Patent Baristas

In a case highlighting the importance of ensuring a correct chain of title when filing a patent application, the UK High Court addressed the issues of loss of priority due to an incomplete assignment, as well as the credibility of expert witnesses.  In particular, it is important to transfer rights to interests initially owned by consultant inventors as soon as possible — especially before the declaration in respect of the claim to priority needs to be made, i.e.,  within 12 months of the date of filing of the priority application.  See, Edwards Lifesciences AG v Cook Biotech Incorporated [2009] EWHC 1304 (Pat) (12 June 2009).

Edwards manufactures the SAPIEN artificial heart valve designed to be compressed onto a balloon catheter for percutaneous delivery via the femoral artery. It can also be delivered transapically through the side of the chest and into the apex (the bottom of the left ventricle) of the heart in patients with severe aortic stenosis. It is primarily used to replace the aortic valve but is also suitable for replacement of the pulmonary valve.

Cook alleged the SAPIEN infringes its patent and Edwards denied infringement and challenged the validity for lack of novelty, obviousness, insufficiency and added new matter. That is, Edwards said the matter disclosed in the specification of the European Patent as granted was extended beyond the original disclosure in the application for the patent as filed.

The international application which led to Cook’s European patent was filed on January 31, 2001, claiming priority from a US patent application filed on January 31, 2000. The claim to priority is disputed by Edwards, a matter of some importance because, if priority is lost, Pavcnik, published later in 2000, is relevant prior art.

The US application was filed in the names of Joe Obermiller, Francisco Osse and Patricia Thorpe, all as joint inventors. Mr Obermiller was an employee of Cook at the time the invention was made. Mr Osse and Ms Thorpe were not. The PCT application was filed in the name of Cook but at that time the only interest it had in the invention was via Mr Obermiller’s contract of employment. It is accepted that Mr Obermiller’s interest, such as it was, belonged to Cook. The interests of Mr Osse and Ms Thorpe were not assigned to Cook until September 2002, that is to say 21 months after Cook filed the PCT application but before the grant of the Patent.

Cook argued that the claim to priority is a good one because it had acquired all rights in the invention before the date of grant of the Patent and in any event always owned Mr Obermiller’s interest. Edwards says the claim is misconceived because the right of priority may only be enjoyed by the person who filed the priority application or his successor in title as at the date the right to priority is claimed, and on 31 January 2001 that was Mr Osse, Ms Thorpe and Cook, not Cook alone.

According to Article 4 of the Paris Convention, a person is to enjoy a right of priority if he has filed a relevant application for a patent or if he is the successor in title (in respect of the invention) to such a person. Furthermore any person wishing to take advantage of the right of priority is required to make an appropriate declaration. Article 4 is implemented by section 5 Patents Act 1977, which requires a declaration made by the applicant which complies with the relevant rules and specifies one or more earlier relevant applications made by the applicant or a predecessor in title.

The Court held that the priority claim was invalid because at the date of filing of the PCT application the right to claim priority belonged jointly to Cook and the two non-employee inventors, and not to Cook alone:

In my judgment the effect of Article 4 of the Paris Convention and section 5 of the Act is clear. A person who files a patent application for an invention is afforded the privilege of claiming priority only if he himself filed the earlier application from which priority is claimed or if he is the successor in title to the person who filed that earlier application. If he is neither the person who filed the earlier application nor his successor in title then he is denied the privilege. Moreover, his position is not improved if he subsequently acquires title to the invention. It remains the case that he was not entitled to the privilege when he filed the later application and made his claim. Any other interpretation would introduce uncertainty and the risk of unfairness to third parties. In reaching this conclusion I derive a measure of comfort from the fact that the Board of Appeal of the EPO has adopted the same approach to the interpretation of Article 87 EPC in two cases: J 0019/87 and T 0062/05.

Therefore, the acquisition by Cook of all rights in the invention in September 2002 did not permit it to claim priority from the US application. Since Cook’s patent was not entitled to its priority date, a document published between the priority and the filing dates was citable as prior art.  The Court held that several claims of the patent were obvious in light of this document.

A question was also raised regarding the credibility of an expert witness and specifically whether an expert changing his opinion undermined his value as an expert.  One expert witness appearing in the case had also appeared as an expert in an earlier decision of the UK High Court involving Edwards and another party.  It was noted that the opinions of the expert differed in material respects between the two cases.  However, the Court decided that opinions may change during the courts of a case, particularly after cross examination and further consideration as to the abilities of the ordinary skilled person.  The expert’s opinions were found to be “cogent and reasonable” rather than partisan.

