 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. The European Patent Office (EPO) amended the rules regarding the filing of divisional applications. Under the amended Rule 36 EPC a voluntary divisional must be filed within 24 months of the examining division's first communication in respect of the earliest application in the sequence. The earlier application must be pending at the time the divisional is filed, i.e. must not have been granted, lapsed, or withdrawn. A mandatory divisional must be filed within 24 months of any communication in which the examining division raises a non-unity objection according to Article 82 EPC in relation to the pending application, with the proviso that the finding of lack of unity is raised for the first time in the communication. The amended versions of Rule 36 EPC only apply to divisionals filed on or after 1 April 2010. Where the 24-month time limits in the amended Rule 36 have expired before 1 April 2010, a divisional application may still be filed until 1 October 2010. This is therefore an important date for any applicants who wish to file divisionals of their pending application and who received a first communication from the examining division, or a non-unity objection, related to that application prior to 1 April 2008. 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
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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. The Mexican Trademark and Patent Office (IMPI) made available through its website the new edition of the Linkage Gazette (Mexican health and IP law regulations require IMPI to publish a gazette every six months listing patents in force that cover allopathic drugs). Regrettably, IMPI decided to exclude formulation patents, limiting the inclusion criteria to compound patents. There are formulation patents included in the list derived from individual Court orders in litigation proceedings where the non-inclusion of specific formulation patents in the Gazette was contested. The current non-inclusion of formulation patents disregards a petition by the Pharmaceutical Association of R&D companies (AMIIF), and does not follow the jurisprudence of the Mexican Supreme Court ruling that formulation patents are to be included in the Linkage Gazette (see "Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations"). Legally, as an administrative authority, IMPI is not bound to follow judicial precedents; nevertheless, there is broad dissatisfaction with the political decision taken by IMPI regarding the denial to include formulation patents in the Linkage Gazette, since following the Supreme Court's criterion would have avoided further litigation from patent holders. The non-inclusion of valuable formulation patents can be contested within the next fifteen working days. Any litigation proceeding at this point will benefit from Supreme Court precedent, which is mandatory for District and Circuit Courts and provides guidelines to decide these cases. Of course, inclusion of formulation patents in the Linkage Gazette provides grounds to prevent or challenge marketing authorizations granted to third parties in violation of formulation patents which in many cases have expiration dates beyond the initial compound patent. Additionally, inclusion of formulation patents is pivotal, as the formulation of drugs is reviewed by the Regulatory Authority (COFEPRIS) upon studying applications for marketing authorizations. Since safety and efficacy of a drug reviewed by COFEPRIS is not limited to compounds, there is no rationale to limit the linkage regulation to compound patents by the linked authorities (IMPI and COFEPRIS), particularly when the highest Court in México has decided that formulation patents for allopathic medicines including an identified compound should be included in the Gazette. 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.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do 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. Time and costs spent searching existing scientific publications and patent registers can avoid costly mistakes when acquiring or licensing technology from a third party or before undertaking a significant R&D program or an extensive patent filing strategy. If the technology in question is anticipated by these earlier publications, then the value of the transaction or the merit of the R&D program or patent filings may be critically reduced. The need for prior art searching is highlighted in Waikatolink Ltd v Comvita New Zealand Ltd. Comvita had entered into a NZ$3.5m agreement with Waikatolink Ltd (WL) to sell it some honey gel patents and license Comvita to use its "honey IP" for wound and skin care products, including the right to use WL's existing and future knowledge about the unique manuka factor (UMF) molecule responsible for antibacterial activity in manuka honey. In all the agreement covered 11 patents with an estimated $8.8m annual turnover. The Tauranga High Court found WL had engaged in misleading and deceptive conduct by making representations to Comvita that it was on the brink of isolating and characterizing the UMF bioactive compound, when in fact (contrary to the belief of its own key staff) it was not. Only after paying $1.5m to WL as a first instalment under the agreement, Comvita made a Google search and found that the UMF molecule had previously been identified by another party.Comvita was granted a $1m set-off from the $2m amount owed to WL under the agreement. Justice Harrison commented that with hindsight Comvita had not taken the necessary steps to protect itself in terms of conducting its own preliminary due diligence. This need to conduct thorough prior art searching will become more critical in the future because of changes to patent laws that will take effect once the new Patents Bill is enacted in early-mid 2011. The Bill will make significant changes designed to provide greater conformity with aspects of the Australian and United Kingdom patents legislation. One of the significant changes proposed in the Bill is that the standard of "local novelty" in determining what is relevant prior art for assessing patentability will be replaced with an "absolute novelty" standard. Whereas currently the novelty of an invention is determined by what is known (published or used) in New Zealand prior to the priority date of a patent application, under the Bill the novelty threshold will be widened to what is known worldwide prior to the priority date. A further proposed change of the Patents Bill is that examination of a patent application will include a consideration of inventive step and usefulness, as well as novelty. Currently examination is conducted on the basis of novelty only, but the claims of an accepted patent have to be inventive for the patent to be valid. Whereas novelty is determined by whether the proposed invention has at least one new feature over similar technology, inventive step is assessed on whether the proposed invention is an obvious modification of known technology, even if novel. This higher inventive step threshold will make examination more rigorous and therefore place greater emphasis on carrying out due diligence prior to filing a patent application. Preliminary searching conducted in-house using one or more of the online patent office databases is strongly recommended before committing to more exhaustive commercial searching conducted by a patent attorney. The time and cost spent understanding the prior art may prevent you from conducting redundant R&D and/or proceeding with patent filings where protection will not ultimately be obtained, or protection obtained is weak or unenforceable and therefore of little commercial value. 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
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Translates innovative concepts to PROFITS.
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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. The hybrid model may be attractive today, he said, given that drug companies are faced with pricing and regulatory pressures across different world markets. But it may not be good for the long term, Mr Aitken told Business Line, giving details from an IMS study that reveals an increased pick-up in branded innovative products after 2015 – as the “patent cliff” (where drugs go off-patent) is passed and research pipeline matures. Off-patent lossCompany heads will have to “manage” their hybrid models against the backdrop of the optimism that the market reveals in terms of innovative products driving growth, said Mr Sameer Savkur, IMS Managing Director, in India.Generic medicines are not covered by patents, while innovative drugs enjoy patent-protection, or market exclusivity for 20 years. The next five years will see $ 94 billion impact from the loss of exclusivity, and a $ 89 billion impact from new launches. The next five years will see reduced impact of $ 66 billion due to loss of exclusivity, and an increase of $ 271 billion from the new products launched in the previous five years, the study said. In the Indian market, the hybrid model is illustrated by Japanese innovative drug-maker Daiichi Sankyo's acquisition of generic drug company Ranbaxy or the more recent acquisition of Piramal Healthcare's domestic formulations business by Abbott. Optimistic Giving a “more optimistic than expected” outlook – the IMS study projects that the pharmaceutical industry is headed to clock $ 1 trillion in 2020, on the back of a renewed pipeline and growth in the pharma-emerging markets, among other things. The study also shows a healthy pipeline of products across 41 focus categories including oncology, diabetes and HIV, a contrast to the gloomy picture that industry often paints.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.
 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.
