Patent Baristas

Chandra Joshi, an Indian patent associate sent an announcement on the  amendments to Indian patent law that took effect on January 1, 2005.  The amendments brings Indian law into compliance with World Trade Organization TRIPs agreement and rationalizes the procedures for patent prosecution.

These changes (1) make the national law compliant with Art. 27 of the TRIPS agreement; (2) provide for product patent protection for all categories of inventions; (3) repeal the provisions concerning Exclusive Marketing Rights (EMRs); (4) provide for a transitional provision to protect EMRs already granted ; (5)  introduce provisions to give effect to the Doha Declaration on TRIPS and Public Health; and (6) empower the IP Appellate Tribunal to adjudicate upon revocation of patents.

India, as you know, had so far permitted Patents only for processes and not products. With the new amendment to the Patent Act, it would now be possible to obtain Patents for product patents in Pharmaceuticals and Agro Chemicals. Under the Product Patent regime no new-use Patents would be granted.

The ordinance seeks to strengthen opposition proceedings by allowing for both pre-grant and post-grant opposition. The ordinance also seeks to simplify and rationalize the time-frame for process of patents. The time limit for giving requests for examination has been reduced to 36 months from 48 months earlier. Security provisions will also be tightened particularly for dual-use patent applications. Such patents will now be scrutinized by the patent office.

Further, software would continue to be copyright protected, embedded software that has technical applications can now be patented.

The reforms are to end decades of policies that allowed Indian firms to make cheap versions of expensive Western products. This could mean enormous changes to India’s pharmaceutical industry. The current revenues of the Indian pharmaceutical industry are estimated at US$5.5 billion and it is expected to grow at a compounded annual growth rate of 19% and reach US$25 billion in revenue by 2010 (The Economic Times, May 1, 2001).  The future of the Indian pharmaceutical industry will depend on strong patent protection.  See more info here.

I thought I’d mention that I have been working on updating my process for disseminating IP news.  I am currently in the process of switching over to TypePad blogging service to make things easier for people to find and review.  I will keep people posted on developments.

I’m sure that you have already heard about last Sunday?s massive earthquake and tsunami. It is expected to become the largest ever as the death toll continues to climb and now tops 115,000 victims, according to the United Nations. Millions of others are now homeless and without the basics needed for survival including food, water, and shelter, and the International Red Cross and Red Crescent Movement and other international aid groups are rushing to fill the need.

The United Nations (UN) World Health Organization warns that up to 5 million people in South Asia are without basic services. Health experts are concerned that in the aftermath, as many people may fall victim to diarrhea diseases, respiratory infections, malaria, and dengue fever, as were affected by the tsunami.

You can help those affected by this crisis and countless others around the world each year by making a financial gift to the American Red Cross International Response Fund, which will provide immediate relief and long-term support through supplies, technical assistance, and other support to those in need. Call 1-800-HELP NOW or 1-800-257-7575 (Spanish). Contributions to the International Response Fund may be sent to your local American Red Cross chapter or to the American Red Cross International Response Fund, P.O. Box 37243, Washington, DC 20013. Internet users can make a secure online contribution by visiting Red Cross

Louisville, Kentucky Office

David S. Kaplan is a Member in the Firm?s Litigation Department.  He concentrates his practice in complex commercial and regulatory disputes, state and federal constitutional questions, and in representation of State and municipal governments.  Mr. Kaplan received his B.A. with highest distinction from the University of North Carolina, his J.D. degree from Harvard Law School, cum laude, and his M.P.P. from Harvard.

Christopher M. Mussler is a Member in the Firm?s Litigation Department.  He concentrates his practice in insurance defense and bad faith litigation.  Mr. Mussler received his B.A. from the University of Kentucky and his J.D. degree from the University of Louisville Brandeis School of Law .

Lexington, Kentucky Office

C. Bradford Harris is a Member in the Firm?s Business/Corporate Department.  He concentrates his practice in banking, securities, mergers and acquisitions and general business law.  Mr. Harris received his B.A. from the University of Kentucky, his J.D. degree from the University of Kentucky, and his M.B.A. from the University of Kentucky.

