Strategies for Immunologists

Transcription

1 Maximizing Patent Term to Increase Product s Profitability 1 Article Authors Many patented drugs & medical devices generate the most money during the end of their patent term, after the drugs & medical devices have been widely distributed. This delayed payday may discourage companies from investing up front in patent prosecution. It is in a company s best interest, however, to manage patent prosecution so it maximizes the length of the final payday patent term. A variety of strategies allows the effective transfer of some of the low value time in the initial stages of product development, to the higher value time after the product has entered distribution. These include FDA-related patent term extensions ( PTE ), USPTO-related Patent Term Adjustment ( PTA ), filing provisional applications, and accelerating prosecution. Patent Term Extensions Companies may be able to take advantage of PTE under the Hatch-Waxman Act, to restore some of the patent coverage lost during the FDA approval process. The maximum allowable restoration is five years, and the total patent term, including any restorations, must not exceed fourteen years following FDA approval. This additional term extension is available only if the patent issues before the drug has received FDA approval. The timing of these events should be managed by a company to its advantage. Patent Term Adjustment Unlike PTE, a patent applicant may obtain extensions based on PTA for a variety of USPTO-related administrative delays, such as for time lost appealing an examiner s decision at the Board of Patent Appeals and Interferences, which may amount to years of extensions. These PTA extensions are offset by the applicant s prosecution delays, e.g., taking extensions of time. Thus, an applicant s delay, even if made early in prosecution, can reduce or even eliminate potential patent term under this provision. While PTA only applies to patent applications filed after May 29, 2000, the past four years data indicate that a growing number of patent applications qualify for an increased patent term. Specifically, from 2006 to 2009, the percentage of patents receiving some form of patent term extension rose from 64% to 76%. Further, to comply with a recent binding court decision, the USPTO must recalculate PTA for its applications, therefore, many applications may be entitled to more PTA than previously indicated. Mark Benedict, Ph.D. mbenedict@ Eli Loots, Ph.D eloots@ Carolyn Favorito Associate carolyn.favorito@ Postpone Patent Termination In addition to optimizing PTE and PTA, one also can effectively postpone the termination of a patent s 20 year patent term by first filing a provisional application. Reserving the priority date of invention, while avoiding starting the clock for the twenty year patent term, enables companies to enjoy exclusivity during the generally more profitable end of the patent s life.

2 Accelerated Prosecution For those with a head start on clinical trials and/or with a product nearing marketing approval from the FDA, accelerated prosecution can allow one to obtain an issued patent much faster to begin capturing market exclusivity (and perhaps qualify for PTE if timed appropriately). Options for accelerating prosecution approach include, procedures initiated by petition to the USPTO, such as filing a Petition to Make Special and/or requesting Accelerated Examination, as well as careful prosecution management, such as responding quickly to outstanding office actions, and shepherding the application through the USPTO by strategic use of examiner interviews, and pursuing accelerated examination. Synchronize Patent Filings Effective patent exclusivity on a product can also be extended by synchronizing new patent filings with on-going R&D innovations. For example, improvements in the immunogen composition of matter, methods of immunization, vaccine formulations, etc., can result in staggered filings, with resultant staggered expiration dates thereby effectively extending the franchise. These, and other, approaches allow a company to help match a patent s enforceability period with the market demand period to maximize the patent s potential value. Of course, other strategies may impact a company s particular needs. For more information regarding these and other strategies for maximizing your company s effective patent lifespan coverage, contact Mark Benedict, Carolyn Favorito and Eli Loots at Knobbe Martens. Have a topic in mind you would like to read or hear about? Please send topic suggestions to info@. Lawyers in the immunology group work within the firm s Biotechnology and Pharmaceutical Practice Group. About Us is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters.

