On January 25, 2012 the USPTO invited the public to on the availability of independent second opinion genetic diagnostic testing and its relationship to the medical field.�� More , the U.S. government is looking for information on the medical detriment of the patent system controlling genetic testing and whether changing the law would stifle innovation in the area.��

The information was to be used in accordance with section 27 of the America Invents Act (hereafter “AIA”) to assist the director of the USPTO in delivering his recommendations on the subject to congress no later than June 15, 2012.�� Along with two public hearings set up at American colleges, the USPTO also received written comments from intellectual property organizations, academic research institutions, companies, and individuals (all are posted on the USPTO ).

The positions of many of the intellectual property organizations followed closely with the interests that they represent.�� For example, the ("PhRMA") has taken the position that the current patent system is essential to support innovation. They also assert that there is not enough information to support a conclusion that independent second opinion testing, done by relaxing patent law, is even medically necessary. ��The ��offered only anecdotal evidence from patients and researchers they have talked to about the desire for independent second opinion genetic testing.�� Indeed one of the only groups that appeared to offer a full analysis of the current issue was one made by the (hereafter “ABA”).�� Their comment begins by outlining the history of genetic testing and the role that it can play in modern diagnostics.�� Starting with the discovery of the structure the DNA in 1953, the comment discusses the initial costs of mapping the human genome and what the current costs are to sequence DNA.�� The focus then moves to the intellectual property issues, where the cost of these new innovations is identified and where the strongest argument for where intellectual property protection comes from.�� They state that the research is funded largely by third-parties and, without protection of intellectual property, investors will likely not fund medical research.

Most importantly, the ABA comment also evaluates the goal of public access to the newest and best diagnostic tests.�� In the medical field, more than in any other field of innovation, there is a goal of using knowledge gained for the good of the public.�� The ABA identifies that patented tests are often much more expensive than the generic ones that are created after the patents expire.�� They also identify the cost of initial innovation as the main reason for why the price of a patented product might be higher than that of a generic. ��They conclude that while competition would undoubtedly decrease prices, the resulting cost to new innovation would be to the overall detriment of the medical field. These issues are understandably complex.�� Medical patents come under a great deal of scrutiny because promoting access to healthcare is a primary goal of most governments.��

The USPTO no doubt acknowledges this complexity because the final report and recommendations that their director was to make before congress were��. ��When he did appear before congress to discuss the AIA on June 20^th, 2012, Mr. Kappos (the director of the USPTO) could only state that the USPTO “solicited comments and held two public hearings on the issue of genetic testing and are finalizing our report to Congress”.����It is worth noting that the AIA doesn't propose to change the law on second opinion genetic testing; ��of the act��only calls for a study to be compiled on the subject.��Therefore any information the USPTO has obtained��does not necessarily need to be available��before��the AIA comes into on September 16, 2012.

Adam Stevenson is a JD Candidate at Western University, Faculty of Law.

The post Genetic Testing Patents: USPTO Presents the 'Generic' Comments appeared first on IPOsgoode.

Here are some of the main features of the AIA:

• The AIA awards a patent to the first inventor to file. That claimant can be dislodged by a showing that someone else was the true inventor. Previous law awarded the patent to the first inventor, not the first to file.
• It becomes far easier for corporations to own inventions. They are now granted much leeway to file for the patent directly, so long as the inventor is contractually obligated to assign the patent. The committee stated that this is to push aside “the antiquated notion that it is the inventor who files the application.”
• A potpourri of other changes includes: new patent marking rules, , failure to obtain legal advice on patent validity cannot be used to prove willful infringement, procedures to correct erroneous patent prosecution information, federal jurisdiction of contracts to assign patents, a prior use defense, and post grant proceedings in the USPTO.

These are significant changes, but they do not comprise a comprehensive reform. The remainder of this blog will discuss elements of a comprehensive reform, rather than focus on shortcomings of the AIA.

Some history. From the twelfth century forward, commercial and industrial classes were steadily gaining influence English law and policy. As that movement gained steam, it persuaded the English Parliament to enact the Statute on Monopolies during the reign of James I. (21, James I Ch. 3, 1623.) The act was intended to abolish all royal grants of monopoly. The act provided an exception: A patent (“lettre patente”) might be allowed for limited years for those who perfect “any manner of new manufacture, within this realm.” The United States Constitution embraced similar criteria. (U.S. Const. art. I §#8, cl.8 ) A recent unanimous Supreme Court decision: reaffirmed that “the primary purpose of our patent laws is not the creation of private fortunes for the owners of patents but is ‘to promote the progress of science and useful arts,’ ” ()

Patents flourished during the industrial revolution. During that period interested parties recognized that the patent monopoly could be used as a source of rent and a means to control economic activity. In short, patents were not simply a limited reward, but were a source of capital. Nurturing patents as capital became the primary emphasis in latter decades of the twentieth century. That emphasis was present throughout the AIA legislative process.

