Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York. Mylan’s filing of an ANDA for what they are calling a generic version of COPAXONE® was not unexpected, as the company announced its intention to do so over a year ago. Teva received Mylan’s Paragraph IV certification notice referring to Teva’s U.S. Patents, which cover the chemical composition of COPAXONE®, pharmaceutical compositions containing it, and methods of using it. These patents are listed in the U.S. Food and Drug Administration’s (FDA) Orange Book and extend through May 24, 2014. While the press release and news accounts have not identified the patents in question, the prescribing information flyer available on copaxone.com lists the following patents as covering the drug — U.S. Patent Nos. 5981589, 6054430, 6342476, 6362161, 6620847, 6939539 and 7199098.

A press release issued earlier today by the Pharmaceutical Care Management Association (PCMA) explained that a new article published in the New England Journal of Medicine (NEJM) urges Congress and the White House to revisit pending biogenerics legislation that would grant biotech companies an a 12-year exclusivity period for biologics. The press release explains that the experts, who are Harvard researchers and unidentified patent experts are adding “to an emerging consensus, including the Federal Trade Commission, which has concluded that 12 years of market exclusivity for biologics is unnecessary.” I suppose anyone can say anything in a press release. I am still troubled by the arrogance on display by PCMA though. Either they do not know what a “consensus” is, or they are simply intentionally misrepresenting the facts in order to further their own agenda. In either case it is appalling that the discourse relating to patents and exclusive rights has devolved to the point where the truth no longer matters and the masses are mislead by things that simply are not true.

Some of the most popular pages month after month on IPWatchdog.com are our Patent Bar information pages, and given that I teach for the PLI Patent Bar Review Course we get a lot of e-mail inquiries regarding the patent bar examination.  Pretty much every week we hear from individuals who are interested in becoming patent agents or patent attorneys, and one of the questions that is most frequently asked relates to whether a certain degree qualifies one to take the Patent Bar Exam.  I completely understand why such a question is asked, and why there is so much uncertainty associated with what really should be a relatively simple inquiry.  Even though the Office of Enrollment & Discipline at the US Patent and Trademark Office provides detailed information about who can qualify, there are a lot of situations where individuals fall between the cracks and are not ideally presumptively able to take the Patent Bar Exam under Category A, and they may not neatly qualify under Category B either.  Hopefully this article will shed some light on the situation.

By now most are likely aware of, or rapidly becoming aware of, the fact that the United States Patent and Trademark Office has finally done the right thing and has scrapped the claims and continuations rules that have divided the patent community for the last 26 months.  It is impossible not to recognize the new and refreshing tone set by David Kappos, the new Director of the USPTO.  Yes, there is a new Sheriff in town and it will not be business as usual.  While I may have strong differences on the direction of substantive patent laws under the Obama Administration, even the sharpest PTO critics must acknowledge that from a process and administration standpoint the Patent Office is off to an exceptionally good start, perhaps even an unprecedented start.  Between the appointment of competent, patent-qualified people to high level management positions within the USPTO, to taking a time out to collect more input from the community regarding the proposed Bilski internal guidelines, to withdrawing the center piece of the Dudas/Doll reforms that would have attacked the most commercially relevant innovations, Secretary of Commerce Gary Locke and his team lead by David Kappos is living up to the hype and delivering.

Yesterday, the Task Force on IP and Genetic Testing submitted its Final Draft Report (titled Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). SACGHS, in turn, voted to accept the recommendations, which will be passed on to Secretary Sebelius, Secretary for Health and Human Services. What follows is a copy of a minority opinion written by Brian Stanton, an ad hoc member of the SACGHS Task Force on Gene Patenting and Licensing Practices. This was submitted electronically to the SACGHS Chair via Sarah Carr, NIH.

UPDATED: 7:19pm on 10/8/2009

Today the Task Force on IP and Genetic Testing submitted its Final Draft Report (titled Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). SACGHS, in turn, voted to accept the recommendations, which will be passed on to Secretary Sebelius, Secretary for Health and Human Services. In this report the Committee comes to the shocking and surprisingly unfounded conclusion that “patents do not serve as powerful incentives for genetics research in the diagnostic arena, disclosure of gene-disease associations, or development of genetic tests.” This will no doubt be music to the ears of the many anti-patent advocates out there, but what makes this report, its recommendations and conclusions so bizarre is that the report itself provides facts and evidence that supports the completely opposite conclusion. To this extent it seems as if the conclusion was reached through some kind of political agenda in spite of the facts, or perhaps the report was originally written to come to a different conclusion and then was hijacked.  In any event, strap your boots on, the Committee is advising that the Secretary for Health and Human Services recommend to Congress the creation of an exemption from patent infringement liability for: (1) infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes; and (2) those who use patent-protected genes in the pursuit of research.  So gene patents would become like medical process patents; you can get them, just not enforce them.

PRESS RELEASE:

GlaxoSmithKline (NYSE: GSK) today announced that it has reached agreement with the United States Patent and Trademark Office (USPTO) to join the USPTO’s motion to dismiss its litigation over Final Regulations published in August 2007 (Triantafyllos Tafas and SmithKline Beecham Corporation, SmithKline Beecham PLC and Glaxo Group Limited vs. David J. Kappos and the United States Patent and Trademark Office). GSK and the USPTO will file a joint motion with the U.S. Court of Appeals for the Federal Circuit to dismiss the litigation and to vacate the previous decision in this case by the U.S. District Court for the Eastern District of Virginia. The USPTO is withdrawing all regulations under dispute.

If you have not already read the letter from Commerce Secretary Gary Locke to Senator Patrick Leahy (Chair of the Senate Judiciary Committee) and Senator Jeff Sessions (Ranking Republican Member), you absolutely need to read it to comprehend the massive changes the Obama Administration is supporting with respect to patent reform.  It would be difficult to over exaggerate the magnitude of the changes being supported by the Obama Administration.  Simply put, if the Obama Administration gets its way US patent laws would be completely re-written and substantively changed to a greater extent than at any time since 1790.  In fact, if the Obama supported patent reforms become enacted into law it would probably be much easier to simply pass legislation withdrawing all US patent laws and putting in its place the patent laws presently in existence in the European Union.  If you do not believe a European style patent system is in the best interest of the United States then you had better step up to the plate, because the stars seem to be aligning and before you know it there may not be any remaining US patent laws.  The steaks are high and it seems as if the once hopelessly derailed patent reform legislation is back with a vengeance, like a resurrected Jason a la Friday the 13th.