3 Use Competitive Intelligence to Your Advantage 2 Article Authors Staying informed of the intellectual property rights of your competitors and the efforts of others to acquire a position that interferes with your product s development is a necessary part of the business. The patent landscape changes rapidly as patents issue and new patent applications are filed, but your company can stay informed of these changes. By conducting a landscape analysis and patentability analysis early-on in a product s research and development phases and continually monitoring publications in the field, a company can best focus the product s development, acquire the strongest patent position, and proceed to commercialization with a better understanding of the risks involved. While no search can provide a freedom to operate or patentability guarantee, knowledge of the competitive environment will provide a company with a better understanding of the road ahead. Landscape Analysis An initial landscape analysis of existing patents and published patent applications should be conducted prior to incurring significant research and development costs. Although a research plan may be founded on amazing science, if several licenses are required to bring the product to market, the product s commercial viability may be lost. Oftentimes slight formulation changes, which can easily be implemented at early stages of R&D, can avoid costly licenses. Companies should proactively design their products armed with the knowledge of others rights in the field to avoid lost development time and costly re-designs. Patentability Analysis A patentability analysis should also be performed early in the product s life cycle and preferably before filing a utility patent application. Without patent protection, the research and development costs, not to mention the costs of obtaining regulatory drug approval are unjustified. A patent and non-patent literature search on the technology not only may help a company avoid costly R&D on a product that has been previously described but it may also reveal potential licensing and collaboration opportunities. Additionally, an understanding of the prior art can improve your patent application s strength because one will be able to anticipate the rejections likely to be raised during examination and, in some cases, perform side-by-side experiments with previously known products to demonstrate your product s unexpected improvements. Eric Furman, Ph.D efurman@ Kathleen Mekjian, Ph.D kmekjian@ Immunology Group Contacts Mark Benedict, Ph.D. mbenedict@ Carolyn Favorito Associate carolyn.favorito@

4 Monitoring Once a patent strategy is implemented, monitoring of patent publications, by keyword searching provides an indispensable tool to protect and grow a company s position in an industry. At Knobbe Martens, we have automated protocols for keyword searching patent and patent applications weekly and for pulling abstracts and claims of relevant publications. Thus, our attorneys can rapidly review the search results for publications of interest at a minimal expense. Not only does the monitoring service reveal the direction of an industry and specific competitors but it also helps to identify potential collaborators, infringers, and targets for offensive legal actions such as reexamination proceedings, third party observations, opposition proceedings, and interferences. U.S. and European laws impose strict time limits in which a company can avail itself of these legal options and monitoring patent and patent publications improves a company s ability to file such actions in the requisite time frame. If you would like more information on landscape analysis, patentability analysis, or setting-up a monitoring service, please contact Eric Furman or Kathleen Mekjian at Knobbe Martens. If you would like to learn more about the services Knobbe Martens can provide, please contact Mark Benedict or Carolyn Favorito at Knobbe Martens. Have a topic in mind you would like to read or hear about? Please send topic suggestions to info@. Lawyers in the immunology group work within the firm s Biotechnology and Pharmaceutical Practice Group. About Us is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters.

5 Global Patent Filing Strategies: Where on Earth Should We File? 3 Article Authors Before making the expensive decision to file patent applications in various regions across the globe, consider a cost-benefit approach to filing. Market Share Obviously, market share plays a significant role in capturing the potential benefit that can be derived from investing in a global patent filing strategy. For instance, the $24 billion global vaccine market in 2008, the United States and Europe enjoyed the lion s market share of about 36% and 30% respectively. Japan s and India s market share each hovers around 4%, with Japan slightly leading India. China s market share approaches 2%. Thus, the US and Europe alone account for about 66% of the global market, while the top five vaccine markets account for about 76% of the global market. Accordingly, for vaccine companies seeking global patent protection, we generally recommend filing an international application (PCT) and entering at least the US and Europe at the national stage. When seeking additional patent protection, a company s goals and budget must be assessed with respect to each additional jurisdiction s market share and patent filing costs. Patent Costs Companies that plan to manufacture and distribute products can balance the costs and potential return for each additional jurisdiction and pinpoint patent protection in those jurisdictions having a favorable cost-benefit projection. For example, translations account for a considerable portion of filing costs. That is, while filing in Japan and China may seem logical from a market share perspective, the filing and later prosecution costs in these countries almost certainly exceed the costs in Canada and Australia, which have respectable market-share-to-cost ratios because translations are not required. After a certain proportion of the world market is covered, however, the return on a patent investment steeply declines. Carolyn Favorito Associate carolyn.favorito@ Immunology Group Contacts Mark Benedict, Ph.D. mbenedict@ Exit Plans and Raising Capital An exit plan involving transferring patented technology requires carefully considering a relatively broader global patent portfolio to maximize the pool of interested parties. For example, interested parties may value patent protection in a variety of jurisdictions where they are domiciled or where the product will be manufactured. Similarly, emerging companies courting venture capitalists may need to consider the attractiveness and breadth of their patent portfolio to gain investor interest, as a venture capitalist s exit plan will likely rely on the sale of the technology, if not the company.