The role of technology and patents today. During the seventeenth through nineteenth centuries the United States and European powers pursued national interest and little else. Events in the twentieth century undermined the economic and political foundations of that approach. World War II exhausted Europe, and after that war, a consensus emerged that aggressive war, racism, widespread hunger and disease must be curtailed and, if possible, eliminated. Much of that consensus exists today, but has not been successfully acted upon. Now, the world population stands at seven billion, the climate is radically altering, while wars, poverty, and lack of education continue to create overwhelming suffering.

Technology can do much to aid the world. Technology advance depends primarily on social resources such as education, research, shared knowledge, and public institutions. Individual insight and company efforts contribute, often strongly, to that progress. One of the great innovators of all time, Isaac Newton, captured the gist of this combination when he urged that if he had seen further, it was because he stood on the shoulders of giants. In a modern environment, scientific and technical advance require investment in research facilities and the efforts of trained professionals. Patents offer a boost to useful innovation, but they are neither a necessary nor sufficient means.

Patents can encourage innovation, but they also can and do discourage it. This negative effect occurs when they are used as power, as a form of capital. A portfolio of minor patents can block introduction of new technologies and prevent delivery of new products to the public. A raft of scholarly writing investigates this problem. John Flock, a veteran patent litigator, observes that patents are used mainly as weapons in “global patent warfare as a way to gain leverage over a competitor in negotiations.” (2011 WL 5618030 ASPATORE). Patents of dubious validity compound this problem. According to Professor F. Scott Kieff businesses “are forced to defend against large numbers of lawsuits over junk patents.” (157 U. Pa. L. Rev. 1937, 1938 (2009)) Professor Mark Lemley echoes that observation, adding, “Even the ones that turn out to be valid are often impossible to understand.” (15 Marq. Intell. Prop. L. Rev. 295, 296 (2011)) It also should be borne in mind that patent procedures and litigation consume legal resources which might be focused on social needs such as reduction of domestic violence, environmental protection, criminal due process, and reducing the resort to warfare and war crimes.

Thus, any patent system ought to be designed to meet human needs. Its rewards ought never to extend beyond rewarding innovative effort or providing for research. United States patent law, for example, fails to assure that any gains from the patent monopoly will be invested in research or development. They can be spent on advertising, executive bonuses, lobbying, acquisitions, “golden parachutes,” etc. Nor does US law require that the patentee actually practice or license the invention during its term. These defects can be remedied by legislation.

Patents ought not function to control the economies or development of nations. The peoples of the world face very different needs and challenges. Huge portions of humanity are ravaged by war and disease. A very small percentage of the world’s population takes part in the levels of income, protection and luxury that are enjoyed by stock holding individuals or leaders of large corporations. The patent monopoly as it exists today fuels those disparities. Thus, rather than focus on increasing corporate values or control, patent laws should focus exclusively on making technological advance available to all at reasonable social and personal expense. This means that national laws need to be altered and that the entire intellectual property treaty structure needs to be reexamined. In major respects, patent law and the related treaties, serve primarily the interests of dominant corporations and national elites.

The world can benefit from cooperation on patent law. In today’s jargon this is called “harmonization.“ The term or its equivalent appears twenty times in the Report. However, the AIA’s emphasis on assuring the United States a “competitive edge in the global economy” runs contrary to international cooperation. This aspect of the AIA amounts to a modern form of mercantilism. Classically, “mercantilism was control of the economy in order to further national interests.” (Thomas B. Nachbar, 91 Va. L. Rev. 1313, 1318 (2005)) The AIA form of mercantilism allows patents to be a form of control that advances corporate interests, rather than national interests. The Report implies that the AIA will “spur innovation as a means to create American jobs and raise standards of living.” However, corporations and others from around the world can own US patents. They are free to locate their workforces anywhere and decide what wages they will offer.