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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. 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". The problem for Pfizer is that next year the patent to exclusively produce and sell Lipitor expires. This "coming off-patent" process will allow other companies to produce and sell generic copies of Lipitor, and it will take a hatchet to Pfizer's revenue stream from the drug. Pfizer's pharmaceutical peers Sanofi-aventis and Bristol-Myers Squibb are facing a similar "generic erosion" of their widely used anti-clotting drug Plavix which comes off-patent next year. But the real issue for the sector is that Lipitor and Plavix mark the start of a coming avalanche of expiring patents of blockbuster drugs over the next few years, known colloquially as the "patent cliff". Some estimate that, over the next five years, drugs currently generating $142bn in sales annually will lose patent protection. The investment management firm AXA Framlington, meanwhile, has said that the leading pharmaceutical companies will lose between 14 per cent and 41 per cent of their existing revenues because of patent expiries. And, despite record levels of investment in research and development by the big pharmaceutical companies, there appear to be few similar blockbuster drugs in the pipeline to plug the gaping revenue hole. At a time when the world's population is getting bigger, older, and more likely to take prescription drugs, it seems counter-intuitive that the $518bn pharmaceutical sector could be entering an era of declining revenues and profits, however, it is a real possibility. The sector is preoccupied with its own evolution; and, as this analysis shows, the challenges, and potential risks and rewards, are immense. Is the 'patent cliff' hype?The "patent cliff" is the chief challenge facing the industry, although some companies will be affected more than others. Patents can sometimes be extended by making slight changes to the chemical composition, for example – a process called "ever-greening". However, some analysts argue that the search for new blockbuster drugs is not good value for money. PricewaterhouseCoopers (PwC), in its report Pharma 2020: The Vision, says that industry leaders' revenues "have come at a very high price". It notes that between 1985 and 2000 the industry's market value increased 85-fold, outpacing the stock market as a whole. But in the six years to 30 March 2007 the FTSE global pharmaceuticals index rose just 1.3 per cent, while the Dow Jones World Index rose by 34.9 per cent. Additionally, it says that only five of the top companies worldwide generate more than 10 per cent of their revenues from products launched since 2001. "Even allowing for inflation, the industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced," it says. Where will all the new drugs come from?"The number of new medicines is at an all-time low and is as low as it has been since the Second World War," says Professor Clive Page, chairman of Verona Pharma. The small biotech company is working on three drugs that alleviate symptoms of hayfever and chronic respiratory diseases, and is emblematic of the new breed of companies providing the innovation and stream of drugs that will feed the big pharma companies' supply chain. Smaller start-up companies have lower costs, smaller teams, more efficient working processes, high scientific expertise and the ability to recognise and produce new molecular entities that could become tomorrow's breakthrough drugs. But it is the big pharma companies that have the financial might to buy or license new drugs and take them through the often expensive second and third phases of testing, with the aim of producing a viable commercial drug at the end. Kevin Johnson, chief executive of PanGenetics, which last November sold an experimental drug for the treatment of chronic pain for $170m to Abbott Laboratories, says: "In my view, it is easier to develop a drug in a small company, at least in the early stages. From there the balance of power shifts; when you get to the later stages of testing the big companies are the right ones to do that. It is about playing to relative strengths". Can the small companies provide these drugs?Securing finance is difficult for any start-up business and particularly tricky in the field of science. Experimental drugs, by their nature, are risky and can fail; scientific discovery can be lengthy, expensive and difficult to explain to a financial backer looking for returns on equity and financial performance. The sector has also had a bad reputation for promising more than it can deliver. This is why Francesco De Rubertis, a partner at the venture capitalist Index Ventures, says the developing division of labour between the big pharma companies and the biotech sector, and emerging collaborations with big academic institutions, should be encouraged. "A new equilibrium has to be reached. We are not there yet but in the long term I am optimistic," he says. Said Darwazah, chief executive of the FTSE 250 pharmaceutical company Hikma, says the changing nature of the business is not surprising: "Why should a scientist work for £100,000 a year in a big pharmaceutical company when he can set up on his own, do exactly the same work, create a new product and sell it for £100m?" Smaller companies also tend to be more businesslike about killing projects that don't work, says Professor Page. "In small companies, people don't have pet projects that they keep throwing money at." Is finding new blockbuster drugs the only option for big pharma?Discovering new drugs is not the only answer for the sector as there are new frontiers opening in emerging markets such as China, Turkey, the Middle East and North Africa. Tim Edwards, chief executive of Cellzome, which is producing chemical proteomics technology that identifies new drugs to treat inflammatory