Cincinnati, Ohio Office

Stephen Albainy-Jenei is a Member in the Firm?s Intellectual Property Department.  He concentrates his practice in patent preparation and prosecution, patentability, validity and infringement opinions, licensing and other intellectual property-related agreements, counseling inventors and management of intellectual property issues.  Mr. Albainey-Jenei received his B.S from the University of Dayton, his J.D. degree from the University of Cincinnati and his M.S. from the University of Dayton.

Kevin L. Cooney is a Member in the Firm?s Business/Corporate Department.  He concentrates his practice in securities and emerging growth companies, mergers and acquisitions, investment companies and public finance.  Mr. Cooney received his B.S. from Purdue University and his J.D. degree from Washington University.

Joanne Wissman Glass is a Member in the Firm?s Labor Department.  She concentrates her practice in worker?s compensation defense and certified worker?s compensation.  Ms. Wissman Glass received her B.A. from Xavier University and her J.D. degree from Chase College of Law.

Nicole Vickroy Hickey is a Member in the Firm?s Intellectual Property Department.  She concentrates her practice in trademarks, unfair competition and copyright.  Ms. Vickroy Hickey received her B.A. from Miami University, cum laude and her J.D. degree from Case Western Reserve University.

Katherine Cook Morgan is a Member in the Firm?s Labor Department.  She concentrates her practice in wrongful discharge and discrimination litigation and ERISA litigation.  Ms. Cook Morgan received her B.A. from Swarthmore College and her J.D. degree from the University of Cincinnati College of Law.

Jeffrey S. Rosenstiel is a Member in the Firm?s Litigation Department.  He concentrates his practice in banking, commercial and bankruptcy litigation.  Mr. Rosenstiel received his B.S. from Kentucky State University, magna cum laude, and his J.D. degree from Salmon P. Chase College of Law, cum laude.

Robert D. Shank is a Member in the Firm?s Litigation Department.  He concentrates his practice in products liability, trade secrets and non-compete provisions, real estate litigation, and employment law.  Mr. Shank received his B.A. from Xavier University and his J.D. degree from Vanderbilt University Law School.

Columbus, Ohio Office

Jeffrey G. Rupert is a Member in the Firm?s Litigation Department.  He concentrates his practice in general business and commercial litigation.  Mr. Rupert received his B.A. from Northwestern University and his J.D. degree from Ohio State University, with honors.

Frost Brown Todd LLC is a regional law firm with approximately 370 attorneys with offices in Kentucky, Ohio, Indiana and Tennessee.   The Firm has been recognized by Corporate Board Member magazine as the top corporate law firm in Kentucky as well as the Top 10 patent Litigation Firms in the United States by Managing Intellectual Property magazine.  In December 2003, United Parcel Service (UPS) awarded Frost Brown Todd its Law Firm of the Year award.

In In re Crish, No. 04-1075 (Fed Cir. December 21, 2004), Crish filed a patent application for purified DNA molecules having promoter activity for the human involucrin gene (hINV). The Federal Circuit held that the claims were anticipated by two other publications that disclosed the complete structure of hINV.

The claimed invention relates to purified DNA molecules having promoter activity for the human involucrin gene (hINV). The outermost layers of the skin and other stratifying squamous epithelia are composed of dead cells densely packed with a fibrous protein called keratin. Involucrin is a protein that interacts with keratin and other intracellular proteins to form a cross-linked envelope within the dead cells to strengthen the plasma membrane of the cells.

As the name indicates, the involucrin gene contains the DNA sequence that codes for involucrin. Crish?s application discloses that Crish has isolated and sequenced the promoter sequence of hINV from plasmid pSP64 ? I-3 H6B using standard molecular biology techniques. Crish determined that the hINV promoter sequence was approximately 2.5 kb (kilobases) in size. Crish?s application also identified and numbered each nucleotide in the hINV promoter sequence and designated it as SEQ ID NO:1.