6 Exit Plans and Raising Capital, continued In these cases, patent prosecution costs may be postponed in various countries. Properly executing this strategy can maximize the portfolio s value while minimizing the company s costs. For example, examination may be grouped for some countries, and the examination results in one country may assist or control the examination in another country. Thus, prosecution strategies that accelerate examination in some countries, while postponing costs in other countries, can simplify and reduce the overall cost of a more extensive global filing strategy. Other Considerations Other factors affecting global filing strategies include a disease s prevalence, population, per capita GNP, health care system, government-imposed trade limitations, window of exclusivity, future market projections, strength of patent system, and ability and likelihood of enforcing patent rights in each jurisdiction. Nonetheless, arming yourself with the proper cost-benefit analysis is the first step in maximizing the products potential value based on selective global patent coverage. For additional guidance in tackling strategic intellectual property matters, please contact Mark Benedict or Carolyn Favorito at Knobbe Martens. Have a topic in mind you would like to read or hear about? Please send topic suggestions to info@. Lawyers in the immunology group work within the firm s Biotechnology and Pharmaceutical Practice Group. About Us is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters.

7 4 Recent and Pending Court Decisions Are Critical to Immunology Industry Article Authors Recent court decisions relating to the standards for assessing the patentability of method claims have raised issues critical to those seeking to obtain patent protection for methods of treatment. In October, 2008, the Court of Appeals for the Federal Circuit rendered its decision in In re Bernard L. Bilski and Rand A. Warsaw (Bilski) in which it considered whether or not claims relating to methods of hedging risk in the field of commodities trading were directed to subject matter that is eligible for patent protection. The Bilski court reviewed previous court decisions establishing that claims directed to certain subject matter was not eligible for patent protection because the claims preempted all uses of natural phenomena, laws of nature, mathematical algorithms or fundamental principles. The Bilski court harkened back to an earlier Supreme Court decision which established that a method claim is eligible for patent protection if it is tied to a particular machine or apparatus or if it transforms a particular article into a different state or thing. Using this standard, the Bilski court determined that the claims in question did not satisfy either of these criteria and were therefore ineligible for patent protection. Daniel Hart, Ph.D dhart@ Immunology Group Contacts Because the subject matter at issue in the Bilski decision is remote from immunologyrelated methods, at first blush Bilski might appear not to be relevant to those working in this field. However, the impact of Bilski quickly spread into decisions relating to methods of treatment. In a pre-bilski decision, Classen Immunotherapies Inc. v. Biogen Idec, a lower court had considered the patentability of claims directed to methods of optimizing vaccination schedules to avoid inducing a chronic immune-mediated disorder. The claimed methods involved comparing the incidence of chronic immune-mediated disorders in two test populations receiving different immunization schedules and administering the regimen which resulted in a lower incidence of such disorders to subjects. The lower court found that the claims were directed to subject matter that was not eligible for patent protection. The lower court decision was then appealed and, in December 2008, the Federal Circuit cited its decision in Bilski in a short non-precedential opinion finding that the claims were not eligible for patent protection. Mark Benedict, Ph.D. mbenedict@ Carolyn Favorito Associate carolyn.favorito@ In another decision, Prometheus Laboratories, Inc. v. Mayo Collaborative Services, a lower court considered the patentability of claims directed to administering particular drugs and measuring the levels of their metabolites wherein metabolite levels below a certain level indicated a need to increase the dosage of the drug and metabolite levels above a certain level indicated a need to reduce the dosage of the drug. The lower court found that the claims were not eligible for patent protection. The Prometheus decision was then appealed to the Federal Circuit.

