthorShruti is a visionary leader,a result-oriented professional and a pharmaceutical scientist targeting path- breaking research and technologies of future.  ArchivesDecember 2010 Categories |
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