I aim to shed light on the extent to which advance in the life sciences was directed by the profit motive and the availability of the patent system … and on the ways that the patent ‘institution’ evolved in response to science and to interest groups, mainly business ones, but also legal practitioners associated with business.
~ Graham Dutfield

In Intellectual Property Rights and the Life Science Industries: Past, Present and Future, Graham Dutfield presents a perspective on how we got to where we are in life sciences patenting — and where we are likely headed –  through the co-evolution of the patent system and the life science industries since the mid-19th century. This book follows the origins of the pharmaceutical industries in advances in synthetic chemistry and in natural products research and how these approaches to drug discovery and business have shaped patent law.

Seven Tales of a Patent

Dutfield reviews the past invention f pharmaceuticals to show the co-development of patents and pharma.  Dutfield describes specific businesses, products and technologies, including Bayer, Pfizer, and GlaxoSmithKline.  He writes of the true stories of the development of mauve dye, aspirin, warfarin, streptomycin, and omeprazole, polymerase chain reaction and the oncomouse.

In one story, we learn that insulin is a natural product that was named, patented and made available for therapeutic use in the 1920s, four decades before its structure was worked out.  Often drugs were patented long before they knew how they worked (see aspirin).  The patents on hormones that the Reich [German] patent office accepted in the 1920s and 1930s established precedents that were used to consolidate the notion that purified biological products in general should become proprietary.

Drugs Past, Present and Future

Historically, it was common to exclude medicines from patentability ostensibly because it was deemed immoral, though it was often really to protect domestic infant industries.

The bulk of the book is a thorough historical grounding of the development of patented drugs.  The middle section then details the growth of Big Pharma, Small Biotech.  Following developments since Watson and Crick discovered the double helix structure of DNA in 1953, Dutfiled leads us through the intertwining workings of genomics and money.

In showing the business of biotechnology, we see that the biotechnology revolution is rooted in the recombinant DNA  invention by Stanley Cohen and Herbert Boyer.  The technique, which enables foreign DNA to be inserted into a genome and passed along subsequent cell divisions was patented by Stanford, bringing in over $200 million in licensing royalties between 1975 and 1997, when the patent expired.

This second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology.  As the patent system has been modified to accommodate biotechnological inventions, it brought with it an opposition from those who felt that “patenting life” as they would call it, was wrong and immoral.

The book ends with the perennial question of “would we have got where we are today without patents?” Dutfield points out that it almost goes without saying both that the pharmaceutical industry is crucially important for human welfare since it produces cures (among other things), and that it is considered to be the most dependent of all industries on patents.

This should remind us of two things that a new institutionalist approach leads us to expect.  First, changes in property rights structures can never make winners out of everybody.  Second, the differences between the gains for some and the losses for others are bound to be great when the biggest right holders have, as they often do, such a firm grip on the regulatory system to the partial or total exclusion of other holders, users and those representing consumer interests.

We highly recommend you read this thought-provoking treatise on the pharmaceutical-patent collaborative.

About the Author

Graham Dutfield is Professor of International Governance at the University of Leeds, United Kingdom. He was formerly Herchel Smith Senior Research Fellow at Queen Mary, University of London. He was also Academic Director of the UNCTAD-ICTSD Capacity-building Project on Intellectual Property Rights and Development.

“Intellectual Property Rights and the Life Science Industries: Past, Present and Future (2nd Edition)” by Graham Dutfield (428 pages; World Scientific Publishing Co.)  is available through Amazon.

Also see, What We’re Reading Now.

Does Patent Reform Need Congressional Action?

The Coalition for Patent Fairness (CPF) has put out a memo trying to debunk what it sees as the myth that patent reform no longer requires congressional action.  From CPF:   “The Court’s ability to effect needed changes is limited because it is restricted by the language Congress enacted more than 50 years ago. Only Congress has the authority and the responsibility to ensure that our patent system is meeting the needs of the 21st century economy and the current need for economic growth and job creation.”  (More here)