During prosecution, the examiner rejected the claims as being anticipated by a Crish publication  and a Welter publication. The Crish publication lists James Crish, coinventor on the ?509 application, as a coauthor. The Crish publication analyzed the phenotype (physical appearance) of mice pups that had hINV (including the promoter region) microinjected into them at the embryonic stage. The microinjected hINV was isolated from the same plasmid pSP64 ? I-3 H6B referenced in Crish?s patent application. The Crish publication also disclosed the complete structure of hINV (the promoter region of hINV used in the Crish publication, however, was not sequenced), including the approximate size (2.5 kb) of the promoter region, and referenced an earlier publication 4 disclosing how the plasmid pSP64 ? I-3 H6B was obtained.

The Welter publication, which also lists James Crish as a coauthor, identified five protein-binding sites on the promoter region of hINV. The publication also confirmed that protein binding on two of those sites was necessary for the cell to begin transcribing the DNA coding region. The hINV that was used for this study was from plasmid pSP64 ? I-3 H/Hc. Although plasmids pSP64 ? I-3 H6B and pSP64 ? I-3 H/Hc are not identical, the PTO contends that the promoter regions of hINV contained in both plasmids are identical.

Crish argued that the Crish and Welter publications cannot anticipate his claims because the prior art does not provide any information regarding nucleotide sequences. According to Crish, the fact that Crish?s application references a prior art plasmid is irrelevant; the pending claims cover a specified novel DNA sequence, not the starting materials. Secondly, Crish asserts that even if the Crish and Welter publications are relevant, a person of ordinary skill in the art starting with the plasmid disclosed in the Crish and Welter publications would not necessarily obtain SEQ ID NO:1. Crish explains that different DNA sequencing techniques, for example, using different restriction enzymes, may result in workers obtaining different DNA sequences.

However, since the promoter region of hINV was not new, the court found the only arguable contribution to the art that Crish?s application makes is the identification of the nucleotide sequence of the promoter region of hINV. However, just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.

The court rejected Crish?s argument that the claims are not anticipated because the Crish publication did not sequence the promoter region of hINV:

While the PTO?s position that the discovery of new properties of a known material does not make claims reciting those properties novel is correct, and we agree with the PTO as to its conclusion, we differ with its characterization of the nucleotide sequence of the gene as a property of that gene. The sequence is the identity of the structure of the gene, not merely one of its properties. The gene may have functional, biological properties, and it may have physical properties, but its structure is its identity, not merely one of its properties. A long line of cases confirms that one cannot establish novelty by claiming a known material by its properties. E.g., In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) material plasmid, is unsound. The starting material plasmid necessarily contains the gene of interest, including the promoter region, and once we have affirmed the PTO?s construction of the claims as ?comprising? more than the recited numbered nucleotides, the claims necessarily encompass the gene incorporated in the starting material plasmid. Accordingly, Crish?s pending claims encompassing the gene plus other nucleotides are anticipated by the starting material plasmid, which consists of the gene plus other nucleotides. .

The court found that it was irrelevant whether other workers used the same plasmid as Crish and obtained a different sequence for the promoter region of hINV:

Crish is claiming what Crish earlier disclosed, and we presume that Crish correctly sequenced the promoter region of the hINV gene from plasmid pSP64 ? I-3 H6B, as he has described in his application on appeal. Crish cannot rely upon the inability of another worker to correctly sequence the promoter region of the hINV gene from plasmid pSP64 ? I-3 H6B when he has sequenced it accurately himself. His own work, as recited in his application, is better evidence than Lopez-Bayghen?s work. Finally, we address Crish?s argument that the Board improperly assumed that the plasmid referenced in Crish?s application is the same plasmid used in the Crish publication. We have previously explained that when the prior art evidence reasonably allows the PTO to conclude that a claimed feature is present in the prior art, the evidence ?compels such a conclusion if the applicant produces no evidence or argument to rebut it.? Spada, 911 F.2d at 708 n.3. Here, the Board reasonably concluded that the plasmids used in Crish?s application and the Crish publication were the same. Several facts support the reasonableness of the Board?s assumption. First, Crish is both an inventor on the subject application and an author of the prior art publication. Secondly, both the application and the publication refer to the promoter region as approximately 2.5 kb in size. Third, both the application and the publication refer to the same source for plasmid pSP64 ? I-3 H6B, a publication by Eckert et al.

