The Dolcera Blog

Ariad filed a claim of infringement against Amgen for its drug Ender.

Ariad’s ‘516 patent claims “A method for diminishing induced NF-kB mediated intracellular signaling comprising reducing NF-kb activity in cells such that NF-kB mediated intracellular signaling is diminished”.

NF-kB activity can be mitigated through two methods: (a) Inside the cells - by modifying the signaling pathway. This is specified in the Ariad patent as done by using decoy molecules and other methods and (b) Outside the cells - by modifying the inducing action of Tumor Necrosis Alpha (TNF-Alpha) that in turn effects the signaling pathway inside the cell which in turn affects the NF-kB activity.

The court in its judgment pronounced Ariad’s claims as invalid. It maintained that the Ariad’s ‘516 patent does not state in its specification any modification of NF-kB activity by preventing the ‘external influencing’ activity of TNF-Alpha. Citing the Philips v/s AWH Corp, the court argued that “a person with ordinary skill in the art, is deemed to read the claim not only in context of the particular claim, but in the context of the entire patent, including the specification”. The court further cited that the patent prosecution history informs ‘how the inventor understood the invention, and whether the inventor narrowed his/her claim during the course of prosecution”.

Going forward, it is going to be imperative for inventors to disclose as broadly as possible the scientific and technical ramifications of their inventions, and ensure that each ramification is well spelt out in the specification of the patent. Failing which, the legal validity of such patents in the court of law will be easily challenged.

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- Lakshmikant Goenka
MD, Dolcera

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The US Patent 6,048,850 held by University of Rochester was found to be invalid for failing to comply with the written description requirement of 35 U.S.C. § 112.

University of Rochester sued G.D. Searle & Co. Inc., Monsanto Co., Pharmacia Corp. and Pfizer Inc. alleging that Pfizer’s sale of its COX-2 inhibitors Celebrex (R) and Bextra (R) infringed the ‘850 patent. The pharmaceutical companies counterclaimed that the patent is invalid.

Traditional non-steroidal anti-inflammatory drugs (“NSAIDs”) such as aspirin, ibuprofen, ketoprofen, and naproxen are believed to function by inhibiting the activity of enzymes called cyclooxygenases which are of two types COX-1/ PGHS-1 and COX-2/ PGHS-2. COX-1 is involved in the production of prostaglandins that serve a beneficial role while COX-2 is expressed in response to inflammatory stimuli, and is thought to be responsible for the inflammation. NSAIDs inhibit both COX-1 and COX-2 and hence are thought to result in undesirable side effects apart from reducing inflammation.

The ‘850 patent claims for the use of a “non-steroidal compound that selectively inhibits activity of the PGHS-2 gene.”

The ’850 patent however was not found to disclose any such compound nor provide any suggestion as to how such a compound could be made or otherwise obtained other than by trial-and-error research.

Three requirements referred to as the “written description requirement,” the “enablement requirement,” and the “best mode requirement” need to be satisfied to claim patentability of an invention disclosed in a patent.

Claims of the ’850 patent were thus found to be invalid as the specification did not describe in detail the method to manufacture or obtain the compound so that a person ordinarily skilled in the art could practice it.

The litigation case brings forward the concept of Reach-through claims seeks to protect things that have not yet been discovered by an inventor, but which might be discovered in the future by making use of their invention. When an invention is made in a widely applicable basic research technology (referred to herein as an “upstream” technology), it is often possible to envisage future technologies (referred to as “downstream” technology) which might be developed using the basic research technology. If the inventor of an upstream invention files a patent application for the upstream invention and attempts to claim downstream inventions which they have not as yet actually made, then the claims to those downstream inventions are referred to as “reach-through” claims.

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- Priyanka Goyal
Knowledge Scientist
Dolcera

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AstraZeneca’s patent on Toprol-XL® was judged to be invalid by Court of Appeals for the Federal Circuit (CAFC). The seeding of the case way backs to 1971. The final judgment is in favor of opponents of Astra as Astra filled double patents for the same drug salts of Metoprolol. This is one amongst most talked about IP cases in world. Read on the complete article and understand how tides turned against Astra in this historic case.

1. 1971: Astra Sweden employee, named Toivo Nitenberg synthesized metoprolol succinate as well as the tartrate and sulfate salts of metoprolol.

2. 1982: Another Astra Sweden employee Lars Lilljequist synthesized a number of metoprolol salts, including metoprolol succinate.

3. 1982: Same year, The parties submitted conflicting evidence as to whether two other Astra employees in Sweden, Curt Appelgren and Christina Eskilsson, had directed Lilljequist to synthesize metoprolol succinate.

4. 1983: Appelgren and Eskilsson left Astra to join another company, Lejus Medical AB (“Lejus”).

5. Jan 1984: Lejus Medical filed a patent application (SE 8400085) with the Swedish Patent Office, describing “delayed and extended release dosage forms of pharmaceutical compositions, including metoprolol succinate” and naming Appelgren and Eskilsson as the inventors.

6. Jan 1985: Lejus Medical filed U.S. application Ser. No. 690,197 (the ’197 Application), claiming priority from the Swedish application filled in Jan 1984.

7. Oct 1985: In the settlement agreement, Lejus agreed to divide claims to “metoprolol succinate” and to a “pharmaceutical composition, characterized in that the active substance is metoprolol succinate” from the ’197 Application and to assign the divided claims to Astra. The settlement agreement listed Appelgren and Eskilsson as the inventors of the divided metoprolol succinate claims. Astra agreed that Lejus retained the rights to the ’197 Application that did not include the divided claims.