Large Hadron Particle Collider Punk’d By Time Traveling Bird

The Large Hadron Collider (LHC), outside Geneva, was shut down by a “bit of baguette” after a passing bird may have dropped the chunk of bread on an electrical substation above the accelerator, causing a power cut.  Some physicists have formulated a theory that suggests a time-traveling bird was sent from the future to sabotage the particle accelerator. Bech Nielsen of the Niels Bohr Institute in Copenhagen and Masao Ninomiya of the Yukawa Institute for Theoretical Physics in Kyoto, Japan, have published several papers over the past year arguing that the CERN experiment may be the latest in a series of physics research projects whose purposes are so unacceptable to the universe that they are doomed to fail, subverted by the future.  (via Time)

Congress May Be Helping European Biotech

European researchers are on the cusp of overtaking their American counterparts in biotechnology innovation. In 2004, European biotech firms had access to only 20% the private equity financing that U.S. firms had. Currently, the European Union has just about as many dedicated biotechnology firms as the U.S.  Now, Congress is considering a bill that would allow drug companies to make knock-off versions of biologics much sooner than in Europe by allowing a data exclusivity period of just five to seven years. Biotech companies believe they won’t have enough time to recoup the hundreds of millions of dollars invested before having to compete with biosimilars.  The biotech sector argues that  the data exclusivity period needs to be at least 12 years to be competitive. (via WSJ)

Post-Grant Review System

The Innovation Alliance recently sent a letter to USPTO Director David Kappos outlining requirements for a post-grant review system that is designed for prevent delay and abusive challenges. The letter proposed that, in order to be fair to all parties, a post-grant review system must prohibit the ability of private parties to later challenge the validity of a patent in court on any grounds that the challenger: (a) Actually raised in a post-grant challenge; (b) Knew about but did not raise; and (c) Would have known through a reasonable search of the prior art as determined by the guidelines the Patent Office developed and already enforces in other contexts. (pdf)

Is The Practice of Medicine Impeding Innovation?

Citing the fact that the majority of patients receiving the personalized medicine drug Herceptin had not been previously administered Herceptin’s diagnostic test, the BiotechBlog asks whether the practice of medicine is capable of keeping pace with medical innovation.  This is important since the diagnostic test can identify those patients most likely to benefit from the drug and exclude those who are likely to see no benefits.  Are the gatekeepers unaware of how to effectively prescribe personalized drugs?  (via IP Think Tank)

Hilter is Furious at the Supreme Court for Granting Cert to Bilski

Using the Hitler rant scene from Oliver Hirschbiegel’s 2004 film Der Untergang (”Downfall“), someone named patentlybilski made a spoof on the Bilski case, as though that case needs anything to make it more surreal.  While this seems somewhat overdone, it’s amusing to those in the field.  The poster notes only:  “Tyranny, like hell, is not easily conquered; yet we have this consolation with us, that the harder the conflict, the more glorious the triumph.”  Decide for yourself.  (via 271 Patent Blog)

In the the Tafas v. Kappos lawsuit, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office David Kappos and the U.S. Patent and Trademark Office filed a joint motion for dismissal of the appeal and to vacate the judgment of the district court below because the USPTO has rescinded the rules that formed the basis of the litigation.  The Federal Circuit agreed that the appeal is now moot and dismissal of the appeal is not only appropriate, but required.

Under Secretary Kappos officially rescinded the highly hated regulations (Final Rules; 72 Federal Register 161 at 46716)that would have limited patented claims and continuations — with an emphasis on the fact that they were proposed by the previous administration. The regulations were published in the Federal Register in August 2007, but were enjoined and never came into effect.

Earlier, the Federal Circuit issued its 55 page decision in Tafas v. Doll holding that aside from the rule limiting continuations, the other rule changes were procedural in nature and the PTO does have the rule-making authority to implement the rules limiting the number of claims in each application, providing for Requests for Continued Examination (RCEs) and requiring Examination Support Documents (ESDs).

Then, an eleven member en banc panel has voted to rehear the case en banc. Tafas v. Doll, 2008-1352 (Fed. Cir. 2009)(Order, per curiam). Now, however, the U.S. Court of Appeals for the Federal Circuit has granted the joint motion for dismissal of the appeal but denied the joint motion for vacatur of the district court’s judgment.  Tafas v. Kappos (08-1352).

The Federal Circuit said that vacating the district court’s judgment is inappropriate under the circumstances since the Supreme Court held that when a party procures the conditions that lead to a case becoming moot, that party should not be able to obtain an order vacating the lower court decision that was adverse to that party. Vacating would only appropriate if the mootness arises from external causes over which the parties have no control, or from the unilateral act of the prevailing party, but not when the mootness is due to a voluntary act by the losing party, such as a settlement. See U.S. Bancorp Mortgage Co., 513 U.S. at 25.