diseases, comments: "The emerging markets could produce revenue which could be equal to the revenue streams lost from drugs coming off patent." Kevin Johnson of PanGenetics adds: "One half of the merger and acquisition dollars that have gone into acquiring companies has been in the emerging markets sector." Many companies that previously focused on branded products are also looking to tap into the growing generic drugs market by setting up their own generic-drug producing and licensing arms. Regulatory environment-Regulatory bodies and the large consumers of drugs, such as the NHS and health maintenance organisations in the US, are playing an increasing role in influencing the actions of pharmaceutical companies. As budgets are cut and healthcare reform gets under way many are buying or recommending only drugs that have a proven record and are cost-effective. It is a contentious issue which was played out again last week as the storm continued over Roche's new bowel cancer drug, Avastin. The UK's healthcare cost agency – the National Institute for Health and Clinical Excellence (Nice) – has rejected the drug again, saying it is too expensive despite the manufacturers having offered new terms. Andrew Dillon, chief executive of Nice, said: "We have to be confident that the benefits justify the considerable cost of this drug." Steve Arlington, a partner at PwC, says the "payer agenda" is "much more powerful now than ever before". He says the industry has to participate in the debate on healthcare funding and demonstrate the value of its products. So is it all doom and gloom?At $518bn, the size of the pharmaceutical industry is still significant; it could grow to between $800bn and $1.3trn by 2020. Global census figures suggest that future consumer demand could be strong. The United Nations projects that the world's population will grow from 6.5 billion in 2005 to 7.6 billion by 2020. Of that, around 719.4 million, or 9.4 per cent, will be 65 or older – up from 477.4 million two years ago. The "grey factor" boosts the need for medicines dramatically, with the UK Department of Health stating that four in five people aged over 75 take at least one prescription product, while more than a third take four drugs or more. PwC says that diseases once more usually associated with developed countries – such as hypertension (high blood pressure) and diabetes – are also increasing in developing markets. It says that in 2004 there were 639 million people in the developing world with hypertension, a figure that is forecast to reach one billion by 2025. http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/12/big-pharma-kisses-its-blockbuster-years.htmlDisclaimer- 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.
 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.
The '653 patent relates to an improved process for preparing highly optically pure esomeprazole, one of the enantiomers of the racemate omeprazole, that is stable against racemisation (i.e. recombination). Claim 8 was the claim at issue and could be read as claiming a salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater. There was no provision as to utility (or use of the invention) in claim 8. This was an important fact, as the Court noted that where the invention relates to a new compound, utility does not need to be included in the claim, so long as it is described in the description portion of the patent. On the other hand, when the patent relates to a new use for an old, known compound, that new use must be set out in the claims. In this case, claim 8 was not directed to a new compound; it was directed to a previously known compound having a particular purity.
Moreover, utility of the compound was simply described in the description of the patent as follows:
It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole.
However, nowhere in the patent, whether in the Examples or otherwise, was any information given to the person skilled in the art as to whether, in fact, the highly pure esomeprazole salt does give an improved therapeutic profile such as a lower degree of interindividual variation. Moreover, there was no evidence from any witness to say that there was anything in the disclosure of the '653 patent that would inform a person skilled in the art that the purified esomeprazole salt would fulfill this promise. As a result, there was a clear question as to whether the invention had a basis for a "sound prediction" as to utility.
The requirements for sound prediction are well established: 1) there must be a factual basis for the prediction; 2) the inventors must have as of the date of the patent application an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis; and 3) there must be proper disclosure.
The facts of the present case did not show that as of the priority date, May 1993, or even the Canadian filing date, May 1994, that the inventors had either a factual basis for a prediction that an esomeprazole salt of a particular purity would have the utility indicated in the patent, nor did they have an articulable and sound line of reasoning for inferring such a result. In addition, clearly there was no proper disclosure in the patent in that respect. As a result, the patent was invalid for a lack of sound prediction.
As to anticipation, the question was, given that prior art German patent application DE 40 35 455 A1 (DE '455) described a process for separating the enantiomers of omeprazole (and salts) into "optically pure" fractions, did the description, particularly Examples 5 and 6 (incorporating Examples 1 and 2) "enable" what was claimed in claim 8 of the '653 patent, a purity of 99.8% (ee) or greater? In this respect, the Court found that to practice DE '455 "would at best only occasionally result in a product with the purity level stipulated in claim 8." On this basis, there was no enablement such as would support an allegation of anticipation.