The court also noted that Crish did not argue that the portions of the plasmid not consisting of the involucrin gene are not nucleotides, nor did he argue that the preamble term purified has any operative meaning in this appeal. It will be interesting to see if these are argued in subsequent appeals.

I want to wish everyone a Happy Festivus. In case you don’t remember the history of Festivus from the show "Seinfeld," Frank Costanza went to buy a doll for his son one Christmas. He went to reach for the last one at the same time as another man and as Frank rained blows upon him, he thought there could be another way. The doll was destroyed, but out of that, a new holiday was born. He named it Festivus.

Festivus takes place during the last few weeks in December, families and friends gather at the dinner table and have "The Airing of Grievances". Durning this time, family and friends share all the ways they have disappointed each other during the past year.

After the Airing of Grievances, the "Feats of Strength" takes place. This is where the head of the household tests his/her strength with another friend or family member. Festivus is not over until the head of the household is pinned.

Finally, the house is decorated with the Festivus Pole, not a tree. It is a metal pole with no decorations. Frank Costanza believed that tinsel is very distracting. The pole is tall and silver.

Cincinnati Children’s Hospital Medical Center will begin making investments in biotech companies built around technologies originally developed at the medical center. Cincinnati Children’s Tomorrow Fund will provide early-stage angel and seed capital to new Cincinnati-based companies to develop to the point where traditional venture capital and other funding is attainable.

The Tomorrow Fund received $500,000 from the State of Ohio’s Third Frontier Validation Fund and Seed Fund Initiative.  Start-up companies that receive investments from the Tomorrow Fund will use the investment capital to further develop their technology, hire employees and management, and refine their commercialization strategy.

Any returns on investment received by Cincinnati Children’s will be used for future Tomorrow Fund investments. Cincinnati Children’s CEO James Anderson said the primary goal of the Tomorrow Fund is to move hospital-owned technologies into the market, where they can become medical products to treat patients around the world.

U.S. District Court Judge Gregory M. Sleet ended the stem cell patent suit by PharmaStem Therapeutics, Inc. against CorCell, Inc. and numerous private umbilical cord blood banks for infringement of its patents 5,004,681 and 5,192,553. Judge Sleet stated that, "There was no legally sufficient evidentiary basis for a reasonable jury to find that all, or any specific number, of the defendants cord blood units infringe the ‘681 patent." This judgment follows a Sept. 14, 2004 ruling by Judge Sleet stating that the defendants did not infringe on the ‘553 patent, the first of two PharmaStem patents in question. The earlier judgment overturned a $7 million award to PharmaStem.

Earlier, the Court held that CorCell is not, and cannot be, liable for patent infringement because they do not sell, or offer for sale umbilical cord blood. The Federal Court’s decision decisively rejects PharmaStem’s effort to prevent CorCell from processing and storing umbilical cord blood for families. The implication of this ruling is that ostetricians and other healthcare providers who simply collect umbilical cord blood for cryopreservation, cannot be liable for contributory infringement of any PharmaStem patent. The Court also declared that a child’s family owns the child’s umbilical cord blood and the private blood banks provide a service, processing and preserving the cord blood for the families.

Earlier, the Court overturned a ruling against ViaCell ruling that the cord blood is owned by the family and because ViaCell only provides services to assist the family, it does not infringe meaning that any individual, corporation or institution providing services to assist a family in preserving the Cord Blood does not infirnge PharmaStem’s patents.