The motion seeks to paint this case as falling into the former category, but it appears to us to fall squarely into the latter. This is not a case in which the regulations have been overridden by a statutory change; instead, it is a case in which the agency itself has voluntarily withdrawn the regulations and thus set the stage for a declaration of mootness. The motion’s statement that an intervening regulatory change is directly analogous to an intervening statutory change is not persuasive. The agency does not control Congress; but it does control the decision to rescind the regulations. Thus, it was the USPTO (the losing party in the district court action) that acted unilaterally to render the case moot, and vacatur is not appropriate.

Therefore, the USPTO is now required to use notice and comment and must observe procedures of the Regulatory Flexibility Act for all rule making.

Now, the USPTO is required to use notice and comment and must observe procedures of the Regulatory Flexibility Act for all rule making.  The Federal Circuit’s decision does not address the fact noted in Tafas’ papers that Office of Management and Budget (OMB) had essentially killed the rules anyway but that’s another matter.

See the whole opinion here.

The next quarterly meeting of the U.S. Patent and Trademark Office’s Biotechnology and Chemical Pharmaceutical Customer Partnership is scheduled:

Wednesday, December 9, 2009 from 10:00 am to 5:00 pm

Auditorium in Madison East, 600 Dulany Street, Alexandria, Virginia.

The Biotechnology and Chemical Pharmaceutical Customer Partnership is designed and developed to be a forum to share ideas, experiences, and insights between individual users and the USPTO. The USPTO does not intend to use these customer partnership groups to arrive at any consensus.

Please contact Cecilia Tsang at 571-272-0562, or by fax at 571-273-0562, or email Cecilia Tsang to confirm your attendance by December 2, 2009.

Agenda is here:  BCP 120909 _Agenda This meeting will be also be webcast.

For information of future meetings and presentations, see additional info here.

Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., a suit by the American Civil Liberties Union and joined by the Public Patent Foundation, challenges the patentability of gene patents on two human genes associated with breast and ovarian cancer.  Along with claims that the patents are illegal, the group charges that they restrict scientific research and patient access to medical care, the suit contends that patents on human genes violate First Amendment and patent law because genes are “products of nature.”

BulletproofBlog has now interviewed Chris Hansen, staff attorney with the ACLU First Amendment Working Group, which scored a major victory on November 2 when the United States District Court for the Southern District of New York ruled the suit can go forward after denying a motion filed by the US Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation to dismiss a lawsuit for lack standing to sue the USPTO, lack of subject matter jurisdiction, and because the action is barred by the sovereign immunity.

What will be the impact of this case?

Chris Hansen: That depends on whether we win it or lose it. The next step is to try it in the U.S. District Court for the Southern District of New York. After that I would expect appeals all the way to the Supreme Court, which might well agree to hear a case of this magnitude.

The issue of whether human genes can be patented has been around a long time and it seemed the Patent Office had concluded the debate was resolved in favor of patent-holders. At the very least, Judge [Robert] Sweet’s decision not to dismiss should disabuse them of that notion.

If we succeed, the potential impact can best be measured by the fact that 20% of the genes in the human body are now patented. Among them are genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma, and many other illnesses

Success in this case will encourage new lawsuits regarding any or all of those patents. Theoretically, the facts in each instance are sufficiently different so that there would be no across-the-board invalidation of the patents. Each case would be separate.

Practically, however, the impact would be even more decisive. A favorable decision upheld throughout the appeals process would effectively establish a guiding principle that no one should be able to patent a part of the human body.

What if you lose?

Chris Hansen: One of the purposes of filing cases like this is to gain visibility for an idea. The idea behind this lawsuit won’t go away.

Meanwhile, the Patent Office under Obama could conceivably change its mind on this issue. Or, Congress could simply pass laws prohibiting patents on genes. There are influential voices on our side of this debate, including the American Medical Association, the March of Dimes, and the American Society for Human Genetics.

What would be the impact on the biotech industry if Congress were to change the law, or if you eventually prevail in your lawsuit? Might it devastate the industry?

Chris Hansen: Quite to the contrary. The industry itself, and the public, needs to realize that, by invalidating patents on human genes, we actually create significant competitive advantages for biotech companies.

On the one hand, Myriad now has the exclusive right to perform diagnostic tests on the patented genes. It’s a monopoly that makes it impossible for women to have access to alternate tests or to even get a second opinion about their results. Myriad can also charge a high rate for its tests.