8. Mar 1988: In accordance with the settlement agreement, Lejus filed U.S. application Ser. No. 172,897 (the ’897 Application), which was a continuation-in-part of the ’197 Application. Lejus filed the ’897 Application with Appelgren and Eskilsson as the named inventors and Astra as assignee.

9. Jan 1989: Astra’s in-house counsel asserted to Astra’s outside U.S. patent counsel that “there remains an open question who is the proper inventor.” The last mention of this issue in the record is a phone call between Astra’s in-house counsel and outside U.S. patent counsel

10. Mar 1991: The ’897 Application (filled in Mar 1988 by Lejus) get issued as U.S. Patent No. 5,001,161 (the ’161 Patent). The only claim of the ’161 Patent reads: “A pharmaceutical composition comprising metoprolol succinate together with a sustained release pharmaceutically acceptable carrier.”

11. Jan 1992: A continuation of the ’897 Application issued as U.S. Patent No. 5,081,154 (the ’154 Patent). The only claim of the ’154 Patent simply reads, “Metoprolol succinate.”

12. 1992: The ’161 (Mar, 1991) and ’154 (Jan 1992) Patents both list Appelgren and Eskilsson as the inventors, and Astra as the assignee. Astra never revealed the inventorship issue to the U.S. Patent & Trademark Office during the prosecution of the two patents.

13 1992: During the same time period, Lejus’s ’197 Application issued as U.S. Patent No. 4,780,318 (the ’318 Patent) in October 1988.

14. District court invalidated Astra’s ’161 and ’154 Patents as double patenting over Lejus’s ’318 Patent.

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- Lakshmikant Goenka
MD, Dolcera

AND

- Harit Mohan
Knowledge Scientist,
Dolcera

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The case refers to a specific compound called Risedronate (3 pyr EHDP), a bisphosphonate.

PnG had filed for a patent ‘406 which genreally talked of bisphosphonates and their role in aiding bone mineralization. Teva’s contention was that Risdronate has significant structural similarities with 2 pyr EHDP, a compound mentioned by Png in its ‘406 patent.

Court ruled in PnG’s favor stating “unexpected results of risedronate’s potency and toxicity rebut a claim of obviousness”. Takedas argument was that homologs, analogs and isomers of known chemical compounds are obvious to a person knowing the arts. However, the court believed that even if this were true, there has to be adequate motivation for a person knowing the arts to modify a known chemical compound. PnG’s argument was that to predict the toxicity and benevolent effects of Risendorate in 1985 when the ‘406 patent was filed was very difficult, since each bisphosphonate shows different chemical and toxicity properties. They also contended that prediction of ‘chemical properties’ based on structural similarities can be highly misleading.

The court ruled that in the light of KSR, and given the unpredictable nature of chemical compounds, Teva failed to prove that an ordinary person skilled in the art could prove predictably that the 3 pyr isomer could have been thought off in 1985.
- Lakshmikant Goenka
MD, Dolcera
For complete article click here

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Affymetrix copied the claims of the granted Agilent patent since it believed it claimed priority to the invention, and hence purposely copied the claim matter to provoke an interference with Agilent.

“This case arises out of an interference proceeding, No. 105,285, between Agilent and Affymetrix. The claims at issue originated in Agilent’s “Schembri” patent, U.S. Patent No. 6,513,968, which claims priority to an application filed August 21, 1998.
After Agilent’s Schembri patent issued on February 4, 2003, Affymetrix, believing it had earlier invented the claimed methods, copied the Schembri claims into its “Besemer” application, U.S. Patent Application No. 10/619,244, to provoke an interference.”

In the court of law, Affymetrix proved that it did indeed have the priority to the claim. The FCC cited Spina as a case in point for ruling in favor of Affymetrix. Rowe et al was not considered relevant by the FCC - since in the ROWE case though the claims were copied to provoke interference, the plaintiffs were challenging the claim validity perse (with no focus on proving claim priority).

- Lakshmikant Goenka
MD, Dolcera

For complete article click here

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In the patent dispute between FMC and Ecolab, the court of appeals successfully ruled in favor of FMC finding cliams of Ecolab ‘769 patent as invalid due to obviousness citing KSR v/s Teleflex as a precedent.

The patent dispute deals with treatment of poultry using a specific acid PAA. Ecolab in its 769 patent claimed a specific method of applying PAA, an antimicrobial substance, to poultry. The method specified a particular concentration of PAA, its application temperature range and a specific pressure range.

FMC’s patent 676 prior art claimed a method of using PAA under specific temperature and concentration. It however did not specify the pressure range under which it could be used. However, FMC’s lawyers found relevant prior art that in a patent that spoke of a Pressure Spray device that claimed the benefits of using pressure spraying of an antimicrobial substance in that under pressure the antimicrobial substances efficacy was high.

Hence, the only novelty of Ecolab was a combination of 3 factors - the concentration of PAA, the temperature range and the pressure range. However, the court of appeals repealed the district courts judgement in favor of Ecolab, by finding the ‘769 patent as invalid due to obviousness citing KSR v/s Teleflex. “See KSR, 127 S. Ct. at 1740 (“If a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”).

- Lakshmikant Goenka
MD, Dolcera

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