8 The Federal Circuit opinion in Prometheus, issued in September, 2009, is encouraging for patent applicants in the pharmaceutical field. In particular, in applying the Bilski standards, the Federal Circuit found that the administration of the drug to the human body, and the various chemical and physical changes that ensued, constituted a transformation of the human body and conferred patentability upon the claims. This conclusion is encouraging for applicants in this field because, like the drugs administered in Prometheus, the administration of another composition also induces physical changes (e.g., an immune response) in the body which could be considered to satisfy the patentability standards. Interestingly, the Prometheus decision made no reference to the decision in Classen. The Federal Circuit s decision in Bilski has been appealed to the Supreme Court and the decicion is imminent. It remains to be seen whether the Supreme Court s decision will make any reference to method of treatment claims or recognize the analysis set forth in the Federal Circuit s Prometheus decision. In view of the frequent changes in intellectual property law that may impact issues critical to those in your field, such as patentability of method claims exemplified above, it is important to stay informed about such changes in the law and consult with intellectual property counsel who can formulate successful patent strategies consistent with the evolving state of the law. For additional information on Bilski and how intellectual property law impacts your field, please contact Dan Hart, Mark Benedict or Carolyn Favorito at Knobbe Martens. Have a topic in mind you would like to read or hear about? Please send topic suggestions to info@. Lawyers in the immunology group work within the firm s Biotechnology and Pharmaceutical Practice Group. About Us is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters.

9 5 Outlicensing Risks: Immunizing your Patent Portfolio Article Authors Various legal issues relating to patentable inventions may arise by outsourcing research and development. To complicate matters, the issues detrimental implications often do not surface for years. Monitoring the agreements terms will prevent legal pitfalls that may impact your company s final rights or the strength of the patent protection. Often, it is useful to monitor these agreements by systematically outlining various parts of the agreements, identifying: 1. the type of obligations (e.g., rights retained vs. obligations), 2. flexibility of terms (e.g., prohibition, approval requirements, notice requirements, etc.), 3. conditions under which the agreement applies (e.g., inventors in common, use of technology, etc.), 4. conditions under which issues arise (e.g., invention, disclosures, filing patent applications, sales, etc.), 5. timeframes that trigger obligations (e.g., prior to invention, during prosecution, for enforcement, etc.), 6. any option to renegotiate, 7. disclosure limitations to outsourcing companies, and Eli Loots, Ph.D eloots@ Immunology Group Contacts Mark Benedict, Ph.D. mbenedict@ 8. the effect of a breach. Even when all of these variables are monitored, an invention s ownership can be a frequent concern. Complications in ownership can arise through inventorship issues if someone outside of the company makes an inventive contribution. For example, contributions such as target organism identification, the rationale for the candidate protein, the antigen, preparation and/or delivery of the antigen (system, route, timing, amount, adjuvant, etc.), and different subsequent uses, can each give rise to new patentable subject matter and potentially a new inventor/owner. Carolyn Favorito Associate carolyn.favorito@ Of course, licensing agreements often define ownership of the IP (but may not necessarily perfect it), and thus, ownership may relate to aspects such as material transfer agreements, technology areas, and know how. In addition, entities may retain ownership rights even if there is no formal licensing agreement, such as government or shop rights. Further, investors, and even law firms representing companies, may retain security interests or liens on the IP.

10 As such, any portfolio should be monitored to ensure that all agreements (formal or otherwise) grant your company ownership or exclusive rights in the relevant field of use and territory, or will at least allow the possibility to solidify the company s rights in the invention. Complications in inventorship that may result from outsourcing can also impact aspects outside of ownership. Complicated inventorship may complicate U.S.P.T.O. information disclosure and Best Mode requirements. Having multiple inventors or inventor locations can also complicate the ability to establish conception and diligence to swear behind a reference, to establish legal representation in front of the U.S.P.T.O., and to file Terminal Disclaimers. Thus, independent of any ownership issues, establishing inventorship of any outsourced patentable subject matter can be a time consuming, but important, process. Ideally, subsequent agreements or addendums to existing agreements can deal with unforeseen outsourcing and IP issues. However, this option may not be practical if the IP s value is now perceived as substantially greater than at the time of the initial agreement. When renegotiation difficulties arise, ownership issues may be remedied by carefully defining the claim scope so that the claimed invention falls outside of the agreement or contribution made by the entity disputing ownership. Furthermore, filing separate applications, each directed to a part of the invention from different outsourcing stages, can increase the certainty that you have complete ownership of at least one patent that covers your invention. Furthermore, diligently requesting an assignment statement with each inventive improvement can also streamline the process down the road. These and other practices can avoid ownership issues, inventorship uncertainty, and conflicting licensing obligations. If you have any questions regarding the management of outsourcing patentable subject matter or in regard to IP generally, please contact Eli Loots, Mark Benedict or Carolyn Favorito at Knobbe Martens. Have a topic in mind you would like to read or hear about? Please send topic suggestions to info@. Lawyers in the immunology group work within the firm s Biotechnology and Pharmaceutical Practice Group. About Us is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters.