For the broader biotech industry, invalidating the patents would provide opportunity to do a much greater volume of testing and treatment because they would obviously not be prevented by existing patents. Of course, they could still patent specific tests and drugs. It would be a free market.

Yet based on a few initial reactions I’ve seen to Judge Sweet’s ruling, the industry does not seem aware that it is very much in their interests for us to finally succeed.

This was originally posted at Bulletproof Blog.  You can see the entire article here.

What is left unsaid?

The impact of the case on future patent challenges is not addressed.  More significant than one crazy suit regarding gene patents is the fact that the suit names the US  Patent & Trademark Office as a defendant, and then asks the court to issue an affirmative injunction requiring the USPTO to revoke the patents in suit.

While the Patent Office moved to dismiss because there is no “case or controversy” involving the USPTO — because the USPTO hasn’t threatened anyone with an infringement suit — the judge felt the court had jurisdiction.  Presumably, the court felt that gene patents sound really scary and this case should be heard.

If this case stands, then anyone could sue the USPTO — and not the actual patent owner — in any Federal District Court, in any jurisdiction, to challenge any patent. It would seem that such a suit could now go forward without participation of the patent holder. his would leave the USPTO to uphold the validity of all patents.

A Telecast by the Program on Information Justice and Intellectual Property, Washington College of Law, American University and the Federal Circuit Bar Association are presenting a telecast on Patentable Subject Matter After the Bilski Oral Argument.

Date: November 19, 2009

Place: Washington College of Law

Time: 4:30- 6:30 p.m. EST

In Bilski v. Kappos, the U.S. Supreme Court addresses limitations on patentable subject matter in the context of a business method invention, analyzing a body of case law in such a way that some say could wrongly call into question the validity of many other patents and types of claims, while others argue it is not restrictive enough. The oral argument – and the subsequent decision – will be studied by a broad range of members of the patent community who are seeking to determine its effects on innovation, prosecution, licensing, and litigation.

The panelists for this program include: Raymond T. Chen, Solicitor, U.S. Patent and Trademark Office, Counsel for Respondent, J. Michael Jakes, Finnegan Henderson, Counsel of Record for Petitioners, Nancy Linck, Rothwell, Figg, Counsel for Amicus Curiae BIO, and Randolph Moss, WilmerHale, Counsel for Amici Curiae Bank of America et al. A period for questions will follow.

Thomas C. Goldstein, Akin, Gump, Counsel for Amicus Curiae American Bar Association and Professor Joshua Sarnoff, Washington College of Law, American University, Counsel for Amici Curiae Eleven Law Professors and the AARP will moderate.

In addition to on-site attendance, the FCBA will also broadcast the program live via the web.  To register for this Program, please visit our website and use registration password “FCBAbilski09”. To view the flyer with coupon codes for reduced rates, click here .

The views of Professor Joshua Sarnoff can be seen at InherentlySarnoff. Professor Sarnoff also authored an amicus brief in Bilski, which is available here.

The Supreme Court finally heard oral arguments in the Bilski v. Doll case and everyone has something to say about it. Whether the Court will make a narrow ruling on that the claim at issue is not patent eligible subject matter rather than some broad ruling that would cover all methods patents is certainly likely but uncertain.

The court may, however, issue various additional reflections that distinguish the claims from the patent eligible process in Diamond v. Diehr.  There could also be various concurrences that help provide guidance for diagnostic patents and other methods currently placed into question.

While we can’t predict how the Supreme Court will ultimately rule in this particular case, we can take a moment to reflect on some of the wonderful quotes batted around by the court.  Pick your favorite gem below:

(sigh)

For even more fun, check out FantasySCOTUS, billed as the premier Supreme Court fantasy league.  The League allows you to compete against your friends, colleagues, and adversaries to determine who has the greatest ability to predict the outcome of Supreme Court cases.  At the end of the Term, you will be ranked against your fellow Associate Justices, and the winner will receive the venerable title of the Chief Justice of Fantasy SCOTUS.  With this title comes some to-be-determined prize.

Yes, now you can finally show off your Supreme Court aptitude and have loads of fun all year!  It’s $5 or $10 to join but the fee is waived for students, law clerks and unemployed attorneys (which is all attorneys, right?).  The site asks that current Supreme Court Clerks not sign up. (via WSJ Law blog).