As to obviousness, the Court was satisfied on the evidence that, as of the claim date, May 1993, it was known that omeprazole could be separated into its enantiomers (+) and (-), that they would be useful, just as omeprazole was, in treating gastric problems, and that they could be processed in salt form with a salt such as magnesium. A purity of 95.6% (ee) for esomeprazole had been reported as having been achieved in the prior art, and such technique could have been used to increase that purity to 99.8% (ee) if desired. In the result, the '653 patent was also found to be invalid for obviousness.
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 The bacteria that thrive in our guts could become the key ingredients for a new generation of treatments that fight everything from life-threatening infections to diabetes, obesity, depression and bowel diseases, according to a team of scientists who have experienced some intriguing early successes with transplants.According to a report in MIT's Technology Review, the scientists were able to cure an infection in a female patient with bacteria transplanted from her husband's gut. Transplanting microbial populations from a healthy person to the sick could transform their entire intestinal system--something that has implications for a broad range of diseases. And it would be a far more radical approach than encouraging people to eat yogurt or take other dietary actions designed to foster healthy microbes.The researchers have also tested this approach in rats and found that they could make significant changes in their intestinal ecosystems. Significantly, the scientists say they saw no evidence that the rat's body rejected the transplant.
Read more: Gut microbes could offer new therapeutic platform - FierceBiotech Researchhttp://www.fiercebiotechresearch.com/story/gut-microbes-could-offer-new-therapeutic-platform/2010-09-07?utm_medium=nl&utm_source=internal#ixzz0yrPIRrEj
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.
More and more drug makers are turning to reformulation to prolong the lifecycle of their top sellers and protect precious revenue from generic copies, as well as supplement dwindling pipelines. The fact that 39 per cent of the total product launches from the 50 top manufacturers between 2002 and 2005 were reformulations is a clear indication of the presence of this trend. Central nervous system (CNS), alimentary and metabolic therapies are the most frequently targeted for reformulation, according to a new research report by Datamonitor. Within the CNS market, reformulated products are predominantly antipsychotics, antidepressants, and ADHD and pain therapies. Reformulated stomach ulcer and insulin therapies make up the bulk of alimentary and metabolic reformulations, while respiratory, anti-infective and genito-urinary and sex hormone therapies have also experienced frequent reformulation, the report says. "This reflects the large patient populations within the major indications of these therapy areas, the high commercial value of many of the products and the highly competitive nature of the markets," said Alistair Sinclair, Datamonitor pharmaceutical markets analyst and report author. "All of which drive companies to be more active in gaining a competitive advantage within the respective markets, but most of all; with product development pipelines looking increasingly barren, on top of spiralling R&D costs, pharmaceutical companies must ensure they maximise revenues of existing brands." Reformulations within these categories include soluble tablets, chewable tablets, extended release tablets, oral liquids and suspensions, pre-filled syringes, transdermal patches, and a variety of gels and creams. Converting injectable drugs into non-injectable forms of delivery is proving particularly popular. However, for all the strategy and planning involved, the success of a reformulation is heavily dependent on the manufacturer's ability to develop an improved version of the original drug, said the report, titled: "Reformulation Strategies - Comparisons of Past and Future Reformulation Strategies." "The key to a successful reformulation is to provide clear therapeutic benefits over their predecessor", said Sinclair. "First and foremost, manufacturers need to ensure there is a market need for their reformulated products, and then ensure the drug displays sufficient differentiation from the original, particularly in terms of efficacy and side effects; launch timing is also of key importance." For many firms this is a daunting task, as they may not have sufficient in-house resources or expertise to rise to the challenge. Therefore, this reformulation trend is good news for the drug formulation industry, which has seen a 38 per cent growth in the past five years and is expected to continue to boom, as drug companies wishing to reformulate are outsourcing the function to specialist formulation companies. Reformulation is still quite a niche field and there are relatively few companies in the world that specialise in individual reformulation areas. Firms that do are now finding themselves inundated with new business. For example, UK form Medpharm said it has been experiencing a growing business demand for topical formulations of drugs, in which it specialises. According to the firm, there is only one other company in the US that specialises in topical drug formulation and provides the full range of services, from mathematical modelling of a drug profile, through to formulation development and optimisation and manufacturing.
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