In sum, I urge that patent laws be based on assessment of what will actually serve all. This requires lawmakers to consider these laws in their full context. It cannot be done by isolating patent policies from other legal policies and needs.

Howard C. Anawalt is a United States attorney, law professor, and writer. ��His article on “Best mode” was featured in IPilogue post.

The post Patents for the Public Good appeared first on IPOsgoode.

I am pleased to join you from south of the border. My work has been focussed in the United States. Intellectual property laws are very powerful and important today. Yet they are but part of the larger body of law in any country. They are also part of a developing fabric of international commercial regulation. I hope that discussions will focus on why one should or should not create personal or exclusive rights in these fields.

To open this conversation, I’ve chosen to focus on a facet of United States patent law, called the “best mode” requirement. This obscure doctrine sheds light on the process and purposes of United States patent law. It also provides a glimpse of how legislators, judges, and attorneys view the inventive process, especially in its commercial environment.

What is “best mode.“ In the US, a patent applicant must disclose all he or she knows about how an invention works. Subject to Supreme Court rulings, the United States has one appellate court, the Federal Circuit, to resolve patent law questions. The Federal Circuit has summed up the disclosure requirements: “To constitute adequate disclosure …, a patent specification must set forth both the manner and process of making and using the invention (the enablement requirement) and the best mode contemplated by the inventor of carrying out the invention (the best mode requirement).” . In short, the�� applicant must describe what to do and how best to do it.

Judge Giles Rich made a major impact on the development of United States patent law. He thought the purpose best mode rule was to assure full disclosure of an invention. “There always exists, on the part of some people, a selfish desire to obtain patent protection without making a full disclosure, which the law, in the public interest, must guard against. Hence section 112 calls for description in ‘full, clear, concise, and exact terms' and the ‘best mode’ requirement does not permit an inventor to disclose only what he knows to be his second-best embodiment, retaining the best for himself.” See (Cust. & Pat. App. 1967).

The “best mode” requirement is unique to United States patent law. Even in the United States only certain attorneys, judges and law students cramming for a patent exam know anything about it. Joseph Root is an attorney who has spent a lifetime in patent law. In a recent 80 page article he observed, “Best mode problems are like falling asteroids… when they do strike, big problems follow.” Joseph E. Root, Ducking the Asteroid…, 36 AIPLA Q.J. 455, 457 (2008).

In September 2011, Congress enacted the “” (AIA). It is a packet of changes to the 1952 United States patent law that goes into effect in September 2012. As part of an effort to “harmonize” United States law with that of other nations, the AIA modified the best mode requirement. The amended law retains the requirement that one disclose the best mode, however, failure to do so will no longer render a patent invalid or unenforceable.

It is tempting say the new rule requires one to disclose, but eliminates consequences for failure to do so. However, that summary is misleading. The fundamental rule remains: Disclose the invention! The law continues to require one to disclose exactly how an invention works. Failure to do so will render a patent invalid. Furthermore, concealing relevant information from the Patent Office will also invalidate a patent.

Don’t hide the ball. Most inventions are improvements of something that came before--engines, suspension systems, antibiotics, software, and on and on. Thus, most disclosures amount to describing a better way of doing something. Better and best overlap. The Federal Circuit has repeatedly emphasized that describing how to do something and the best way of doing it converge: “The focus of the best mode requirement, as it was with the enablement requirement, is on the claimed invention. Thus, before determining whether there is evidence of concealment, the scope of the invention must be delimited.”.

The bottom line for practitioners and applicants remains the same before and after the effective date of the AIA. When applying for a patent, one must disclose what one knows about the invention. Candor is the essence of the patent system. The constitutional goal of the US patent system is to expand knowledge and to provide useful new inventions to the public. Attorney Root summed the matter up: “Never appear to hide the ball: Always disclose specially made materials, inventor choices based on test results, and essential process steps.”

The new rules clearly change how courts handle claims that a patent is invalid. However, as the Federal Circuit emphasized, best mode and enablement overlap. Thus, much of the same evidence will come into a trial before and after the effective date. Failure to include information can be found to be “hiding the ball” from the Patent Office. In some cases, it may amount to failure to disclose fully the enablement.

Howard C. Anawalt is a United States attorney, law professor, and writer. His latest book is Idea Rights: A Guide to��Intellectual Property (Carolina Academic Press 2011). He discusses the subject in an Authors@Goggle presentation,

The post "Don't Hide The Ball" - Best Mode in the US Patent System appeared first on IPOsgoode.