11 6 What Companies Need To Know About Combining Data and Patent Exclusivity: Biosimilar Provisions in the Senate and House Healthcare Bills Article Authors The healthcare reform bills approved by the House (H.R. 3962) and presented in the Senate (H.R. 3590) in November may have many long term implications for various Research and Development communities. One message, however, is clear: Congress is motivated to create a pathway for follow-on biosimilars. Designed to be akin the current ANDA pathway for small molecules, the biosimilar pathway would accelerate approvals for follow-on products by allowing applicants to use the data from an earlierfiled biological product. There has been much debate regarding the balance of encouraging the introduction of low-cost products into the market vs. rewarding a branded company s research and development with market exclusivity. Both bills include a twelve-year period of data exclusivity. Thus, any follow-on product that relied upon the data from the originator of the biological product would have to wait at least twelve years from the initial marketing. Twelve years is towards the longer end of the spectrum of the proposed durations and, importantly is for longer than the five years exclusivity currently afforded to pharmaceutical products. Many believe that this long twelve-year exclusivity is appropriate, given the greater development costs for biologics. Eli Loots, Ph.D eloots@ Immunology Group Contacts Mark Benedict, Ph.D. mbenedict@ Providing a shortcut for follow-on biologics may be seen as weakening the unlimited exclusivity currently available to those selling biologics. That unlimited de-facto exclusivity will vanish with the advent of a follow-on pathway. The length of the data exclusivity period thus will be a tool for balancing competing public interests going forward. Those managing intellectual property portfolios involving biologics such as vaccines, should carefully consider the FDA-approved label, and biosimilar variations thereof, when drafting patent claims designed to provide patent exclusivity that extends beyond the twelve-year period of data exclusivity. For example, claims that recite aspects that must be present for an alternative vaccine to be considered a biosimilar (such as purity and potency) may still afford a patent owner the benefit of the longer term of patent exclusivity. Similarly, if properly used, functional language that reflects the requirements of any biosimilar may also maintain effective protection. Carolyn Favorito Associate carolyn.favorito@

12 The twelve-year exclusivity is only one of many complex aspects of these bills. Both bills include significant incentives for generics to challenge any issued patents covering the biological product. Indeed, rather than 180 days of exclusivity to the first challenger (as exists for ANDA applicants), both current bills provide for 18 months of exclusivity for the first follow-on product. This would provide follow-on applicants with an even greater incentive to challenge the validity or scope of relevant patents. Thus, strategies that have been successfully used in thwarting validity challenges to patents directed to small molecules may also prove useful when developing patent strategies for a vaccine. Further, such strategies should include delayed and/or staggered filing of patent applications tailored to cover biosimilars, as well as aggressive pursuit of patent term extension under 35 U.S.C. 156, thereby potentially providing patent exclusivity beyond the twelve-year period of data exclusivity. If you have any questions regarding combining data and patent exclusivity or in regard to intellectual property in general, please contact Eli Loots, Mark Benedict or Carolyn Favorito at Knobbe Martens. Have a topic in mind you would like to read or hear about? Please send topic suggestions to info@. Lawyers in the immunology group work within the firm s Biotechnology and Pharmaceutical Practice Group. About Us is a law firm practicing exclusively in the area of intellectual property law including patents, trademarks, copyrights, trade secrets, rights of publicity, unfair competition, and related litigation and licensing. The firm maintains offices in Orange County, San Diego, San Francisco, Los Angeles, Riverside, Washington DC, and Seattle. Services are provided to clients throughout the United States and the world. At present, the firm is composed of more than 275 lawyers and scientists, nearly all of whom hold undergraduate or graduate degrees in either engineering or the technical sciences. This combination of law and technology makes Knobbe Martens uniquely qualified to represent a diverse array of clients in a broad spectrum of intellectual property matters.