Posts Tagged ‘FDA’

Biotech’s PR Problems Continue

Friday, February 15th, 2013

Maybe “Fish gotta swim” but the FDA has extended the approval period for transgenic Salmon genetically engineered to reach market weight sooner. No evidence at all has been presented that filets from these fish would present a danger human consumers – and may well provide a benefit to an increasingly hungry world.

This report once again reminded me how far scientific advances in biotech have exceeded the industry’s attempts to explain their benefits to the consuming public. As biotech companies wisely sold the advantages of herbicide resistant corn, cotton and soybeans to farmers well prior to their “launch”. Farmers were tired of using herbicides that could kill their human handlers. By the time the Supreme Court decided that plants were patentable (in 2002), about 65% of U.S. corn was transgenic (and patented as well). However, the EU countries don’t grow much corn, and the lack of lobbying there contributed to the general ban on imports of genetically engineered crops and sandwich shops that advertise that their snacks have no GMO’s.

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Edwards Lifesciences v. Corevalve – Pig Valve Implants Enabling

Monday, November 19th, 2012

In Edwards Lifesciences AB v. Corevalve, Inc. (now a part of Medtronic), Appeal No. 2011-1215-1257 (Fed. Cir. Nov. 13, 2012), Corevalve challenged the validity of US Pat. No. 5,411,552 directed to a “transcather heart valve” on the basis that the valve had only been implanted in pigs as of the effective filing date of the patent, and that not all of the experimental implants were successful. The Fed. Cir. disagreed, and Edwards provides a succinct review of the standards for enablement based on animal testing.

The panel began by reminding the parties that “[t]he enablement requirement is met if the description [in the specification] enables any mode of making and using the invention.” Johns Hopkins Univ. v. CellPro, Inc. 152 F.3d 1342, 1361 (Fed. Cir. 1998). In other contexts, this statement permits claims based on “benchtop” syntheses, even if the claimed compound or process is being produced or practiced on a pilot plant scale. “The most efficient commercial embodiment need not be disclosed. Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298 (Fed. Cir. 2001).”

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Legal Challenge To “ObamaCare” Threatens Generic Biologicals

Thursday, March 29th, 2012

What should not be lost on pharma/biotech patent attorneys or their clients, amidst all the attention given to the Supreme Court’s review of the “Patient Protection and Affordable Health Care Act” – public law 111-48, is that it contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. As I wrote here on March 26, 2010, Title IV of the law is “Improving Access to Innovative Medicial Therapies” – Subtitle A and is referred to as the “Biologics Price Competition and Innovation Act of 2009.” It can be most easily be followed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590. The Act amends section 351 of 42 USC 262 and 35 USC 271(e). In my March 26th post I reviewed many of its Hatch-Waxman-like features.

Since enactment, there have been many seminars, workshops and symposia about how best to implement these procedures at the FDA/USPTO, and the FDA has finally begun to work with the stakeholders to provide a regulatory pathway for generic biologicals. Without such a pathway –as currently – a generic biological has to endure the same NDA route to approval as any other new drug. Questions of what degree of “biosimilarity” should be required and what the market exclusivity period should be for the first generic biological to be approved have been hotly debated.

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Bayh-Dole Act Turns Thirty – Dec. 1st Fete Planned

Thursday, November 18th, 2010

With major litigation looming over invention ownership rights affected by the Bayh Dole Act (see my post of November 3rd on Stanford v. Roche), the link below is to a site created by AUTM and a number of other organizations concerned with university tech transfer. The site provides some good background on the history and the impact of the Act.  A House resolution honoring the Act has been introduced and a celebration is planned in DC for December 1st.

Since 1980, thousands of companies (not all still with us) have been created in the U.S. due to patenting and licensing activities mandated by the Bayh-Dole Act, and hundreds of millions of dollars in licensing revenue have flowed into universities from patenting and out-licensing technology to established corporations (like big pharma) as well as to start-ups that go the distance (often to take-over by a larger med tech company). I emphasize life sciences commercialization because more than 80% of university/institutional patenting is in this area.  Not bad for an “unfunded mandate.” A recent study that was published in Nature Reviews-Drug Discovery, looked at FDA approvals between 1997 and 2008 and found that 24% of approved drugs originated from university research. All had been licensed to pharma or biotech companies. (Find story here.)

On a more personal note, the first two IP talks I ever did were for the Chemistry and the Law Division of the American Chemical Society at National Meetings in 1987 and 1988. The first was entitled, “Selected Aspects of Patent Law Affecting the University Inventor,” and the second was “”Technology Transfer: From Non-Profit Research to Profit.” I expected a huge audience of professors eager to learn how to commercialize their discoveries but I was ahead of my time, and the meager audience was mostly lonely patent attorneys looking for clients and company. I also spoke at AUTM for the first time in 1989, when it was still the “Society of University Patent Administrators.” I was part of a plenary session and there were probably 50 people in the room, but it was a start, both for me and for university tech transfer. ‘Happy, happy birthday, baby.” You’ve come a long way.

AUTM b-d30